DETAILED ACTION
Status of Claims
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1 and 77-96 are pending.
Claims 2-76 are cancelled.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 03/26/2026 has been entered.
Response to Arguments
Applicant argues that the prior art of record does not teach the limitation “wherein associating the wearable diagnostic device with the testing session includes determining that the wearable diagnostic device is being worn by the test subject at a first time based at least in part on the first sensor data received from the one or more sensors coupled to the user device sensing: a) an identification signal sent by the wearable diagnostic device; or b) the test subject and comparing the first sensor data sensed from the test subject with identification data associated with the test subject,” as recited in claims 1, 94, and 95. Applicant writes:
Nothing in Hoskuldsson discloses that the data is collected by a user device that senses either an identification signal or the test subject and is used to confirm the wearable device is being worn by the test subject. The Final Office Action notes that Hoskuldsson discloses body-worn sensors such as a pulse oximeter disclosed in paragraph 8 that only provides valid data when worn and thus is an indication of the wearable device being worn on the test subject. However, this data is not sensed by sensors on a user device and moreover, it is not compared to identification data as an indication that the wearable device is being worn by the test subject as now recited by the independent claims. In relation to claims 80- 81, the Final Office Action paragraphs 124-125 of Hoskuldsson as disclosing a Nox T3 device having Bluetooth connectivity, but this only relates to identification data received over the communication link, not sensing for an identification signal. These paragraphs also disclose a locked sensor showing a code on a display as a confirmation code, but this does not disclose the user device sensing an identification signal as now recited in the amended claims.
See Remarks at 10.
Applicant’s argument has been fully considered but it is not persuasive.
HÖSKULDSSON teaches calculating coherence values of two different signals. See, e.g., [0020] (“A coherency value is determined between components of the extracted first signal and components of the extracted second signal. And the correspondence of the physiological study data is determined based on the determined coherency value.”); [0071] (“The coherence of two signals originating from a single source may be high even though their correlation may be low.”); [0080] (“Furthermore, the method can be used for chain-of-custody purposes by confirming that a first sensor is attached to a person using any method, while confirming that other sensors are fastened to that same person by using the coherence between the first sensors signals and the other sensors.”).
HÖSKULDSSON discloses that coherence values may be used to identify the correct test subject when sensors are being worn by a different subject. See, e.g., [0008] (“One scenario is that two persons or subjects undergo a study in close proximity. One sensor in the study is a wireless sensor, for example, a pulse oximeter. For some reason the persons or subjects may accidently be given the wrong sensors or may accidently switch their sensors. In this scenario, the method in the disclosure can be used to identify which set of signals belong to which patient or subject. And instead of having lost two measurements from the study, the mistake can be corrected, and the signals can be correctly attributed to the correct person or subject. This may well become more important as the number of wireless sensors in hospitals and clinics increases.”).
Accordingly, HÖSKULDSSON discloses “wherein associating the wearable diagnostic device with the testing session includes determining that the wearable diagnostic device is being worn by the test subject at a first time based at least in part on the first sensor data received from the one or more sensors coupled to the user device sensing: a) an identification signal sent by the wearable diagnostic device [construed as one signal in the coherency pair]; or b) the test subject and comparing the first sensor data sensed from the test subject with identification data associated with the test subject [construed as the other signal in the coherency pair],” as recited in claims 1, 94, and 95.
All claims are drawn to the same invention claimed in the application prior to the entry of the submission under 37 CFR 1.114 and could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 77-81, 85-86, 88-89, and 91-95 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by HÖSKULDSSON et al. (US 20180344241 A1, 2018-12-06) (hereinafter “HÖSKULDSSON”).
Regarding claims 1, 77-81, 85-86, 88-89, and 91-95, as discussed above (Response to Arguments incorporated by reference herein), HÖSKULDSSON teaches a method comprising: receiving, at a user device, first sensor data from one or more sensors coupled to the user device (e.g., [0019]-[0020], [0084]); receiving identity enrollment information associated with a test subject engaging in a testing session (e.g., [0004]); establishing a communication link between the user device and a wearable diagnostic device (e.g., [0005]-[0008]); associating the wearable diagnostic device with the testing session (e.g., [0080]), wherein associating the wearable diagnostic device with the testing session includes determining that the wearable diagnostic device is being worn by the test subject at a first time based at least in part on the first sensor data, received from the one or more sensors coupled to the user device sensing: a) an identification signal sent by the wearable diagnostic device; orb) the test subject and comparing the first sensor data sensed from the test subject with identification data associated with the test subject (e.g., [0020], [0071, [0080], [0008]); receiving second sensor data from the wearable diagnostic device after the first time; analyzing the second sensor data to identify an interference instance indicative that the wearable diagnostic device is no longer worn by the test subject at a second time; generating a chain of custody determination based at least in part on the interference instance; and associating the chain of custody determination with the testing session (e.g., [0080]-[0081], [0092]-[0110], [0131]-[0133]) (as recited in claim 1); further comprising generating one or more test results associated with the testing session based at least in part on the received second sensor data used to identify the interference instance (e.g., [0072]) (as recited in claim 77); wherein receiving identity enrollment information includes: i) receiving identification card image data; ii) receiving facial image data of the test subject; iii) receiving image data of an identifiable physical feature of the test subject; iv) receiving a machine readable identification script; v) receiving image data of a barcode; v) receiving identification information from a radiofrequency tag; vi) receiving a biometric passport parameter; vii) receiving electronic identification information from an identification chip; or viii) any combination of i-vii (e.g., [0124]-[0127]) (as recited in claim 78); wherein associating the wearable diagnostic device with the testing session includes: analyzing the second sensor data to detect a movement pattern of the wearable diagnostic device; comparing the detected movement pattern with an expected movement pattern; and confirming that the wearable diagnostic device is being worn by the test subject based on the comparison of the detected movement pattern with the expected movement pattern (e.g., [0075], [0083]-[0084]) (as recited in claim 79); wherein associating the wearable diagnostic device with the testing session further includes: i) receiving a unique identifier associated with the wearable diagnostic device over the communication link; ii) receiving user input indicative of a unique identifier associated with the wearable diagnostic device; or iii) any combination of i-ii (e.g., [0005]-[0008], [0089], [0124] (disclosing Nox T3 device which has Bluetooth connectivity using unique identifiers) (as recited in claim 80); wherein associating the wearable diagnostic device with the testing session further includes: presenting an instruction to perform an action with the wearable diagnostic device, wherein the wearable device transmits a signal in response to performance of the action; receiving the signal from the wearable device via the communication link; detecting performance of the instructed action in response to receiving the signal (e.g., [0124]-[0125]) (as recited in claim 81); wherein analyzing the second sensor data to identify the interference instance includes: determining one or more physiological parameters based at least in part on the second sensor data; identifying an out-of-threshold change in the one or more physiological parameters (e.g., [0152]-[0181], [0184]-[0193]) (as recited in claim 85);.further comprising: accessing one or more historical physiological parameters of the test subject; analyzing the one or more historical physiological parameters of the test subject to establish a threshold value for the out-of-threshold change (as recited in claim 86); wherein the one or more physiological parameters includes i) blood oxygen saturation; ii) heart rate; iii) heart rate variability; iv) a temperature of the test subject; v) a skin tone of the test subject; vi) a peripheral arterial tone; vii) a blood oxygen saturation curve shape; viii) blood pressure; ix) electroencephalogram data; x) electrooculography data; xi) electromyography data; xii) micromovement data; xiii) respiration rate; xiv) a breathing curve; or xv) any combination of i-xiv (as recited in claim 88); wherein the chain of custody determination is indicative that the received second sensor data acquired between the first time and the second time is valid (as recited in claim 89); wherein the wearable diagnostic device is wearable on a body extremity of the test subject (as recited in claim 91); wherein the wearable diagnostic device includes a photoplethysmography sensor, and wherein the second sensor data includes photoplethysmography data (e.g., [0169]) (as recited in claim 92); further comprising: establishing a communication link between a respiratory therapy system and at least one of the user device and the wearable diagnostic device; associating the respiratory therapy device with the testing session, wherein associating the respiratory therapy device with the testing session includes determining that the respiratory therapy device is being used by the test subject based at least in part on the first sensor data; and identifying a respiratory therapy interference instance indicative that the respiratory therapy device is no longer used by the test subject, wherein generating the chain of custody determination is further based at least in part on the respiratory therapy interference instance (as recited in claim 93); a system comprising: a user device having one or more sensors, one or more processors, and a memory having stored thereon machine readable instructions which, when executed by the one or more processors cause the user device to perform operations including: receiving, at the user device, first sensor data from the one or more sensors; receiving identity enrollment information associated with a test subject engaging in a testing session; establishing a communication link between the user device and a wearable diagnostic device; associating the wearable diagnostic device with the testing session, wherein associating the wearable diagnostic device with the testing session includes determining that the wearable diagnostic device is being worn by the test subject at a first time based at least in part on the first sensor data, received from the one or more sensors coupled to the user device sensing: a) an identification signal sent by the wearable diagnostic device; orb) the test subject and comparing the first sensor data sensed from the test subject with identification data associated with the test subject (e.g., [0020], [0071, [0080], [0008]); receiving second sensor data from the wearable diagnostic device after the first time; analyzing the second sensor data to identify an interference instance indicative that the wearable diagnostic device is no longer worn by the test subject at a second time; generating a chain of custody determination based at least in part on the interference instance; and associating the chain of custody determination with the testing session (as recited in claim 94); a non-transitory computer readable medium product comprising instructions which, when executed by a computer, cause the computer to carry out: receiving, at a user device, first sensor data from one or more sensors coupled to the user device; wherein the first sensor data is an indication of the wearable device being worn on the test subject and is received from at least one of the test subject or the wearable diagnostic device; receiving identity enrollment information associated with a test subject engaging in a testing session; establishing a communication link between the user device and a wearable diagnostic device; associating the wearable diagnostic device with the testing session, wherein associating the wearable diagnostic device with the testing session includes determining that the wearable diagnostic device is being worn by the test subject at a first time based at least in part on the first sensor data received from the one or more sensors coupled to the user device sensing: a) an identification signal sent by the wearable diagnostic device; orb) the test subject and comparing the first sensor data sensed from the test subject with identification data associated with the test subject (e.g., [0020], [0071, [0080], [0008]); receiving second sensor data from the wearable diagnostic device after the first time; analyzing the second sensor data to identify an interference instance indicative that the wearable diagnostic device is no longer worn by the test subject at a second time; generating a chain of custody determination based at least in part on the interference instance; and associating the chain of custody determination with the testing session (as recited in claim 95).
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:
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.
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.
Claims 82-84 are rejected under 35 U.S.C. 103 as being unpatentable over HÖSKULDSSON in view of LINN et al. (US 20210326546 A1, 2021-10-21) (hereinafter “LINN”).
Regarding claims 82-83, HÖSKULDSSON teaches a method for chain of custody determination, as discussed above, except a determination of approximate distance to the wearable diagnostic device.
LINN teaches determining separation distance for the purpose of chain of custody determination. See, e.g., [0057].
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to incorporate the teachings of LINN with the invention taught by HÖSKULDSSON such that the invention further comprises, wherein associating the wearable diagnostic device with the testing session further includes determining an approximate distance to the wearable diagnostic device based at least in part on i) the first sensor data; ii) the second sensor data; iii) additional sensor data from a distance sensor; iv) a parameter of the communication link; or v) any combination of i-iv (as recited in claim 82); wherein analyzing the second sensor data to identify the interference instance further includes: determining an approximate distance to the wearable diagnostic device; determining an approximate distance to the test subject based at least in part on the first sensor data; and determining that the approximate distance to the wearable diagnostic device and the approximate distance to the test subject differ by a threshold amount; and identifying the interference instance in response to determining that the approximate distance to the wearable diagnostic device and the approximate distance to the test subject differ by the threshold amount (as recited in claim 83); wherein analyzing the second sensor data to identify the interference instance includes identifying a dropout in the second sensor data at the second time or identifying no dropout in the communication link at the second time; and wherein analyzing the second sensor data to identify the interference instance further includes: determining one or more pre-dropout physiological parameters based at least in part on the second sensor data between the first time and the second time; continuing, at a third time, to receive the second sensor data after the second time; determining one or more post-dropout physiological parameters based at least in part on the second sensor data after the third time; and comparing the one or more pre-dropout physiological parameters with the one or more post-dropout physiological parameters to determine that the identified dropout is indicative that the wearable diagnostic device is no longer worn by the test subject (e.g., [0131]) (as recited in claim 84) in order to improve the accuracy of the chain of custody determination.
Claims 87 and 90 are rejected under 35 U.S.C. 103 as being unpatentable over HÖSKULDSSON in view of AUGUSTINE et al. (US 20220183915 A1, 2022-06-16) (hereinafter “AUGUSTINE”).
Regarding claims 87 and 90, HÖSKULDSSON teaches a method for chain of custody determination, as discussed above, except utilizing machine learning and databases. AUGUSTINE teaches utilizing machine learning and databases for the purpose of chain of custody determination. See, e.g., [0011], [0033].
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to incorporate the teachings of AUGUSTINE with the invention taught by HÖSKULDSSON such that the invention further comprises wherein analyzing the second sensor data to identify the interference instance includes: determining one or more physiological parameters based at least in part on the second sensor data; applying the one or more physiological parameters to a trained machine learning algorithm to identify the interference instance, wherein the trained machine learning algorithm is trained based at least in part on one or more historical physiological parameters of the test subject (as recited in claim 87); wherein receiving identity enrollment information further includes: accessing a database of enrollment information; and authenticating the test subject based at least in part on the identity enrollment information and the database of enrolment information (as recited in claim 90) in order to improve the accuracy of the chain of custody determination.
Allowable Subject Matter
Claim 96 is allowed.
The prior art of record does not teach or suggest the claimed invention of a method for chain of custody determination, as recited in claim 1, comprising wherein the first sensor data includes an image of the test subject and an image of the wearable diagnostic device.
For these reasons the claims are believed to be allowable over the art of record.
Conclusion
All claims are drawn to the same invention claimed in the application prior to the entry of the submission under 37 CFR 1.114 and could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). 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 mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SCOTT T LUAN whose telephone number is (571)270-1860. The examiner can normally be reached on 9am-5pm, M-F (generally).
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, William Thomson, can be reached on 571-272-3718. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Scott Luan
/SCOTT LUAN/Primary Examiner, Art Unit 3792
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