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 .
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, 8-9, 13-14, 16-18, 21, 23-24, 28-29 and 31-34 are rejected under 35 U.S.C. 103 as being unpatentable over Brauker et al. (US 20070208244 A1- Previously cited), hereinafter Brauker, further in view of Morland et al. (US 20150245782- Previously cited), hereinafter Morland.
Regarding claims 1 and 16, Brauker teaches a system and method for receiving sensor data from an analyte sensor (see abstract) comprising:
an in vivo analyte sensor (10,16,32), wherein at least a portion of the in vivo analyte sensor is positioned in contact with a bodily fluid (¶ [0184,0198,0280], the senor is configured to obtain “a substance or chemical constituent in a biological fluid (for example, blood, interstitial fluid, cerebral spinal fluid, lymph fluid or urine) that can be analyzed”)
a reader (158) in wireless communication with the in vivo anayte sensor; and one or more processors in communication with the reader (¶ [0263,0445], “Electronics can be affixed to a printed circuit board (PCB) within analyte sensor system”; “The receiver 158 provides much of the processing and display of the sensor data, and can be selectively worn and/or removed at the host's convenience”), wherein the one or more processors are configured to:
receive a signal from the in vivo analyte sensor, wherein the signal is based on current output of the in vivo analyte sensor (¶[0102,0210], “analyte data received from sensor electronics module” and “an amount of electrical current produced by a predetermined amount (unit) of the measured analyte. For example, in one preferred embodiment, a sensor has a sensitivity (or slope) of about 3.5 to about 7.5 picoAmps of current for every 1 mg/dL of glucose analyte”)
determine blood alcohol concentration, in part, based on the received signal from the analyte sensor (¶[0183], “other analytes are contemplated as well, including but not limited to …alcohol dehydrogenase”); and
detect an adverse condition of the in vivo analyte sensor (¶[0525], sensor stability (adverse condition) is detected), wherein the adverse condition
is based on a variation in an amplitude of the background signal (¶[0525], adverse condition can be based on an amplitude of sensor sensitivity (background
signal)); and
output an indication based on the detected adverse condition (¶ [0515], the sensor stability is output).
Brauker fails to teach wherein the in vivo analyte sensor is an amperometric sensor, and wherein the adverse condition is detected based on a variation of the amplitude exceeding a threshold.
Kamath teaches a system for detecting noise when using an analyte sensor to measure analytes (abstract). The system uses an amperometric sensor configuration to measure the analytes and signal artifacts (¶[0117,0297,0303]). The signal artifacts are used to determine when the sensor current signal amplitude exceeds a threshold, thus discarding such unreliable and/or erroneous data that should not be used in the signal estimation algorithm (¶[0125,0297], “measurable electronic current”). As such, it would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Brauker, such that the in vivo analyte sensor is an amperometric sensor, and the adverse condition is detected based on a variation of the amplitude exceeding a threshold, as taught by Kamath, to aid in measuring analytes and determining when the sensor signal is unreliable such that it is discarded from being used to estimate analyte information.
Brauker-Kamath fail to teach wherein the background signal variation threshold is different during an initial wear period of the in vivo analyte sensor than in a remainder of a wear period of the in vivo analyte sensor.
Morland teaches a patient monitoring system comprising a medical sensor configured to obtain sensor amplitude signals and compare the signal to a dynamic threshold and determine an adverse event (corrupt data, e.g., sensor stability) correlated to proper and/or improper sensor placement (see abstract and para. [0024,0045]). The dynamic thresholds are computed based on a moving average which requires a period of obtaining data to establish a new threshold, the time period set by the user (¶ [0045,0099] and fig. 13, “so long as the signals are split into a manageable and/or a desired period of time”).
It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Brauker-Kamath, such that the background signal variation threshold of the amplitude is different during an initial wear period of the in vivo analyte sensor than in a remainder of a wear period of the in vivo analyte sensor, as taught by Morland, to aid in determining an adverse event associated with the sensor.
Regarding claims 2 and 17, Brauker teaches wherein the adverse comprises a malfunction of the in vivo analyte sensor (¶ [0515], the electronics are configured sensor stability or lack therof).
Regarding claims 3 and 18, Brauker teaches wherein the in vivo analyte sensor is an alcohol sensor used to detect ethanol levels (¶ [0184,0254], “the sensor can be any sensor capable of determining the level of an analyte in the body” indicating that ethanol levels are detected).
Regarding claims 6 and 21, Brauker-Morland teach determining the adverse condition when a signal amplitude (¶ [0443], continuous digital counts, representative of the amplitude, are measured to determine an adverse condition) of the in vivo analyte sensor decreases below the amplitude of the background signal (¶ [0009,0297] of Kamath, “detecting an occurrence of a signal artifact event comprises determining an amplitude of sensor data and determining an amplitude of a signal artifact” and “discarding sensor data when signal artifacts detection detects values outside of a predetermined threshold (e.g., oxygen concentration below a set threshold, temperature above a certain threshold, signal amplitude above a certain threshold” (emphasis added) which inherently encompasses a signal below or above a threshold).
Regarding claims 8 and 23, Brauker-Kamath-Morland teaches detecting an abrupt decrease in signal amplitude of the in-vivo analyte sensor (¶[0443,0525] of Brauker, since the invention can detect amplitude, it will also detect an abrupt change as well; ¶[0009,0297] of Kamath, “detecting an occurrence of a signal artifact event comprises determining an amplitude of sensor data and determining an amplitude of a signal artifact” would also detecting any abrupt increase or decrease).
Regarding claims 9 and 24, Brauker teaches wherein the in vivo analyte sensor is attached to an adhesive pad configured to be applied to a skin and wherein the adhesive patch is configured to be unusable when removed from the skin (see fig, 2, adhesive pad 8; it is noted that any device can be disposable after a single use, ¶ [0473], “In some embodiments the sensing membrane can be disposable or suitable for a single use”; a skilled artisan would acknowledge that an exposed adhesive after removal from skin would result in hardening, e.g., band aid).
Regarding claims 13 and 28, Brauker teaches wherein the one or more processors are configured to display the blood alcohol content on the reader (¶ [0445], “the receiver 158, which provides much of the processing and display of the sensor data”).
Regarding claims 14 and 29, Brauker teaches wherein the indication is visual (¶ [0443], an error flag is marked on the sensor).
Regarding claims 31 and 32, Brauker-Kamath-Morland fail to explicitly teach wherein the initial wear period is in a range of 2 days to 7 days. However, Morland teaches that the sensor signals are received for a monitoring period, the monitoring period ranging from seconds to “a desired period of time” (¶ [0099-100]). Since the initial wear period is not specifically disclosed ,e.g., range, suggests it is subject to optimization based on the desired performance. As such, the initial wear period is a results effective variable that would have been optimized through routine experimentation based on the desired performance. It would have been obvious to one of ordinary skill at the time the invention was effectively filed to select the initial wear period in the range 2 to 7 days and/or the suggested seconds as a starting point, so as to obtain the desired performance.
Regarding claims 33-34, Brauker teaches in a different embodiment wherein the background signal is indicative of one or more oxidizable compounds and detected by the in vivo analyte sensor (¶ [0525], sensor stability can further be detected by detecting interfering species indicative of oxidizable compounds, e.g., urea). As such it would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Brauker-Kamath-Morland, such that the background signal is indicative of one or more oxidizable compounds, as taught by Brauker, to aid in detecting an adverse condition/sensor stability.
Claims 4 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Brauker in view of Kamath and Morland, as applied to claim 1, further in view of Harper (US 20100280782- Previously cited).
Regarding claims 4 and 19, Brauker teaches wherein the in vivo analyte sensor comprises a temperature sensor (¶ [0432], “Optional temperature probe 140 is shown, wherein the temperature probe is located on the electronics assembly”).
Brauker-Kamath-Morland fail to teach wherein the one or more processors are configured to: determine the adverse condition when a detected temperature decreases below a threshold body temperature after a certain wear period.
Harper teaches an analyte sensing system (see abstract) comprising at least one processor configured to determine an unsuitable sensor condition including when a temperature measurement is outside a predetermined range (¶ [0052-53]). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Brauker-Kamath-Morland, such that the processor determine the adverse condition when a detected temperature decreases below a threshold body temperature after a certain wear period, as taught by Harper, to aid in disabling output of the sensor data and determine when the adverse condition is no longer present in the system (¶ [0005]).
Claims 5 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Brauker in view of Kamath and Morland, as applied to claim 1, further in view of Hayter (US 20100057040- Previously cited).
Regarding claims 5 and 20, Brauker teaches wherein the in vivo analyte sensor comprises a glucose sensor (¶ [0005]).
Brauker-Kamath-Morland fails to teach wherein the processor is configured to determine the adverse condition based on at least one of a glucose level or an ethanol level.
Hayter teaches a system for monitoring a closed loop control operation from an analyte sensor (see abstract). The system comprises a processor configured to perform the step of determine analyte sensor condition in the system, wherein the sensor signal indicates an adverse condition based on the glucose level (¶ [0006,0060,0081]).
It would have been obvious to one of ordinary skill in the art to have modified the device of Brauker-Kamath-Morland, such that the adverse condition determination is based on the detected glucose level, as taught by Hayter, to aid in improving sensor anomalies such as signal dropouts and early signal attenuation (¶ [0082]).
Claims 10-11 and 25-26 are rejected under 35 U.S.C. 103 as being unpatentable over Brauker in view of Kamath and Morland, as applied to claim 1, further in view of Garai et al. (US 20200337608- Previously cited), hereinafter Garai, and Ganton et al. (US 20180014787-Previosuly cited), hereinafter Ganton.
Regarding claims 10 and 25, Brauker-Kamath-Morland fail to teach wherein the in vivo analyte sensor comprises a proximity sensor, and wherein an adhesive patch comprises a component sensed by the proximity sensor, and wherein the one or more processors are configured to detect that the in vivo analyte sensor is removed from the adhesive patch when a connection between the proximity sensor and the component is disrupted.
Garai teaches a sensor introducer for a physiological sensor assembly, both the sensor introducer and sensor assembly comprising a proximity sensor to determine when the assembly is placed or coupled onto the users body and removed from the introducer (see abstract and para. [0153] and figs. 2 and 11). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Brauker-Kamath-Morland, such that the analyte sensor comprises a proximity sensor, as taught by Garai, as it would merely be combining prior arts elements (analyte sensors) according to known methods (analyte sensor comprising proximity sensors) to yield predictable results.
Ganton teaches a device and method for detecting activation of a biometric device (see abstract) comprising processors configured to detect removal of an adhesive of the electronic device to aid in determining if something goes wrong in the activation and validation sequence (¶ [0094], it is noted that the capacitance sensor is considered the proximity sensor). Ganton further teaches electronic device comprises proximity sensor (501,502) which can be part of a needle and an adhesive base that the proximity sensor is configured to sense and determine when it has been removed (¶ [0036-37,0091-94], “One or more sensors in the electronic device 100 may be configured to detect when the base 120 has been removed”, “For instance, removal of the base 120 from the housing 110 may cause the electronic device 100 to transition from a low-power mode (e.g., shelf mode) to a high-power mode (e.g., active mode)” and “first sensor 501 can be a capacitance sensor that detects removal of an adhesive base” indicating that there is a component in the base, formed with an adhesive, that is sensed by the proximity sensor).
It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Brauker-Kamath-Morland-Garai, such that detection that the adhesive patch has been removed/disrupted from the analyte sensor based on a component sensed by the proximity sensor, as taught by Ganton, to aid in determining if something goes wrong in the activation and validation sequence.
Regarding claims 11 and 26, Garai teaches wherein the proximity sensor is a magnetic sensor (¶ [0118,0120], magnetic sensors 85 and 124).
Claims 12 and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Brauker in view of Kamath and Morland, as applied to claim 1, further in view of Li et al. (US 20150035680- Previously cited), hereinafter Li.
Regarding claims 12 and 27, Brauker teaches wherein the temperature probe is affixed to the analyte sensor (¶ [0432], “ the temperature probe is located on the electronics assembly or the glucose sensor itself”).
Brauker-Kamath-Morland fail to teach wherein the temperature strip includes a visual indicator comprising a color that indicates a change in temperature above a temperature threshold.
Li teaches a conformal sensor device strip configured to be affixed to an object, e.g., sensor, to detect a change in temperature measured and change a color of the light source of the strip based on the measurement exceeding a threshold indicative of a fever condition, over-exertion during exercise, a sporting event, or other physical activity, or extreme environmental conditions (see abstract and para. [0002,0197] and fig. 2). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Brauker-Kamath-Morland, such that the temperature strip includes a visual indicator comprising a color that indicates a change in temperature above a temperature threshold, as taught by Li, to aid in indicating a fever condition, over-exertion during exercise, a sporting event, or other physical activity, or extreme environmental conditions.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Brauker in view of Kamath and Morland, as applied to claim 1, further in view of Heinrich et al. (US 20180229674- Previously cited), hereinafter Heinrich.
Regarding claim 15, Brauker-Morland fail to teach wherein the one or more processors are further configured to activate or disable an external device based on the determined blood alcohol concentration.
Heinrich teaches a wearable device for receiving physiological signals, such as for determining blood alcohol, and causing an external device, i.e., vehicle, to disable (see abstract and para. [0035]). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the device of Brauker-Kamath-Morland, such that an external device is disabled based on the determined blood alcohol, as taught by Heinrich, to aid in determining whether or not the user is incapable of driving the vehicle (¶ [0035]).
Response to Arguments
Applicant's arguments filed 02/11/2026 have been fully considered but they are not fully persuasive.
Applicant’s arguments with respect to 35 U.S.C. 103 rejection of independent claims 1 and 16 have been considered but are moot because the amendment requires new grounds of rejection.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Kamath teaches discarding sensor data when signal artifacts detection detects values outside of a predetermined threshold (e.g., oxygen concentration below a set threshold, temperature above a certain threshold, signal amplitude above a certain threshold, etc). US 20080033254
Ye teaches a self-adaptive threshold method differs from the prior art threshold method based on baselines in that it comprises three aspects: amplitude, time and area. US 20070135726 A1
Mahajan teaches the adaptive peak detection threshold value is updated to be a specified percentage or fraction (e.g., 60%) of the amplitude of the identified signal peak in the secondary cardiac signal when the secondary signal is determined to be non-noisy. US 20120203123
Ricci teaches an amplitude processing unit that 1) estimates and tracks the local average signal amplitude to form an adaptive threshold, and then 2) clips the signal by limiting its absolute excursion in either direction from zero to that threshold value. US 20210038115
Dasgupta teaches fixed or adaptive threshold may comprise one or more of a frequency threshold and an amplitude threshold. US 20220175322
Gunderson teaches the amplitude threshold may be a fixed, predetermined value, or may be a variable value, e.g., determined based on amplitudes of R-waves, or cardiac signal generally, when ventricular lead was not dislodged. US 20170274204
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 MARTIN NATHAN ORTEGA whose telephone number is (571)270-7801. The examiner can normally be reached M-F 7:10 am - 5:00 pm.
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, Robert (Tse) Chen can be reached at (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.
/MARTIN NATHAN ORTEGA/Examiner, Art Unit 3791 /TSE W CHEN/Supervisory Patent Examiner, Art Unit 3791