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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 08/03/2026 has been entered.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-6, 8-11, 13-21, 23-26, 28-34 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) as a whole, considering all claim elements both individually and in combination, do not amount to significantly more than an abstract idea. A streamlined analysis of claim 16 follows.
STEP 1
Regarding claim 16, the claim recites a series of steps or acts, including detecting an adverse condition of the in vivo analyte sensor. Thus, the claim is directed to a process, which is one of the statutory categories of invention.
STEP 2A, PRONG ONE
The claim is then analyzed to determine whether it is directed to any judicial exception. The step of detecting an adverse condition of the in vivo analyte sensor sets forth a judicial exception. This step describes a concept performed in the human mind (including an observation, evaluation, judgment, opinion). Thus, the claim is drawn to a Mental Process, which is an Abstract Idea.
STEP 2A, PRONG TWO
Next, the claim as a whole is analyzed to determine whether the claim recites additional elements that integrate the judicial exception into a practical application. The claim fails to recite an additional element or a combination of additional elements to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limitation on the judicial exception. Claim 16 recites outputting an indication of the adverse condition, which is merely adding insignificant extra-solution activity to the judicial exception (MPEP 2106.05(g)). The indication does not provide an improvement to the technological field, the method does not effect a particular treatment or effect a particular change based on the indication, nor does the method use a particular machine to perform the Abstract Idea.
STEP 2B
Next, the claim as a whole is analyzed to determine whether any element, or combination of elements, is sufficient to ensure that the claim amounts to significantly more than the exception. Besides the Abstract Idea, the claim recites additional steps of acquiring analyte sensor signal data, determining blood alcohol constituents, detecting variations in amplitude of a background signal from the analyte device, and comparing the variations to a first threshold that dynamically changes after an initial period. Obtaining data in order to compare it to threshold data is well-understood, routine and conventional activity for those in the field of medical diagnostics. Further, the acquiring and comparison steps are each recited at a high level of generality such that it amounts to insignificant presolution activity, e.g., mere data gathering step necessary to perform the Abstract Idea. When recited at this high level of generality, there is no meaningful limitation, such as a particular or unconventional step that distinguishes it from well-understood, routine, and conventional data gathering and comparing activity engaged in by medical professionals prior to Applicant's invention. Furthermore, it is well established that the mere physical or tangible nature of additional elements such as the obtaining and comparing steps do not automatically confer eligibility on a claim directed to an abstract idea (see, e.g., Alice Corp. v. CLS Bank Int'l, 134 S.Ct. 2347, 2358-59 (2014)).
Consideration of the additional elements as a combination also adds no other meaningful limitations to the exception not already present when the elements are considered separately. Unlike the eligible claim in Diehr in which the elements limiting the exception are individually conventional, but taken together act in concert to improve a technical field, the claim here does not provide an improvement to the technical field. Even when viewed as a combination, the additional elements fail to transform the exception into a patent-eligible application of that exception. Thus, the claim as a whole does not amount to significantly more than the exception itself. The claim is therefore drawn to non-statutory subject matter.
Regarding claim 1, the device recited in the claim is a generic device comprising generic components configured to perform the abstract idea. The recited amperometric sensor is a generic sensor configured to perform pre-solutional data gathering activity and the computer system is configured to perform the Abstract Idea. According to section 2106.05(f) of the MPEP, merely using a computer as a tool to perform an abstract idea does not integrate the Abstract Idea into a practical application.
The dependent claims also fail to add something more to the abstract independent claims as they generally recite method steps pertaining to data processing and output. The acquiring and comparing steps recited in the independent claims maintain a high level of generality even when considered in combination with the dependent claims.
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 Kamath et al. (US 20100179409- Previously cited) and Estes et al. (US 20170273606), hereinafter Estes.
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 identify when variations in the sensor signal indicate that the signal is unreliable and should not be used in estimating the analyte information.
Brauker-Kamath fail to teach wherein the background signal variation threshold is higher during an initial wear period of the in vivo analyte sensor comprising a first number of days than in a remainder of a wear period of the in vivo analyte sensor comprising a second number of days.
Estes teaches a system and method for applying time dependent algorithmic compensations function to data output from a continuous analyte sensor (abstract). Estes further teaches that in vivo analyte sensors experience “the greatest rate of drift occurs during the first day to three days after implantation of a new sensor, after which the rate of change of drift typically levels off. Thus, the need to recalibrate the sensor is greatest during the first day to three days after implantation.” (emphasis added) (¶[0008]). That is, recalibration can occur after two days, on day three, due to drift (¶[0006], “ As the sensor electronics continue to receive sensor data, the sensor may be occasionally recalibrated to account for possible changes in sensor sensitivity and/or baseline”). A first drift compensation function is applied at a first elapsed time ,e.g. days (¶[0234]).The function relies on an adaptive boundary test, that is, two boundaries (upper/lower) that represent the acceptability of the sensor (¶[0234-40], “the boundary lines 1400, 1402 can adaptively adjust, or change, based on the elapsed time since implantation; namely, taking into consideration an expected change in a conversion function over time during implantation associated with changes in baseline and/or sensitivity thereof,” and “ By ‘change,’ it is meant that the allowable boundaries may increase, decrease, tighten in range or loosen in range, for example” (emphasis added)).
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, threshold is higher during an initial wear period of the in vivo analyte sensor comprising a first number of days than in a remainder of a wear period of the in vivo analyte sensor comprising a second number of days, as taught by Estes, to account for sensor drift following implantation, thereby accommodating expected initial sensor variation and detection of adverse conditions, while the sensor stabilizes.
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 fails to teach, and where Kamath discloses, further determining, by the processor, the adverse condition when a signal amplitude (¶ [0133] of Kamath, 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).
Therefore, it would have been obvious to one of ordinary skill in the art to have modified the system of Brauker-Kamath-Estes, to determine the adverse condition when a signal amplitude of the in vivo analyte sensor decreases below the amplitude of the background signal, as taught by Kamath, to aid in minimizing the effects of adverse conditions (¶[0002] of Estes).
Regarding claims 8 and 23, Brauker-Kamath-Estes 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-Estes teach wherein the initial wear period is in a range of 2 days to 7 days (¶[0008] of Estes, calibration should be done within first 3 days).
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-Estes, 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 Estes, 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-Estes 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-Estes, 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 Estes, 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-Estes 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-Estes, 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 Estes, 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-Estes 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-Estes, such that the analyte sensor comprises a proximity sensor, as taught by Garai, to aid in determining whether the sensor assembly is coupled to or removed from another component of the device.
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-Estes-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 Estes, 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-Estes 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-Estes, 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 Estes, as applied to claim 1, further in view of Heinrich et al. (US 20180229674- Previously cited), hereinafter Heinrich.
Regarding claim 15, Brauker-Kamath-Estes 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-Estes, 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, see Remarks, filed 07/01/2026, with respect to 35 U.S.C. 103 rejections have been fully considered and are persuasive in view of the amendments. The previous rejection has been withdrawn. Amendments require new grounds of rejection in view of Estes.
Applicant contends that one of ordinary skill in the art would not have been motivated to modify Brauker in view of Kamath, on pages 9-10 of the Remark. Examiner disagrees. Kamath is not relied upon for assessing sensor stability in the same manner as Brauker. Instead, Kamath is used to teach the use of a threshold applied to sensor signal amplitude to identify unreliable sensor data. Kamath discloses that the amperometric analyte sensor is employed and identifies signal artifacts based on whether the sensor current signal amplitude exceeds a threshold, resulting in identifying unreliable or erroneous sensor data that should not be used in analyte information determination (¶[0117,0125,0297,0303] of Kamath). Therefore, Kamath demonstrates that evaluating variations in an analyte sensor signal with a threshold was known for determining when the signal produced by the sensor is unreliable. Accordingly, the combination is obvious to modify Brauker’s sensor signal analysis to employ Kamath’s threshold technique in order to identify variations indicative of unreliable sensor operation, and thereby detect an adverse condition of the sensor.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Park teaches the electronic device can update the threshold M to another threshold S corresponding to the level of ambient noise. For example, the electronic device can decrease the threshold as the level of ambient noise increases. That is, in an environment with a higher level of ambient noise, the electronic device can output a notification sound even when the distance from the user is relatively short. US 20160259905
Burnet teaches calibration could be performed when the user first obtains the device, or at another time. Calibration could also be continuous, in that each time a user performs a skin prick test (or other reading of BGL), they could have the option of storing the tremor signal and entering the corresponding BGL level. This would allow continuous adjustment of the thresholds. US 20140343462
Viklund teaches dynamic thresholds can include multiple dimensions and may be different for each dimension. The dynamic threshold is used to determine if a deviation from expected activity is enough to generate an alert. Different dimensions of the dynamic threshold may change by different amounts and/or in different directions. US 20190272725
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/MARTIN NATHAN ORTEGA/Examiner, Art Unit 3791 /TSE CHEN/Supervisory Patent Examiner, Art Unit 3791
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