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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 8/4/2025 has been entered.
Status of Claims
This office action is responsive to the amendment filed on 8/4/2025. As directed by the amendment, claims 1, 2, 6-8, 12, and 20 have been amended. Thus claims 1-20 remain pending.
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.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea. The claimed invention as a whole, considering all claim elements both individually and in combination, do not amount to significantly more than a mental process. A subject matter eligibility analysis of claims 1, 12, and 20 is as follows: Step 1: Claim 1 and 12 recite a system and a method, respectively, which falls within one of the four categories of invention. Claim 20 recites a non-transitory computer-readable storage media which under the broadest reasonable interpretation falls within of the four categories of invention as a machine or manufacture.
Step 2A; prong one: When analyzing claim 1 to determine whether the claim recites or is directed to any judicial exception, the claim recites the limitations “determine whether the projected levels of glucose fall outside a prescribed range; generate, when the projected levels of glucose in the patient fall outside the prescribed range during the time frame and based on the alert data, a graphical alert indicating that the projected levels of glucose will fall outside the prescribed range; automatically detect occurrence of a maintenance event that modified the projected levels of glucose; determine revised projected levels of glucose based on a maintenance event such that the revised projected levels of glucose do not fall outside the prescribed range” sets forth a judicial exception. Under broadest reasonable interpretation, the limitation describes a process capable of being performed in the human mind (including observation, evaluation, judgment, opinion, but for the recitation of generic computer components. The claim does not set forth any structure for performing the judicial exception, thus the claim is drawn to a mental process, which is an abstract idea.
When analyzing claim 12 to determine whether the claim recites or is directed to any judicial exception, the claim recites the limitations “determining… whether the projected levels of glucose fall outside a prescribed range; generating… when the projected levels of glucose in the patient fall outside the prescribed range, and based on alert data, a graphical alert indicating that the projected levels of glucose will fall outside the prescribed range; automatically detecting occurrence of a maintenance event that modified the projected levels of glucose; determining… revised projected levels of glucose based on a maintenance event such that the revised projected levels of glucose do not fall outside the prescribed range” sets forth a judicial exception. Under broadest reasonable interpretation, the limitation describes a process capable of being performed in the human mind (including observation, evaluation, judgment, opinion, but for the recitation of generic computer components. The claim does not set forth any structure for performing the judicial exception, thus the claim is drawn to a mental process, which is an abstract idea.
When analyzing claim 20 to determine whether the claim recites or is directed to any judicial exception, the claim recites the limitations “determine whether the projected levels of glucose fall outside a prescribed range; generate, when the projected levels of glucose in the patient fall outside the prescribed range and based on an alert template, a graphical alert indicating that the projected levels of glucose will fall outside the prescribed range; automatically detect occurrence of a maintenance event that modified the projected levels of glucose; determine revised projected levels of glucose based on a maintenance event such that the revised projected levels of glucose do not fall outside the prescribed range” sets forth a judicial exception. Under broadest reasonable interpretation, the limitation describes a process capable of being performed in the human mind (including observation, evaluation, judgment, opinion, but for the recitation of generic computer components. The claim does not set forth any structure for performing the judicial exception, thus the claim is drawn to a mental process, which is an abstract idea.
Step 2A prong two: When analyzing claim 1 as a whole to determine whether the claims recite additional elements that integrate the judicial exception into a practical application besides the abstract idea, the claim recites, “a memory configured to store alert data: and one or more processors configured: communicatively couple to a glucose sensor to obtain one or more analyte values; obtain projected levels of glucose in a patient over a time frame based on the one or more analyte values from the glucose sensor;” and “present the graphical alert to the patient… and clear the previously presented graphical alert for a temporary period of time without user input and based on a determination that the revised projected levels of glucose do not fall outside the prescribed range.” These claimed elements fail to recite any additional element or combination of additional elements that apply, or use the judicial exception in a manner that imposes a meaningful limitation on the judicial exception. As recited in claim 1 “a memory configured to store alert data: and one or more processors configured: communicatively couple to a glucose sensor to obtain one or more analyte values; obtain projected levels of glucose in a patient over a time frame based on the one or more analyte values from the glucose sensor” and “present the graphical alert to the patient… and clear the previously presented graphical alert for a temporary period of time without user input and based on a determination that the revised projected levels of glucose do not fall outside the prescribed range” is pre-solution and post solution activity of data gathering and merely displaying the data using generic computer components, further the limitation does not link the use of the judicial exception to a particular technological environment (SEE MPEP 2106.05 (e)). When analyzing claim 12 as a whole to determine whether the claims recite additional elements that integrate the judicial exception into a practical application besides the abstract idea, the claim recites “communicatively couple to a glucose sensor to obtain one or more analyte values; obtaining, by one or more processors, projected levels of glucose in a patient over a time frame based on the one or more analyte values from the glucose sensor” and “causing presentation of the graphical alert to the patient” and “automatically clearing the previously presented graphical alert for a temporary period of time, by the one or more processors and based on a determination that the revised projected levels of glucose are within the prescribed range.” These claimed elements fail to recite any additional element or combination of additional elements that apply, or use the judicial exception in a manner that imposes a meaningful limitation on the judicial exception. As recited claim 12 “communicatively couple to a glucose sensor to obtain one or more analyte values; obtaining, by one or more processors, projected levels of glucose in a patient over a time frame based on the one or more analyte values from the glucose sensor” and “causing presentation of the graphical alert to the patient” and “automatically clearing the previously presented graphical alert for a temporary period of time, by the one or more processors and based on a determination that the revised projected levels of glucose are within the prescribed range” is pre-solution and post solution activity of data gathering and merely displaying the data using generic computer components and non-descript sensor, further the limitation does not link the use of the judicial exception to a particular technological environment (SEE MPEP 2106.05 (e)). When analyzing claim 20 as a whole to determine whether the claims recite additional elements that integrate the judicial exception into a practical application besides the abstract idea, the claim recites “one or more processors to: communicatively couple to a glucose sensor to obtain one or more analyte values; obtain projected levels of glucose in a patient over a time frame based on the one or more analyte values from the glucose sensor” and “cause presentation of the graphical alert to the patient…and automatically clear the previously presented graphical alert for the temporary period of time without user input, and based on a determination that the revised projected levels of glucose are within the prescribed range.” These claimed elements fail to recite any additional element or combination of additional elements that apply, or use the judicial exception in a manner that imposes a meaningful limitation on the judicial exception. As recited in claim 20 “one or more processors to: communicatively couple to a glucose sensor to obtain one or more analyte values; obtain projected levels of glucose in a patient over a time frame based on the one or more analyte values from the glucose sensor” and “cause presentation of the graphical alert to the patient… and automatically clear the previously presented graphical alert for the temporary period of time without user input, and based on a determination that the revised projected levels of glucose are within the prescribed range” is pre-solution and post solution activity of data gathering and merely displaying the data using generic computer components, further the limitation does not link the use of the judicial exception to a particular technological environment (SEE MPEP 2106.05 (e)). Consideration of the additional elements as combination also adds no other meaningful
limitations to the judicial exception not already present when the elements are considered
separately. Unlike the eligible claim considered in Diamond v. Diehr, 450 U.S at 188, 209 USPQ
at 9 (1981) in which the additional elements limiting the judicial exception are individually
conventional, but taken together the act in concert to improve a technical field, the additional
elements of claims 2-10 and 12-19 do not provide an improvement to the technical field.
Therefore, even when viewed as combination, the additional elements fail to transform the
judicial exception into a patent eligible application of the judicial exception.Step 2B: The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception, when considered separately and in combination.
Analyzing the additional limitation individually, the additional limitation that are not directed to mental process in claim 1 are “a memory configured to store alert data: and one or more processors configured: communicatively couple to a glucose sensor to obtain one or more analyte values; obtain projected levels of glucose in a patient over a time frame based on the one or more analyte values from the glucose sensor” and “present the graphical alert to the patient… and clear the previously presented graphical alert for a temporary period of time without user input and based on a determination that the revised projected levels of glucose do not fall outside the prescribed range,” in claim 12 “communicatively couple to a glucose sensor to obtain one or more analyte values; obtaining, by one or more processors, projected levels of glucose in a patient over a time frame based on the one or more analyte values from the glucose sensor” and “causing presentation of the graphical alert to the patient” and “automatically clearing the previously presented graphical alert for a temporary period of time, by the one or more processors and based on a determination that the revised projected levels of glucose are within the prescribed range,” in claim 20 “one or more processors to: communicatively couple to a glucose sensor to obtain one or more analyte values; obtain projected levels of glucose in a patient over a time frame based on the one or more analyte values from the glucose sensor” and “cause presentation of the graphical alert to the patient… and automatically clear the previously presented graphical alert for the temporary period of time without user input, and based on a determination that the revised projected levels of glucose are within the prescribed range” are limitations conventional and routine in the art. For example, generic computer components that are simply used to carry out the abstract method does not qualify as significantly more. Also, the glucose sensor, which is only claimed in claim 12, is nondescript and conventional, as evidenced by (See US20170311903 Davis [0005] [0030]), and insufficient pre-solution or post solution activity to the abstract idea that merely collects data to be used by the abstract idea. In view of above claim 1, 12, and 20 fail to recite patent eligible subject matter under 35 U.S.C. 101. Dependent claims 2-11 and 13-19 fail to cure the deficiencies of claim 1 and claim 12 by merely reciting additional abstract ideas or further limits on the abstract idea already recited.
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.
Claims 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Davis et al. (US20170311903A1; hereinafter known as “Davis”; previously cited) in view of Agrawal et al. (US20130338630A1; hereinafter known as Agrawal; previously cited) in view of Cobelli et al. (US20140118138; hereinafter known as “Cobelli”).Regarding claim 1, Davis teaches a device for assisting in therapy delivery (See Davis Figure 45), the device comprising:
a memory configured to store alert data (See Davis [0021][0247-0249] program memory 216 and other memory 218); and
one or more processors configured to (See Davis Figure 45-part 490 analyte processor):
communicatively couple to a glucose sensor to obtain one or more analyte values (See Figure 45 part 10 sensor with electronics which communicated with 490);
obtain projected levels of glucose in a patient over a time frame based on the one or more analyte values from the glucose sensor (See Davis [0030], identifying a current or future diabetic state warranting attention may include measuring a glucose signal signature and comparing the measured signature with a plurality of binned signatures);
determine whether the projected levels of glucose fall outside a prescribed range (See Davis [0006] [0030][0106], glucose concentration is hovering within a range for a period, or the trace is depicting above or below range));
generate, when the projected levels of glucose in the patient fall outside the prescribed range during the time frame and based on the alert data, a graphical alert indicating that the projected levels of glucose will fall outside the prescribed range (See Davis Figure 7-10, also see [0106][0182-0186], user alerted diabetic state warranting attention and may further provide details of current glucose values, expected glucose values, e.g., expected within a certain timeframe, e.g., 20 minutes);
determine a maintenance event such that the projected levels of glucose do not fall outside the prescribed range (See Davis [0160] [0114] [0105], if system detects insulin delivery smart alert can be suspended or delayed to account for the change in hyperglycemic state); and
and based on a determination that the projected levels of glucose such that the projected levels of glucose do not fall outside the prescribed range, (See Davis [0104], when user is having a typical response, such as exercising or eating the system uses machine learning to suppress the issuance of an alert).
Davis is silent with respect to revised projected levels of glucose based on a maintenance event.
Agarwal teaches automatically detect occurrence of a maintenance event that modifies the projected levels of glucose; determine revised projected levels of glucose based on maintenance event (See Agarwal Figure 3, determine common event occurrence in glucose level and analyze the readings to determine a pattern and then calculate the dosage needed).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present application to provide Davis with revised projected levels of glucose based on a common maintenance event as taught by Agarwal to modify the Davis device so as to determine glucose patterns based on common events to ensure consistency in the diabetes therapy (See Davis [0002]).
Davis in view of Agarwal is silent with respect to clear the previously presented graphical alert for a temporary period of time, without user input and based on a determination that the revised projected levels of glucose do not fall outside the prescribed range.
Cobelli teaches clearing the previously presented graphical alert for a temporary period of time, without user input and based on a determination that the revised projected levels of glucose do not fall outside the prescribed range (See Cobelli [0138-0143], the alert only is sent again when a certain threshold (sensor data) is met and a certain time point, the user is not re-alerted, therefore the alert is temporarily suspended).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present application to provide Davis in view of Agarwal with the function to clear the previously presented graphical alert for a temporary period of time, without user input and based on a determination that the revised projected levels of glucose do not fall outside the prescribed range as taught by Cobelli to avoid undesirable re-alerts to the user which are solely time-based (See Cobelli [0138]).
Regarding claim 2, Davis teaches one or more processors are configured (See Davis Figure 45-part 490 analyte processor) to:
determine based on the one or more analyte values obtained from the glucose sensor a current level of glucose in the patient (See Davis [0030], current diabetic state by measuring a glucose signal signature); and
obtain, based on the current level of glucose, the projected levels of glucose in the patient over the time frame (See Davis [0030], identifying a current or future diabetic state warranting attention may include measuring a glucose signal signature and comparing the measured signature with a plurality of binned signatures, also se Figure 7 and 8).
Regarding claim 3, Davis teaches the one or more processors are (See Davis Figure 45-part 490 analyte processor), when determining the projected levels of glucose (See Davis [0105-106], if system detects events smart alert can be suspended or delayed to account for the change in hyperglycemic state), configured to: automatically detect a meal event indicating that the patient is currently eating a meal (See Davis [0024] [0269], determine if user is eating meal);
obtain, based on the meal event, the projected levels of glucose; and determine that the projected levels of glucose do not fall outside the prescribed range (See Davis [0024] [0105-0106][0127-0128], glucose response to events such as eating determined by machine learning to generate an alerts also see [0030]).
Davis is silent to revised projected levels of glucose based on a maintenance event.
Agarwal teaches revised projected levels of glucose based on maintenance event (See Agarwal Figure 3, the determine common event occurrence in glucose level and analyze the readings to determine a pattern and then calculate the dosage needed).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present application to provide Davis with revised projected levels of glucose based on maintenance event as taught by Agarwal to modify Davis device to determine glucose patterns based on common events to assist in the management of diabetes therapy (See Davis [0002]).
Regarding claim 4, Davis teaches the one or more processors (See Davis Figure 45-part 490 analyte processor) are configured to:
interface with a wearable computing device worn by the patient to identify movements performed by the patient (See Davis [0214] Figure 45 mobile 18 can be connected to smart watch also see [0214] identify movements using GPS [0132]); and
automatically detect, based on the movements, the meal event indicating that the patient is currently eating a meal (See Davis [0132], GPS determines user location and likely to consume meal).
Regarding claim 5, Davis teaches the one or more processors (See Davis Figure 45-part 490 analyte processor) are, when determining the projected levels of glucose, configured to:
automatically detect an insulin delivery event indicating that the patient has injected insulin; obtain, based on the insulin delivery event, the projected levels of glucose; and determine that the projected levels of glucose do not fall outside the prescribed range (See Davis [0030][0160][0114][0105], if system detects insulin delivery smart alert can be suspended or delayed to account for the change in hyperglycemic state, also see [0104] uses machine learning to suppress or delay the issuance of an alert).
Davis is silent to revised projected levels of glucose based on a maintenance event.
Agarwal teaches revised projected levels of glucose based on maintenance event (See Agarwal Figure 3, the determine common event occurrence in glucose level and analyze the readings to determine a pattern and then calculate the dosage needed).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present application to provide Davis with revised projected levels of glucose based on maintenance event as taught by Agarwal to modify Davis device to determine glucose patterns based on common events to ensure consistency in the diabetes therapy (See Davis [0002]).
Regarding claim 6, Davis teaches the maintenance event is a first maintenance event (See Davis [0104], when user is having a typical response such as exercising or eating the system uses machine learning to suppress the issuance of an alert), and wherein the one or more processors (See Davis Figure 45-part 490 analyte processor) are further configured to: detect initiation of a second maintenance event (See Davis [0024] [0269], determine if user is eating meal);
determine an amount associated with the second maintenance event; and
determine, an amount of carbohydrates consumed by patient associated with the second maintenance event, is insufficient to keep that the projected levels of glucose within prescribed range (See Davis [See Davis [0024] [0105-0106][0127-0128], glucose response to events such as eating determined by machine learning to generate an alerts also see [0030]).
Davis is silent to second revised projected levels.
Agarwal teaches second revised projected levels of glucose based on maintenance event (See Agarwal Figure 3, the determine common event occurrence in glucose level and analyze the readings to determine a pattern and then calculate the dosage needed).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present application to provide Davis with second revised projected levels of glucose based on maintenance event as taught by Agarwal to modify Davis device to determine glucose patterns based on common events to ensure consistency in the diabetes therapy (See Davis [0002]). Regarding claim 7, Davis teaches wherein the one or more processors (See Davis Figure 45-part 490 analyte processor) are further configured to:
present the graphical alert along with an audible alert to the patient (See Davis [0176], can be visual or audible display),
present, responsive to determining that the projected levels of glucose will fall outside the prescribed range (See Davis Figure 7-10, also see [0182-0186], user alerted diabetic state warranting attention and may further provide details of current glucose values, expected glucose values, e.g., expected within a certain timeframe, e.g., 20 minutes), a haptic alert in place of the audible alert such that the audible alert is cleared for the temporary period of time (See Davis [0215]).
Davis is silent to second revised projected levels.
Agarwal teaches second revised projected levels of glucose based on maintenance event (See Agarwal Figure 3, the determine common event occurrence in glucose level and analyze the readings to determine a pattern and then calculate the dosage needed).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present application to provide Davis with revised projected levels of glucose based on maintenance event as taught by Agarwal to modify Davis device to determine glucose patterns based on common events to ensure consistency in the diabetes therapy (See Davis [0002]). Davis in view of Agarwal is silent with respect to automatically clearing the previously presented alert for a temporary period of time. Cobelli teaches the automatically clearing of the previously presented alert for a temporary period of time (See Cobelli [0138]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the present application to provide Davis in view of Agarwal with automatically clearing the previously presented alert for a temporary period of time as taught by Cobelli to avoid undesirable re-alerts to the user which are solely time-based (See Cobelli [0138]). Regarding claim 8, Davis teaches the one or more processors (See Davis Figure 45-part 490 analyte processor) are further configured to:
predicting a time a next hyperglycemic hypoglycemic event will occur based on the revised projected levels of glucose, determine based on the predicted time to clear the previously presented graphical alert such that the cleared graphical alert is presented prior to the predicted time (See Davis [0160], if a hyperglycemic diabetic state warranting attention occurs, but the smart alerts functionality app uses data from an insulin sensor to detect that there is a degree of insulin on board, then the smart alerts functionality may suppress an alert until such time as it is determined that the current insulin is no longer able to control the hyperglycemia and that the user is not cognitively aware of a need for more.)
Davis is silent to second revised projected levels.
Agarwal teaches second revised projected levels of glucose based on maintenance event (See Agarwal Figure 3, the determine common event occurrence in glucose level and analyze the readings to determine a pattern and then calculate the dosage needed).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present application to provide Davis with revised projected levels of glucose based on maintenance event as taught by Agarwal to modify Davis device to determine glucose patterns based on common events to ensure consistency in the diabetes therapy (See Davis [0002]).
Regarding claim 9, Davis teaches the graphical alert further includes a prompt for a user to clear the graphical alert for the temporary period of time via user input (See Davis Figure 31).
Regarding claim 10, Davis teaches the one or more processors (See Davis Figure 45-part 490 analyte processor) are configured to:
determine a duration until the projected levels of glucose are projected to fall outside the prescribed range; and determine, based on the duration, the temporary period of time by which to automatically clear the graphical alert (See Davis [0160], if a hyperglycemic diabetic state warranting attention occurs, but the smart alerts functionality app uses data from an insulin sensor to detect that there is a degree of insulin on board, then the smart alerts functionality may suppress an alert until such time as it is determined that the current insulin is no longer able to control the hyperglycemia and that the user is not cognitively aware of a need for more.).
Davis is silent to revised projected levels.
Agarwal teaches revised projected levels of glucose (See Agarwal Figure 3, the determine common event occurrence in glucose level and analyze the readings to determine a pattern and then calculate the dosage needed).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present application to provide Davis with revised projected levels of as taught by Agarwal to modify Davis device to determine glucose patterns based on common events to ensure consistency in the diabetes therapy (See Davis [0002]). Regarding claim 11, Davis teaches the prescribed range (See Davis [0006]) includes values between a lower threshold identifying a hypoglycemic condition for the patient and an upper threshold identifying a hyperglycemic condition for the patient (See Davis [0006][0087][0162][0168][0186], alerted when a patient above 200mg/dl and below 80mg/dl, . For example, a user's high alert threshold may be set at 180 mg/dL low threshold 55md/dl).
Regarding claim 12, Davis teaches a method for assisting in therapy delivery (See Davis Figure 45), the method comprising:
communicatively couple to a glucose sensor to obtain one or more analyte values (See Figure 45 part 10 sensor with electronics which communicated with 490); obtaining projected levels of glucose in a patient over a time frame based on the one or more analyte values from the glucose sensor (See Davis [0030], identifying a current or future diabetic state warranting attention may include measuring a glucose signal signature and comparing the measured signature with a plurality of binned signatures);
determining, by the one or more processors, whether the projected levels of glucose fall outside a prescribed range (See Davis [0030], glucose concentration is hovering within a range for a period);
generating, by the one or more processors, when the projected levels of glucose in the patient fall outside the prescribed range, and based on alert data, a graphical alert indicating that the projected levels of glucose will fall outside the prescribed range (See Davis Figure 7-10, also see [0182-0186], user alerted diabetic state warranting attention and may further provide details of current glucose values, expected glucose values, e.g., expected within a certain timeframe, e.g., 20 minutes);
determining, by the one or more processors, the projected levels of glucose such that the projected levels of glucose based on a maintenance event do not fall outside the prescribed range (See Davis [0160][0114][0105], if system detects insulin delivery smart alert can be suspended or delayed to account for the change in hyperglycemic state which can be caused by an event such as meal, insulin delivery or exercising); and
based on the determination the projected levels of glucose such that the projected levels of glucose are within the prescribed range (See Davis [0104], when user is having a typical response, such as exercising or eating the system uses machine learning to suppress the issuance of an alert).
Davis is silent to revised projected levels of glucose based on a maintenance event.
Agarwal teaches the automatically detecting of occurrence of a maintenance event that modifies the projected levels of glucose and determining by the one or more processors, revised projected levels of glucose based on maintenance event (See Agarwal Figure 3, the determine common event occurrence in glucose level and analyze the readings to determine a pattern and then calculate the dosage needed).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present application to provide Davis with revised projected levels of glucose based on maintenance event as taught by Agarwal to modify Davis device to determine glucose patterns based on common events to ensure consistency in the diabetes therapy (See Davis [0002]). Davis in view of Agarwal is silent with respect to the previously presented graphical alert for a temporary period of time, without user input and based on a determination that the revised projected levels of glucose do not fall outside the prescribed range. Cobelli teaches a previously presented graphical alert for a temporary period of time, without user input and based on a determination that the revised projected levels of glucose do not fall outside the prescribed range (See Cobelli [0138-0143], the alert only is sent again when a certain threshold (sensor data) is met and a certain time point, the user is not re-alerted, therefore the alert is temporarily suspended).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present application to provide Davis in view of Agarwal with automatically detect occurrence of a maintenance event that modifies the projected levels of glucose and the previously presented graphical alert for a temporary period of time, without user input and based on a determination that the revised projected levels of glucose do not fall outside the prescribed range as taught by Cobelli to avoid undesirable re-alerts to the user which are solely time-based (See Cobelli [0138]). Regarding claim 13, Davis teaches obtaining the projected levels of glucose comprises: obtaining, from the glucose sensor, a current level of glucose in the patient (See Davis [0030], current diabetic state by measuring a glucose signal signature); and
obtaining, based on the current level of glucose, the projected levels of glucose in the patient over the time frame (See Davis [0030], identifying a future diabetic state warranting attention may include measuring a glucose signal signature and comparing the measured signature with a plurality of binned signatures, also se Figure 7 and 8).
Regarding claim 14, Davis teaches determining that the maintenance event alters the projected levels of glucose (See Davis [0105-106], if system detects events smart alert can be suspended or delayed to account for the change in hyperglycemic state) comprises: automatically detecting a meal event indicating that the patient is currently eating a meal (See Davis [0024] [0269], determine if user is eating meal;);
obtaining, based on the meal event, a version of the projected levels of glucose; and
determining that the projected levels of glucose do not fall outside the prescribed range (See Davis [0024] [0105-0106][0127-0128], glucose response to events such as eating determined by machine learning to generate an alerts also see [0030]).
Davis is silent to revised projected levels of glucose based on a maintenance event.
Agarwal teaches revised projected levels of glucose based on maintenance event (See Agarwal Figure 3, the determine common event occurrence in glucose level and analyze the readings to determine a pattern and then calculate the dosage needed).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present application to provide Davis with revised projected levels of glucose based on maintenance event as taught by Agarwal to modify Davis device to determine glucose patterns based on common events to ensure consistency in the diabetes therapy(See Davis [0002]).
Regarding claim 15, Davis teaches automatically detecting the meal event comprises: interfacing with a wearable computing device worn by the patient (See Davis [0214] Figure 45 mobile 18 can be connected to smart watch also see [0214] identify movements using GPS [0132]) to identify movements performed by the patient; and
automatically detecting, based on the movements, the meal event indicating that the patient is currently eating a meal (See Davis [0132], GPS determines user location and likely to consume meal).
Regarding claim 16, Davis teaches determining the projected levels of glucose comprises: automatically detecting an insulin delivery event indicating that the patient has injected insulin; obtaining, based on the insulin delivery event, a revised version of the projected levels of glucose; and determining that the projected levels of glucose do not fall outside the prescribed range (See Davis [0030][0160][0114][0105], if system detects insulin delivery smart alert can be suspended or delayed to account for the change in hyperglycemic state, also see [0104] uses machine learning to suppress or delay the issuance of an alert).
Davis is silent to revised projected levels of glucose based on a maintenance event.
Agarwal teaches revised projected levels of glucose based on maintenance event (See Agarwal Figure 3, the determine common event occurrence in glucose level and analyze the readings to determine a pattern and then calculate the dosage needed).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present application to provide Davis with revised projected levels of glucose based on maintenance event as taught by Agarwal to modify Davis device to determine glucose patterns based on common events to ensure consistency in the diabetes therapy(See Davis [0002]).
Regarding claim 17, Davis teaches the maintenance event is a first maintenance event (See Davis [0104], when user is having a typical response such as exercising or eating the system uses machine learning to suppress the issuance of an alert), and wherein the one or more processors (See Davis Figure 45-part 490 analyte processor) are further configured to: detect initiation of a second maintenance event (See Davis [0024] [0269], determine if user is eating meal);
determine an amount carbohydrates consumed by the patient associated with the second maintenance event; and
determine, based on the amount of carbohydrates associated with the second maintenance event, that the projected levels of glucose will fall outside the prescribed range (See Davis [See Davis [0024] [0105-0106][0127-0128], glucose response to events such as eating determined by machine learning to generate an alerts also see [0030]).
Davis is silent to second revised projected levels.
Agarwal teaches second revised projected levels of glucose based on maintenance event (See Agarwal Figure 3, the determine common event occurrence in glucose level and analyze the readings to determine a pattern and then calculate the dosage needed).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present application to provide Davis with revised projected levels of glucose based on maintenance event as taught by Agarwal to modify Davis device to determine glucose patterns based on common events to ensure consistency in the diabetes therapy (See Davis [0002]).
Regarding claim 18, Davis teaches wherein the one or more processors (See Davis Figure 45-part 490 analyte processor) are further configured to:
present the graphical alert along with an audible alert to the patient (See Davis [0176], can be visual or audible display),
present, responsive to determining that the projected levels of glucose will fall outside the prescribed range (See Davis Figure 7-10, also see [0182-0186], user alerted diabetic state warranting attention and may further provide details of current glucose values, expected glucose values, e.g., expected within a certain timeframe, e.g., 20 minutes), a haptic alert in place of the audible alert such that the audible alert is cleared for the temporary period of time (See Davis [0215]).
Davis is silent to second revised projected levels.
Agarwal teaches second revised projected levels of glucose based on maintenance event (See Agarwal Figure 3, the determine common event occurrence in glucose level and analyze the readings to determine a pattern and then calculate the dosage needed).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present application to provide Davis with revised projected levels of glucose based on maintenance event as taught by Agarwal to modify Davis device to determine glucose patterns based on common events to assist in the management of diabetes therapy (See Davis [0002]).
Regarding claim 19, Davis teaches the one or more processors (See Davis Figure 45-part 490 analyte processor) are further configured to:
determine a duration until the projected levels of glucose are projected to fall outside the prescribed range; and determine, based on the duration, the temporary period of time by which to automatically clear the graphical alert (See Davis [0160], if a hyperglycemic diabetic state warranting attention occurs, but the smart alerts functionality app uses data from an insulin sensor to detect that there is a degree of insulin on board, then the smart alerts functionality may suppress an alert until such time as it is determined that the current insulin is no longer able to control the hyperglycemia and that the user is not cognitively aware of a need for more.)
Davis is silent to second revised projected levels.
Agarwal teaches second revised projected levels of glucose based on maintenance event (See Agarwal Figure 3, the determine common event occurrence in glucose level and analyze the readings to determine a pattern and then calculate the dosage needed).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present application to provide Davis with revised projected levels of glucose based on maintenance event as taught by Agarwal to modify Davis device to determine glucose patterns based on common events to assist in the management of diabetes therapy (See Davis [0002]).
Regarding claim 20, Davis teaches a non-transitory computer-readable storage medium having instructions stored thereon that (See Davis [0035] [0260]), when executed, cause one or more processors (See Davis Figure 45-part 490 analyte processor) to:
communicatively couple to a glucose sensor to obtain one or more analyte values (See Figure 45 part 10 sensor with electronics which communicated with 490); obtain projected levels of glucose in a patient over a time frame based on the one or more analyte values from the glucose sensor (See Davis [0030], identifying a current or future diabetic state warranting attention may include measuring a glucose signal signature and comparing the measured signature with a plurality of binned signatures); determine whether the projected levels of glucose fall outside a prescribed range (See Davis [0006][0030][0106], glucose concentration is hovering within a range for a period, or the trace is depicting above or below range); generate, when the projected levels of glucose in the patient fall outside the prescribed range and based on an alert template, a graphical alert indicating that the projected levels of glucose will fall outside the prescribed range (See Davis Figure 7-10, also see [0106][0182-0186], user alerted diabetic state warranting attention and may further provide details of current glucose values, expected glucose values, e.g., expected within a certain timeframe, e.g., 20 minutes); determine that the projected levels of glucose such that the projected levels of glucose do not fall outside the prescribed range (See Davis [0160][0114][0105], if system detects insulin delivery smart alert can be suspended or delayed to account for the change in hyperglycemic state); based on the determination the revised projected levels of glucose such that the projected levels of glucose are within the prescribed range, (See Davis [0104], when user is having a typical response such as exercising or eating the system uses machine learning to suppress the issuance of an alert).
Davis is silent to automatically detect occurrence of a maintenance event that modifies the projected levels of glucose; determined revised projected levels of glucose based on a maintenance event.
Agarwal teaches revised projected levels of glucose based on maintenance event (See Agarwal Figure 3, the determine common event occurrence in glucose level and analyze the readings to determine a pattern and then calculate the dosage needed).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the present application to provide Davis with revised projected levels of glucose based on maintenance event as taught by Agarwal to modify Davis device to determine glucose patterns based on common events to ensure consistency in the diabetes therapy(See Davis [0002]). Davis in view of Agrawal is silent with respect to the automatically clearing of the previously presented graphical alert for the temporary period of time without user input and based on a determination that the revised projected levels of glucose are within the prescribed range.
Cobelli teaches determine a temporary period of time to clear the previously presented graphical alert based on the revised projected levels of glucose and automatically clear the previously presented graphical alert for the temporary period of time without user input and based on a determination that the revised projected levels of glucose are within the prescribed range (See Cobelli [0138-0143], the alert only is sent again when a certain threshold (sensor data) is met and a certain time point, the user is not re-alerted, therefore the alert is temporarily suspended). It would have been obvious to one of ordinary skill in the art before the effective filing date of the present application to provide Davis in view of Agarwal with automatically detect occurrence of a maintenance event that modifies the project levels of glucose, determine a temporary period of time to clear the previously presented graphical alert based on the revised projected levels of glucose and automatically clear the previously presented graphical alert for the temporary period of time without user input and based on a determination that the revised projected levels of glucose are within the prescribed range as taught by Cobelli to avoid undesirable re-alerts to the user which are solely time-based (See Cobelli [0138]).
Response to Arguments
Applicant’s argument with respect to rejection regarding claim 2 under 35 U.S.C 112 (b) has been fully considered and is persuasive.
Applicant’s argument with respect to rejection regarding claims 1-20 under 35 U.S.C. 101 specifically regarding “communicatively couple to a glucose sensor to obtain one or more analyte value integrates any alleged abstract idea into a practical application under Step 2A, prong two, because this limitation recites the use of a particular machine” and “automatically detect occurrence of a maintenance event that modifies the project levels of glucose. At least this limitation cannot be performed in the mind and accordingly the claims, as emended are not directed to the abstract idea.” has been fully considered and is not persuasive. The applicant states communicatively couple to a glucose sensor to obtain one or more analyte value integrates any alleged abstract idea into a practical application under Step 2A, prong two, because this limitation recites the use of a particular machine, however merely using conventional well-known components to perform pre-solution activity does not integrate the abstract idea into a practical application. These claimed elements fail to recite any additional elements or combination of additional elements that apply or use the judicial exception in a manner that imposes a meaningful limitation on the judicial exception. Further the applicant states “automatically detect occurrence of a maintenance event that modifies the project levels of glucose. At least this limitation cannot be performed in the mind and accordingly the claims, as amended are not directed to the abstract idea,” however the Applicant’s specification recites “a maintenance event” as a meal event or insulin injection event (See Applicant specification [0081]), a meal event or insulin event can be perceived therefore can be performed by a human mind. Applicant’s argument with respect to rejection regarding claims 1-20 under 35 U.S.C. 103 specifically regarding “The independent claims, as amended, recite” clear the previously present graphical alert for a temporary period of time without user input and based on a determination that the revised projected levels of glucose do not fall outside the prescribed range” has been fully considered and is persuasive. Therefore, the rejection has been withdrawn, however a new ground of rejection has been made in view of Davis in view of Agarwal in view of Cobelli.
Applicant’s argument with respect to rejection regarding claims 1-20 under 35 U.S.C. 103 specifically regarding “Roslin teaches away from that is recited in the independent claims. Roslin states ‘a footer 1512 may include a snooze function that can be selected by the user. In other words, Roslin describes snoozing a banner or alert with user input. This is the opposite of what is recited in Applicant’s independent claims, which recite “clear, without user input.’” has been fully considered and is persuasive. Therefore, the rejection has been withdrawn, however a new ground of rejection has been made in view of Davis in view of Agarwal in view of Cobelli.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Meghan R Kumar whose telephone number is (571)272-7125. The examiner can normally be reached Monday-Friday, 8a.m - 5p.m.
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, Charles Marmor can be reached at 571-2722-4730. 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.
/M.R.K./Examiner, Art Unit 3791
/MATTHEW KREMER/Primary Examiner, Art Unit 3791
Prosecution Insights