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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 12/23/2025 has been entered.
Status of Claims
Applicant's arguments, filed 12/23/2025, have been fully considered. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Applicants have amended their claims, filed 12/23/2025.
Applicants have amended claims 1, 10-12, 16, and 19.
Applicants have left claims 3, 7-8, 13-15, and 18 as originally filed/previously presented.
Applicants have canceled/previously canceled claims 2, 4-6, 9, and 17.
Claim 20 remains withdrawn from further consideration by the examiner, as being drawn to a non-elected invention, the election made without traverse in the Non-Final Rejection mailed on 10/24/2023.
Claims 1, 3, 7-8, 10-16, and 18-19 are the current claims hereby under examination.
Claim Objections - Withdrawn and Newly Applied Necessitated by Applicant’s Amendments
Claim 1 is objected to because of the following informalities:
Regarding claim 1, line 12 recites “changes in settings”, however it appears it should read --change in settings-- (emphasis added) to maintain consistent claim language.
Response to Arguments
Applicant’s arguments, see page 7 of Remarks, filed 12/23/2025, with respect to claim 19 have been fully considered and are persuasive. Applicants have amended the claim rendering the objection moot. The objection of claim 19 has been withdrawn. However, Applicants amendments have necessitated new claim objections.
Claim Rejections - 35 USC § 112 - Withdrawn and Newly Applied Necessitated by Applicant’s Amendments
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 12 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 12, the term “sufficient” in line 5 is a relative term which renders the claim indefinite. The term “sufficient” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The disclosure filed 08/31/2020 does not recite “sufficient”. Is “sufficient” referring to a user having a glucose level within a certain range? Is “sufficient” referring to a user maintaining a glucose level in a certain range for a period of time? Is “sufficient” referring to a user no going above or below a threshold? What is the certain range? What is the threshold? Are the certain ranges and thresholds specific for each user? Does “sufficient” allow for a number of instances above/below the certain ranges/thresholds? For the purposes of examination, “notifying the user of a possibility of the second settings if the user has demonstrated glucose level control quality of a sufficient level to warrant access to the second settings” is being interpreted as notifying the user of a possibility of second settings if the user meets any criteria of glucose levels.
Response to Arguments
Applicant’s arguments, see pages 7-8 of Remarks, filed 12/23/2025, with respect to claims 6, 9-12, and 16 have been fully considered and are persuasive. Applicants have amended/canceled the claims rendering the 112(b) rejections moot. The 112(b) rejections of claims 6, 9-12, and 16 have been withdrawn. However, Applicants amendments have necessitated new 112(b) rejections.
Claim Rejections - 35 USC § 103 - Newly Applied Necessitated by Applicant’s Amendments
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 3, 7-8, 10-16, and 18-19 are rejected under 35 U.S.C. 103 as being unpatentable over Mazlish et al. (US 20170189614 A1) (previously cited), hereinafter referred to as Mazlish, in view of El-Khatib et al. (WO 2021011738 A1), hereinafter referred to as El-Khatib, in view of Ahmad Haidar (US 20200197605 A1) (previously cited), hereinafter referred to as Haidar.
The claims are generally directed towards a method performed by an automated insulin delivery (AID) system having a processor, comprising: establishing first settings for a control approach of the AID system, wherein the first settings includes weight values for a cost function used by the control approach in determining how much insulin to deliver to a user; calculating metrics of glucose level control quality of the user, the metrics including multiple ones of a mean glucose level of the user over a period, a frequency that the glucose level of the user is in a desired range, or a duration of hypoglycemic events and/or hyperglycemic events; based on multiple ones of the calculated metrics of glucose level control quality of the user, determining whether to trigger a change in settings; where the changes in settings is trigger, with the processor, automatically changing the first settings of the AID system to second settings that have a different degree of aggressiveness than the first settings, where the degree of aggressiveness reflects an amount of hypoglycemic risk or hyperglycemic risk potential that is posed by the settings, and wherein the second settings contain at least one different one of the weight values for the cost function used by the control approach than the first settings; and where the change in settings is not triggered, not automatically changing the first settings to the second settings.
Regarding claim 1, Mazlish discloses a method performed by an automated insulin delivery (AID) system having a processor (Abstract, Fig. 1A, Fig. 4, para. [0011], para. [0043]), comprising:
establishing first settings for a control approach of the AID system (Fig. 7A, element 402, element 408, para. [0120], “particular insulin delivery mode can be selected …”, para. [0125], “operates the multi-modal medicine delivery system in the selected delivery mode …”);
calculating metrics of glucose level control quality of the user, the metrics including a mean glucose level of the user over a period, a frequency that the glucose level of the user is in a desired range, or a duration of hypoglycemic events and/or hyperglycemic events (Fig. 7B, element 452, element 454, element 456, para. [0143-0145], “determination can be made as to whether to update the parameters and/or models that are currently being used … update may be determined to be warranted when the readings and dosage data fall outside of one or more predetermined threshold/target values … blood glucose reading of a user is consistently above or below a target … basal profile … may be updated … user-specific dosage parameters can be determined and/or updated based on historical sensory feedback data (e.g., historical blood glucose data) …”);
based on the calculated metrics of glucose level control quality of the user, determining whether to trigger a change in settings (Fig. 7B, element 456, element 458, element 460, para. [0143-0147], “update may be determined to be warranted when the readings and dosage data fall outside of one or more predetermined threshold/target values …”);
where the changes in settings is triggered, with the processor, automatically changing the first settings of the AID system to second settings that have a different degree of aggressiveness than the first settings, where the degree of aggressiveness reflects an amount of hypoglycemic risk or hyperglycemic risk potential that is posed by the settings (Fig. 7B, element 456, element 458, element 460, para. [0072], para. [0144], “updated so that the user receives more or less insulin … underlying parameters and models may be updated to account for the observed patterns … user-specific dosage parameters can be determined and/or updated based on historical sensory feedback data …” - changing the amount of insulin changes an amount of hypoglycemic risk or hyperglycemic risk potential for the patient); and
where the change in settings is not triggered, not automatically changing the first settings to the second settings (Fig. 7B, element 456, para. [0145], “determined that the update is not warranted, the process repeats operations …”).
However, Mazlish does not explicitly disclose the metrics of glucose level control quality of the user include multiple ones of the mean glucose level of the user over a period, the frequency that the glucose level of the user is in a desired range, or the duration of hypoglycemic events and/or hyperglycemic events; and determining whether to trigger the change in settings based on multiple ones of the calculated metrics of glucose level control quality of the user.
El-Khatib teaches an analogous method of automated insulin delivery (Abstract, para. [0005]). El-Khatib further teaches calculating metrics of glucose level control quality of the user, the metrics including multiple ones of a mean glucose level of the user over a period, a frequency that the glucose level of the user is in a desired range, or a duration of hypoglycemic events and/or hyperglycemic events, and based on multiple ones of the calculated metrics of glucose level control quality of the user, determining whether to trigger a change in settings (para. [0259-0260], “evaluation over a time horizon … in addition, adjustments can be evaluated and effected online when some metric satisfies a threshold or meets certain criteria … in addition, adjustments can be effected after some evaluation related to the glucose signal … mean value …”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method disclosed by Mazlish to explicitly include calculating multiple ones of the mean glucose level of the user over a period, the frequency that the glucose level of the user is in a desired range, or the duration of hypoglycemic events and/or hyperglycemic events; and determining whether to trigger the change in settings based on multiple ones of the calculated metrics of glucose level control quality of the user, as taught by El-Khatib. This is because El-Khatib teaches multiple variables triggering a change allows for dynamic changing of the insulin doses, which one of ordinary skill would recognize as leading to more accurate adjustments to the settings (para. [0259-0260]).
However, modified Mazlish does not explicitly disclose wherein the first settings include weight values for a cost function used by the control approach in determining how much insulin to deliver to a user, and wherein the second settings contain at least one different one of the weight values for the cost function used by the control approach than the first settings.
Haidar teaches of an analogous method for controlling glucose concentrations in a patient using a closed loop artificial pancreas (Abstract). Haidar further teaches first settings for the closed loop artificial pancreas include weight values for a cost function used by the control approach in determining how much insulin to deliver to the user (Fig. 3, Fig. 4, para. [0048], para. [0083-0087]). Haidar further teaches the closed loop artificial pancreas includes second settings which contain at least one different one of the weight values for the cost function used by the control approach than the first settings (para. [0083-0087]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method disclosed by modified Mazlish to additionally adjust weight values for a cost function for the first and second settings, as taught by Haidar. This is because Haidar teaches modifying weights of a cost functions allows for an optimal basal deviation to be determined based on historical glucose values and what the glucose target is for the user, allowing a user to obtain better glycemic control (para. [0083], para. [0093]).
Regarding claim 3, modified Mazlish discloses the method of claim 1, wherein the second settings also have a different range of target glucose level values of the user that are permitted by the control approach than the first settings (para. [0155], “target blood glucose levels may correspond to one or more monitored sensory feedback signals … target blood glucose levels can be determined statistically or empirically by the controller device … implementing a secondary feedback loop …”).
Regarding claim 7, modified Mazlish discloses the method of claim 1, wherein the automatically changing of the first settings to the second settings is permanent in that the settings cannot be changed again (para. [0146], “warrant updating beyond or outside of the pre-determined range of values, an alert or notification may be sent to one or more entities/people who are authorized to approve such deviations …” - The closed loop system does not change the settings unless the change is authorized. If it is not authorized the settings are not changed again).
Regarding claim 8, modified Mazlish discloses the method of claim 1, wherein the automatically changing of the first settings to the second settings is temporary and wherein the method further comprises disabling the second settings with the processor (para. [0144-0145], “user consistently eats a meal at 12:00 PM, the underlying parameters and models may be updated to ensure that the user receives an increase in insulin dosing around 12:00 PM … determined that an updated is warranted, then an update to the parameters and/or models … can be determined …” - the updating of the settings is temporary until a change is warranted, and the second settings are “disabled” because the settings have been updated).
Regarding claim 10, modified Mazlish discloses the method of claim 9, wherein the method further comprises: disabling the second settings with the processor responsive to the calculated metrics of glucose level control quality of the user for a time after the changing to the second settings (Fig. 7B, para. [0145], “update is warranted, then an update to the parameters and/or models based, at least in part, on the data and the current parameters and/or models …”, para. [0147], “repeat operation … continually refine the user-specific dosage parameter and/or models …”, para. [0161], “initially calculate the dosage parameters … continue to update the dosage parameters during future iterations …”).
Regarding claim 11, modified Mazlish discloses the method of claim 9, wherein the method further comprises: responsive to the calculated metrics of glucose level control quality of the user for a time after the changing to the second settings: with the processor, automatically adjusting the settings to third settings that differ from the first settings and the second settings (Fig. 7B, para. [0145], “update is warranted, then an update to the parameters and/or models based, at least in part, on the data and the current parameters and/or models …”, para. [0147], “repeat operation … continually refine the user-specific dosage parameter and/or models …”, para. [0161], “initially calculate the dosage parameters … continue to update the dosage parameters during future iterations …”), or with the processor, providing a party with an ability to adjust the settings from the second settings to the third settings (para. [0146], “alert or notification may be sent to one or more entities/people who are authorized to approve such deviations …”).
Regarding claim 12, modified Mazlish discloses the method of claim 1, wherein the method further comprises: based on multiple ones of the calculated metrics of glucose level control quality of the user, determining to notify the user of a possibility of the second settings if the user has demonstrated glucose level control quality of a sufficient level to warrant access to the second settings (para. [0136], para. [0143-0145], para. [0174], “updated parameters and/or models can be provided/made available … triggering event notifications”).
Regarding claim 13, modified Mazlish discloses the method of claim 1, wherein the second settings pose a greater potential degree of hypoglycemia risk (Fig. 7B, element 456, element 458, element 460, para. [0072], para. [0144], “updated so that the user receives more or less insulin … underlying parameters and models may be updated to account for the observed patterns … user-specific dosage parameters can be determined and/or updated based on historical sensory feedback data …” - changing the amount of insulin changes an amount of hypoglycemic risk or hyperglycemic risk potential for the patient).
Regarding claim 14, modified Mazlish discloses the method of claim 1, wherein the second settings pose a greater potential degree of hyperglycemia risk (Fig. 7B, element 456, element 458, element 460, para. [0072], para. [0144], “updated so that the user receives more or less insulin … underlying parameters and models may be updated to account for the observed patterns … user-specific dosage parameters can be determined and/or updated based on historical sensory feedback data …” - changing the amount of insulin changes an amount of hypoglycemic risk or hyperglycemic risk potential for the patient).
Regarding claim 15, modified Mazlish discloses the method of claim 1, further comprising: receiving a request from the user to revert back to the first settings for the AID system; in response to the request, with the processor, reverting to the first settings for the AID system (Fig. 7A, element 416, para. [0132], “transition trigger has been detected … user may access a menu option displayed by the multi-modal delivery system and press a user interface button that triggers the user’s requested change …”).
Regarding claim 16, modified Mazlish discloses the method of claim 1, wherein the method further comprises: before the calculating of the metrics of glucose level control quality of the user, the second settings are not visible to the user or are visibly indicated as being unavailable to the user (para. [0143-0145], “determination can be made as to whether to update the parameters … user-specific dosage parameters (e.g., insulin sensitivity, carbohydrate ratio, insulin onset time, insulin on board duration, and basal rate profile) …” - the parameters are not visible to the user as they are stored within the controller device/computing device).
Regarding claim 18, modified Mazlish discloses the method of claim 1, wherein repeating of the steps of the method is triggered by a period of time elapsing, an event occurring or a condition arising (para. [0063], “every five minutes, makes a determination as to how much insulin to infuse over the next five minutes, and subsequently delivers said amount of insulin over that time period …”).
Regarding claim 19, Mazlish discloses a non-transitory computer-readable storage medium storing instruction that when executed by a processor cause the processor to (Abstract, Fig. 1A, Fig. 4, para. [0011], para. [0041], para. [0043-0044]):
establish first settings for a control approach of an automated insulin delivery (AID) system (Fig. 7A, element 402, element 408, para. [0120], “particular insulin delivery mode can be selected …”, para. [0125], “operates the multi-modal medicine delivery system in the selected delivery mode …”);
calculate metrics of glucose level control quality of the user, the metrics including a mean glucose level of the user over a period, a frequency that the glucose level of the user is in a desired range, or a duration of hypoglycemic events and/or hyperglycemic events (Fig. 7B, element 452, element 454, element 456, para. [0143-0145], “determination can be made as to whether to update the parameters and/or models that are currently being used … update may be determined to be warranted when the readings and dosage data fall outside of one or more predetermined threshold/target values … blood glucose reading of a user is consistently above or below a target … basal profile … may be updated … user-specific dosage parameters can be determined and/or updated based on historical sensory feedback data (e.g., historical blood glucose data) …”);
based on the calculated metrics of glucose level control quality of the user, determine whether to trigger a change in settings (Fig. 7B, element 456, element 458, element 460, para. [0143-0147], “update may be determined to be warranted when the readings and dosage data fall outside of one or more predetermined threshold/target values …”);
where the change in settings is triggered, automatically change the first settings of the AID system to second settings that have a different degree of aggressiveness than the first settings, where the degree of aggressiveness reflects an amount of hypoglycemic risk or hyperglycemic risk that is posed by the settings (Fig. 7B, element 456, element 458, element 460, para. [0072], para. [0144], “updated so that the user receives more or less insulin … underlying parameters and models may be updated to account for the observed patterns … user-specific dosage parameters can be determined and/or updated based on historical sensory feedback data …” - changing the amount of insulin changes an amount of hypoglycemic risk or hyperglycemic risk potential for the patient);
where change in settings is not triggered, not change the first settings to the second settings (Fig. 7B, element 456, para. [0145], “determined that the update is not warranted, the process repeats operations …”).
However, Mazlish does not explicitly disclose the metrics of glucose level control quality of the user include multiple ones of the mean glucose level of the user over a period, the frequency that the glucose level of the user is in a desired range, or the duration of hypoglycemic events and/or hyperglycemic events; and determining whether to trigger the change in settings based on multiple ones of the calculated metrics of glucose level control quality of the user.
El-Khatib teaches an analogous method of automated insulin delivery (Abstract, para. [0005]). El-Khatib further teaches calculating metrics of glucose level control quality of the user, the metric including multiple ones of a mean glucose level of the user over a period, a frequency that the glucose level of the user is in a desired range, or a duration of hypoglycemic events and/or hyperglycemic events, and based on multiple ones of the calculated metrics of glucose level control quality of the user, determining whether to trigger a change in settings (para. [0259-0260], “evaluation over a time horizon … in addition, adjustments can be evaluated and effected online when some metric satisfies a threshold or meets certain criteria … in addition, adjustments can be effected after some evaluation related to the glucose signal … mean value …”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the processor disclosed by Mazlish to explicitly be configured for calculating multiple ones of the mean glucose level of the user over a period, the frequency that the glucose level of the user is in a desired range, or the duration of hypoglycemic events and/or hyperglycemic events; and determining whether to trigger the change in settings based on multiple ones of the calculated metrics of glucose level control quality of the user, as taught by El-Khatib. This is because El-Khatib teaches multiple variables triggering a change allows for dynamic changing of the insulin doses, which one of ordinary skill would recognize as leading to more accurate adjustments to the settings (para. [0259-0260]).
However, modified Mazlish does not explicitly disclose wherein the first settings includes weight values for a cost function used by the control approach in determining how much insulin to deliver to a user, and wherein the second settings contain at least one different one of the weight values for the cost function used by the control approach than the first settings.
Haidar teaches of an analogous method for controlling glucose concentrations in a patient using a closed loop artificial pancreas (Abstract). Haidar further teaches first settings for the closed loop artificial pancreas include weight values for a cost function used by the control approach in determining how much insulin to deliver to the user (Fig. 3, Fig. 4, para. [0048], para. [0083-0087]). Haidar further teaches the closed loop artificial pancreas includes second settings which contain at least one different one of the weight values for the cost function used by the control approach than the first settings (para. [0083-0087]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method disclosed by modified Mazlish to additionally adjust weight values for a cost function for the first and second settings, as taught by Haidar. This is because Haidar teaches modifying weights of a cost functions allows for an optimal basal deviation to be determined based on historical glucose values and what the glucose target is for the user, allowing a user to obtain better glycemic control (para. [0083], para. [0093]).
Response to Arguments
Applicant’s arguments, see pages 8-11 of Remarks, filed 12/23/2025, with respect to the rejection(s) of claim(s) 1, 3, 6-16, 18, and 19 under 35 USC 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of El-Khatib et al. (WO 2021011738 A1), hereinafter referred to as El-Khatib.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KYLE W KRETZER whose telephone number is (571)272-1907. The examiner can normally be reached Monday through Friday 8:30 AM to 5:30 PM.
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/K.W.K./Examiner, Art Unit 3791
/JASON M SIMS/Supervisory Patent Examiner, Art Unit 3791