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 .
Status of Claims
Applicant's arguments, filed 06/05/2026, 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 06/05/2026.
Applicants have amended claims 1, 12, and 19.
Applicants have left claims 3, 7, 8, 10, 11, 13-16, 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Claim 20 remains withdrawn from further consideration by the examiner, as being drawn to a non-elected invention, the election made without traverse in the Non-Final Rejection mailed on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Claim Objections - Withdrawn
Response to Arguments
Applicant’s arguments, see page 7 of Remarks, filed 06/05/2026, with respect to claim 1 have been fully considered and are persuasive. Applicants have amended the claim rendering the objection moot. The objection of claim 1 has been withdrawn.
Claim Rejections - 35 USC § 112 - Withdraw
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.
Response to Arguments
Applicant’s arguments, see pages 7-8 of Remarks, filed 06/05/2026, with respect to claim 12 have been fully considered and are persuasive. Applicants have amended the claim rendering the 112(b) rejection moot. The 112(b) rejections of claim 12 has been withdrawn.
Claim Rejections - 35 USC § 103 - Maintained
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) (previously cited), 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 the multiple ones of the calculated metrics of glucose level control quality of the user, determining whether to trigger a change in settings; where the change 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 from that of 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 from that of 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 the 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 the 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 the 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: determining to notify the user of a possibility of the second settings if the user has demonstrated glucose level control quality that meets a threshold level based on the multiple ones of the calculated metrics of glucose level control quality of the user 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 from that of 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 the 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 the 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 the 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 filed 06/05/2026 have been fully considered but they are not persuasive.
Applicants have argued on pages 8-11 of Remarks, filed 06/05/2026, that “El-Khatib does not teach the claimed ‘multiple ones of’ requirement” … the primary basis for Tmax adaptation is the ‘glucose-control performance’ - a single, overarching assessment. The specific items that follow are secondary indicators introduced by ‘including’ and connected by ‘or’, presenting them as alternative indications …”.
The Examiner respectfully disagrees. As recited above, El-Khatib explicitly teaches evaluating a glucose level control based on multiple different criteria by reciting “in addition” (see para. [0260]).
Applicants have argued on page 11 of Remarks, filed 06/05/2026, that “First, El-Khatib’s evaluation … not whether to trigger a conditional change … Second, the purpose of El-Khatib’s evaluation is fundamentally different from the claimed invention …”.
The Examiner respectfully disagrees. First, in response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). As recited above, the rejection relies on at least Mazlish in view of El-Khatib for teaching the claimed change in settings. Second, as recited above, El-Khatib explicitly teaches adjusting a control parameter, for explain different dosing, based on an evaluation of the multiple different criteria (para. [0259-0260]).
Applicants have argued on page 12 of Remarks, filed 06/05/2026, that “Haidar’s changes to the cost function weights are not triggered based on the calculated metrics of glucose level control quality of the user …”.
The Examiner respectfully disagrees. Applicants cited para. [0048] of Haidar explicitly recites “The cost functions and the weighting depend on one or more of the following values including, but not limited to time since meal, meal size, and exercise level”. As reiterated in the rejection, Haidar further recites the cost function can further be changed on multiple different parameters, including glucose values (para. [0083-0087]).
Applicants have argued on pages 12-13 of Remarks, filed 06/05/2026, “the three-reference combination itself is the product of impermissible hindsight reconstruction … the Examiner’s motivation statements … are generic statements that could justify combining any AID system features …”.
First, as reiterated above, specific cited reasoning is provided, specifically, utilizing multiple variables for adjusting settings provides for dynamic changing, increasing adjustment accuracy (El-Khatb; para. [0259-0260]), and utilizing a cost function and modifying a cost function based on historical glucose values/target values allows for better glycemic control of the patient (Haidar; para. [0083], para. [0093]). Second, "[a]ny judgment on obviousness is in a sense necessarily a reconstruction based on hindsight reasoning, but so long as it takes into account only knowledge which was within the level of ordinary skill in the art at the time the claimed invention was made and does not include knowledge gleaned only from applicant’s disclosure, such a reconstruction is proper." In re McLaughlin, 443 F.2d 1392, 1395, 170 USPQ 209, 212 (CCPA 1971).
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to 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
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