DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 26 August 2026 has been entered.
Status of Claims
Claim(s) 10, 14, 16-20, 23, 25-26, 30, 33 and 35-36 is/are currently amended. Claim(s) 1-9, 11, 21 and 31 has/have been canceled. Claim(s) 10, 12-20, 22-30 and 32-42 is/are pending.
Rejections Withdrawn
Rejections under 35 U.S.C. 112(a) (or pre-AIA 35 U.S.C. 112, first paragraph) and/or under 35 U.S.C. 112(b) (or pre-AIA 35 U.S.C. 112, second paragraph) made of record in the prior Office action (mailed 03 June 2026, "3rd Final Rejection") not reproduced below has/have been withdrawn in view of Applicant's amendments to the claims and/or submitted remarks.
Claim Rejections - 35 USC § 112
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 pre-AIA 35 U.S.C. 112, 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(s) 10, 12-20, 22-30 and 32-42 is/are rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, 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 pre-AIA the applicant regards as the invention.
Regarding claim 10, claim 20, claim 30 and claims dependent thereon, the limitation "coordinating distribution of the metabolic measurement data, the metabolic disturbance data, the metabolic treatment data, and an estimate of a glucose concentration input data to three or more control functions; computing, in a first control function of the three or more control functions, a first reference insulin infusion based, at least in part, on an estimate of a metabolic state and a first profile descriptive of a statistical insulin utilization for the patient, wherein the estimate of a metabolic state is derived, at least in part, from the metabolic measurement data and the metabolic treatment data" of claim 10 and the comparable limitations of claims 20 and 30 are indefinite.
The scope of "coordinating distribution" is unclear, particularly in view of Applicant's submitted remarks (e.g., page 18). Specifically, Applicant contends the disclosure of Thukral (US 2009/0006061 A1) "has modular software and that certain data are used in a basal recommendation calculation." The examiner agrees that Thukral has modular software. Further, Thukral discloses that certain data is used in various aspects of a basal recommendation calculation, as discussed in the prior Office action(s). It is unclear to the examiner how Thukral providing/routing the data necessary for those various aspects is different than "coordinating distribution…" of the present claims. In particular, it is unclear what, if anything, is required by "coordinating distribution" beyond merely providing/routing the recited data to a "control function" (functional unit, module, algorithm, etc.) requiring that data. Indeed, Applicant's own disclosure indicates the system coordinator acts as a "router" (pg. 11, lines 11-16).
Secondly, the relationship between "an estimate of a glucose concentration" and "an estimate of a metabolic state" is unclear. Applicant discloses an "estimate of a metabolic state," produced by the short-term observer, requires at least an estimate of glucose concentration (e.g., pg. 9, lines 25-31). Accordingly, it is unclear if the above-noted limitations are intended to indicate that the "estimate of a metabolic state" utilized by the first control function is the "estimate of a glucose concentration" distributed to the first control function, or the "estimate of a metabolic state" is/comprises a separate/different estimate of glucose concentration than the glucose estimate distributed to and used by the second control function.
Thirdly, in view of the second point discussed above, as there is no clear indication in the claims that any of the distributed data (metabolic measurement data, metabolic disturbance data, metabolic treatment data, or an estimate of a glucose concentration) is utilized by the first control function in computing the first reference insulin infusion, it is unclear what is/may be distributed to the first control function. Given that none of the recited data is clearly distributed to the first control module, it is unclear to what at least third "control module" said data is distributed. Additionally, none of the claimed control functions are recited as directly using the metabolic measurement data or the metabolic treatment data in their respective insulin infusion computations. Accordingly, it is similarly unclear to what "control modules" the metabolic measurement and/or treatment data is distributed.
Regarding claim 14, claim 23 and claim 33 and claims dependent thereon, the limitation "wherein the first residual insulin infusion is computed based, at least in part, on the estimated second glucose excursion" of claim 14 and the comparable limitations of claims 23 and 33 are indefinite. Applicant discloses the meal (third) control function estimates a glucose excursion in response to a meal, or in anticipation of a meal arrival (pg. 13, lines 1-22); the system coordinator estimates a glucose concentration offset by the estimated contribution of meals based on a metabolic state estimate and the glucose excursion due to meals computed by the meal (third) control function (pgs. 30-10); and the compensation control to target (second) control function uses said glucose concentration calculated by the system coordinator to compute a residual insulin value (pgs. 14, lines 1-19). In view of the above, the relationship between the estimate of a glucose concentration used by the second control function and the "estimated second glucose excursion" of claims 14, 23 and 33 is unclear (i.e., are these the same value and/or is the same value somehow utilized twice; are a distinct glucose concentration and a glucose excursion used by the second control function; etc.).
Regarding claim 17, claim 19, claims 26-27, claims 36-37 and claims dependent thereon, the limitation "assessing at least one of the first profile, the second profile, or the third profile" of claim 17, the limitation "assessing the first profile, the second profile, and the third profile at least monthly" of claim 19, and the comparable limitations of claims 26-27 and 26-27 are indefinite. It is unclear what is required by "assessing" the profile(s), particularly as there is no indication in the respective independent claims that the profiles are produced by the method or system as claimed. Rather, the pending claims appear to only require the profile to be used by respective control functions. Does "assessing" the profile(s) indicate that the method/system as claimed is generating/estimating said profile(s) (claim 17), e.g., monthly (claim 19), or is some different or separate "assessment" of an externally generated profile(s) that is/are used by the control functions of the method/system performed, e.g., monthly? If the latter, it is further unclear what such an assessment requires/encompasses and how, if at all, said assessment factors into determining an insulin infusion.
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of pre-AIA 35 U.S.C. 112, first paragraph:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim(s) 10, 12-20, 22-30 and 32-42 is/are rejected under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claim 10, claim 20, claim 30 and claims dependent thereon, as discussed above, the relationship between the "estimate of a glucose concentration" and the "estimate of a metabolic state" is unclear. It is unclear if these are the same value (i.e., the "estimate of a metabolic state" is the "estimate of a glucose concentration," and is derived based on the metabolic measurement data and the metabolic treatment data") or each estimate is a different glucose concentration value. If it is Applicant's intention that these are the same glucose concentration value, this limitation appears to lack sufficient support in the application as filed. Applicant discloses the estimate of metabolic state (and/or glucose concentration) utilized by the daily profile (first) control function to compute a reference insulin signal is the metabolic state data is derived from metabolic measurement and treatment data by a short-term observer module (x̃̂(t)) (pg. 12, lines 11-17). Applicant discloses the glucose concentration utilized by the compensation control to target (second) control function to compute a residual insulin signal is an estimate of blood glucose concentration offset by the estimated contribution of meals derived by the system coordinator (gr(t)) (pg. 11, line 30 – pg. 12, line 5; pg. 14, lines 2-16). Even if it is Applicant's intention that the claimed metabolic state estimate and estimate of glucose concentration are different values, as noted above, Applicant only discloses a particular estimate of glucose concentration (i.e., glucose concentration offset by the estimated contribution of meals) that is utilized by the compensation control to target (second) control function, particularly when the meal (third) control function is active as is required by the present claims. Accordingly, assuming that the estimate of metabolic state and the estimate of glucose concentration are intended to be different values, the full scope/breadth of the claim as presented is still not sufficiently supported by the application as filed.
The limitation "coordinating distribution of the metabolic measurement data, the metabolic disturbance data, the metabolic treatment data, and an estimate of a glucose concentration input data to three or more control functions" of claim 10 and the comparable limitations of claims 20 and 30 lack sufficient support in the application as filed. While Applicant uses the language "one or more control modules" throughout the specification as filed (e.g., pg. 24, line 15 – pg. 25, line 18), only three control modules are sufficiently described, the daily profile, compensation control to target, and meal control modules/functions. The remaining sufficiently described module to which the system coordinator distributes data is not described as a control module/function, but a safety module/function. Accordingly, Applicant fails to sufficiently disclose more than three control functions to which distribution of data is coordinated, such that the full scope of the above-noted limitation lacks sufficient support in the application as filed.
The limitation "computing, in a second control function of the three or more control functions, a first residual insulin infusion based, at least in part, on the estimate of a glucose concentration and a second profile descriptive of patient behavior for the patient that is at least a function of time of day" lacks sufficient support in the specification as filed. Applicant discloses the compensation control to target (second) control function utilizes an exercise behavioral profile as a function of a time of day produced by a long-term observer module, η(t) (pg. 8, line 19 – pg. 9, line 5). Applicant discloses at least one additional behavior profile that is descriptive a patient's meal behavior as a function of time of day, β(t). Applicant fails to disclose using any behavior profile other than the exercise behavior profile in the compensation control to target (second) control function. However, the language of the claims is not limited to which behavior profile is utilized by said control function, therefore reasonably encompassing using the meal behavior as a function of time of day as the "second profile." As this lacks sufficient support in the application as filed, the full scope of the above-noted limitation lacks sufficient support in the application as filed.
The examiner notes each of the above rejections of the independent claims under both 35 U.S.C. 112(a) and 35 U.S.C. 112(b) could be overcome by amending the independent claims within the scope of the following, e.g., with respect to claim 10:
A method of adaptive diabetes control by a diabetes control system, the method comprising:
receiving input data including:
metabolic disturbance data;
a first estimate of a metabolic state, wherein the first estimate of a metabolic state is derived, at least in part, from metabolic measurement data including a first glucose input reflective of glucose sample processing of a patient by a continuous glucose monitor (CGM) sensor, and metabolic treatment data including a first insulin delivery command representing a most recent command to an insulin delivery device relative to a time of the first glucose input;
a first profile descriptive of a statistical insulin utilization of the patient as a function of time of day;
a second profile descriptive of exercise behavior of the patient as a function of time of day; and
a third profile descriptive of meal behavior of the patient as a function of time of day;
determining an estimate of glucose concentration offset by an estimated excursion due to meals based, at least in part, on the estimate of metabolic state;
coordinating distribution of the received input data and the estimate of glucose concentration offset by the estimated contribution of meals to three control functions;
computing, in a first of the three control functions, a first reference insulin infusion based, at least in part, on the first estimate of a metabolic state and the first profile;
computing, in a second of the three control functions, a first residual insulin infusion based, at least in part, on the estimate of glucose concentration offset by the estimated contribution of meals and the second profile;
computing, in a third of the three control functions, a first meal accommodation insulin infusion based, at least in part, on the metabolic disturbance data and the third profile;
determining a first total insulin infusion based on the first reference insulin infusion, the first residual insulin infusion, and the first meal-accommodation insulin infusion; and
commanding the insulin delivery device to deliver the determined first total insulin infusion via a second insulin delivery command.
Regarding claim 14, claim 23 and claim 33 and claims dependent thereon, Applicant discloses the meal (third) control function estimates a glucose excursion in response to a meal, or in anticipation of a meal arrival (pg. 13, lines 1-22); the system coordinator estimates a glucose concentration offset by the estimated contribution of meals based on a metabolic state estimate and the glucose excursion due to meals computed by the meal (third) control function (pgs. 30-10); and the compensation control to target (second) control function uses said glucose concentration calculated by the system coordinator to compute a residual insulin value (pgs. 14, lines 1-19). The value derived by the system coordinator based on the glucose excursion due to meals is a glucose concentration, rather than a glucose "excursion." Accordingly, the limitations "estimating, based on the estimated first glucose excursion, a second glucose excursion from the target that is not due to the at least one of a meal or a response to a meal, wherein the first residual insulin infusion is computed based, at least in part, on the estimated second glucose excursion" of claim 14 and the comparable limitations of claims 23 and 33 lack sufficient support in the application as filed. Consistent with the claim language of claim 10 above, amendments to claim 14 commensurate in scope with the following would similarly overcome the above rejection, "The method of claim 10, further comprising: estimating, in the third control function, a first glucose excursion from a target due to at least one of a meal or a response to a meal, wherein determining the estimate of glucose concentration offset by an estimated excursion due to meals is based on the estimated first glucose excursion.
Allowable Subject Matter
Claims 10, 20 and 30 would be allowable if rewritten or amended to overcome the rejections under 35 U.S.C. 112(a) (or pre-AIA 35 U.S.C. 112, first paragraph) and under 35 U.S.C. 112(b) (or pre-AIA 35 U.S.C. 112, second paragraph), set forth in this Office action (e.g., within the scope of the exemplary claim language noted above).
Applicant's arguments with respect to prior art rejections, in view of the above-noted understanding of the difference between the recited estimate of a metabolic state and the particular glucose concentration used by the second control function (i.e., estimate of glucose concentration offset by an estimated excursion due to meals based, at least in part, on the estimate of metabolic state) commensurate in scope with/sufficiently supported by the application as filed as disclosed above, have been fully considered and are persuasive. Therefore, the prior art rejections under pre-AIA 35 U.S.C. 103(a) have been withdrawn.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Meredith Weare whose telephone number is 571-270-3957. The examiner can normally be reached Monday - Friday, 9 AM - 5 PM.
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/Meredith Weare/Primary Examiner, Art Unit 3791
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