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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 2/24/2026 has been entered.
Claim Rejections - 35 USC § 112
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 the first paragraph of pre-AIA 35 U.S.C. 112:
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.
Claims 1-12 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 1, 5 and 9 recite the limitation “in response to a detected increase in glucose, infusing only the selected insulin in accordance with the adjusted control of the basal infusion”. Instant applications PG PUB [0010] recites this limitation but does not disclose that ‘only’ the selected insulin may be delivered. The recitation in [0010] is broad “infusing the selected insulin in accordance with the adjusted control” such that the method/system could encompass delivering another treatment along with the selected insulin.
Allowable Subject Matter
The following is a statement of reasons for the indication of allowable subject matter:
Regarding independent claims 1, 5, and 9, the prior art fails to disclose singly or in combination before the effective filing date, the claimed method, system and non-transient computer readable medium.
The closest prior art of record is Crecil Dias, Cifha, Surekha Kamath, and Sudha Vidyasagar. "Blood glucose regulation and control of insulin and glucagon infusion using single model predictive control for type 1 diabetes mellitus." IET Systems Biology 14.3 (2020): 133-146. Hereinafter “Crecil”.
Crecil teaches a method of artificial pancreas (AP) control for attaining normoglycemia following an unannounced meal of a subject (see Pg. 140 col 2 last full paragraph teaching the linear MPC is developed to respond to Disturbance: random disturbance of meal (unannounced meal)), comprising:
for a selected insulin, determining at least a corresponding absorption level (See Pg. 139 Col 1 first paragraph teaching how the model estimates the predicted glucose trajectory from the insulin infusion rate, “The glucose concentration predictions only depend on x^kk−1, yk and the insulin infusion rates.”, this is considered to the ‘determining a corresponding absorption level’ of the insulin);
based on a corresponding duration of insulin action (DIA) in dependence on the at least a corresponding absorption level, adjusting the control to change, from a datum, at least a first control parameter configured to avoid insulin stacking by penalizing insulin deviation in a rate of insulin delivery from basal rate (See Pg. 139 Col 1 first paragraph teaching a ‘damping parameter λ’ to prevent too large changes in insulin infusion rate; the examiner takes the position that damping parameter λ is a control parameter ‘penalizing’ deviation from basal rate (large changes in insulin infusion rate)) and at least a second control parameter configured to represent a difference in dosage between two consecutive insulin infusions (See Pg. 139, col 2 paragraph after equation (45) teaching a second control parameter Uk, representing a difference between the insulin infusion rate at two consecutive time measurements); and
in response to a detected increase in glucose, infusing the selected insulin in accordance with the adjusted control of the basal insulin infusion (Pg. 139 col 2 last paragraph "Then an optimal control law is formulated subjected to the prediction model, control inputs, and output constraints. The main objective is to avoid and to reduce the occurrence of hyperglycaemia and hypoglycaemia."; also see Fig 11 on Pg. 140 showing the MPC includes a step of infusing insulin if there is a detected increase in BG).
Crecil does not specify that only the selected insulin is delivered in response to a detected increase glucose. Furthermore, no art was found that would have made it obvious to one having ordinary skill in the art to modify Crecil to satisfy these limitations.
Response to Arguments
Applicant’s arguments, see Pgs. 5-9, filed 2/2/2026, with respect to the rejection(s) of claim(s) 1,5 and 9 under 35 USC 102 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a 35 USC 112(a) new matter rejection is made in view of the amendments filed 2/2/2026.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Yodfat et al. (US 20110224646) teaches a method of determining appropriate dosage of insulin based on a first control parameter (see [0062] and Fig 4, 404 teaching comparing BG to the TBG) and at least a second control parameter representing a difference between two consecutive insulin infusions (see [0012]).
Hayter et al. (US 20100298685) teaches an adaptive insulin delivery system that takes into consideration glucose absorption profiles based on meal information.
Vinas et al. (US 20190192774) teaches an adaptive bolus control calculator including an insulin absorption pharmacokinetic (PK) model.
Doyle et al. (US 20140200559) teaches a controller response to unannounced meals, including a parameter ID’(k) representing a deviation insulin delivery rate from basal(k).
Zheng et al. (US 20220241503) teaches a method of AP control using a calculation of adjusted basal need based on DIA.
Kovatchev (WO 2008067284) teaches a control algorithm to recommend changes to insulin delivery based on defining an actuation period, time between two consecutive update of insulin injection (Pg. 17 lines 14-20).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NEERAJA GOLLAMUDI whose telephone number is (571)272-6449. The examiner can normally be reached Mon-Fri 8-5.
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/NEERAJA GOLLAMUDI/ Examiner, Art Unit 3783
/WESLEY G HARRIS/Examiner, Art Unit 3783
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