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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 01/07/2026 has been entered.
Applicant Response
Applicant's response, filed 01/07/2026, has been fully considered. Rejections and/or objections not reiterated from previous Office Actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claim Status
Claims 1-20 and 37-39 are canceled.
Claims 41-43 are newly added.
Claims 21-36 and 40-43 are pending and under examination herein.
Claim 26 is objected to.
Claims 21-36 and 40-43 are rejected.
Priority
The instant application, filed 07/27/2020 is a Continuation of 15/354451 , filed 11/17/2016, which is a Divisional of 13/870910 , filed 04/25/2013, which claims priority from US Provisional Applications 61/694950 filed 08/30/2012, 61/694961 filed 08/30/2012, and 61/812874 filed 04/17/2013. As such, the effective filing date assigned to each of claims 21-36 and 40-43 is 08/30/2012.
Information Disclosure Statement
The Information Disclosure Statement filed 01/07/2026 is in compliance with the provisions of 37 CFR 1.97 and has therefore been considered. A signed copy of the IDS is included with this Office Action.
Claim Objections
Claim 26 is objected to because of the following informalities: “comprises” should be “further comprises”. Appropriate correction is required. This objection is newly recited and necessitated by claim amendments.
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.
Claims 21-36 and 40-43 appear free of a rejection under 35 U.S.C. 101, as the claims integrate the judicial exception into practical application with the additional elements in the independent claims. Specifically, the limitations in the independent claims of “operating the insulin infusion device to deliver the insulin in a different mode based on the determination that the difference exceeds the threshold amount to lower the glucose level of the patient toward the target glucose range” integrate the recited judicial exceptions into practical application under Step 2A, Prong 2, because the additional elements apply or use the recited judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition (Step 2A, Prong 2: YES).
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 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.
Claims 25 and 32 are 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. This rejection is newly recited after further consideration.
Claim 25 and 32 recites the limitation "the training sampling period" in line 2, respectively. There is insufficient antecedent basis for this limitation in the claim, as claims 23 and 30, on which claims 25 and 32 respectively depend from, do not recite “a training sampling period”.
Claim Rejections - 35 USC § 102
(e) the invention was described in a patent granted on an application for patent by another filed in the United States before the invention thereof by the applicant for patent, or on an international application by another who has fulfilled the requirements of paragraphs (1), (2), and (4) of section 371(c) of this title before the invention thereof by the applicant for patent.
The changes made to 35 U.S.C. 102(e) by the American Inventors Protection Act of 1999 (AIPA) and the Intellectual Property and High Technology Technical Amendments Act of 2002 do not apply when the reference is a U.S. patent resulting directly or indirectly from an international application filed before November 29, 2000. Therefore, the prior art date of the reference is determined under 35 U.S.C. 102(e) prior to the amendment by the AIPA (pre-AIPA 35 U.S.C. 102(e)).
Claims 21-23, 26-30, 33-36 and 40-43 are rejected under pre-AIA 35 U.S.C. 102(e) as being anticipated by Sloan et al. US8597274B2; hereafter referred to as Sloan; newly cited). This rejection is newly cited and necessitated by claim amendments.
With respect to claims 21-22, 28-29 and 35-36, Sloan discloses systems and methods for management of a user's glucose level, including systems and methods for improving the usability and safety of such systems, and further discloses systems with devices such as computers, continuous glucose monitors and a drug delivery pumps (fig 1; col 2, lines 32-36; col 5, line56-col 6, line 29).
Sloan further discloses the system may be a closed-loop, semi closed-loop, or open loop system operable in a conventional manner to deliver insulin, as appropriate, based on glucose information provided thereto by the user (col 8, lines 1-23 and 60-64). Sloan discloses that in the system a controller is programmed to provide a “basal rate” of insulin delivery or administration, which is the rate of continuous supply of insulin by an insulin delivery device such as a pump that is used to maintain a desired glucose level in the user, and in a typical situation, an insulin pump normally delivers insulin without user intervention when delivering the insulin at the basal insulin delivery rate (i.e. an automatic mode) (col 13, lines 45-49; col 14, lines 1-3).
Sloan discloses obtaining user glucose concentration and interstitial glucose level from the user and/or analyte monitors(col 8, line 10-13; col 13, lines 58-59; claim 1).
Sloan further discloses providing a glucose level and predicting a future glucose level in order to determine an appropriate insulin bolus value for a latest control command, and further discloses models are used to estimate current glucose level or to predict future glucose levels, using a model based state estimation to determine predicted future glucose level and assess the likelihood that a CGM measurement that exceeds a high or low threshold is due to a true event or sensor artifact and that the likelihood is determined by comparing the difference between the latest CGM measurement and interstitial glucose computed by the model prior to the latest CGM measurement (col 4, lines 10-16; col 4, lines 24-27; col 13, lines 33-34).
Sloan further discloses using the likelihood to adjust a tiered alarm mechanism and changing the alarm threshold (i.e. the delay for sounding the hypoglycemia/hyperglycemia alarm), such as when the likelihood reaches a risk level (“The same types of mechanisms may be applied to hyperglycemia detection, with the tiered thresholds increasing in the order of threshold values. For example, where the CGM glucose level crosses a 180 mg/dL threshold the longest delay time is implemented; where the CGM glucose level crosses a 200 mg/dL threshold, a shorter delay time is implemented before sounding an alarm; and where the CGM glucose level crosses a 220 gm/dL threshold, an even shorter delay time is implemented, up to a maximum threshold with a zero delay time“)(col 24, like 13-col 25, line 14). As the methods and systems of Sloan perform an action after the determination that the likelihood reaches a risk level, it also suggests that the action is performed when the likelihood exceeds the risk level.
Sloan further discloses if the user has a system including a CGM and an insulin delivery pump, information from the devices can be pooled or shared, and a model-based monitoring system can be used to modify the alarm mechanism to more efficiently minimize false alarms without imposing unnecessary risk to the patient (col 24, lines 13-17). Sloan also discloses that at times, however, the pump may detect conditions that warrant providing an alarm or other signal to the user that intervention in the insulin delivery by the user is necessary, and deliver a manual correction bolus of insulin to bring their glucose level back within an acceptable range (col 14, line 1-33; col 21, lines 17-44).
With respect to claims 23 and 30, Sloan discloses , the model based state estimation is a Kalman filter (which use measurements observed over time), using information from CGM and insulin delivery pumps (col 4, lines 17-18; col 24, lines 13-41).
With respect to claims 26, 33 and 40, Sloan discloses a Kalman framework may be used to determine the likelihood for a predicted future glucose level, given the user's current CGM glucose level and other insulin delivery history (col 24, lines 39-41). Sloan further discloses these models are used to estimate current glucose level or to predict future glucose levels and that such models may also take into account unused insulin remaining in the user (col 13, lines 33-38) Sloan further discloses the insulin pump is configured to wirelessly transmit information relating to insulin delivery to the handheld device, and that the system is able to track the IOB amount by keeping track of insulin delivery data corresponding to the actual delivery of insulin to the user (col 9, lines 12-17; col 16, lines 24-31).
With respect to claims 27, 34 and 42, Sloan discloses obtaining current values of glucose using a measurement from CGM device (i.e. a interstitial sensor), and further that the model based state estimation assesses the likelihood that a CGM measurement that exceeds a high or low threshold is due to a sensor artifact, such as sensor drop-out (col 2, lines 65-66; col 4, lines 21-23).
With respect to claims 27, 34 and 42, Sloan discloses obtaining current values of glucose using a measurement from CGM device (i.e. a interstitial sensor), and further that the model based state estimation assesses the likelihood that a CGM measurement that exceeds a high or low threshold is due to a sensor artifact, such as sensor drop-out (col 2, lines 65-66; col 4, lines 21-23).
With respect to claim 41, Sloan discloses computing interstitial glucose by the model (col 4, lines 10-26).
With respect to claim 43, Sloan discloses for users with insulin pumps, open-loop operation typically includes a pre-programmed insulin basal rate, suggesting that while operating in manual mode, the insulin pump can deliver a pre-programmed insulin basal rate of insulin (col 15, lines 44-46).
Claim Rejections - 35 USC § 103
The rejections of claims 37-39 under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Yodfat et al. (US9457145B2; hereafter referred to as Yodfat; previously cited), in view of Jacobs et al. (Annual International Conference of the IEEE Engineering in Medicine and Biology Society 2011, Boston, MA, USA, pp. 397-400; hereafter referred to as Jacobs; previously cited) are withdrawn in view of cancelation of the claims in the claim amendments filed 01/07/2026.
The rejections of claims 21, 23-28, 30-35, and 40 under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Yodfat et al. (US9457145B2; hereafter referred to as Yodfat; previously cited), in view of Jacobs et al. (Annual International Conference of the IEEE Engineering in Medicine and Biology Society 2011, Boston, MA, USA, pp. 397-400; hereafter referred to as Jacobs; previously cited) are withdrawn in view of claim amendments filed 01/07/2026, as the cited prior art does not appear to disclose determination of a predicted value for the glucose level of the patient that is a different parameter than a target glucose value representing the patient being euglycemic, determining a difference between the current value and the predicted value, and determining that the difference exceeds a threshold amount.
The rejections of claims 22, 29 and 36 under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Yodfat et al. (US9457145B2; hereafter referred to as Yodfat; previously cited), in view of Jacobs et al. (Annual International Conference of the IEEE Engineering in Medicine and Biology Society 2011, Boston, MA, USA, pp. 397-400; hereafter referred to as Jacobs; previously cited), as applied to claims 21, 28 and 35 above, and further in view of Scaramuzza et al. (Diabetes Technology & Therapeutics 2011, 13.2: 99-103;hereafter referred to as Scaramuzza; previously recited) are withdrawn in view of claim amendments filed 01/07/2026, as the cited prior art does not appear to disclose determination of a predicted value for the glucose level of the patient that is a different parameter than a target glucose value representing the patient being euglycemic, determining a difference between the current value and the predicted value, and determining that the difference exceeds a threshold amount.
Response to applicant’s arguments
Applicant stated that the prior art does not teach “operating the [device]…in response to…” and further states the prior art do not teach the newly added claim limitations of determining the predicted value and that the predicted value is a different parameter than a target glucose value representing the patient being euglycemic (Applicant’s Arguments, p 7, para 2-p 10, para 1).
The argument that the prior art do not teach the newly added claim limitations was found to be persuasive, and the rejections were withdrawn. New prior art has been cited to teach these limitations. However, it is noted that the amended claims no longer recite “in response to”.
Prior Art
Claims 24-25 and 31-32 appear to be free from prior art as the closest prior art do not appear to suggest or teach that the sampling periods comprising a training and predication sampling period, or that a baseline glucose value is obtained during the training sampling period.
The prior art to Sloan et al. (US8597274B2; newly cited; hereafter referred to as Sloan) discloses the model based state estimation is a Kalman filter (which use measurements observed over time) (col 4, lines 17-18; col 24, lines 13-41).
The prior art to Dassau et al. (Diabetes care, 33(6), 1249-1254; newly cited; hereafter referred to as Dassau) discloses a real-time hypoglycemia prediction algorithm (HPA) combines five individual algorithms, including a Kalman filter and statistical predication algorithm which is divided into three components: 1) calibration, which converts raw CGM and capillary blood glucose measurements into a physiologically consistent, accurate blood glucose history; 2) prediction, which uses training data and the recent calibrated blood glucose history to generate predictions and associated accuracy estimates; and 3) hypoglycemic alarming, which transforms the predictions and accuracy estimates into a probability of the patient becoming hypoglycemic, which is then thresholded into a binary alarm (abstract; p 1250, col 2, para 1-p 1251, col 1, para 1).
The prior art to Cinar and Oruklu (US20110106011A1; newly cited; hereafter referred to as Cinar), also discloses a method and device for monitoring or treating patient glucose levels, in which device includes a glucose sensor for measuring a glucose level of a patient, a physiological status monitoring system for measuring at least one physical or metabolic variable of the patient, and an automatic controller in communication with the glucose sensor and the physiological status monitoring system and the controller includes a prediction module for automatically predicting a future glucose level using data measured by the glucose sensor and the physiological sensor (abstract). Cinar further discloses a patient-specific recursive modeling strategy that describes glucose homeostasis in the patient body using models are developed from a patient's continuous glucose monitoring (CGM) device data by using time-series model identification techniques (para 0006; para 0041). Cinar further discloses the model developed is subject-specific and dynamically captures inter- or intra-subject variability, with parameters first being identified recursively using the weighted RLS using glucose measurements at different timesteps ( including recent history), taking fasting conditions into account, and that the modeling algorithm estimates future glucose and physiological signal levels using recent history of measurements only (para 0043-0050).
However, none of Sloan, Dassau, nor Cinar appear to disclose that the sampling periods comprising a training and predication sampling period, or that a baseline glucose value is obtained during the training sampling period.
Conclusion
No claims allowed.
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/N.D./ Examiner, Art Unit 1686
/Karlheinz R. Skowronek/ Supervisory Patent Examiner, Art Unit 1687