Prosecution Insights
Last updated: July 17, 2026
Application No. 18/390,081

SYSTEM COORDINATOR AND MODULAR ARCHITECTURE FOR OPEN-LOOP AND CLOSED-LOOP CONTROL OF DIABETES

Non-Final OA §101§103§112
Filed
Dec 20, 2023
Priority
May 29, 2009 — provisional 61/182,454 +5 more
Examiner
WEARE, MEREDITH H
Art Unit
3791
Tech Center
3700 — Mechanical Engineering & Manufacturing
Assignee
University of Virginia Patent Foundation
OA Round
1 (Non-Final)
50%
Grant Probability
Moderate
1-2
OA Rounds
1y 3m
Est. Remaining
82%
With Interview

Examiner Intelligence

Grants 50% of resolved cases
50%
Career Allowance Rate
353 granted / 706 resolved
-20.0% vs TC avg
Strong +32% interview lift
Without
With
+32.4%
Interview Lift
resolved cases with interview
Typical timeline
3y 10m
Avg Prosecution
44 currently pending
Career history
763
Total Applications
across all art units

Statute-Specific Performance

§101
11.3%
-28.7% vs TC avg
§103
63.4%
+23.4% vs TC avg
§102
2.1%
-37.9% vs TC avg
§112
16.2%
-23.8% vs TC avg
Black line = Tech Center average estimate • Based on career data from 706 resolved cases

Office Action

§101 §103 §112
DETAILED ACTION Notice of Pre-AIA or AIA Status The present application is being examined under the pre-AIA first to invent provisions. In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status. Response to Amendment The preliminary amendment to the claims filed 20 December 2023 has been entered. Claims 1-9 have been canceled. New claims 10-39 have been added, and are pending. Information Disclosure Statement (IDS) Non-Patent Literature Cite No. 25 on the IDS submitted 20 December 2023 has not been considered. Applicant has not provided sufficient identifying information (e.g., as required by 1.98(b)(5)) for the examiner to determine to which publication the citation refers. Claim Objections Claim(s) 22 is/are objected to because of the following informalities: "system of claim 212" contains an obvious typographical error that should be corrected to "system of claim 21." Appropriate correction is required. 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) 12, 15-16, 19, 23, 27-28, 31, 36, 39 and claims dependent thereon 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 12, claim 23 and claims dependent thereon, the limitation "determining, based on at least one of the first data or the second data, that there is an increased risk of hypoglycemia" of claim 12 and the comparable limitation of claim 23 is indefinite. "Increased risk" is a relative term. It is unclear on what basis (i.e., relative to what) a determination that risk is "increased" is based. Regarding claims 15-16, claims 27-28, claim 36 and claims dependent thereon, the limitations "the first data and the second data each includes a representation of a behavioral pattern of the patient" and "the first data and the second data each includes a representation of a metabolic state of the patient" of claims 15-16, and the comparable limitations of claims 27-28 and 36 are indefinite. Applicant discloses, "The one or more observer modules may include a short term observer module. The short term observer module may contain information relating to: metabolic state; meal excursion; and/or metabolic state and meal excursion. The short term observer module observes X times per hour, where X is 0<X<7200. It should be appreciated that the frequency may be greater or less as desired or required. The short term observer module may be configured to output one of the following: a vector of estimates of key metabolic states of an individual; a single, processed glucose sample at a specific time, or a history of glucose samples up to a specific time, or a statistic computed from glucose samples up to a specific time; or both the vector of estimates of key metabolic states and the sample or history of processed glucose samples. The vector of estimates may include plasma glucose and plasma insulin. The one or more observer modules may include a long term observer module. The long term observer module may contain information relating to behavioral profiles. The behavioral profiles may be daily behavioral profiles, but may vary as desired or required. The long term observer module may assess behavioral profiles X times per month, where X is 0<X<60. It should be appreciated that the frequency may be greater or less as desired or required. The long term observer module may be configured to output one or more of the following types of information: a daily profile of an individual's meal behavior as a function of the time of day; a daily profile of the individual's exercise behavior as a function of the time of day; and a daily profile of the individual's utilization of insulin as a function of the time of day" (¶¶ [0315]-[0316] as published). Applicant does not appear to disclose any one profile output by the long-term observer module is assessed using glucose samples over different/longer period of time than any other profile output by the long-term observer module. In view of the above, to the best of the examiner's understanding, "the first data…based on an observation of glucose samples over a first period of time" and "the second data…based on an observation of glucose samples over a second period of time longer than the first period of time" refer to the data output by a short-term observer(s) and output by a long-term observer(s), respectfully. In view of this understanding, Applicant appears to disclose the first data represents a metabolic state of the patient including at least one of "a vector of estimates of key metabolic states of an individual; a single, processed glucose sample at a specific time, or a history of glucose samples up to a specific time, or a statistic computed from glucose samples up to a specific time; or both the vector of estimates of key metabolic states and the sample or history of processed glucose samples;" and the second data represents a behavioral pattern of the patient including at least one of "a daily profile of an individual's meal behavior as a function of the time of day; a daily profile of the individual's exercise behavior as a function of the time of day; and a daily profile of the individual's utilization of insulin as a function of the time of day." Accordingly, it is unclear what "representation of a behavioral pattern of the patient" may be included in the "first data" (as required/encompassed by claims 15, 27 and 36) and what "representation of a metabolic state of the patient" may be included in the "second data" (as required/encompassed by claims 16, 28 and 36). Regarding claim 19, claim 31, claim 39 and claims dependent thereon, the limitation "the diabetes control system assessing the profile at least monthly" of claim 19, and the comparable limitations of claims 31 and 39 are indefinite. It is unclear what is required by "assessing" the profile descriptive of the patient's statistical insulin utilization, particularly as there is no indication in the claim that the profile is produced by the method or system as claimed. Rather, the pending claims appear to only require the profile to be "received" as the first data and/or second data. Does "assessing the profile" indicate that the method/system as claimed is generating/estimating said profile at least monthly, or is some different "assessment" of an externally-generated profile that is received by the method/system being performed monthly? If the latter, it is further unclear what said assessment requires 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) 15-16, 27-28, 36 and claims dependent thereon 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 claims 15-16, claims 27-28, claim 36 and claims dependent thereon, as noted with respect to rejections under 35 U.S.C. 112(b) above, the limitations of claims 15-16, 27-28 and 36 are indefinite. It is unclear to what "representation of a behavioral pattern of the patient" and "representation of a metabolic state of the patient" refer based on the different time periods of observations associated with first and second data as required by the respective independent claims. Additionally, Applicant fails to sufficiently disclose an algorithm commensurate in scope with these limitations. Particularly, Applicant does not disclose any "representation of a behavioral pattern of the patient," or algorithm for calculating such a representation, that is based on a shorter period of glucose sample observations than the claimed second data related to the glycemic state of the user. Similarly, Applicant does not disclose any "representation of a metabolic state of the patient," or algorithm for calculating such a representation, that is based on a longer period of glucose sample observations than the claimed first data related to the glycemic state of the user. Further, the limitations of claims 15-16, claims 27-28, claim 36 appear to encompasses each of the first data and second data including the same "representation," just calculated based on glucose sample observations over different lengths of time. No such arrangement/algorithm is sufficiently disclosed in the application as filed. Rather, as noted above with respect to rejections under 35 U.S.C. 112(b), Applicant discloses each of the short-term and long-term observer modules, each output different "representations." Specifically, the short-term observer module is disclosed as outputting a representation of metabolic state based on an observation of, inter alia, glucose samples during a time period; and the long-term observer module is disclosed as outputting a representation of a behavioral pattern(s) based on observation of, inter alia, glucose samples during a longer period of time. Therefore, the full scope of claims 15-16, 27-28, and 36 is not adequately disclosed. 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. Claim(s) 10-12, 15-23, 26-34 and 36-39 is/are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception(s) without significantly more. Claims 10-12, 15-23, 26-34 and 36-39 recite the steps of determining an insulin infusion based on the first data, the second data, the glucose input, and the first insulin delivery command; determining an allowed insulin infusion, for example, based on a safety evaluation of the determined insulin infusion by determining a risk of at least one of hypoglycemia or hyper-glycemia, or an increased risk of hypoglycemia, based on the first data and/or the second data; and assessing a profile of the first and/or second data monthly. These limitations, as drafted, are a process that, under their BRI, cover performance of the limitations in the mind but for the recitation of generic computer components. That is, other than reciting the steps are performed by control system, or processor thereof, nothing in the claim elements preclude the step from practically being performed in the mind. For example, but for the control system/processor language, the above-noted claim limitations encompass a user mentally or manually judging his/her current metabolic state based on current and/or historical glucose measurements and administered insulin; and considering his/her typical pattern of behaviors (e.g., times of meals, content of meals, exercise habits, etc.) to estimate how much insulin to administer while taking into account if he/she is at risk (or increased risk) of hypoglycemia (e.g., near or trending low) in making said judgement. This is comparable to the decision process in conventional self-monitoring and/or diabetes management performed regularly by diabetic individuals (see, e.g., Magni '187, pg. 3, line 28 - pg. 4, line 14). Additionally, the step of assessing a profile of the first and/or second data monthly presumably encompasses assessing whether his/her behavior(s), such as statistical insulin utilization, have changed from one month to the next. If claim limitations, under their BRI, cover performance of the limitation in the mind but for the recitation of generic computer components, then they fall within the "mental processes" grouping of abstract ideas. Accordingly, claims 10-12, 15-23, 26-34 and 36-39 recite an abstract idea. This judicial exception is not integrated into a practical application. The claims recite the additional element of using a generic computer component (e.g., control system or processor thereof), or a generic personal device having said generic computer component, to perform the above-noted steps, as well as generic steps in which the data necessary for performing the abstract idea is received by the generic computer component/device. The computer component/device is recited at a high-level of generality (i.e., as a generic processor or personal device performing a generic computer function of analyzing received information). The inclusion of the generic computer component and the generic receiving steps do no more than merely invoke a computer component/device as a tool, such that the additional elements recited in the claim, either alone or in combination, amount to no more than mere instructions to apply the exception using a generic computer component. Accordingly, the additional elements of the claims do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. Therefore, claims 10-12, 15-23, 26-34 and 36-39 are directed to an abstract idea. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional element of using a generic computer component to perform the abstract idea amounts to no more than mere instructions to apply the exception using a generic computer component. Additionally, the courts have recognized generically receiving data, as is recited in the additional elements of the pending claims, as insignificant extra-solution activity and/or a well‐understood, routine, and conventional computer function (see MPEP 2106.05(d)(II)). Mere instructions to apply an exception using a generic computer component, adding insignificant extra-solution activity to the judicial exception and/or simply appending well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception cannot provide an inventive concept (see MPEP 2106.05(I)(A)). Therefore claims 10-12, 15-23, 26-34 and 36-39 are not patent eligible. Claim Rejections - 35 USC § 103 The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action: (a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) are summarized as follows: Determining the scope and contents of the prior art. Ascertaining the differences between the prior art and the claims at issue. Resolving the level of ordinary skill in the pertinent art. Considering objective evidence present in the application indicating obviousness or nonobviousness. This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a). Claim 10, 13-21, 24, 27-33 and 35-39 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over WO 2009/059187 A1 ("Magni '187") in view of US 2010/0145262 A1 ("Bengtsson"). Regarding claims 10, 21 and 33, Magni '187 discloses and/or suggests a system for diabetes control, the system comprising: at least one processor and at least one non-transitory computer-readable medium or memory having control/computer program logic stored thereon that is executable by the at least one processor (e.g., pg. 7, lines 4-12; Figs. 1-4, 8-10, etc.) to perform a method of (or operations for) adaptive diabetes control, the method/operations comprising, by the diabetes control system: receiving a glucose input reflective of glucose sample processing by a continuous glucose monitor (CGM) sensor of a patient (pg. 2, lines 16-23, previous glucose samples; pg. 17, lines 16-23, the filtered value of the glucose concentration obtained from the CGM, Gmed (k); etc.); receiving a first insulin delivery command, the first insulin delivery command representing a most recent command to an insulin pump of the patient relative to a time of the glucose input (pg. 2, lines 16-23, previous values of the external insulin infusion; pg. 17, lines 16-23, nominal insulin rate, unom (k); etc.); receiving first data related to a glycemic state of a user, wherein the first data is based on an observation of glucose samples over a first period of time (pg. 17, line 23 - pg. 18, line 2, state vector x(k); claim 15, state vector; etc.); receiving second data related to the glycemic state of the user based on an observation of data over a second period of time longer than the first period of time (pg. 17, line 23 - pg. 18, line 2, vector of future glucose disturbances inferred from patient behavioral data collected during a screening visit; claim 15, future glucose disturbances; etc.); determining an insulin infusion based on the first data, the second data, the glucose input, and the first insulin delivery command (pg. 17, line 23 - pg. 18, line 2, given the state vector and future glucose disturbances, a nominal insulin rate, unom (k), is computed; claim 15; etc.); and determining an allowed insulin infusion based on a safety evaluation of the determined insulin infusion (pg. 18, line 13, safety limits are applied to modify unom (k)). Magni '187 does not expressly disclose the second data is based on an observation of glucose samples over a second period of time longer than the first period of time. Specifically, Magni '187 discloses the second data is inferred from "patient behavioral data β" obtained during a screening visit (pg. 17), but does not expressly disclose what said behavioral data is/includes. Bengtsson discloses/suggests determining second data related to the glycemic state of a user based on an observation of glucose samples over a relatively long period of time (e.g., ¶ [0014] days, weeks, etc.) (Abstract, calculating an estimated event forecast based on logged historical data such as drug delivered and corresponding physiological parameters such as blood glucose level; ¶ [0014]; etc.). Accordingly, Bengtsson discloses/suggests second data related to the glycemic state of the user, such as representation of a behavioral pattern of the user (e.g., future disturbances, events, etc.), may be determined based an observation of glucose samples over the second period. It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the method/operations of Magni '187 with the second data being based on an observation of glucose samples over a second period of time longer than the first period of time (e.g., being inferred from logged historical data including blood glucose level) as taught/suggested by Bengtsson in order to facilitate inferring/forecasting future glucose disturbances (e.g., meals, exercise, etc.) to compute optimal insulin injection to safely regulate glucose concentration (Magni '187, pg. 2, lines 17-23; Bengtsson, Abstract; etc.). Regarding claims 13, 24 and 35, Magni '187 as modified discloses and/or suggests the method/operations further comprise(s) commanding an insulin pump to deliver the allowed insulin infusion to the patient via a second insulin delivery command (pg. 18, pump command). Regarding claim 14, Magni '187 as modified discloses and/or suggests the diabetes control system is external to the insulin pump and the commanding includes sending the second insulin delivery command to the insulin pump over a wireless communications channel (e.g., Figs. 2, 4, etc.). Regarding claims 15 and 27, Magni '187 as modified discloses and/or suggests the second data includes a representation of a behavioral pattern of the patient (e.g., Magni '187, pg. 17, lines 28-30, vector of future glucose disturbances is inferred from past patient behavioral data; Bengtsson, ¶ [0014]; etc.). Magni '187 as modified does not disclose the first data includes a representation of a behavioral pattern of the patient. However, at the time the invention was made, it would have been an obvious matter of design choice to a person of ordinary skill in the art to modify the method/operations of Magni '187 with the first data including a representation of a behavioral pattern of the patient because Applicant has not disclosed that the first data including a representation of a behavioral pattern of the patient provides an advantage, is used for a particular purpose, or solves a stated problem. Rather, as noted with respect to rejections under 35 U.S.C. 112(b) above, Applicant appears to disclose the first data is instead a representation of a metabolic state of the patient. As no evidence has been provided to the contrary, one of ordinary skill in the art, furthermore, would have expected Applicant's invention to perform equally well with the first data including a representation of metabolic state as taught/suggested by Magni '187/Magni '187 as modified because said arrangement permits computing optimal insulin injection to safely regulate the glucose concentration. Regarding claims 16 and 28, Magni '187 as modified discloses and/or suggests the first data includes a representation of a metabolic state of the patient (pg. 17, line 23 - pg. 18, line 2, state vector x(k); claim 15, state vector; etc.). Magni '187 as modified does not disclose the second data includes a representation of a metabolic state of the patient. However, at the time the invention was made, it would have been an obvious matter of design choice to a person of ordinary skill in the art to modify the method/operations of Magni '187 with the second data including a representation of a metabolic state of the patient because Applicant has not disclosed that the second data including a representation of a metabolic state of the patient provides an advantage, is used for a particular purpose, or solves a stated problem. Rather, as noted with respect to rejections under 35 U.S.C. 112(b) above, Applicant appears to disclose the second data is instead a representation of a behavioral pattern(s) of the patient. As no evidence has been provided to the contrary, one of ordinary skill in the art, furthermore, would have expected Applicant's invention to perform equally well with the second data including a representation of a behavioral pattern as taught and/or suggested by Magni '187/Magni '187 as modified because said arrangement permits computing optimal insulin injection to safely regulate the glucose concentration. Regarding claims 17, 29 and 37, Magni '187 as modified discloses and/or suggests the first data includes first observational data related to a metabolic state of the user over the first period of time (e.g., pg. 17, lines 16-25, the state vector and/or observed data related to the metabolic state thereof, e.g., glucose concentration, differential glucose, etc.); and the second data includes second observational data related to a behavioral pattern of the user based over the second period of time (e.g., Magni '187, pg. 17, lines 28-30, vector of future glucose disturbances is inferred from past patient behavioral data; Bengtsson, ¶ [0014]; etc.). Regarding claims 18, 30 and 38, Magni '187 as modified discloses and/or suggests at least one of the first data or the second data includes a profile descriptive of the patient's statistical insulin utilization (pg. 17, lines 1-25, state vector is based on/includes basal insulin, ub (k), i.e., the patient's time-varying basal insulin rate). Regarding claims 18-19, 30-31 and 38-39, Magni '187 as modified discloses/suggests at least one of the first data or the second data includes a profile descriptive of the patient's statistical insulin utilization, as discussed above. Alternatively/Additionally, Bengtsson discloses/suggests determining second data related to the glycemic state of a user based on an observation of glucose samples over a relatively long period of time, said data including a profile descriptive of the patient's statistical insulin utilization (¶ [0137] average use of insulin from historical data, e.g., the last 'z' days), and discloses/suggests said profile can be updated at least monthly (¶ [0105] assessing changes in average insulin profile, e.g., over the last 'z' days; ¶ [0135] adaptive learning ensures algorithm settings are adjusted if user changes his/her habits; etc.). It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the method and/or operations of Magni '187 with the second data including a profile descriptive of the patient's statistical insulin utilization that is assessed at least monthly as taught/suggested by Bengtsson in order to ensure algorithm settings are adjusted if user changes his/her habits (Bengtsson, ¶ [0135]); to enable providing additional safety filters or limits (Bengtsson, ¶ [0104]); etc. Regarding claims 20 and 32, Magni '187 as modified discloses and/or suggests determining an insulin infusion includes computing the insulin infusion via at least a model predictive control (MPC) technique (throughout document, e.g., pg. 17, line 31 - pg. 18, line 10). Regarding claim 36, Magni '187 as modified discloses and/or suggests the first data and the second data each includes a representation of at least one of: a behavioral pattern of the patient (Magni '187, pg. 17, lines 28-30, vector of future glucose disturbances is inferred from past patient behavioral data; Bengtsson, ¶ [0014]); or a metabolic state of the patient (pg. 17, lines 16-25, first data comprises a state vector). Claim 11-12, 22-23 and 34 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Magni '187 in view of Bengtsson as applied to claim(s) 10, 21 and 33 above, and further in view of US 6,923,763 B1 ("Kovatchev '763"). Regarding claims 11-12, 22-23 and 34, Magni '187 as modified discloses/suggests the limitations of claim 10, 21 and 33, as discussed above, but does not expressly disclose determining the allowed insulin infusion includes: determining a risk of, or "increased" risk of, hypoglycemia based on at least one of the first data or the second data; and modifying, such as reducing, the insulin infusion based on the determined risk/determination of increased risk, the allowed insulin infusion including the modified insulin infusion. Kovatchev '763 discloses and/or suggests a method comprising determining a risk, or increased risk, of hypoglycemia based on metabolic state data (e.g., blood glucose, insulin records) (Abstract, estimating BG in the near feature to estimate risk of the onset of hypoglycemia; col. 7, line 53 - col. 8, line 57); and modifying, e.g., reducing, an allowed insulin infusion based on/in response to the determined risk/increased risk (col. 5, lines 11-15; col. 5, lines 47-58; etc.). It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the method/operations of Magni '187 with determining allowed insulin infusion including determining a risk of, or "increased" risk of, hypoglycemia based on at least one of the first data or the second data; and modifying, such as reducing, insulin infusion based on the determined risk/determination of increased risk, the allowed insulin infusion including the modified insulin infusion as taught/suggested by Kovatchev '763 in order to provide an additional safety filter or limit for reducing complications of abnormal, e.g., hypoglycemic, glucose levels (Magni '187, pg. 18, line 13; Kovatchev '763, col. 4, lines 20-35; etc.). Claim 25-26 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Magni '187 in view of Bengtsson as applied to claim(s) 24 and 21 above, and further in view of US 2004/0193025 A1 ("Steil '025"). Regarding claims 25-26, Magni '187 as modified discloses and/or suggests the limitations of claim 24 and 21, as discussed above, and further discloses and/or suggests the system is device comprising an interface for wireless or cellular communication (e.g., pg. 9, lines 28-30, communications may be implemented using a cellular phone link, an RF link, an infrared link, and other wireless communications channels), wherein the operations include sending the second insulin delivery command to the insulin pump via the interface for wireless communication (e.g., Figs. 2, 4, etc.). Magni '187 as modified does not expressly disclose the device is a personal device further including a display. Steil '025 discloses/suggests a comparable system comprising a personal device (e.g., ¶ [0358] hand held personal digital assistant, such as described in incorporated-by-reference US application number 09/487,423 (issued as USPN 6,558,320 to Causey, III)), said personal device including a display (Steil '025, ¶ [0358] touch screen; Causey, III, Fig. 7, display 102 of PDA 10). It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the system of Magni '187 with the controller/device comprising personal device further comprising a display as taught/suggested by Steil '025 in order to reduce the number of separate personal electronic devices a user needs to carry (Causey, III, col. 1, line 59 - col. 2, line 2). Conclusion The prior art made of record and not relied upon is considered pertinent to Applicant's disclosure: see attached PTO-892. 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. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. Applicant is encouraged to use the USPTO Automated Interview Request at http://www.uspto.gov/interviewpractice to schedule an interview. If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Tse Chen, can be reached on 571-272-3672. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /Meredith Weare/Primary Examiner, Art Unit 3791
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Prosecution Timeline

Dec 20, 2023
Application Filed
May 08, 2026
Non-Final Rejection mailed — §101, §103, §112
Jul 16, 2026
Interview Requested

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Prosecution Projections

1-2
Expected OA Rounds
50%
Grant Probability
82%
With Interview (+32.4%)
3y 10m (~1y 3m remaining)
Median Time to Grant
Low
PTA Risk
Based on 706 resolved cases by this examiner. Grant probability derived from career allowance rate.

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