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 .
Receipt of Applicant’s Remarks filed February 6, 2026, are acknowledged.
Election/Restrictions
Applicant’s election without traverse of Invention II (claims 10-16) in the reply filed on February 6, 2026, is acknowledged.
Response to Amendment
Claims 1-9 and 17-20 have been withdrawn. Claims 10-16 are pending and are provided to be examined upon their merits.
Specification
The disclosure is objected to because of the following informalities:
Paragraph [0032] at the end has “…. reference to the example of Figs. 2 and 3).” where there is neither a figure 3 no an opening parenthesis “(“.
Paragraph [0034] at the end has “..a version of an AID algorithm with.” where the sentence is incomplete. As a reminder, no new matter can be added to the specification.
Appropriate correction is required.
Claim Objections
Claims 13 and 14 are objected to because of the following informalities:
Claims 13 and 14 need to end in a period.
Appropriate correction is required.
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 10-16 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Claims 10-16 are directed to a product, which are statutory categories of invention. (Step 1: YES).
The Examiner has identified product Claim 10 as the claim that represents the claimed invention for analysis.
Claim 10 recites the limitations of:
A non-transitory computer readable medium embodied with programming instructions executable by a processor that when executed by the processor cause the processor to:
obtain a glucose measurement history;
obtain a liquid drug delivery history;
calculate an expected drug delivery amount based on the obtained glucose measurement history and the obtained liquid drug delivery history;
calculate a plurality of respective drug delivery amounts implemented using different advisory mode algorithms;
select a respective advisory drug delivery amount of the plurality of respective advisory drug delivery amounts; and
generate a recommendation based on the selected respective advisory drug delivery amount.
These above limitations, under their broadest reasonable interpretation, cover performance of the limitation as certain methods of organizing human activity. The claim recites elements, highlighted in bold above, which covers performance of the limitation as a managing personal behavior. Obtain glucose measurement history, obtain liquid drug delivery history (following rules/instructions), calculate an expected drug delivery amount and calculate a plurality of drug delivery amounts (teaching), select a respective advisory drug delivery amount (following rules/instructions), and generate a recommendation (teaching) is managing personal behavior. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation as a managing personal behavior, then it falls within the “Certain Methods of Organizing Human Activity” grouping of abstract ideas. Accordingly, the claim recites an abstract idea. (Step 2A-Prong 1: YES. The claims are abstract)
In as much as a person can read (in their mind) glucose measurement history and liquid delivery history, calculate expected drug delivery amounts using obtained (read) history (analyze mentally with pen and paper), calculate a plurality of respective drug delivery amounts using different algorithms (mentally with pen and paper), select a respective advisory drug delivery amount, and generate (write with pen and paper) a recommendation, the claims are also abstract under mental process grouping of abstract ideas. See also MPEP 2106.04(a)(2) III C where using a generic computer was not enough to make abstract claims statutory under Mental Processes.
Calculate a plurality of drug delivery amounts using different advisory mode algorithms is also abstract as a mathematical concept.
This judicial exception is not integrated into a practical application. In particular, the claims only recite: non-transitory computer readable medium, processor (Claim 10). The computer hardware is recited at a high-level of generality (i.e., as a generic processor performing a generic computer function) such that it amounts no more than mere instructions to apply the exception using a generic computer component. Accordingly, these additional elements, when considered separately and as an ordered combination, do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. Therefore claim 10 is directed to an abstract idea without a practical application. (Step 2A-Prong 2: NO. The additional claimed elements are not integrated into a practical application)
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because, when considered separately and as an ordered combination, they do not add significantly more (also known as an “inventive concept”) to the exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional element of using a computer hardware amounts to no more than mere instructions to apply the exception using a generic computer component. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept. See Applicant’s specification para. [0024] about implantation using general purpose or special purpose computing devices and MPEP 2106.05(f) where applying a computer as a tool is not indicative of significantly more. Accordingly, these additional elements, when considered separately and as an ordered combination, do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. Steps such as obtain (receiving) are steps that are considered insignificant extra solution activity and mere instructions to apply the exception using general computer components (see MPEP 2106.05(d), II). Thus claim 10 is not patent eligible. (Step 2B: NO. The claims do not provide significantly more)
Dependent claims 11-16 further define the abstract idea that is present in their independent claim 10 and thus corresponds to Certain Methods of Organizing Human Activity, Mental Processes, and Mathematical Concepts and hence are abstract for the reasons presented above. Claim 11 recites output a control signal to deliver the selected drug delivery amount, which is an intended result that may not happen (delivering never happens), would be some type of unknown treatment (liquid drug), and is also incidental to the invention of calculate drug delivery amounts using different advisory modes. The dependent claims also recite abstract elements or further limit abstract elements. The dependent claims do not include any additional elements that integrate the abstract idea into a practical application or are sufficient to amount to significantly more than the judicial exception when considered both individually and as an ordered combination. Therefore, the claims 11-16 are directed to an abstract idea. Thus, the claims 10-16 are not patent-eligible.
Examiner Request
The Applicant is requested to indicate where in the specification there is support for amendments to claims should Applicant amend. The purpose of this is to reduce potential 35 U.S.C. §112(a) or §112 1st paragraph issues that can arise when claims are amended without support in the specification. The Examiner thanks the Applicant in advance.
Claim Rejections - 35 USC § 103
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 (i.e., changing from AIA to pre-AIA ) 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.
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 1-6 are rejected under 35 U.S.C. 103 as being unpatentable over Pub. No.US 2020/0397989 to Mazlish et al. in view of Pub. No. US 2010/0295686 to Sloan et al.
Regarding claim 10
A non-transitory computer readable medium embodied with programming instructions executable by a processor that when executed by the processor cause the processor to:
obtain a glucose measurement history;
Mazlish et al. teaches:
Use (obtain) historical glucose values…
“After continuous glucose monitor 50 is calibrated or replaced with a new continuous glucose monitor or has a new sensor shaft 56 installed, however, a discontinuity of reported glucose data from the continuous glucose monitor 50 can occur. In some cases, methods and systems provided herein, however, can use and report historical blood glucose values in selecting insulin basal rates and/or profiles. In some cases, methods and systems provided herein can revise stored and/or reported blood glucose levels based on data from one or more continuous glucose monitors in order to transition between different continuous glucose monitor sensors and/or to data produced after a calibration. In some cases, a continuous glucose monitor 50 can provide each blood glucose value with an estimated rate of change, and the rate of change information can be used to retrospectively adjust one or more historical estimated blood glucose values from data from a continuous glucose monitor 50. For example, the rate of change of the pre-calibration reported blood glucose value may be used to determine an estimated post-calibration value assuming the same rate of change. A ratio of the post-calibration reported blood glucose value to the estimated post-calibration value can then be used to linearly interpolate multiple historical blood glucose values based on that ratio. In some cases, all readings between calibrations can be linearly interpolated. In some cases, data from a predetermined amount of time prior to a calibration can be linearly interpolated (e.g., fifteen minutes, thirty minutes, one hour, two hours, three hours, or six hours).” [0279]
obtain a liquid drug delivery history;
Communicate out from historical pump usage information including dosage logs including bolus dose from historical pump usage (liquid drug delivery history)…
“Such user-specific dosage parameters may include, but are not limited to, one or more of the following: total daily basal dosage limits (e.g., in a maximum number of units/day), various other periodic basal dosage limits (e.g., maximum basal dosage/hour, maximum basal dosage/six hour period), insulin sensitivity (e.g., in units of mg/dL/insulin unit), carbohydrate ratio (e.g., in units of g/insulin unit), insulin onset time (e.g., in units of minutes and/or seconds), insulin on board duration (e.g., in units of minutes and/or seconds), and basal rate profile (e.g., an average basal rate or one or more segments of a basal rate profile expressed in units of insulin unit/hour). Also, the control circuitry 240 can cause the memory device 242 to store (and can cause reusable pump controller 200 to periodically communicate out to the mobile computing device 60) any of the following parameters derived from the historical pump usage information: dosage logs, average total daily dose, average total basal dose per day, average total bolus dose per day, a ratio of correction bolus amount per day to food bolus amount per day, amount of correction boluses per day, a ratio of a correction bolus amount per day to the average total daily dose, a ratio of the average total basal dose to the average total bolus dose, average maximum bolus per day, and a frequency of cannula and tube primes per day. To the extent these aforementioned dosage parameters or historical parameters are not stored in the memory device 242, the control circuitry 240 can be configured to calculate any of these aforementioned dosage parameters or historical parameters from other data stored in the memory device 242 or otherwise input via communication with the mobile computing device 60.” [0061]
calculate an expected drug delivery amount based on the obtained glucose measurement history and the obtained liquid drug delivery history;
Based on analysis (calculate) of predicted (expected) glucose levels, a basal delivery profile or rate can be selected…
“… Based on an analysis of a variation of predicted blood glucose levels performed at block 264, a basal delivery profile or rate generated at block 263 can be selected at block 265, and the system can deliver basal insulin according to that selected basal delivery profile or rate to the PWD for a select period of time at block 272. In some cases, the pump assembly 15 of system 10 of FIG. 1 can be used to deliver the insulin. In some cases, the blocks 263, 264, 265, and 272 can each be conducted by reusable pump controller 200 of system 10. In some cases, the blocks 271, 263, 264, and 265 can all be conducted by continuous glucose monitor 50 of system 10, with data regarding the selected delivery rate being sent to reusable pump controller 200. In some cases, the blocks 251, 252, 261, 262, 263, 264, and 265 can all be conducted on mobile computing device 60 of system 10 of FIG. 1, with data regarding the selected delivery rate being sent to reusable pump controller 200 from the mobile computing device 60.” [0144]
Can use historical glucose values in selecting insulin basal rates and profiles…
“After continuous glucose monitor 50 is calibrated or replaced with a new continuous glucose monitor or has a new sensor shaft 56 installed, however, a discontinuity of reported glucose data from the continuous glucose monitor 50 can occur. In some cases, methods and systems provided herein, however, can use and report historical blood glucose values in selecting insulin basal rates and/or profiles…” [0276]
See History below.
calculate a plurality of respective drug delivery amounts implemented using different advisory mode algorithms;
Determining (calculate) control parameters that work across delivery modes (different advisory mode algorithms)…
“Methods and systems provided herein can in some cases include multiple delivery modes. In some cases, methods and systems provided herein can monitor the presence of blood glucose using one or more blood glucose measuring devices or methods, control or monitor the dispensation of medicine, and determine and/or update the user-specific dosage parameters regardless of the operating mode. For example, possible operating modes could include closed-loop or hybrid closed-loop modes that automatically adjust basal rates based on continuous glucose monitoring data (CGM) and other user-specific dosage parameters (e.g., baseline basal rate (BBR), insulin sensitivity factor (ISF), and carbohydrate-to-insulin ratio (CR)), modes that can use blood glucose monitor (BGM) data to update user-specific dosage parameters (e.g., BBRs, ISFs, and CRs) for different time blocks over longer periods of time, manual modes that require a patient to manually control the therapy program using an insulin pump, and advisory modes that recommend dosages for a PWD to inject using an insulin pen or syringe. By determining optimized control parameters that work across delivery modes, systems and methods provided herein can provide superior analyte control even when a PWD switches to a different delivery mode. For example, methods and systems provided herein may be forced to switch away from a hybrid closed-loop delivery mode that adjusts basal insulin delivery away from a BBR if a continuous glucose monitor malfunctions or the system otherwise loses access to continuous data. In some cases, data can be collected when the system is in an advisory or manual mode to optimize control parameters in preparation for a PWD to switch to a hybrid closed-loop system (e.g., in preparation for a PWD to start use of a continuous glucose monitor (CGM) and/or an insulin pump).” [0216]
Another example of use different mathematical formulas (algorhtims)….
“Methods and systems provided herein can evaluate each future basal delivery profile by predicting blood glucose for the basal delivery profiles and calculating a variation index of the predicted blood glucose values from the target blood glucose values. Methods and systems provided herein can then select the profile of basal rate delivery actions that corresponds to the lowest variation index. The variation index can use a variety of different mathematical formulas to weight different types of variations. The variation index can be a cost function. In some cases, methods and systems provided herein can use a cost function that sums up squares of differences for the projected blood glucose values from target blood glucose values for multiple diurnal time segments…” [0281]
select a respective advisory drug delivery amount of the plurality of respective advisory drug delivery amounts; and
Select a basal insulin profile or rate…
“Methods and systems provided herein can use a model to predict multiple future blood glucose levels for multiple different basal insulin delivery profiles or basal insulin delivery rates, and select one of the basal insulin delivery profiles or basal insulin delivery rates based on prediction of which profile or rate will approximate a target blood glucose level, or more specifically, select the profile that minimizes the differences between the predicted future blood glucose values and one or more target blood glucose values. In some cases, the profile that minimizes, lessons, or lowers variations from one or more target blood glucose levels in the future may be selected. The selected basal profile can then be delivered to the PWD at least until a process of evaluating different basal insulin delivery profiles or rates is repeated…” [0206]
generate a recommendation based on the selected respective advisory drug delivery amount.
Example of conservative level (generate recommendation)…
“Updated blood glucose targets for a particular diurnal period can be based on historical blood glucose patterns for the PWD and the risk of hypoglycemia for the PWD over the course of a day. The updated blood glucose targets can also consider a set FHI. For example, based on an FHI selection, an initial blood glucose target at a conservative level (e.g., 120 mg/dl) can be set, and over the course of a period of days and/or weeks as more information is gained about variability patterns, the blood glucose target(s) can be adjusted. A slow adjustment can prevent the blocks 283 and 261 from overreacting to short term disturbances but still allow blood glucose target individualization to a PWD's lifestyle and habits over time.” [0293]
History
Mazlish et al. teaches history and profile. They do not literally teach history with glucose and insulin
Sloan et al. also in the business of history teaches:
Compute basal amount based on insulin and glucose history…
“When the system receives a temporary basal command, the closed loop system may, given the IOB, insulin history, glucose history, predicted glucose (in the near future horizon), and pre-programmed basal insulin delivery rate, compute a temporary basal amount and duration such that if the closed loop operation of the system terminates, the combination of the basal rate of that amount and the specified duration and the subsequent transition to the pre-programmed basal rate is such that the predicted glucose value of the user in the foreseeable future horizon will remain within a specified safe target. This safe target may be different from the specified nominal target value for the optimal calculation, in that it can be designed to be more conservative from a hazards prevention perspective.”
It would have been obvious to one of ordinary skill in the art before the effective filing date to include in the method and system of Mazlish et al. the ability to use history of insulin and glucose as taught by Sloan et al. since the claimed invention is merely a combination of old elements and in the combination each element merely would have performed the same function as it did separately, and one of ordinary skill in the art would have recognized that the results of the combination were predictable. Further motivation is provided by Sloan et al. who teaches the advantages of using historical data for calculating basal amounts and duration that provide safe values.
Regarding claim 11
The computer readable medium of claim 10, wherein the processor is further caused to:
receive confirmation of the generated recommendation; and
Mazlish et al. teaches:
Example of confirmation of modified parameters…
“As illustrated in the user interfaces 612, 614, and 616, a user may verify one or more therapeutic parameters. For example, via the user interface 612 a user may review one or more manually input therapeutic parameters, via the user interface 614, the user may input authenticating credentials to verify that the user is authorized to modify therapeutic parameters, and the user interface 616 may be a confirmation of the modified parameters.” [0099]
in response to the confirmation, output a control signal to deliver the selected respective advisory drug delivery amount.
One example of control signal to dispense (deliver) the fluid (drug delivery amount)…
“… Thus, when disposable pump 100 and reusable pump controller 200 are mechanically attached and thereby electrically connected, reusable pump controller 200 communicates electronic control signals via a hardwire-connection (e.g., electrical contacts along electrical connector 118 or the like) to the drive system or other components of disposable pump 100. In response to the electrical control signals from reusable pump controller 200, the drive system of disposable pump 100 causes medicine to incrementally dispense from the fluid cartridge 120. Power signals, such as signals from a battery (not shown) of reusable pump controller 200 and from the power source (not shown) of disposable pump 100, may also be passed between reusable pump controller 200 and disposable pump 100.” [0054]
Regarding claim 12
The computer readable medium of claim 10, wherein the selecting the respective advisory drug delivery amount, the processor is further caused to:
evaluate each respective advisory drug delivery amount of the plurality of respective advisory drug delivery amounts with respect the expected drug delivery amount; and,
Mazlish et al. teaches:
Predict (evaluate) multiple different profiles (drug delivery amount)…
“Methods and systems provided herein can use a model to predict multiple future blood glucose levels for multiple different basal insulin delivery profiles or basal insulin delivery rates, and select one of the basal insulin delivery profiles or basal insulin delivery rates based on prediction of which profile or rate will approximate a target blood glucose level, or more specifically, select the profile that minimizes the differences between the predicted future blood glucose values and one or more target blood glucose values. In some cases, the profile that minimizes, lessons, or lowers variations from one or more target blood glucose levels in the future may be selected…” [0206]
identify the respective advisory drug delivery amount of the plurality of respective advisory drug delivery amounts that most closely matches the expected drug delivery amount, wherein the identified respective advisory drug delivery amount is the selected respective advisory drug delivery amount.
Select (identify) basal profile (drug delivery amount) that minimizes the differences (most closely matches) the predicted future (expected) glucose value, where the profile (basal profile) that minimizes or lowers variations is selected (therefore expected drug delivery amount)…
“Methods and systems provided herein can use a model to predict multiple future blood glucose levels for multiple different basal insulin delivery profiles or basal insulin delivery rates, and select one of the basal insulin delivery profiles or basal insulin delivery rates based on prediction of which profile or rate will approximate a target blood glucose level, or more specifically, select the profile that minimizes the differences between the predicted future blood glucose values and one or more target blood glucose values. In some cases, the profile that minimizes, lessons, or lowers variations from one or more target blood glucose levels in the future may be selected. The selected basal profile can then be delivered to the PWD at least until a process of evaluating different basal insulin delivery profiles or rates is repeated. In some cases, methods and systems provided herein can repeat a process of evaluating multiple different basal insulin delivery profiles or basal insulin delivery rates at a time interval that is less than the time interval for the plurality of future predicted blood glucose values.…” [0206]
Regarding claim 13
The computer readable medium of claim 10, wherein the glucose measurement history includes glucose measurement data obtained over a plurality of measurement cycles
Mazlish et al. teaches:
Historical glucose data for person with diabetes (PWD) set for diurnal periods (repeats/cycle)…
“…In some cases, historical continuous glucose monitor data for the PWD prior to the PWD using the system can be used to set initial blood glucose targets (either for specific diurnal periods or for an entire day). In some cases, methods provided herein can have a PWD wear a CGM for a preliminary period of time (e.g., at least twenty-four hours, at least forty-eight hours, at least five days, or at least ten days) prior to allowing the methods and systems provided herein from delivering insulin at rates other than the BBR to detect blood glucose variability data for the PWD to set one or more initial blood glucose targets.” [0223]
Regarding claim 14
The computer readable medium of claim 10, wherein the liquid drug delivery history includes liquid drug data based on deliveries of a liquid drug by a drug delivery device over a plurality of drug delivery cycles
Mazlish et al. teaches:
Insulin (liquid drug) administered using an insulin pump with periodic release (delivery cycles)…
“Historically, diabetes is treated with multiple, daily injections of rapid and long acting insulin via a hypodermic syringe. One or two injections per day of a long acting insulin is administered to provide a basal level of insulin and additional injections of a rapidly acting insulin is administered before or with each meal in an amount proportional to the size of the meal. Insulin therapy can also be administered using an insulin pump that provides periodic or continuous release of the rapidly acting insulin to provide for a basal level of insulin and larger doses of that same insulin at the time of meals. Insulin pumps allow for the delivery of insulin in a manner that bears greater similarity to the naturally occurring physiological processes and can be controlled to follow standard or individually modified protocols to give the patient better glycemic control. In some circumstances, an insulin pump device can store (via input from a clinician or a user) a number of settings (e.g., dosage parameters or other settings) that are customized by the physician for the particular user.” [0004]
Regarding claim 15
The computer readable medium of claim 10, wherein the programming instructs further cause the processor to:
calculate each respective drug delivery amount using different sets of inputs in an advisory mode algorithm.
Mazlish et al. teaches:
One example of evaluation process calculated using different inputs…
“The different basal insulin delivery profiles or rates for each evaluation process can be generated using any suitable techniques. In some cases, multiple profiles or delivery rates are generated using one or more user-specific dosage parameters. In some cases, one or more user-specific dosage parameters can be entered by a user, calculated by information entered by a user, and/or calculated by monitoring data generated from the PWD (e.g., monitoring insulin delivery rates and blood glucose data while the PWD is using a pump in an open loop mode)…” [0207]
Regarding claim 16
The computer readable medium of claim 15, wherein the different sets of inputs are categorized as an aggressive input set, a standard input set or a conservative input set for execution in the advisory mode algorithm.
Mazlish et al. teaches:
Example of fear of hypoglycemia (FHI) and high (conservative), low (aggressive) or moderate (standard)…
“In some cases, such as shown in FIG. 11 at block 251, a user can enter a fear of hypoglycemia index (FHI), which can be used to determine and/or adjust blood glucose targets. An FHI can be represented to the user in a number of ways. In some cases, the FHI can be represented to the user as an aggressiveness index, which could be set at “prefer high,” “prefer low,” or “prefer moderate.” In some cases, the FHI can be represented to the user as a target blood glucose level or target average blood glucose level (e.g., 100 mg/dl, 120 mg/dl, or 140 mg/dl). In some cases, the FHI can be represented to the user as a target A1C level. In some cases, the FHI can be represented to the user as a probability of going above or below a certain threshold (e.g., a five percent chance of going below 80 mg/dl, or a three percent chance of going above 200 mg/dl). In these and other cases, a user interface may be generated with an interactive feature (e.g., radio buttons, check boxes, hyperlinked images/text, drop-down list, etc.) that a user can interact with to make a selection of the FHI. In some cases, the PWD may interact with the interface to select the FHI, and in some cases, the user can be a health care professional that selects the FHI.” [0224]
“Updated blood glucose targets for a particular diurnal period can be based on historical blood glucose patterns for the PWD and the risk of hypoglycemia for the PWD over the course of a day. The updated blood glucose targets can also consider a set FHI. For example, based on an FHI selection, an initial blood glucose target at a conservative level (e.g., 120 mg/dl) can be set, and over the course of a period of days and/or weeks as more information is gained about variability patterns, the blood glucose target(s) can be adjusted. A slow adjustment can prevent the blocks 283 and 261 from overreacting to short term disturbances but still allow blood glucose target individualization to a PWD's lifestyle and habits over time.” [0293]
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
The following prior art teaches at least insulin or fluid and using different algorithms:
US-20220189604-A1; US-20220240848-A1; US-20210030955-A1; US-20210121628-A1; US-20190336683-A1; US-20170189614-A1; US-20200342974-A1; US-20210016006-A1; US-8977504-B2; US-10500334-B2; US-8818782-B2; CA-3109754-A1; CA-3236573-A1; CN-110650683-A; JP-2019509074-A; EP-2562664-B1
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KENNETH BARTLEY whose telephone number is (571)272-5230. The examiner can normally be reached Mon-Fri: 7:30 - 4:00 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, SHAHID MERCHANT can be reached at (571) 270-1360. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KENNETH BARTLEY/Primary Examiner, Art Unit 3684
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