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 .
Response to Amendment
The amendment filed on 10/31/2025 has been entered. Claims 1-20 are pending in the application. Claims 10-20 remain withdrawn. The amendments to the claims overcome each and every objection previously set forth in the Non-Final Office Action mailed on 8/6/2025.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 10/31/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Booth et al. (US 2015/0217055 A1).
Regarding claim 1, Booth discloses a method performed by a processor (processors 112/132/142, par. [0078] and [0081]-[0083]) for controlling a medicament delivery device (insulin device 123) (see Fig. 1A-C, par. [0081]-[0085]), comprising:
gathering data regarding insulin delivery and glucose levels of a user (see par. [0078]-[0079] and [0085]);
analyzing with the processor (processors 112/132/142) the gathered data with the processor (processors 112/132/142) to identify factors indicating that an insulin to carbohydrate ratio for the user or a correction factor for the user should be increased (see par. [0146], [0213], [0216]-[0225], [0228]);
analyzing with the processor (processors 112/132/142) the gathered data with the processor (processors 112/132/142) to identify factors indicating that the insulin to carbohydrate ratio for the user or the correction factor should be decreased (see par. [0146], [0213], [0216]-[0225], [0228]);
weighing the identified factors indicating that the insulin to carbohydrate ratio for the user or the correction factor for the user should be increased and the identified factors indicating that the insulin to carbohydrate ratio for the user or the correction factor should be decreased with the processor (processors 112/132/142) to determine whether to increase or decrease the insulin to carbohydrate ratio or the correction factor (see par. [0146], [0213], [0216]-[0225], [0228], factors such as previous insulin to carbohydrate ratios CIR, adjustment factors AF, total daily insulin dose TDD, and a configurable constant CFR are recited as factoring into equations weighing whether to increase or decrease the insulin to carbohydrate ratio and/or the correction factor); and
increasing or decreasing the insulin to carbohydrate ratio or the correction factor for the user based on the determination and the weighing of the identified factors indicating that the insulin to carbohydrate ratio for the user or the correction factor for the user should be increased and the identified factors indicating that the insulin to carbohydrate ratio for the user or the correction factor should be decreased to adjust insulin delivery by the medicament delivery device (insulin device 123) (see par. [0146], [0213], [0216]-[0225], [0228], factors such as previous insulin to carbohydrate ratios CIR, adjustment factors AF, total daily insulin dose TDD, and a configurable constant CFR are recited as factoring into equations weighing whether to increase or decrease the insulin to carbohydrate ratio and/or the correction factor and once the equations are performed, the insulin to carbohydrate factor and/or the correction factor are accordingly increased or decreased).
Regarding claim 2, Booth discloses the method of claim 1, wherein the identified factors indicating that the insulin to carbohydrate ratio for the user or the correction factor for the user should be increased include at least one of: the user experiencing hyperglycemia in a time interval, the user delivered less than a threshold number of insulin boluses in a time period, the user experienced a glucose concentration above an elevated threshold for a duration, or a non-bolus insulin delivery to the user exceeds a percentage threshold (see par. [0146], [0213], [0216]-[0225], [0228]; adjustment factors AF are a function of blood glucose such that an elevated glucose or hyperglycemia increases the insulin to carb ratio).
Regarding claim 3, Booth discloses the method of claim 1, wherein the identified factors indicating that the insulin to carbohydrate ratio for the user or the correction factor should be decreased include at least one of: the user experiencing hypoglycemia in a time interval, the user delivered more than a threshold number of insulin boluses in a time period, the user experienced a glucose concentration below a depressed threshold for a duration, or a bolus insulin delivery to the user exceeds a percentage threshold, variability among glucose concentration readings for the user is greater than a variability threshold, or the user activates a mode to protect against hypoglycemia more often than a frequency threshold (see par. [0146], [0213], [0216]- [0225], [0228]; adjustment factors AF are a function of blood glucose such that a lower glucose or hypoglycemia decreases the insulin to carb ratio).
Regarding claim 4, Booth discloses the method of claim 1, wherein weighing the identified factors indicating that the insulin to carbohydrate ratio for the user or the correction factor for the user should be increased and the identified factors indicating that the insulin to carbohydrate ratio for the user or the correction factor should be decreased comprises assigning weights to the identified factors indicating that the insulin to carbohydrate ratio for the user or the correction factor for the user should be increased and the identified factors indicating that the insulin to carbohydrate ratio for the user or the correction factor should be decreased (see par. [0146], [0213], [0216]-[0225], [0228], factors such as previous insulin to carbohydrate ratios CIR, adjustment factors AF, total daily insulin dose TDD, and a configurable constant CFR are recited as factoring into equations weighing whether to increase or decrease the insulin to carbohydrate ratio and/or the correction factor).
Regarding claim 5, Booth discloses the method of claim 4, wherein some of the weights are positive and some of the weights are negative (see par. [0146], [0213], [0216]-[0225], [0228]; the equations for adjusting CIR and CF include values which can be either positive or negative).
Regarding claim 6, Booth discloses the method of claim 4, further comprising summing the weights to produce a final adjustment factor (see par. [0145]) and comparing the final adjustment factor to one or more weight thresholds to device whether to increase or decrease the insulin to carbohydrate ratio or the correction factor (see par. [0146] and [0228]).
Regarding claim 7, Booth discloses the method of claim 1, wherein the increasing or decreasing the insulin to carbohydrate ratio or the correction factor comprises increasing both the insulin to carbohydrate ratio and the correction factor (see par. [0146], [0213], [0216]-[0225], [0228], factors such as previous insulin to carbohydrate ratios CIR, adjustment factors AF, total daily insulin dose TDD, and a configurable constant CFR are recited as factoring into equations weighing whether to increase the insulin to carbohydrate ratio and the correction factor).
Regarding claim 8, Booth discloses the method of claim 1, wherein the increasing or decreasing the insulin to carbohydrate ratio or the correction factor comprises decreasing both the insulin to carbohydrate ratio and the correction factor (see par. [0146], [0213], [0216]-[0225], [0228], factors such as previous insulin to carbohydrate ratios CIR, adjustment factors AF, total daily insulin dose TDD, and a configurable constant CFR are recited as factoring into equations weighing whether to decrease the insulin to carbohydrate ratio and the correction factor).
Regarding claim 9, Booth discloses the method of claim 1, further comprising delivering insulin to the user with the medicament delivery device (insulin device 123) based on the increased or decreased insulin to carbohydrate ratio or the increased or decreased correction factor (see Fig. 16, par. [0242]).
Response to Arguments
Applicant's arguments filed 10/31/2025 have been fully considered but they are not persuasive.
Applicant argues that Booth fails to teach the limitations “weighing the identified factors indicating that the insulin to carbohydrate ratio for the user or the correction factor for the user should be increased and the identified factors indicating that the insulin to carbohydrate ratio for the user or the correction factor should be decreased with the processor to determine whether to increase or decrease the insulin to carbohydrate ratio or the correction factor”. However, the Examiner respectfully disagrees. Booth teaches a method which regularly calculates and recalculates the correction factor and the insulin to carbohydrate ratio, and the recalculated correction factor or insulin to carbohydrate ratio can therefore be increased or decreased if they are changed from their original values. To calculate the correction factor, the processing software performs the following equation: CF=CFR/TDD (where CF is the correction factor; CFR is a configurable constant stored in the memory; and TDD is the total daily dose of insulin which is equal to the sum over the previous day of all basal doses + all meal boluses + all correction boluses) (see par. [0145]-[0146]). If CFR and TDD are considered the “identified factors”, the weight in this equation would be one (i.e. CF=1*(CFR/TDD)). If CFR was considered the “identified factors”, the weight would be 1/TDD. If TDD (or 1/TDD) was considered the “identified factors”, the weight would be CFR. Any values of CFR and TDD which would increase the correction factor would be the “factors indicating that the correction factor should be increased” and any values of CFR and TDD which would decrease the correction factor would be the “factors indicating that the correction factor should be decreased”. Thus, each interpretation of the equation for the correction factor can be considered as including “identifying factors that the correction factor should be increased/decreased” and “weighing the identified factors” in the manner claimed. Similarly, to calculate the insulin to carbohydrate ratio, the processing software performs the following equation: CIR=previous CIR/AF (where CIR is the insulin to carbohydrate ratio, and AF is an adjustment factor which is calculated by its own algorithm which is a function of blood glucose values as shown in Fig. 8) (see par. [0216]-[0225]). In the same manner described above for the correction factor equation, the variables in the insulin to carbohydrate ratio equation also include “identifying factors that the insulin to carbohydrate ratio should be increased/decreased” and “weighing the identified factors” in the manner claimed.
It appears that the Examiner may have a broader interpretation of the aforementioned claim limitations than what is intended by the Applicant. “Factors” is not limited to any type of factor in particular such that “factors” can include any variable included in the method of calculating the correction factor and the insulin to carbohydrate ratio. Further, “weighing the factors” is not limited to any particular method of weighing such that any equation which calculates the correction factor or the insulin to carbohydrate ratio by multiplying “the identified factors” by a multiplier (even if the multiplier is one) can be considered “weighing the factors” as currently claimed. In other words, the Examiner believes this limitation is relatively broad and further amendments could be made to specify what is meant by “weighing the factors” and how it is different from the Booth method.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AVERY SMALE whose telephone number is (571)270-7172. The examiner can normally be reached Mon.-Fri. 8-4 ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Sirmons can be reached at (571) 272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/AVERY SMALE/Examiner, Art Unit 3783
/KAMI A BOSWORTH/Primary Examiner, Art Unit 3783