DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 29 January 2026 has been entered.
Response to Amendment
This office action is responsive to the amendment filed on 29 January 2026. As directed by the amendment: claims 1, 5, 10, 15, and 20 have been amended. Thus claims 1-20 are presently pending in this application. Applicant’s amendments to the Claims have overcome each claim objection previously set forth in the Final Office Action mailed 4 December 2025.
Response to Arguments
Applicant’s arguments, see REMARKS, filed 29 January 2026, with respect to the rejection(s) of claim(s) 1, 15, and 20 have been fully considered but they are not persuasive. Applicant argues that Blomquist describes determining blood glucose level after a specified time duration after delivery of a bolus amount of fluid, not “based on an inflection point in the rate of change of the physiological condition” as recited in the amended claims.
The examiner respectfully disagrees. Blomquist does describe determining blood glucose after a specified time duration, but Blomquist also describes measuring the rate of change and identifying an inflection point, in the form of identifying when the rate of change of the blood glucose becomes stable, which, as shown in Fig 2, is when the rate changes from negative to 0. Blomquist teaches the system will “end a carbohydrate ratio test early and calculate a carbohydrate ratio when it determines that the blood glucose is stable” [0042].
Specification
The disclosure is objected to because of the following informalities:
Lines 11-14 of paragraph [0065] recite “Thereafter, in one or more embodiments, the pump control system 520, 600 monitors or otherwise analyzes the rate of change between successive sensor glucose values until identifying an inflection point at time TPK. The pump control system 520, 600 identifies the current sensor glucose value at time TPK as the post-prandial sensor glucose reference value (SGPP)[…]”
The underlined recitations of TPK, should instead recite TPP, which is the post-prandial time.
Appropriate correction is required.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-3, 5, 8, 10-17, and 19-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Blomquist (US 2008/0206799 A1).
Regarding Claim 1, Blomquist discloses a system for controlling fluid delivery (Controller 115), the system comprising: one or more processors (¶0023 the controller comprises processor); and one or more processor-readable storage media (116) storing instructions (¶0043) which, when executed by the one or more processors (¶0023), cause performance of: obtaining a plurality of sensor measurements representative of a physiological condition of a patient ([0028] “a blood glucose sensor to produce a blood glucose signal representative of a blood glucose level of the patient”) determining a rate of change of the physiological condition based on the plurality of sensor measurements ([0042] “Taking into account the rate of change of blood glucose”); identifying a residual value indicative of a difference between a first value (805 Before bolus blood glucose reading) and a second value (810 blood glucose level obtained after a time duration of an initial carbohydrate insulin bolus), the first value corresponding to the physiological condition of a patient before delivery of a bolus amount of fluid (805 blood glucose level before administration of a bolus), and the second value corresponding to the physiological condition of the patient after delivery of the bolus amount of the fluid (810 the blood glucose measurement after a time after delivery of an initial carbohydrate insulin bolus), wherein the second value is determined based on an inflection point in the rate of change of the physiological condition ([0042] “the carbohydrate ratio module 120 uses the rate of change of blood glucose to determine that the blood glucose level is stable, such as by when the rate of change is less than a specified threshold rate of change for example. The carbohydrate ratio module 120 may end a carbohydrate ratio test early and calculate a carbohydrate ratio when it determines that the blood glucose is stable”, the blood glucose is stable as shown in Fig 2 when the rate of change changes from a negative value to 0 which is an inflection point); determining, based on the residual value, a residual carbohydrate value ([0031] “correction insulin”) that indicates an amount of carbohydrates overcompensated for or undercompensated for by the bolus (correction insulin indicates over and under compensation by the bolus); determining a ratio adjustment factor based on the residual carbohydrate value (the ratio adjustment factor is the denominator in the “New Ratio” calculation in [0031] “(initial insulin + correction insulin)” and [0034] “(initial insulin - correction insulin)”); determining, based on the ratio adjustment factor, an updated value for a ratio (the “New Ratio” in the calculation in [0031]) that influences delivery of bolus amounts of the fluid (as described in the example in [0033] the new ratio is the carbohydrate ratio used to calculate carbohydrate amount per unit of insulin to determine an insulin bolus); and delivering fluid using an infusion device (330 Fig 3) in accordance with the updated value for the ratio ([0050] “The insulin may be delivered through boluses such as a correction bolus or a carbohydrate bolus”).
Regarding Claim 2, Blomquist discloses the system of claim 1, wherein the bolus amount of fluid is a first bolus amount of fluid (¶0070 at block 810 initial carbohydrate insulin bolus delivery), and wherein the one or more processor-readable storage media (116) further store instructions (¶0043) which, when executed by the one or more processors (¶0023) the controller comprises processor, cause performance of: generating information indicative of a second bolus amount of fluid based on the updated value for the ratio (820 Carbohydrate ratio using the BG management device according to a difference between the blood glucose baseline and the blood glucose level of the patient after the specified time duration; the ratio updates and informs the next bolus for the future).
Regarding Claim 3, Blomquist discloses the system of claim 2 wherein generating information indicative of the second bolus amount of fluid based on the updated value for the ratio comprising generating information indicative of the second bolus amount of fluid based on the updated value for the ratio and an input carbohydrate amount (820 Carbohydrate ratio using the BG management device according to a difference between the blood glucose baseline and the blood glucose level of the patient after the specified time duration; the ratio updates and informs the next bolus for the future ¶0046).
Regarding Claim 5, Blomquist discloses the system of claim 1, wherein the bolus amount of fluid is influenced by a previous value for the ratio, and wherein determining, based on the ratio adjustment factor, the updated value for the ratio comprises: scaling the previous value for the ratio by the ratio adjustment factor to determine the updated value for the ratio (820 Carbohydrate ratio using the BG management device according to a difference between the blood glucose baseline and the blood glucose level of the patient after the specified time duration; the ratio updates and informs the next bolus for the future ¶0046; incorporating the ratio into Table 1 provides an example of scaling the next dosage with input).
Regarding claim 11, Blomquist discloses the system of claim 1. Blomquist further discloses wherein determining the residual carbohydrate value comprises dividing the residual value by a carbohydrate conversion factor (the residual carbohydrate value is the correction insulin, as described in the example in [0032] and [0033] correction insulin is calculated using the residual value (40 mg/dl) divided by the conversion factor (80 mg/dl/unit), the correction insulin is 0.5 units in this example).
Regarding claim 8, Blomquist discloses the system of claim 11. Blomquist further discloses the carbohydrate conversion factor is patient specific ([0033] “Further assume that the correction factor for the patient is set to one unit per 80 mg/dl. A correction factor refers to the amount in drop in blood sugar, or blood glucose, for one unit of insulin”).
Regarding claim 10, Blomquist discloses the system of claim 1. Blomquist further discloses wherein determining the ratio adjustment factor based on the residual carbohydrate value comprises: determining a ratio of a difference between an input amount of carbohydrates and the residual carbohydrate value to the input amount of carbohydrates (the ratio adjustment factor is the denominator in the “New Ratio” calculation in [0031] “(initial insulin + correction insulin)” and [0034] “(initial insulin - correction insulin)”, the initial insulin is based on the input amount of carbohydrates and the residual carbohydrate value is the correction insulin, the calculation determines the ratio difference).
Regarding Claim 12, Blomquist discloses the system of claim 1, wherein the fluid comprises insulin (¶0001 insulin management and therapy are the center of treatment), wherein the physiological condition comprises a glucose level (¶0005 measured physiological metric is a sampled blood glucose level), wherein the residual value comprises a residual glucose value representing a difference between: a pre-bolus glucose level; and a post-bolus and insulin metabolization glucose level (820 difference between blood glucose baseline and the blood glucose level of patient after the specified time duration of receiving carbohydrate insulin bolus for metabolizing).
Regarding Claim 13, Blomquist discloses the system of claim 1, wherein the residual value comprises a residual glucose value (820 difference between blood glucose baseline and the blood glucose level of patient after the specified time duration of receiving carbohydrate insulin bolus for metabolizing).
Regarding Claim 14, Blomquist discloses the system of claim 13, wherein the updated value comprises an updated carbohydrate ratio adjusted to compensate for the residual glucose value (820 Carbohydrate ratio using the BG management device according to a difference between the blood glucose baseline and the blood glucose level of the patient after the specified time duration; ¶0045-0046).
Regarding Claim 15, Blomquist discloses a processor-implemented method (¶0023 the controller comprises processor) for controlling (controller 115) insulin delivery (¶0005 insulin delivery), the method comprising: obtaining a plurality of sensor measurements representative of a physiological condition of a patient ([0028] “a blood glucose sensor to produce a blood glucose signal representative of a blood glucose level of the patient”); determining a rate of change of the physiological condition based on the plurality of sensor measurements ([0042] “Taking into account the rate of change of blood glucose”); identifying a residual value indicative of a difference between a first value (805 Before bolus blood glucose reading) and a second value (810 blood glucose level obtained after a time duration of an initial carbohydrate insulin bolus), the first value corresponding to the physiological condition of a patient before delivery of a bolus amount of fluid (805 blood glucose level before administration of a bolus), and the second value corresponding to the physiological condition of the patient after delivery of the bolus amount of the fluid (810 blood glucose level obtained after a time duration of an initial carbohydrate insulin bolus), wherein the second value is determined based on an inflection point in the rate of change of the physiological condition ([0042] “the carbohydrate ratio module 120 uses the rate of change of blood glucose to determine that the blood glucose level is stable, such as by when the rate of change is less than a specified threshold rate of change for example. The carbohydrate ratio module 120 may end a carbohydrate ratio test early and calculate a carbohydrate ratio when it determines that the blood glucose is stable”, the blood glucose is stable as shown in Fig 2 when the rate of change changes from a negative value to 0 which is an inflection point); determining, based on the residual value, a residual carbohydrate value ([0031] “correction insulin”) that indicates an amount of carbohydrates overcompensated for or undercompensated for by the bolus (correction insulin indicates over and under compensation by the bolus); determining a ratio adjustment factor based on the residual carbohydrate value (the ratio adjustment factor is the denominator in the “New Ratio” calculation in [0031] “(initial insulin + correction insulin)” and [0034] “(initial insulin - correction insulin)”); determining, based on the ratio adjustment factor, an updated value for a ratio (the “New Ratio” in the calculation in [0031]) that influences delivery of bolus amounts of the fluid (as described in the example in [0033] the new ratio is the carbohydrate ratio used to calculate carbohydrate amount per unit of insulin to determine an insulin bolus); and delivering fluid using an infusion device in accordance with the updated value for the ratio ([0050] “The insulin may be delivered through boluses such as a correction bolus or a carbohydrate bolus”).
Regarding Claim 16, Blomquist discloses the method of claim 15, further comprising: generating information indicative of a second bolus amount of fluid based on the updated value for the ratio (820 Carbohydrate ratio using the BG management device according to a difference between the blood glucose baseline and the blood glucose level of the patient after the specified time duration; the ratio updates and informs the next bolus for the future).
Regarding Claim 17, the method of claim 16, wherein generating information indicative of the second bolus amount of fluid based on the updated value for the ratio comprises generating information indicative of the second bolus amount of fluid based on the updated value for the ratio and an input carbohydrate amount (820 Carbohydrate ratio using the BG management device according to a difference between the blood glucose baseline and the blood glucose level of the patient after the specified time duration; the ratio updates and informs the next bolus for the future; the ratio updates and informs the next bolus for the future ¶0046).
Regarding Claim 19, Blomquist discloses the system of claim 15, wherein the bolus amount of fluid is influenced by a previous value for the ratio, and wherein determining, based on the ratio adjustment factor, the updated value for the ratio comprises: scaling the previous value by the ratio adjustment factor to determine the updated value for the ratio (820 Carbohydrate ratio using the BG management device according to a difference between the blood glucose baseline and the blood glucose level of the patient after the specified time duration; the ratio updates and informs the next bolus for the future ¶0046; incorporating the ratio into Table 1 provides an example of scaling the next dosage with input).
Regarding Claim 20, Blomquist discloses one or more non-transitory processor-readable storage media (116) storing instructions which, when executed by one or more processors, cause performance of: obtaining a plurality of sensor measurements representative of a physiological condition of a patient ([0028] “a blood glucose sensor to produce a blood glucose signal representative of a blood glucose level of the patient”) determining a rate of change of the physiological condition based on the plurality of sensor measurements ([0042] “Taking into account the rate of change of blood glucose”); identifying a residual value indicative of a difference between a first value (805 Before bolus blood glucose reading) and a second value (P0070 blood glucose reading after bolus 810), the first value corresponding to the physiological condition of a patient before delivery of a bolus amount of fluid (805 Before bolus blood glucose reading), and the second value corresponding to the physiological condition of the patient after delivery of the bolus amount of the fluid (¶0005 a blood glucose level of the patient at the end of the specified time duration post carbohydrate meal bolus delivery), wherein the second value is determined based on an inflection point in the rate of change of the physiological condition ([0042] “the carbohydrate ratio module 120 uses the rate of change of blood glucose to determine that the blood glucose level is stable, such as by when the rate of change is less than a specified threshold rate of change for example. The carbohydrate ratio module 120 may end a carbohydrate ratio test early and calculate a carbohydrate ratio when it determines that the blood glucose is stable”, the blood glucose is stable as shown in Fig 2 when the rate of change changes from a negative value to 0 which is an inflection point); determining, based on the residual value, a residual carbohydrate value ([0031] “correction insulin”) that indicates an amount of carbohydrates overcompensated for or undercompensated for by the bolus (correction insulin indicates over and under compensation by the bolus); determining a ratio adjustment factor based on the residual carbohydrate value (the ratio adjustment factor is the denominator in the “New Ratio” calculation in [0031] “(initial insulin + correction insulin)” and [0034] “(initial insulin - correction insulin)”); determining, based on the ratio adjustment factor, an updated value for a ratio (the “New Ratio” in the calculation in [0031]) that influences delivery of bolus amounts of the fluid (as described in the example in [0033] the new ratio is the carbohydrate ratio used to calculate carbohydrate amount per unit of insulin to determine an insulin bolus); and delivering fluid using an infusion device in accordance with the updated value for the ratio ([0050] “The insulin may be delivered through boluses such as a correction bolus or a carbohydrate bolus”).
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.
Claims 4, 6-7, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Blomquist (US 2008/0206799 A1).
Regarding Claim 4, Blomquist discloses the system of claim 1, wherein the one or more processor-readable storage media (116) further store instructions (¶0043).
The current embodiment of Blomquist is silent on when executed by the one or more processors, cause performance of: storing the updated value for the ratio.
One embodiment however explains that after ratios are determined, the controller may change a stored pattern or profile for that meal’s ratio (¶0046; Fig 1). This would be to have a more accurate dosage for treatment for each meal.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the system of Blomquist to include storing the updated value for the ratio taught by the figure 1 embodiment of Blomquist for the purpose of a more accurate dosage for treatment for each meal.
Regarding Claim 6, the modified Blomquist discloses the system of claim 1, wherein the one or more processor-readable storage media (116) further store instructions which (¶0043), when executed by the one or more processors.
The current embodiment of the modified Blomquist is silent on determining the bolus amount of fluid based on an input carbohydrate amount and a previous value for the ratio.
The embodiment presented in figure 1 however presents determining the bolus amount of fluid based on an input carbohydrate amount from the meal database and the stored ratio from previous ratio tests (¶0043 and Fig 1). This is to quickly calculate the bolus necessary for a given meal selection of the user.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the system of Blomquist to include determining the bolus amount of fluid based on an input carbohydrate amount and a previous value for the ratio taught by the figure 1 embodiment of the modified Blomquist for the purpose of quickly calculating the bolus necessary for a given meal selection of the user.
Regarding Claim 7, the modified Blomquist discloses the system of claim 1.
The current embodiment of the modified Blomquist is silent on wherein the first value comprises a pre-prandial value of the physiological condition, and the second value comprises a post-prandial value of the physiological condition after metabolization of the bolus amount of the fluid.
The Figure 2 embodiment of the modified Blomquist however teaches that the blood glucose is measured before a meal as a baseline (210) and then a patient ingests carbohydrates as a meal (215) and has their meal bolus and glucose is taken some time after metabolization period (225, 230). This is for the purpose of determining a correction insulin to add to the initial carbohydrate insulin amount for that meal and determine a ratio (¶0031 New Ratio=(Carbohydrates)/(initial insulin+correction insulin)).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the system of the modified Blomquist to include the first value comprises a pre-prandial value of the physiological condition , and the second value comprises a post-prandial value of the physiological condition after metabolization of the bolus amount of the fluid taught by the figure 2 embodiment of Blomquist for the purpose of determining a correction insulin to add to the initial carbohydrate insulin amount for that meal and determine a ratio.
Regarding Claim 18, Blomquist discloses the system of claim 15, wherein the one or more processor-readable storage media (116) further store instructions (¶0043).
The current embodiment of Blomquist is silent on when executed by the one or more processors, cause performance of: storing the updated value for the ratio.
One embodiment however explains that after ratios are determined, the controller may change a stored pattern or profile for that meal’s ratio (¶0046; Fig 1). This would be to have a more accurate dosage for treatment for each meal.
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the system of Blomquist to include storing the updated value for the ratio taught by the figure 1 embodiment of Blomquist for the purpose of a more accurate dosage for treatment for each meal.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Blomquist (US 2008/0206799 A1), in view of Blomquist et al. (US 2009/0177147 A1), hereinafter Blomquist ‘147.
Regarding claim 9, Blomquist discloses the system of claim 11. However, Blomquist is silent to the carbohydrate conversion factor is dependent on a time of day.
Blomquist ‘147 teaches the carbohydrate conversion factor ([0098] “correction factor”) is dependent on a time of day ([0098] “the device 1400 may use a different correction factor at a different time of the day according to a time of day schedule”). It would have been obvious to one of ordinary skill in the art at the time of effective filing for the carbohydrate conversion factor to be dependent on a time of day as taught by Blomquist ‘147 to shift the parameters to be more accurate and improve insulin therapy [0098].
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Saint et al. (US 2014/0276556 A1) discloses various ways to determine when to take a measurement for a second value including “when blood glucose levels have flattened or stabilized after the infusion of insulin” [0063].
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Anna Vargas whose telephone number is (571)270-3873. The examiner can normally be reached Mon-Fri 4:00 PM-9:00 PM EST.
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/A.E.V./Examiner, Art Unit 3783
/COURTNEY FREDRICKSON/Primary Examiner, Art Unit 3783
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