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 .
Claim Objections
Claim 12 is objected to because of the following informalities:
In claim 12, line 1, “the electronic device of claim 12” should read “the electronic device of claim 11”
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.
Claim(s) 1, 5-6, 11-12 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mensinger et al. (US Pub No. 20220211944 A1, herein Mensinger).
Regarding claim 1, Mensinger discloses an electronic device (companion device 30, Fig. 3) comprising:
a display for displaying content (display unit 36, Fig. 3); and
a processor (processor 32, Fig. 3) configured to:
determine projected basal (“… bolus or basal insulin dose calculators…” – Para [0049]) insulin delivery amounts (“Insulin Dose Recommendation…” – Para [0014], Produce a recommended dose of insulin… 122, Fig. 6) by an automated insulin delivery (AID) device (peripheral medical device 20, Fig. 1) to the user over an interval (“The app may calculate all of these values for a time point in the near future, for example 30 minutes from the time of calculation.” – Para [0014], “… companion device 30 includes a health management app 40…” – Para [0053]) based on a current rate of change (RoC) of a glucose level of a user (“Insulin Dose Recommendation “R” = [BG Correction]+[Trend Adjust]… where [Trend Adjust]=(Glucose rate of change in mg/dL/minute…” – Para [0014]), a current amount of insulin on board for the user (Determine or receive an insulin on board (IOB) parameter for the patient user 116, Fig. 6) and a most recent glucose level reading for the user (“Insulin Dose Recommendation “R” = [BG Correction]…” – Para [0014], “[BG Correction] = [(Current glucose level in mg/dL)…” – Para [0011]), and
output an indication of the projected basal insulin delivery amounts by the AID device to the user over the interval on the display (Display produced recommended dose of insulin on a display unit of a delivery device and/or companion device 124, Fig. 6).
Examiner interprets the insulin dose recommendation disclosed by Mensinger to be inclusive of basal insulin.
Regarding claim 5, Mensinger discloses the electronic device (companion device 30, Fig. 3) recited above, wherein,
in determining the projected insulin delivery (Produce a recommended dose of insulin… 122, Fig. 6) by the AID device (peripheral medical device 20, Fig. 3) to the user over an interval, the processor (processor 32, Fig. 3) is configured to compare the current RoC of glucose level of the user (“[Trend Adjust] = (Glucose rate of change in mg/dL/minute) x (Projection Time in minutes) / (insulin sensitivity factor in mg/dL/U).” – Para [0014]) to one or more thresholds (“…insulin sensitivity factor…” – Para [0014]), compare the current amount of insulin on board for the user (“…the carbohydrates on board (COB) adjustment parameter subtracted by the insulin on board (IOB) parameter.” – Para [0094]) and the most recent glucose level reading for the user to thresholds (“... (Current glucose level in mg/dL) – (Target glucose level in mg/dL) …” – Para [0011]), and based on the comparing of the current RoC, the comparing of the current amount insulin on board and the comparing of the most recent glucose level reading for the user, determine the projected insulin delivery amounts by the AID device to the user (Produce a recommended dose of insulin based on an estimated sum of the blood glucose concentration parameter, the glucose trend adjustment parameter, the carbohydrates cover parameter, and the COB adjustment parameter subtracted by the IOB parameter 122, Fig. 6).
Examiner interprets the insulin sensitivity factor (e.g. amount of insulin required to adjust BG) as the threshold the current RoC is being compared to, the carbohydrates on board (COB) as the threshold the current amount of insulin on board is being compared to, and the target glucose level in mg/dL as the threshold the most recent glucose level reading is being compared to. Examiner interprets the division/subtraction of the thresholds from their respective parameters as a comparison of the parameters to the thresholds.
Regarding claim 6, Mensinger discloses the electronic device (companion device 30, Fig. 3) recited above, wherein
the processor (processor 32, Fig. 3) is further configured to determine anticipated glucose levels (“ … the app may calculate future values of BG … “ – Para [0028]) for the user over the interval (“The app may calculate all of these values for a time point in the near future … “ – Para [0028]) in view of the projected basal insulin delivery amounts (“ … the app 40 may result in a dose recommendation of 12 units of insulin, but the worst-case calculation predicts that 12 U could drive the user’s BG level as low as 20 mg/dL … “ – Para [0121]).
Regarding claim 11, Mensinger discloses the electronic device (companion device 30, Fig. 3) recited above, wherein
the interval extends from a current time (“… the time of calculation … “– Para [0028]) to a time in the future (“The app may calculate all of these values for a time point in the near future, for example 30 minutes from the time of calculation.” – Para [0028])
Regarding claim 12, Mensinger discloses the electronic device (companion device 30, Fig. 3) recited above, wherein
the time in the future is a time in a range of 15 minutes after the current time to two hours after the current time (“The app may calculate future projections of BG levels in the leading 2 hours in increments of 5 minutes … “ – Para [0099]).
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.
Claim(s) 2 and 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mensinger et al. (US Pub No. 20220211944 A1, herein Mensinger) in view of Patek et al. (US Pub No. 20220199213 A1, herein Patek).
Regarding claim 2, Mensinger discloses the electronic device (companion device 30, Fig. 3) recited above
Mensinger does not expressly disclose that the indication includes a description of the projected basal insulin delivery amounts by the AID device to the user over the interval.
Patek teaches that the indication (“At 350 a recommendation is output to a diabetes management system.” – Para [0154]) includes a description of the projected basal insulin delivery amounts (Determine a recommendation for one or more aspects of daily insulin… 340, Fig. 3) by the AID device (Insulin device 110, Fig.1, “… may include… AID (automated insulin delivery) system)…” – Para [0064]) (“The recommendation(s) may be in the form of a report, a command, or a signal or instructions to an insulin delivery system … or the like … “– Para [0154]) to the user over an interval (“basal insulin data… are received for the patient over the time period…” – Para [0007]).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the electronic device of Mensinger to include that the indication includes a description of the projected basal insulin delivery amounts by the AID device to the user over the interval as taught by Patek to “ensure an optimum balance of basal, bolus, and/or total daily insulin while minimizing hypoglycemic risk and hyperglycemic risk” (Patek, Para [0006]).
Regarding claim 3, Mensinger discloses the electronic device (companion device 30, Fig. 3) recited above
Mensinger does not expressly disclose that the description indicates at least one of the following: that basal insulin delivery to the user will be suspended during at least a portion of the interval, that basal insulin delivery amounts to the user during the interval will be substantially equal to a current basal insulin delivery amount delivered to the user, the basal insulin delivery to the user will be increased during the interval to increased amounts relative to the current basal insulin delivery amount delivered to the user, or the basal insulin delivery amounts delivered to the user will be significantly increased to significantly increased amounts during the interval relative to current basal insulin delivery amount delivered to the user.
Patek teaches that the description (“… the recommendation comprises a change in at least one of basal insulin … and outputting the recommendation to a diabetes management system.” – Para [0007]) indicates at least one of the following: that basal insulin delivery to the user will be suspended during at least a portion of the interval (“basal … should be increased, decreased … or neither.” – Para [0113]), that basal insulin delivery amounts to the user during the interval will be substantially equal to a current basal insulin delivery amount delivered to the user (“basal … should be increased, decreased … or neither.” – Para [0113]), the basal insulin delivery to the user will be increased during the interval (“basal… should be increased … “ – Para [0113]) to increased amounts relative to the current basal insulin delivery amount delivered to the user (“ … calculating a plurality of aspects of daily insulin for each day over the time period … “ – Para [0007]), or the basal insulin delivery amounts delivered to the user will be significantly increased (“basal… should be increased … “ – Para [0113]) to significantly increased amounts during the interval relative to current basal insulin delivery amount delivered to the user (“ … calculating a plurality of aspects of daily insulin for each day over the time period … “ – Para [0007]).
Examiner interprets neither increasing nor decreasing the basal insulin delivery amounts as inclusive of both the delivery amount being suspended and being unchanged. Examiner interprets an increase in the basal insulin delivery amount to be inclusive of both the delivery amount being increased and significantly increased.
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the electronic device of Mensinger to include that the indication includes a description of the projected basal insulin delivery amounts by the AID device to the user over the interval as taught by Patek to “ensure an optimum balance of basal, bolus, and/or total daily insulin while minimizing hypoglycemic risk and hyperglycemic risk” (Patek, Para [0006]).
Claim(s) 4, 7-10, 17-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mensinger et al. (US Pub No. 20220211944 A1, herein Mensinger) in view of Zhong et al. (US Pub No. 20220105269 A1, herein Zhong).
Regarding claim 4, Mensinger discloses the electronic device (companion device 30, Figure 3) recited above
Mensinger does not expressly disclose that the indication includes graphical content.
Zhong teaches that the indication (“… alert… “ – Para [0024]) includes graphical content (“… the patient device 24 may present a graphical alert … “– Para [0024]).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the electronic device of Mensinger to include that the indication includes graphical content as taught by Zhong to “assist in therapy delivery…” (Zhong, Para [0008]).
Regarding claim 7, Mensinger discloses the electronic device (companion device 30, Fig. 3) recited above
Mensinger does not expressly disclose that the processor is additionally configured to determine whether the anticipated glucose levels for the user over the interval will exceed a desired range of glucose levels.
Zhong teaches that that the processor is additionally configured to determine whether the anticipated glucose levels for the user over the interval will exceed a desired range of glucose levels (“… processor 28 may determine … projected glucose levels over a time frame (e.g., 1 hour …”, “When the projected glucose levels exceed a prescribed range (e.g., above an upper threshold or below a lower threshold.” – Para [0079]).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the electronic device of Mensinger to include that the processor is additionally configured to determine whether the anticipated glucose levels for the user over the interval will exceed a desired range of glucose levels as taught by Zhong to “proactively control delivery of insulin to patient…” (Zhong, Para [0079]).
Regarding claim 8, Mensinger discloses the electronic device (companion device 30, Fig. 3) recited above
Mensinger does not expressly disclose that the processor is additionally configured to notify the user that the anticipated glucose levels for the user over the interval will exceed the desired range of glucose levels.
Zhong teaches that the processor is additionally configured to notify the user that the anticipated glucose levels for the user over the interval will exceed the desired range of glucose levels (“… patient device 24 may present a graphical alert… indicating that the projected glucose levels will leave the prescribed range, i.e. drop below a lower bound of the range or rise above an upper bound of the range… “ – Para [0079])
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the electronic device of Mensinger to include that the processor is additionally configured to notify the user that the anticipated glucose levels for the user over the interval will exceed the desired range of glucose levels as taught by Zhong for “… improving engagement of patient 12 with patient device 24.” (Zhong, Para [0079]).
Regarding claim 9, Mensinger discloses the electronic device (companion device 30, Fig. 3) as recited above
Mensinger does not expressly disclose that the processor is additionally configured to determine whether the anticipated glucose levels of the user over the interval will fall below the desired range of glucose levels.
Zhong teaches that the processor is additionally configured to determine whether the anticipated glucose levels of the user over the interval will fall below the desired range of glucose levels (“… processors 28 may determine… projected glucose levels over a time frame (e.g., 1 hour… “, “When the projected glucose levels exceed a prescribed range (e.g., above an upper threshold or below a lower threshold… “ – Para [0079]).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the electronic device of Mensinger to include that the processor is additionally configured to determine whether the anticipated glucose levels of the user over the interval will fall below the desired range of glucose levels as taught by Zhong to “proactively control delivery of insulin to patient…” (Zhong, Para [0079]).
Regarding claim 10, Mensinger discloses the electronic device (companion device 30, Fig. 3) recited above
Mensinger does not expressly disclose that the processor is additionally configured to notify the user that the anticipated glucose levels for the user over the interval will fall below the desired range of glucose levels.
Zhong teaches that the processor (processors 28, Fig. 1) is additionally configured to notify the user that the anticipated glucose levels for the user over the interval will fall below the desired range of glucose levels (“… patient device 24 may present a graphical alert… indicating that the projected glucose levels will leave the prescribed range, i.e. drop below a lower bound of the range or rise above an upper bound of the range… “ – Para [0079]).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the electronic device of Mensinger to include that the processor is additionally configured to notify the user that the anticipated glucose levels for the user over the interval will fall below the desired range of glucose levels as taught by Zhong for “… improving engagement of patient 12 with patient device 24.” (Zhong, Para [0079]).
Regarding claim 17, Mensinger discloses a method (method 119, Fig. 6) performed by a processor (processor 32, Fig. 3) of an electronic device (companion device 30, Fig. 3) that includes a display (display unit 36, Fig. 3), comprising:
determining projected basal insulin delivery amounts by an automatic insulin delivery (AID) device (peripheral medical device 20, Fig. 1) to a user (Produce a recommended dose of insulin… 122, Fig. 6) over a future time window (“The app may calculate all of these values for a time point in the near future, for example 30 minutes from the time of calculation.” – Para [0028]);
determining anticipated glucose levels of the user over the future time window (“… the app may calculate future values of BG… “ – Para [0028]) in view of the determined projected basal insulin delivery amounts (“… the app 40 may result in dose recommendation of 12 units of insulin, but the worst-case calculation predicts that 12 U could drive the user’s BG level as low as 20mg/dL… “ – Para [0121]); and
a visual cue of the projected basal insulin delivery amounts to inform the user of the projected basal insulin delivery amounts (Display produced recommended dose of insulin on a display unit of a delivery device and/or companion device 124, Fig. 6).
Mensinger does not expressly disclose displaying a user interface on the display, wherein the user interface includes graphical content regarding the anticipated glucose levels
Zhong teaches displaying a user interface on the display (“… patient device 24 may display a user interface… “ – Para [0044]), wherein the user interface includes graphical content regarding the anticipated glucose levels (“… a graphical alert indicating that the projected levels of glucose will leave the prescribed range… “ – Para [0009]).
Therefore, it would have been obvious, before the filing date of the claimed invention, to modify the method of Mensinger to include displaying a user interface on the display, wherein the user interface includes graphical content regarding the anticipated glucose levels as taught by Zhong to for “… improving engagement of patient 12 with patient device 24.” (Zhong, Para [0079]).
Regarding claim 18, Mensinger discloses the method (method 119, Fig. 6) recited above, wherein
the determining of the projected basal insulin delivery amounts (Produce a recommended dose of insulin… 122, Fig. 6) is based on a current glucose level of the user (“Insulin Dose Recommendation = [BG Correction]…” – Para [0009], “[BG Correction] = [(Current glucose level in mg/dL)… “ – Para [0011]), a current rate of change of glucose level of the user (“Insulin Dose Recommendation “R” = [BG Correction]+[Trend Adjust]… where, [Trend Adjust] = (Glucose rate of change in mg/dL/minute)… “ – Para [0014]) and total daily insulin for the user (Determine of receive an insulin on board (IOB) parameter for the patient user 116, Fig. 6).
Regarding claim 19, Mensinger discloses the method (method 119, Fig. 6) recited above, further comprising
Mensinger does not expressly disclose determining that at least some of the anticipated glucose levels over the future time window will exceed a threshold and in response, outputting a recommendation on the display of action that the user may take to reduce the anticipated glucose levels over the future time window
Zhong teaches determining that at least some of the anticipated glucose levels over the future time window will exceed a threshold (“… processor 28 may determine… projected glucose levels over a time frame (e.g., 1 hour… “, “When the projected glucose levels exceed a prescribed range (e.g., above an upper threshold or below a lower threshold… “ – Para [0079]) and in response, outputting a recommendation on the display of action that the user may take to reduce the anticipated glucose levels over the future time window (“… patient device 24 may recommend a dosage of 2 units of insulin to bring patient 12 back within prescribed range… “ – Para [0014], Fig. 5C).
Therefore, it would have been obvious, before the filing date of the claimed invention, to modify the method of Mensinger to include determining that at least some of the anticipated glucose levels over the future time window will exceed a threshold and in response, outputting a recommendation on the display of action that the user may take to reduce the anticipated glucose levels over the future time window as taught by Zhong to
Regarding claim 20, Mensinger discloses the method (method 119, Fig. 6) recited above, further comprising
Mensinger does not expressly disclose determining that at least some of the anticipated glucose levels over the future time window will fall below a threshold and in response, outputting a recommendation on the display of action that the user may take to increase the anticipated glucose levels over the future time window
Zhong teaches that determining that at least some of the anticipated glucose levels over the future time window will fall below a threshold and in response (“… processors 28 may determine… projected glucose levels over a time frame (e.g., 1 hour… “, “When the projected glucose levels exceed a prescribed range (e.g., above an upper threshold or below a lower threshold… “ – Para [0079]) outputting a recommendation on the display of action that the user may take to increase the anticipated glucose levels over the future time window (“… an indication of a remedy to the hypoglycemic event (e.g., “You may need to eat carbs.”).” – Para [0106], Fig. 4B)
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the method of Mensinger to include determining that at least some of the anticipated glucose levels over the future time window will fall below a threshold and in response, outputting a recommendation on the display of action that the user may take to increase the anticipated glucose levels over the future time window as taught by Zhong to “… warn the patient of the hypoglycemic event or hyperglycemic event.” (Zhong, Para [0025]).
Claim(s) 13-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zhong et al. (US Pub No. 20220105269 A1, herein Zhong) in view of Mensinger et al. (US Pub No. 20220211944 A1, herein Mensinger).
Regarding claim 13, Zhong discloses an electronic device (patient device 24 and insulin pump 14, Fig. 1), comprising:
a display for displaying content (“… patient device 24 may display a user interface… “ – Para [0044]); and
determine if anticipated glucose levels of the user for the future interval stay within a desired range (“… processors 28 may determine… projected glucose levels over a time frame (e.g., 1 hour… “, “When the projected glucose levels exceed a prescribed range (e.g., above an upper threshold or below a lower threshold… “ – Para [0079]), and
if the anticipated glucose levels of the user for the interval are determined to not stay within a desired range (“Predicted low glucose in 1 hour”, Fig. 4A), output a recommendation on the display for action by the user to adjust their glucose level (“You may need to eat carbs”, Fig. 4A, “… an indication of a remedy to the hypoglycemic event… “– Para [0106]).
Zhong does not expressly disclose a processor configured to: determine projected insulin delivery amounts by an automatic insulin delivery (AID) device to a user over a future interval
Mensinger teaches that a processor (processors 28, Fig. 1) configured to:
determine projected insulin delivery amounts (Produce a recommended dose of insulin… 122, Fig. 6) by an automatic insulin delivery (AID) device (peripheral medical device 20, Fig. 1) to a user over a future interval (“The app may calculate all of these values for a time point in the near future, for example 30 minutes from the time of calculation.” – Para [0028]).
Therefore, it would have been obvious, before the effective filing date of the claimed invention, to modify the electronic device of Zhong to include a processor configured to: determine projected insulin delivery amounts by an automatic insulin delivery (AID) device to a user over a future interval as taught by Mensinger to “forecast whether a hypoglycemic (or hyperglycemic) excursion is likely within a particular leading time period…” (Mensinger, Para [0099]).
Regarding claim 14, Zhong teaches the electronic device (patient device 24 and insulin pump 14, Fig. 1) as recited above, wherein
the recommendation is for the user to receive a correction insulin bolus and/or the exercise (“… patient device 24 may recommend a dosage of 2 units of insulin to bring patient 12 back within prescribed range… “– Para [0114], Fig. 5C)
Regarding claim 15, Zhong teaches the electronic device (patient device 24 and insulin pump 14, Fig. 1) as recited above, wherein
the recommendation is for the user to consume carbohydrates (“… an indication of a remedy to the hypoglycemic event (e.g., “You may need to eat carbs.”).” – Para [0106], Fig. 4B).
Regarding claim 16, Zhong discloses the electronic device (patient device 24 and insulin pump 14, Fig. 1) as recited above, wherein
The electronic device is at least one of a management device for the AID device, the AID device (“… patient device 24 may be a special programmer or controller for insulin pump 14.” – Para [0042], “Insulin pump 14 may be considered as an example of an automated insulin delivery (AID) device.” – Para [0039], “… clinician may utilize patient device 24 to communicate with insulin pump 14.” – Para [0042]), a smartphone, a wearable device or a handheld device (“Examples of patient device 24 include mobile devices, such as smartphones, or tablet computers, laptop computers, and the like.” – Para [0042]).
Examiner interprets the electronic device to be the patient device in communication with the insulin pump/AID device.
Conclusion
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/ESHA PRAKASH KASHYAP/ Examiner, Art Unit 3783
/CHELSEA E STINSON/ Supervisory Patent Examiner, Art Unit 3783