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 .
Claim Rejections - 35 USC § 103
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) 1-17 and 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication 2020/0152312 to Connor in further view of “Prediction and prevention of hypoglycaemic events in type-1 diabetic patients using machine learning” by Vehi et al. in further view of U.S. Patent Application Publication 2019/0221307 to Mazlish et al.
As to claims 1 and 17 Connor discloses a device for assisting in therapy delivery, the device comprising:
a memory configured to store first projected levels of glucose in a patient over a first time frame (Connor [0051]):
one of more processors configured to:
determine an occurrence of an event that alters how projected levels of glucose are to be output (Connor [0286], [0194] where the event is food consumption);
automatically determine, based on the event, a second time frame that differs from the first time frame (Connor [0183], [0194] the time frame is a period of time between spectroscopic scans based on gesture indicating food consumption);
obtain a current glucose level of the patient (Connor [0363]-[0364] and [0183] “a system can select a recommended insulin dosage in response to specific attributes of a trigger”);
obtain, based on the current glucose level, second projected levels of glucose in the patient over the second time frame (Connor [0183 a system can select a recommended insulin dosage in response to specific attributes of a trigger and [0363]-[0364]) and
output the second projected levels of glucose for the second time frame (Connor [0347] and [0183]).
However, Connor does not explicitly teach:
Automatically determine, based on the event, a second time frame comprising a start and an end time, that differs from the first time frame, over which to project glucose levels.
Vehi discloses:
Automatically determine, based on the event, a second time frame comprising a start and an end time, that differs from the first time frame, over which to project glucose levels (Vehi see table 1 and discussion of methods where prediction windows of various length are used based on events e.g. a postprandal assessment of 4hrs based on when a patient announces a meal and nocturnal assessment of 6hrs based on patient reported sleep announcement.
It would have been obvious to one of ordinary skill in the art at the time of the effective filing of the invention to utilize different window lengths based on different events as in Vehi in the system of Connor to improve predictions of hypoglycemic and hyperglycemic events.
However, Vehi and Connor do not explicitly teach causing a graph of a second projected levels of glucose over the second time frame to be displayed. Mazlish discloses causing a graph of a second projected levels of glucose over the second time frame to be displayed (Mazlish [0048]).
It would have been obvious to one of ordinary skill in the art at the time of the invention to graphically display predicted glucose as in Mazlish using the predictive algorithm of Connor and Vehi to better apprise the patient of their condition so that they may take actions to improve their health.
As to claim 2, see the discussion of claim 1, additionally, Connor discloses the device wherein the event comprises one or more of a time of day event (Connor [0363]-[0364]).
As to claim 3, 19, see the discussion of claim 1, additionally, Connor discloses the device wherein the one or more processors are further configured to:
determine whether the second projected levels of glucose leave a prescribed range (Connor [0115]-[0116]);
generate, responsive to determining that the second projected levels of glucose leave the prescribed range, a graphical alert medicating that the second projected levels of glucose will leave the prescribed range during the second time frame (Connor [0115]-[0116]); and
output the alert (Connor [0115]-[0116]);.
As to claim 4, see the discussion of claim 3, additionally, Connor discloses the device wherein the prescribed range includes values between a lower threshold identifying a hypoglycemic condition for the patient and an upper threshold identifying a hyperglycemic condition for the patient (Connor [0115]-[0116]).
As to claim 5, see the discussion of claim 1, additionally, Connor discloses the device
wherein the one or more processors are, when determining the occurrence of the projection event, configured to automatically detect a meal event indicating that the patient is currently eating a meal (Connor [0183], [0194]), and
wherein the one or more processors are, when automatically determining the second time frame, configured to automatically determine, based on the meal event, the second time frame (Connor [0183], [0194]).
As to claim 6, see the discussion of claim 5, additionally, Connor discloses the device, wherein the second time frame is greater than or equal to two hours (Connor [0244]).
As to claim 7, see the discussion of claim 5, additionally, Connor discloses the device wherein the second time frame is a time frame of at least four hours (Connor [0244]).
As to claim 8, see the discussion of claim 5, additionally, Connor discloses the device wherein the one or more processors are configured to:
interface with a wearable computing device worn by the patient to identify movements performed by the patient (Connor [0183], [0194]); and
automatically detect, based on the movements, the meal event indicating that the patient is currently eating a meal (Connor [0183], [0194]).
As to claim 9, see the discussion of claim 1, additionally, Connor discloses the device wherein the one or more processors are, when determining the occurrence of the projection event, configured to automatically detect an insulin delivery event indicating that the patient has received insulin (Connor [0345]), and
wherein the one or more processors are, when automatically determining the second time frame, configured to automatically determine, based on the insulin delivery event, the second time frame (Connor [0345]).
As to claim 10, see the discussion of claim 1, additionally, Connor discloses the device wherein the one or more processors are, when determining the occurrence of the projection event, configured to automatically detect an exercise event indicating that the patient is currently exercising (Connor [0286]), and
wherein the one or more processors are, when automatically determining the second time frame, configured to automatically determine, based on the exercise event, the second time frame (Connor [0315]-[0316]).
As to claim 11, see the discussion of claim 1, additionally, Connor discloses the device
wherein the one or more processors are, when determining the occurrence of the projection event, configured to automatically detect a sleep event indicating that the patient is expected to sleep (Connor [0286]), and
wherein the one or more processors are, when automatically determining the second time frame, configured to automatically determine, based on the sleep event, the second time frame (Connor [0244]).
As to claim 12, see the discussion of claim 11, additionally, Connor discloses the device wherein the second time frame is a time frame of greater than or equal to four hours (Connor [0244]).
As to claim 13, see the discussion of claim 11, additionally, Connor discloses the device wherein the second time frame is a time frame of at least eight hours (Connor [0244]).
As to claim 14, see the discussion of claim 1, additionally, Connor discloses the device
wherein the projection event is a first projection event (Connor [0363]-[0364]), and
wherein the one or more processors are configured to:
determine an occurrence of a second projection event that alters how the projected levels of glucose is to be output(Connor [0363]-[0364]);
automatically determine, based on the second projection event, a third time frame that differs from the first time frame and the second time frame (Connor [0363]-[0364]):
obtain the current glucose level of the patient (Connor [0363]-[0364]);
obtain, based on the current glucose level, projected third levels of glucose in the patient over the third time frame (Connor [0363]-[0364]): and
output the third projected levels of glucose for the third time frame (Connor [0363]-[0364]).
As to claim 15, see the discussion of claim 1, additionally, Connor discloses the device wherein the one or more processors are further configured to interface with a glucose monitor to obtain the current glucose level sensed by an insulin pump implanted in the patient (Connor [0356]).
As to claim 16, see the discussion of claim 1, additionally, Connor discloses the device wherein the first time frame is for a first duration (Connor [0363]-[0364]), and
wherein the second time frame is for a second duration that is different than the first duration (Connor [0363]-[0364]).
Claim Rejections - 35 USC § 103
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) 20-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication 2020/0152312 to Connor “Prediction and prevention of hypoglycaemic events in type-1 diabetic patients using machine learning” by Vehi et al. in further view of U.S. Patent Application Publication 2019/0221307 to Mazlish et al.in view of U.S. Patent 12,171,547 to Constantin et al.
As to claim 20 Connor discloses a device for assisting in therapy delivery, the device comprising:
a memory configured to store first projected levels of glucose in a patient over a first time frame (Connor [0051]):
one of more processors configured to:
determine an occurrence of an event that alters how projected levels of glucose are to be output (Connor [0286], [0194] where the event is food consumption);
automatically determine, based on the event, a second time frame that differs from the first time frame (Connor [0183], [0194] the time frame is a period of time between spectroscopic scans based on gesture indicating food consumption);
obtain a current glucose level of the patient (Connor [0363]-[0364] and [0183] “a system can select a recommended insulin dosage in response to specific attributes of a trigger”);
obtain, based on the current glucose level, second projected levels of glucose in the patient over the second time frame (Connor [0183 a system can select a recommended insulin dosage in response to specific attributes of a trigger and [0363]-[0364]) and
output the second projected levels of glucose for the second time frame (Connor [0347] and [0183]).
However, Connor does not explicitly teach determine, based on the event, a duration of a second time frame that differs from a duration of a first time frame. Constantin discloses determine, based on the event, a duration of a second time frame that differs from a duration of a first time frame (Constantin column 31 lines 56-67 and column 32 lines 1-34).
It would have been obvious to one of ordinary skill in the art at the time of the effective filing of the invention by Applicant to modify a time frame based upon a detected event as in Constantin in the system of Connor and Vehi to reduce unnecessary alarms and ensure proper monitoring.
As to claim 21, see the discussion of claim 20, additionally, Connor discloses automatically determine, based on the event, the second time frame that differs from the first time frame comprises changing the first time frame to the second time frame (Constantin column 31 lines 56-67 and column 32 lines 1-34).
Response to Arguments
Applicant's arguments filed 12/3/25 have been fully considered but they are not fully persuasive.
Applicant’s arguments are moot in view of new grounds of rejection.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 Eliza Lam whose telephone number is (571)270-7052. The examiner can normally be reached Monday-Friday 8-4:30PST.
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/ELIZA A LAM/Primary Examiner, Art Unit 3681
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