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 .
This office action is in response to applicant’s communication of 1/28/2022. Currently claims 1-20 are pending and rejected below.
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.
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.
Claim(s) 1-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rosinko (US 2017/0182248 A1) in view of Steil et al. (US 2008/0097289 A1).
Rosinko discloses a system for closed loop diabetes therapy (para [0011]), comprising: a pump (12) mechanism configured to facilitate delivery of insulin to a user([0012]); a communications interface adapted to receive glucose levels from a continuous glucose monitor (see 20 and [0027]-[0028]); at least one processor (42) functionally linked to the pump mechanism and the communications device, the at least one processor configured to: automatically modify a basal rate of insulin delivered to the user with a closed loop delivery algorithm based on glucose levels received from the continuous glucose monitor ([0012]), the closed loop delivery algorithm configured to calculate modifications to the basal rate to maintain the user's glucose levels at a glucose target (see para [0032]), the closed loop delivery algorithm determine based on the glucose levels received from the continuous glucose monitor that the user may have eaten a meal and not taken a bolus of insulin to counteract the carbohydrates consumed in the meal; increase the amount by which the limiter function will permit the basal rate to be increased from the previous basal rate in response to determining that the user may have eaten a meal and not taken a bolus of insulin to counteract the carbohydrates consumed in the meal(see para [0034]); determine a modified basal rate according to the increased amount; and automatically deliver insulin to the user with the pump mechanism according to the modified basal rate(see para [0035],[0037]-[0040]).
Rosinko discloses the claimed invention except for a limiter function providing a limit on an amount by which the basal rate can be increased from a previous basal rate. Steil teaches that it is known to use a limiter function providing a limit on an amount by which the basal rate can be increased from a previous basal rate as set forth in paragraph [0025] to provide a safety protocol and precaution for effective and controlled delivery of a therapeutic to a hyperglycemic/hypoglycemic patient.. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system as taught by Rosinko with a limiter function providing a limit on an amount by which the basal rate can be increased from a previous basal rate as taught by Steil, since such a modification would provide the system with a limiter function providing a limit on an amount by which the basal rate can be increased from a previous basal rate for providing a safety protocol and precaution for effective and controlled delivery of a therapeutic to a hyperglycemic/hypoglycemic patient.
Concerning claim 2 and the at least one processor (42) is configured to determine the user may have eaten a meal and not taken a bolus of insulin to counteract the carbohydrates consumed in the meal when a current glucose level of the user is over a high glucose threshold and a predicted future glucose level of the user is a predetermined amount over the glucose target (see para [0032]).
Concerning claim 3 and the at least one processor is configured to determine the user may have eaten a meal and not taken a bolus of insulin to counteract the carbohydrates consumed in the meal when a glucose level of the user is above the glucose target by more than a predetermined amount and the user's glucose levels are increasing at greater than a predetermined rate (again see para [0032]).
Concerning claim 4 and the glucose level of the user is a current glucose level of the user received from the continuous glucose monitor (again see para [0032]).
Concerning claim 5 and the glucose level of the user is a predicted future glucose level of the user based on the glucose levels received from the continuous glucose monitor (again see para [0032]).
Concerning claim 6 and determining that a user's glucose levels are increasing at greater than a predetermined rate includes comparing a predicted future glucose level of the user and a current glucose level of the user to a threshold (see para [0033]).
Concerning claim 7 and the glucose target used by the closed loop algorithm is a single glucose value (see para [0032] and target value).
Concerning claim 8 and the glucose target used by the closed loop algorithm is a target glucose range (see para [0032] and threshold which examiner is of the position is a range type).
Concerning claim 9 Rosinko discloses a system for closed loop diabetes therapy (para [0011]), comprising: a pump mechanism (12) configured to facilitate delivery of insulin to a user; a communications interface adapted to receive glucose levels from a continuous glucose monitor (see 20 and [0027]-[0028]); at least one processor (42) functionally linked to the pump mechanism and the communications device, the at least one processor configured to: automatically modify a basal rate of insulin delivered to the user with a closed loop delivery algorithm based on glucose levels received from the continuous glucose monitor ([0012]), the closed loop delivery algorithm configured to calculate modifications to the basal rate to maintain the user's glucose levels at a glucose target (see para [0032]), the closed loop delivery algorithm (see para [0034]); determine from the glucose levels received from the continuous glucose monitor that a glucose level of the user is above the glucose target by more than a predetermined amount and that the user's glucose levels are increasing at greater than a predetermined rate; increase the amount by which the limiter function will permit the basal rate to be increased from the previous basal rate in response to determining that the glucose level of the user is above the glucose target by more than the predetermined amount and that the user's glucose levels are increasing at greater than the predetermined rate(see para [0034]); determine a modified basal rate according to the increased amount; and automatically deliver insulin to the user with the pump mechanism according to the modified basal rate (see para [0035],[0037]-[0040]).
Rosinko discloses the claimed invention except for a limiter function providing a limit on an amount by which the basal rate can be increased from a previous basal rate. Steil teaches that it is known to use a limiter function providing a limit on an amount by which the basal rate can be increased from a previous basal rate as set forth in paragraph [0025] to provide a safety protocol and precaution for effective and controlled delivery of a therapeutic to a hyperglycemic/hypoglycemic patient.. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system as taught by Rosinko with a limiter function providing a limit on an amount by which the basal rate can be increased from a previous basal rate as taught by Steil, since such a modification would provide the system with a limiter function providing a limit on an amount by which the basal rate can be increased from a previous basal rate for providing a safety protocol and precaution for effective and controlled delivery of a therapeutic to a hyperglycemic/hypoglycemic patient.
Concerning claim 10 and the glucose level of the user is a current glucose level of the user received from the continuous glucose monitor (again see para [0032]).
Concerning claim 11 and the glucose level of the user is a predicted future glucose level of the user based on the glucose levels received from the continuous glucose monitor (again see para [0032])..
Concerning claim 12 and determining that a user's glucose levels are increasing at greater than a predetermined rate includes comparing a predicted future glucose level of the user and a current glucose level of the user to a threshold (see para [0033]).
Concerning claim 13 and the glucose target used by the closed loop algorithm is a single glucose value (see para [0032] and target value).
Concerning claim 14 and the glucose target used by the closed loop algorithm is a target glucose range (see para [0032] and threshold which examiner is of the position is a range type).
Concerning claim 15 Rosinko discloses a system for closed loop diabetes therapy (para [0011]), comprising: a pump mechanism (12) configured to facilitate delivery of insulin to a user; a communications interface adapted to receive glucose levels from a continuous glucose monitor (see 20 and [0027]-[0028]); at least one processor (42) functionally linked to the pump mechanism and the communications device, the at least one processor configured to:automatically modify a basal rate of insulin delivered to the user with a closed loop delivery algorithm based on glucose levels received from the continuous glucose monitor ([0012]), the closed loop delivery algorithm configured to calculate modifications to the basal rate to maintain the user's glucose levels at a glucose target (see para [0032]), the closed loop delivery algorithm; determine based on the glucose levels received from the continuous glucose monitor that a current glucose level of the user is over a high glucose threshold and a predicted future glucose level of the user is a predetermined amount over the glucose target; increase the amount by which the limiter function will permit the basal rate to be increased from the previous basal rate in response to determining that the current glucose level of the user is over a high glucose threshold and the predicted future glucose level of the user is a predetermined amount over the glucose target (see para [0034]); determine a modified basal rate according to the increased amount; and automatically deliver insulin to the user with the pump mechanism according to the modified basal rate (see para [0035],[0037]-[0040]).
Rosinko discloses the claimed invention except for a limiter function providing a limit on an amount by which the basal rate can be increased from a previous basal rate. Steil teaches that it is known to use a limiter function providing a limit on an amount by which the basal rate can be increased from a previous basal rate as set forth in paragraph [0025] to provide a safety protocol and precaution for effective and controlled delivery of a therapeutic to a hyperglycemic/hypoglycemic patient.. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system as taught by Rosinko with a limiter function providing a limit on an amount by which the basal rate can be increased from a previous basal rate as taught by Steil, since such a modification would provide the system with a limiter function providing a limit on an amount by which the basal rate can be increased from a previous basal rate for providing a safety protocol and precaution for effective and controlled delivery of a therapeutic to a hyperglycemic/hypoglycemic patient.
Concerning claim 16 and wherein the at least one processor is further configured to determine that the user's glucose levels are increasing at greater than a predetermined rate and the at least one processor is configured to provide a further increase to the amount by which the limiter function will permit the basal rate to be increased if the user's glucose levels are increasing at greater than the predetermined rate (see para [0032], [0035], and [0037]-[0040]).
Concerning claim 17 and the high glucose threshold is a different glucose level than the glucose target (see para [0032]).
Concerning claim 18 and the high glucose threshold is a higher glucose level than the glucose target (see para [0032]-[0033]).
Concerning claim 19 and the glucose target used by the closed loop algorithm is a single glucose value(see para [0032] and target value).
Concerning claim 20 and the glucose target used by the closed loop algorithm is a target glucose range (see para [0032] and threshold which examiner is of the position is a range type).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PHILLIP A GRAY whose telephone number is (571)272-7180. The examiner can normally be reached M-F 9-5 EST (FLEX).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached at (571)270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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PHILLIP A. GRAY
Primary Examiner
Art Unit 3783
/PHILLIP A GRAY/Primary Examiner, Art Unit 3783