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 03/13/2026 has been entered. Claims 1-22 are pending in the application, claims 11-20 are withdrawn.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 21 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Para 0054-0057 of the instant specification details determining the insulin formulation based on event values wherein Para 0060-0063 of the instant specification details determining the insulin formulation based on slope of change of glucose. These appear to be distinct embodiments wherein the slope is not relied upon when calculating the insulin dose based on event values and event values are not relied upon when calculating the insulin dose based on the slope. Therefore, there is no support for determining the insulin formulation ratio base on event values and slope of glucose change.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 7, 9, and 21 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 7 recites “at least one event value” in line 3. It is unclear if this is the same or different “event value” than the one recited in claim 1. For the sake of examination, the limitation will be interpreted as reciting “the at least one event value”.
Claim 9 recites “the glucose information comprising a plurality of event values” in line 2. It is unclear if this is the same or different “event value” than the one recited in claim 1. For the sake of examination, the limitation will be interpreted as reciting “the at least one event value comprising a plurality of event values”.
Claim 21 recites “determine the insulin formulation ratio for the insulin dose to be delivered in the current delivery cycle based on the calculated slope of the glucose change”. It is unclear if the insulin formulation ratio is to be determined based on the at least one event value or the slope of the glucose change. For the sake of examination, claim 1 will be interpreted as reciting “determine an insulin formulation ratio using the plurality of insulin types for an insulin dose to be delivered in a current delivery cycle based on the insulin strength converted from the at least one event value or based on a slope of the glucose change”.
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 1-3, 7-9, 22 are rejected under 35 U.S.C. 103 as being unpatentable over De Paula (US 2012/0302990) in view of Magni (US 2010/0262117) and further in view of Breton (US 2017/0056591).
Regarding claim 1, De Paula discloses an automated insulin delivery device (device of Fig 1) configured to deliver insulin to a user, comprising: a wireless interface (Para 0047, lines 4-7) with a glucose sensor (150, Fig 1) for providing blood glucose concentration readings of a user (Para 0053); a plurality of insulin reservoirs (storage compartments of fluid delivery devices 160 and 170, Fig 1), each of the plurality of insulin reservoirs holding a different one of a plurality of insulin types, each of the plurality of insulin types having a different strength (Para 0060; Slow acting and fast acting insulin); a storage medium (121, 156, 169, 173, Fig 1) storing programming instructions and user glucose information (Para 0059), the user glucose information comprising the blood glucose concentration readings and user activity information (Para 0053); a processor (119, Fig 1) for executing the programming instructions in the storage media (Para 0047, lines 1-4) to: determine an insulin formulation ratio using the plurality of insulin types for an insulin dose to be delivered in a current delivery cycle based on sensor data (Para 0060); an insulin formulation device (180, Fig 9; the drive mechanisms of the delivery device s 160, 170 are activated to dispense the calculated amounts of fast acting and slow acting insulin and thereby generates the insulin formulation) to generate the insulin formulation (Para 0071); and an insulin delivery component (168a-b, Fig 11) to deliver the insulin formulation to the user (Para 0055).
De Paula is silent regarding the user glucose information comprising predicted future blood glucose concentration readings; the processor configured to: set at least one event value indicating whether at least one type of event has occurred; converting the at least one event value into an insulin strength.
Magni teaches an automated insulin delivery device (100, Fig 2) comprising: a wireless interface with a glucose sensor (10, Fig 2) for providing blood glucose concentration readings of a user; a storage medium (storage in controller 12 that provides previous history, Para 0044) storing programming instructions and user glucose information, the user glucose information comprising the blood glucose concentration readings, predicted future blood glucose concentration readings, and user activity information (Para 0021 and Para 0044); and a processor (12, Fig 2) for executing the programming instructions in the storage media.
Breton teaches a processor (500, Fig 5) for executing the programming instructions in the storage media to: set at least one event value (“patient physical activity”) indicating whether at least one type of event has occurred; converting the at least one event value into an insulin dose (Para 0126, 0132; the patient physical activity data is used to calculate insulin sensitivity which in turn is used to calculate the insulin dosage).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the processor and storage media to store and utilize predicted future blood glucose concentration readings as taught by Magni and to use an event value to calculate an insulin dosage as taught by Breton in order to track the state of the patient’s condition and adjust treatment plans so that the appropriate treatment regimen is applied to a patient (Para 0021 -Magni; Para 0007 -Breton).
Examiner notes that while Breton does not teach using multiple insulin types, De Paula details calculating the amounts of the plurality of insulin types based on glucose signals. The modification in view of Breton would incorporate insulin sensitivity into the calculations of the amounts of the plurality of insulin types. Therefore, the modified invention of De Paula, Magni, and Breton would disclose all of the limitations of the independent claim.
Regarding claim 2, the modified invention of De Paula, Magni, and Breton discloses the plurality of reservoirs (storage compartments of fluid delivery devices 160 and 170, Fig 1 -De Paula) comprising two reservoirs, a first reservoir of the two reservoirs holding a rapid-acting insulin (“fast acting insulin”; Para 0060 -De Paula) and a second reservoir of the two reservoirs holding a long-acting insulin (slow acting insulin”; Para 0060 -De Paula).
Regarding claim 3, the modified invention of De Paula, Magni, and Breton discloses the user glucose information comprising at least one of a meal event value, a carbohydrate ingestion value, or an increased activity value (Para 0053 -De Paula; Para 0132 -Breton).
Regarding claim 7, the modified invention of De Paula, Magni, and Breton discloses the processor executes the programming instructions to access insulin strength information and determine the insulin strength by comparing at least one event value determined based on the user glucose information to the insulin strength information (Para 0053,0060 -De Paula; Para 0126,0132 -Breton; the insulin delivery amounts are determined by measured body signals that can include heart rate or exercise events).
Regarding claim 8, the modified invention of De Paula, Magni, and Breton discloses the plurality of insulin comprising at least two of rapid-acting insulin, long-acting insulin, short-acting insulin, or intermediate acting insulin (NPH) (Para 0060 -De Paula).
Regarding Claim 9, the modified invention of De Paula, Magni, and Breton discloses the at least one event value comprising a plurality of event values, each of the plurality of event values being assigned a weight for determining the insulin strength (Para 0130 -Breton).
Regarding Claim 22, the modified invention of De Paula, Magni, and Breton discloses the at least one event value comprises an event intensity (“circadian rhythm information”; sleep and wake patterns are collected by the patient physical activity module which is indicative of activity intensity), and the insulin strength is determined, at least in part, based on the event intensity (Para 0132 -Breton).
Claims 1 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Richard (US 2007/0088271) in view of De Paula (US 2012/0302990) and further in view of Magni (US 2010/0262117) and further in view of Breton (US 2017/0056591).
Regarding claim 1, Richard discloses an automated insulin delivery device (20, Fig 1), comprising: a wireless interface with a glucose sensor for providing blood glucose concentration readings of a user (“glucometer”; Para 0024); a plurality of reservoirs (32, 38, 66, Fig 1), each of the plurality of reservoirs holding a different fluid (Para 0021); a storage medium storing programming instructions and user glucose information, the user glucose information comprising the blood glucose concentration readings; a processor (28, Fig 1) for executing the programming instructions in the storage media to: determine an insulin amount based on the user glucose information (Para 0030); a fluid formulation device (36 and 42, Fig 1) to generate the fluid formulation (Para 0021); and an insulin delivery component (62, Fig 2) to deliver the insulin formulation to the user (Para 0026).
Richard is silent regarding the plurality of reservoirs being insulin reservoirs holding a different one of a plurality of insulin types, each of the plurality of insulin types having a different strength; the user glucose information comprising predicted future blood glucose concentration readings, and user activity information; a processor for executing the programming instructions in the storage media to: calculate a slope of a glucose change based on the user glucose information, and determine an insulin formulation ratio based on the calculated slope of the glucose change, and determine an insulin formulation ratio to generate an insulin formulation having the insulin strength using the plurality of insulin types.
De Paula teaches an automated insulin delivery device (device of Fig 1), comprising: a wireless interface (Para 0047, lines 4-7) with a glucose sensor (150, Fig 1) for providing blood glucose concentration readings of a user (Para 0053); a plurality of insulin reservoirs (storage compartments of fluid delivery devices 160 and 170, Fig 1), each of the plurality of insulin reservoirs holding a different one of a plurality of insulin types, each of the plurality of insulin types having a different strength (Para 0060; Slow acting and fast acting insulin); a storage medium (121, 156, 169, 173, Fig 1) storing programming instructions and user glucose information (Para 0059), the user glucose information comprising the blood glucose concentration readings and user activity information (Para 0053); a processor (119, Fig 1) for executing the programming instructions in the storage media (Para 0047, lines 1-4) to: determine an insulin formulation ratio using the plurality of insulin types for an insulin dose to be delivered in a current delivery cycle based on the sensor data (Para 0060); an insulin formulation device (180, Fig 9; the drive mechanisms of the delivery device s 160, 170 are activated to dispense the calculated amounts of fast acting and slow acting insulin and thereby generates the insulin formulation) to generate the insulin formulation (Para 0071); and an insulin delivery component (168a-b, Fig 11) to deliver the insulin formulation to the user (Para 0055).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the reservoirs, storage medium, and processor disclosed by Richard to be insulin reservoirs, each of the plurality of insulin reservoirs holding a different one of a plurality of insulin types, each of the plurality of insulin types having a different strength (fast acting and slow acting insulin); to be a storage medium storing programming instructions and user glucose information, the user glucose information comprising the blood glucose concentration readings and user activity information; and the processor for executing the programming instructions in the storage media to: determine an insulin formulation ratio using the plurality of insulin types for an insulin dose to be delivered in a current delivery cycle based on the sensor data as taught by De Paula in order to have a device that can more accurately control glucose levels by utilizing two strengths of insulin (Para 0060).
The modified invention of Richard and De Paula is silent regarding the user glucose information comprising predicted future blood glucose concentration readings; the processor configured to: set at least one event value indicating whether at least one type of event has occurred; converting the at least one event value into an insulin strength.
Magni teaches an automated insulin delivery device (100, Fig 2) comprising: a wireless interface with a glucose sensor (10, Fig 2) for providing blood glucose concentration readings of a user; a storage medium (storage in controller 12 that provides previous history, Para 0044) storing programming instructions and user glucose information, the user glucose information comprising the blood glucose concentration readings, predicted future blood glucose concentration readings, and user activity information (Para 0021 and Para 0044); and a processor (12, Fig 2) for executing the programming instructions in the storage media.
Breton teaches a processor (500, Fig 5) for executing the programming instructions in the storage media to: set at least one event value (“patient physical activity”) indicating whether at least one type of event has occurred; converting the at least one event value into an insulin dose (Para 0126, 0132; the patient physical activity data is used to calculate insulin sensitivity which in turn is used to calculate the insulin dosage).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the processor and storage media to store and utilize predicted future blood glucose concentration readings as taught by Magni and to use an event value to calculate an insulin dosage as taught by Breton in order calculate the optimal dose of insulin necessary to meet a particular patient’s specific needs at any given time (Para 0021 -Magni; Para 0007 -Breton).
Examiner notes that while Breton does not teach using multiple insulin types, De Paula details calculating the amounts of the plurality of insulin types based on glucose signals. The modification in view of Breton would incorporate insulin sensitivity into the calculations of the amounts of the plurality of insulin types. Therefore, the modified invention of De Paula, Magni, and Breton would disclose all of the limitations of the independent claim.
Regarding claim 10, the modified invention of Richard, De Paula, Magni, and Breton discloses at least one of the plurality of reservoirs (66, Fig 2 -Richard) configured to store the insulin formulation for delivery to the user (Para 0026 -Richard; both fluids or insulins from lumen 50 and 52 are mixed at the socket as it enters the cannula 62 ).
Claims 4-6 are rejected under 35 U.S.C. 103 as being unpatentable over De Paula (US 2012/0302990) in view of Magni (US 2010/0262117) and further in view of Breton (US 2017/0056591) and further in view of Terashima (US 2011/0257496).
Regarding claim 4, the modified invention of De Paula, Magni, and Breton discloses all of the elements of the invention as discussed above, however, is silent regarding the user glucose information comprising a meal event value determined based on a glucose concentration trend deviation factor and one or more secondary factors.
Terashima teaches a device (1, Fig 1) that stores user glucose information comprising the blood glucose concentration readings and user activity information; user glucose information further comprising a meal event value determined based on a glucose concentration trend deviation factor and one or more secondary factors (Para 0661; Para 0680-0702; the secondary factors are METs and time of day).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed by De Paula, Magni, and Breton to include meal event detection as taught by Terashima in order to have a device that can improve blood glucose management by automatically determining meal events without user input (Para 0659-0660).
Regarding claim 5, the modified invention of De Paula, Magni, and Breton is silent regarding the user glucose information comprising a carbohydrate ingestion event value determined based on a glucose concentration trend deviation factor and one or more secondary factors.
Terashima teaches a device (1, Fig 1) that stores user glucose information comprising the blood glucose concentration readings and user activity information; user glucose information further comprising a carbohydrate ingestion event value determined based on a glucose concentration trend deviation factor and one or more secondary factors (Para 0661; Para 0680-0702; the secondary factors are METs and time of day).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed by De Paula, Magni, and Breton to include carbohydrate ingestion event detection as taught by Terashima in order to have a device that can improve blood glucose management by automatically determining meal events without user input (Para 0659-0660).
Regarding claim 6, the modified invention of De Paula, Magni, Breton, and Terashima discloses the one or more secondary factors comprising at least one of a time of day or historical mealtimes of the user (“time of day”; Para 0696 and 0701 -Terashima).
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over De Paula (US 2012/0302990) in view of Magni (US 2010/0262117) and further in view of Breton (US 2017/0056591) and further in view of Rule (US 2010/0121170).
Regarding Claim 21, the modified invention of De Paula, Magni, and Breton discloses all of the elements of the invention as discussed above, however, is silent regarding the processor is further configured to: calculate, for a current delivery cycle, a slope of a glucose change based on the user glucose information, and determine the insulin formulation ratio for the insulin dose to be delivered in the current delivery cycle based on the calculated slope of the glucose change by performing one or more of: applying the slope as a parameter in an equation that calculates relative amounts of the plurality of insulin types, or looking up the slope in a lookup table that maps the slope to the relative amounts of the plurality of insulin types.
Rule teaches a processor (2652, Para 0421) for executing the programming instructions in the storage media to: calculate, for a current delivery cycle (Para 0440; the delivery cycle, 4600, can be less than one minute to more than one hour), a slope of a glucose change based on the user glucose information, and determine an insulin dose for an insulin dose to be delivered in the current delivery cycle based on the calculated slope of the glucose change to generate an insulin dose by performing one or more of: applying the slope as a parameter in an equation that calculates amounts of insulin (Para 0431; Para 0437-0438; as detailed in the cited paragraphs the insulin sensitivity is calculated based on a slope of glucose which is in tern used to calculated the recommended insulin dosage).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the processor and storage media to calculate the insulin sensitivity based on the slope of the glucose change and determine the insulin delivery based on the slope as taught by Rule in order calculate the optimal dose of insulin necessary to meet a particular patient’s specific needs at any given time (Para 0417 -Rule).
Response to Arguments
Applicant’s arguments filed 03/13/2026, on pages 7-9, regarding De Paula and Terashima do not teach the insulin strength being determined based on event values have been fully considered but are moot in view of the current rejection that relies on Breton to teach the insulin dosage being determined based in event values (activity events) as detailed in the rejection of claim 1 above.
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 ANTARIUS S DANIEL whose telephone number is (571)272-8074. The examiner can normally be reached M-F 7:00am to 4:30pm EST.
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/ANTARIUS S DANIEL/Examiner, Art Unit 3783
/KEVIN C SIRMONS/Supervisory Patent Examiner, Art Unit 3783
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