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 .
Election/Restrictions
Applicant’s election without traverse of group I (claims 1-15 and 18-20) in the reply filed on 18 May 2026 is acknowledged. Claims 16-17 are withdrawn from consideration.
Claim Objections
Claims 1, 4, and 11 are objected to because of the following informalities:
In claim 1, line 7: “a sensor” should be “a glucose sensor”
In claim 4, line 4: “the sensor values” should be “[[the]] sensor values”
In claim 4, line 4: “the sensor” should be “the glucose sensor”
In claim 4, line 7: “senor” should be “sensor”
In claim 4, line 8, the claim should end with a period “.”
In claim 11, line 8: “the sensor values” should be “[[the]] sensor values”
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.
Claims 1-3 and 8-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Steil et al (US 2003/0130616).
Regarding claim 1, Steil discloses:
A medicament delivery device (34; Fig. 5) for delivering a medicament to a user (¶0097), comprising: a non-transitory computer-readable storage medium (12; Fig. 1) storing computer programming instructions (¶0092); a processor (¶0097) configured to execute the computer programming instructions to cause the processor to: adjust a received sensor value from a sensor (Fig. 39a; ¶0099 – the glucose sensor raw values go through a sensor compensation step) for an interval in a period based on an accuracy estimate for the glucose sensor (¶0169 – the sensor value is adjusted based on the sensor accuracy); use the adjusted received sensor value to determine a dose of medicament to be delivered to the user for the interval (¶0099 – the insulin dose is adjusted based on the adjusted sensor value); and cause the determined dose of the medicament to be delivered by the medicament delivery device to the user (¶0099 – the compensated insulin dose is delivered to the body).
Regarding claim 2, Steil discloses:
The medicament delivery device of claim 1, wherein the accuracy estimate is based at least in part on a manufacturer accuracy estimate for the sensor (¶0169 – the sensor accuracy is a known value in the system and is therefore part of the specification of the sensor, which would be from the manufacturer).
Regarding claim 3, Steil discloses:
The medicament delivery device of claim 1, wherein executing the computer programming instructions further causes the processor to determine the accuracy estimate (¶0099 – the sensor compensation can be based on the closed loop of the system, which means that using the loop and executing the instructions of the program results in adjustment in the accuracy estimate).
Regarding claim 8, Steil discloses:
The medicament delivery device of claim 1, wherein the sensor is a glucose monitor (Fig. 39a – glucose sensor).
Regarding claim 9, Steil discloses:
The medicament delivery device of claim 1, wherein the medicament comprises insulin (¶0099).
Regarding claim 10, Steil discloses:
The medicament delivery device of claim 1, wherein the medicament delivery device has a lifespan and wherein the period is the lifespan (¶0168 – the period can be a moving window of time, which means the period can be the lifespan of the device itself).
Allowable Subject Matter
Claims 4-7 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claims 11-15 and 18-20 are allowed.
The following is an examiner’s statement of reasons for allowance:
The closest prior art of record, Steil, fails to disclose or make obvious a device as described in claims 11 and 18. Specifically, Steil fails to disclose or make obvious a device, in combination with the other elements of the claim, comprising “a processor” that executes the steps to “determine an accuracy target for sensor values from a sensor over a period as an average of expected accuracy of the sensor values over a period,” “determine a robustness factor for the sensor values for an interval in the period as a quotient of the determined accuracy target divided by an expected accuracy of a sensor value for the interval,” “adjust a sensor value generated by the sensor for the interval based on the determined robustness factor,” and using the adjusted value in “determining a dose of medicament to be delivered to a user.”
Steil teaches a medicament delivery device (34; Fig. 5) for delivering insulin (¶0097) with a processor (¶0097) that adjusts a received sensor value from a sensor (Fig. 39a; ¶0099 – the glucose sensor raw values go through a sensor compensation step) based on an accuracy estimate for the glucose sensor (¶0169 – the sensor value is adjusted based on the sensor accuracy), uses the adjusted received sensor value to determine a dose of medicament to be delivered to the user for the interval (¶0099 – the insulin dose is adjusted based on the adjusted sensor value), and causes the determined dose of the medicament to be delivered by the medicament delivery device to the user (¶0099 – the compensated insulin dose is delivered to the body). However, Steil is silent regarding calculating a “robustness factor” that is based on a determined accuracy value and an expected accuracy. Instead, Steil is concerned with adjusting a small value of the sensor reading in order to effectively deliver insulin. As such, a prima facie case of obviousness or an anticipation rejection cannot be established with respect to the claimed combination of elements as set forth in claims 11 and 18. Claims 12-15 and 19-20 are allowed for incorporating the above limitations due to their respective dependencies on the independent claims.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TASNIM M AHMED whose telephone number is (571)272-9536. The examiner can normally be reached M-F 9am-5pm Pacific time.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bhisma Mehta can be reached at (571)272-3383. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TASNIM MEHJABIN AHMED/Primary Examiner, Art Unit 3783
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