DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/26/2025 has been entered.
Response to Amendment
Regarding the Office action mailed 10/01/2025, the rejection of claims 37, 38 and 40 under 35 USC 112(b) are withdrawn in view of the amendment to claim 37.
All rejections set forth under 35 USC 103 are withdrawn in view of the amendments to the independent claims indicating “a sensor control unit comprising an adhesive for securing the sensor control unit to a skin surface of the user”.
New rejections are set forth below in response to the amendments. Applicant’s arguments will be addressed following the rejections.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 pre-AIA 35 U.S.C. 103(a) 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.
This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 21, 22, 23, 26, 27 and 36 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Kircher (US 2010/0292634, IDS reference) in view of Bequette (Proceedings of the 2004 American Control Conference, vol. 1, pp. 958-962, previously cited) and Mann (US 6,809,653, previously cited).
Regarding claim 21, Kircher disclosed a system comprising:
an analyte sensor configured for insertion into a body fluid of a user, the analyte sensor configured to monitor an analyte level;
Figure 1, paragraph [0063], blood glucose sensors 108. Paragraph [0062]: “The blood glucose sensor system 102 may be implanted, for example, subcutaneously, intramuscularly or intravenously. The blood glucose sensor system 102 may measure blood glucose levels directly or indirectly. For example, the blood glucose sensor system 102 may be configured to measure interstitial fluid glucose levels.”
a display device in communication with the analyte sensor
Figure 1, paragraph [0070], user output device 164, “which may comprise, for example, a visual display”.
a sensor control unit…wherein the sensor control unit is…connected to the analyte sensor and comprises one or more processors configured to determine a rate of change in the monitored analyte level based on signals received from the analyte sensor
Figure 1, blood glucose controller 106 (paragraph [0061]) and see paragraph [0071]: “…blood glucose analyzer 166 [comprised in blood glucose controller 106] may use data received from the blood glucose sensor system 102 to determine a current blood glucose level, an indication of a rate of change of the blood glucose level (e.g., a first time derivative), and/or an indication of an acceleration of the blood glucose level (e.g., a second time derivative).”
wherein the sensor control unit further comprises a communication device configured to transmit…to a controller module integrated with a drug administration system as a single unit for use in determining a dose of a drug
Figure 1, “sensor control unit” is blood glucose controller 106; “communication device” is communication system 146 (paragraph [0069], “…communication system 146 sends and receives data and control signals…”); “controller module” is control system 140; “drug administration system” is insulin pump 126. Figure 1, paragraph [0066]: “…insulin dispenser 104…comprises an insulin pump 126…and a control system 140…”. As illustrated in Figure 1 and discussed in paragraph [0074], “the blood glucose controller 106 selectively transmits a radio-frequency control signal 172 to the insulin dispenser 104”. Therefore, the “communication device” of the “sensor control unit” is “configured to transmit” to the “controller module” integrated with the “drug administration system”.
wherein the controller module determines a predicted analyte level…
Paragraph [0226]: “…the blood glucose level predictor 1008 may be incorporated into the control system 140 of FIG. 1. In some embodiments, the predictions may be used to control the dispensing of insulin.”
Regarding claims 22 and 23, Kircher disclosed determining the rate of change of glucose over 15 minutes (paragraphs [0114], [0115], [0122], [0220], [0221]).
Regarding claim 26, Kircher disclosed (paragraph [0062]): “The blood glucose sensor system 102 may be implanted, for example, subcutaneously…”.
Regarding claim 27, Kircher disclosed a system comprising:
an analyte sensor configured for insertion into a body fluid of a user, the analyte sensor configured to monitor an analyte level;
Figure 1, paragraph [0063], blood glucose sensors 108. Paragraph [0062]: “The blood glucose sensor system 102 may be implanted, for example, subcutaneously, intramuscularly or intravenously. The blood glucose sensor system 102 may measure blood glucose levels directly or indirectly. For example, the blood glucose sensor system 102 may be configured to measure interstitial fluid glucose levels.”
a display device in communication with the analyte sensor
Figure 1, paragraph [0070], user output device 164, “which may comprise, for example, a visual display”.
a sensor control unit…wherein the sensor control unit is…connected to the analyte sensor and comprises one or more processors configured to determine a rate of change in the monitored analyte level based on signals received from the analyte sensor
Figure 1, blood glucose controller 106 (paragraph [0061]) and see paragraph [0071]: “…blood glucose analyzer 166 [comprised in blood glucose controller 106] may use data received from the blood glucose sensor system 102 to determine a current blood glucose level, an indication of a rate of change of the blood glucose level (e.g., a first time derivative), and/or an indication of an acceleration of the blood glucose level (e.g., a second time derivative).”
and a communication device configured to transmit…;
As illustrated in Figure 1 and discussed in paragraph [0074], “the blood glucose controller 106 selectively transmits a radio-frequency control signal 172 to the insulin dispenser 104”. Therefore, the “communication device” of the “sensor control unit” is “configured to transmit”.
and a controller module integrated with a drug administration system as a single unit and that is in communication with at least one of the sensor control unit and the display device
Figure 1, “sensor control unit” is blood glucose controller 106; “communication device” is communication system 146; “controller module” is control system 140; “drug administration system” is insulin pump 126. As illustrated in Figure 1 and discussed in paragraph [0074], “the blood glucose controller 106 selectively transmits a radio-frequency control signal 172 to the insulin dispenser 104”. Therefore, the “controller module” integrated with the “drug administration system” is “in communication” with at least the “sensor control unit”.
wherein the controller module is configured to determine an initial dose of a drug, and to adjust the initial dose of the drug…
Paragraph [0226]: “…the blood glucose level predictor 1008 may be incorporated into the control system 140 of FIG. 1. In some embodiments, the predictions may be used to control the dispensing of insulin.”
Paragraph [0228]: “More generally, as a component of an integrated system, the Blood Glucose Prediction method could be resident on a system that included an insulin infusion pump and a blood glucose sensor. In this implementation, the Blood Glucose Prediction method could predict blood sugar as above and also automatically adjust the insulin pump dosing to maintain safe blood sugar levels.” Note that an adjusted dose would serve as the “initial dose” for the next adjustment.
and wherein the controller module determines a predicted analyte level…
Paragraph [0226]: “…the blood glucose level predictor 1008 may be incorporated into the control system 140 of FIG. 1. In some embodiments, the predictions may be used to control the dispensing of insulin.”
Regarding claim 36, Kircher disclosed an insulin infusion pump (e.g., paragraph [0228]).
Regarding claims 21 and 27, as to predicting an analyte level, Kircher disclosed (paragraph [0022], emphasis provided): “In one embodiment, a method of predicting blood glucose levels comprises receiving historical data related to blood glucose levels, automatically analyzing the historical data, and automatically predicting a future blood glucose level based on the analysis…In one embodiment, the automatically analyzing comprises comparing changes in blood glucose levels with time.”
Regarding claim 21, while Kircher disclosed that the controller module (control system 140) of the insulin dispenser 104 received signals received from the blood glucose controller 106 (paragraph [0067]), and while Kircher disclosed that the blood glucose analyzer 166 of blood glucose controller 106 determined a glucose rate of change (paragraph [0071]), and while Kircher disclosed that the blood glucose level predictor was incorporated into the control system 140 of insulin dispenser 104, Kircher did not disclose that the communication device (communication system 146) of blood glucose controller 106 transmitted the rate of change from blood glucose controller 106 to the control system 140 of insulin dispenser 104. Nor did Kircher disclose that the controller module (control system 140) of insulin dispenser 104 used the glucose rate of change in predicting the blood glucose level (though Kircher did disclose using “changes in blood glucose levels with time” (paragraph [0022]) as noted above).
Regarding claim 27, Kircher did not disclose predicting the blood glucose level based on the glucose rate of change (though Kircher did disclose using “changes in blood glucose levels with time” (paragraph [0022]) as noted above), or adjusting an initial insulin dose based on the rate of change.
In addition, Kirchner did not disclose that the “sensor control unit” (blood glucose controller 106) comprised an adhesive for securing it to a skin surface of the user, or that it was “electrically connected” to the “analyte sensor” (blood glucose sensor system 102) (rather, these components communicated wirelessly, as illustrated by signals 170 and 174 in figure 1).
Bequette disclosed that blood glucose rate of change “can obviously be used to predict when a critical value of blood glucose will be reached” (page 961, right column, first full paragraph). Bequette further disclosed (page 962, left column): “The rate-of-change (first derivative) and the second derivative of glucose are used as estimated variables, and used to predict future concentrations of subcutaneous glucose.” Bequette disclosed (id.): “By appending a state related to the rate-of-change of blood glucose a natural formulation for predicting possible hypoglycemia arises. This predictor can then be used in a hypoglycemia awareness monitor, to provide diabetics with enough time to take corrective action to prevent hypoglycemia. The estimation strategy presented can also be used in a model-based “artificial pancreas” to regulate blood glucose based on subcutaneous measurements and the adjustment of insulin infusion rates to maintain a desired blood glucose setpoint.”
Mann disclosed an alternative arrangement between a blood glucose sensor (figure 1, percutaneous sensor set 10; column 4, line 16) (analogous to Kirchner’s blood glucose sensor system 102) and a device (figure 1, telemetered characteristic monitor transmitter device 100; column 4, lines 16-17) (analogous to Kirchner’s blood glucose controller 106). In this arrangement, the two components were electrically connected by a cable 102 (figure 1). Mann disclosed that the telemetered characteristic monitor transmitter device 100 comprised a housing containing a processor for processing signals from the sensor, and a transmitter for transmitting the processed signals to a receiving device, which could be a medication delivery device, such as an infusion pump (column 2, lines 20-39). Mann disclosed that the telemetered characteristic monitor transmitter device 100 could include an adhesive laver to secure the housing to the skin surface of the user (column 2, lines 53-56; column 8, line 66 through column 9, line 10).
It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to modify the system and method of Kircher by transmitting, using communication system 146, the rate of change data from blood glucose analyzer 166 to control system 140, which comprised the glucose level predictor, in order to allow the glucose level predictor to make use of the rate of change data to predict future glucose levels as described by Bequette in order to provide warning of hypoglycemic events and to allow for automatic adjustment of insulin administration. Note that because the predicted glucose would be based on the rate of change, and because Kircher taught adjustment of insulin based on the predicted glucose (paragraph [0226]), the adjustment of insulin would also be based on the rate of change.
It would also have been obvious to modify the system of Kirchner by providing the alternative arrangement of connecting the blood glucose sensor system 102 and the blood glucose controller 106 via a direct, electrical connection as in the system of Mann (as illustrated by cable 102 in Mann figure 1), thereby obviating the need for wireless communication between the blood glucose sensor system 102 and blood glucose controller 106, such that the blood glucose controller 106, with an adhesive backing could be worn by the user in an integrated arrangement of the sensor and sensor controller. This merely represents an alternative arrangement for communication between an implanted sensor and a processor for processing signals from the sensor and transmitting the processed signals to an infusion pump.
Claims 29-33 and 35 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Kircher (US 2010/0292634, IDS reference) in view of Bequette (Proceedings of the 2004 American Control Conference, vol. 1, pp. 958-962) and Mann (US 6,809,653, previously cited) as applied to claims 21, 22, 23, 26, 27 and 36 above, and further in view of Blomquist (US 2008/0206799, previously cited).
The disclosures of the Kircher, Bequette and Mann have been discussed. These did not disclose or suggest:
-adjusting the initial dose of a drug when the rate of change exceeded a threshold, or more particularly a threshold of 2 mg/dl/min as recited in claims 29, 30 and 40
-increasing the initial dose of the drug by a predetermined amount when the rate of change indicated that the analyte level was increasing as recited in claim 31
-making a first adjustment to the initial dose when the rate of change exceeded a first threshold, and a second adjustment when the rate of change exceeded a second threshold as recited in claim 35
Blomquist disclosed the use of a look-up table with different rate of change values used for making different corrections to insulin dosage; see para [0039] and Table 1. One of the thresholds was 2 mg/dl/min. That is, when the rate of change exceeded the range bounded on the upper end by +2.0 mg/dl/min, the next higher adjustment to the dose was indicated. Moreover, the table provides multiple different rates of change thresholds and a corresponding multiple different adjustments to the dose.
It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to use multiple thresholds for the rate of change, and use a different adjustment to the dose based on the particular threshold exceeded, as this was disclosed by Blomquist. One would have been motivated to do so in order to provide the patient with the appropriate dose of insulin for the patient’s rate of change in glucose.
Regarding claims 32 and 33, while Blomquist’s look-up table did not include values of 10%-20% adjustment, as set forth in MPEP 2144.05, "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Response to Arguments
Applicant’s arguments as to the previous rejections under 35 USC 103 have been considered but are not persuasive. The arguments are based upon the amendments to the claims, but the new grounds of rejection set forth below have taken these amendments into consideration and the new limitations have been addressed.
Allowable Subject Matter
Claims 28, 37, 40 and 41 are free of the prior art. These claims require a controller module integrated with a drug administration system as a single unit, wherein the controller module comprises a display screen, which displays a rate of change in a monitored analyte level received by the controller module from a sensor control unit. This is not taught or suggested in the prior art. The closest prior art would be Kirchner, who describes a display of what could be called a sensor control unit, and separately describes what could be called a controller module integrated with a drug administration system, but there is no suggestion in Kirchner or other prior art to relocate the display to the controller module and display a rate of change in the monitored analyte thereon.
Conclusion
Claims 37, 40 and 41 are free of the prior art. Claim 28 is 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAMUEL C WOOLWINE whose telephone number is (571)272-1144. The examiner can normally be reached 9am-5:30pm.
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/SAMUEL C WOOLWINE/ Primary Examiner, Art Unit 1681