DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Response to Amendment
The rejections set forth in the Office action mailed 03/24/2026 are withdrawn in view of the amendment. New grounds of rejection are set forth below. Because the rejection as applied to claims 37, 40 and 41, previously indicated allowable, were not caused by the amendment, but rather as a result of further search and consideration, this Office action is NON-FINAL.
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 27, 36, 37, 42, 43 and 46 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Say (US 6,175,752, IDS ref) in view of Bequette (Proceedings of the 2004 American Control Conference, vol. 1, pp. 958-962, previously cited).
Regarding claim 27, Say disclosed:
A therapy management system, comprising:
a controller module integrated with a drug administration system as a single unit
See Fig. 25 and column 54, lines 25-28: “In some cases, the receiver/display unit 256, data storage and controller module 258, and drug administration system 260 may be integrated in a single unit.”
and that is in communication with a sensor control unit electrically connected to an analyte sensor configured for insertion into a body fluid of the user to monitor an analyte level in the body fluid
See Fig. 25 and column 54, lines 21-23: “The drug delivery system includes one or more (and preferably two or more) subcutaneously implanted sensors 252, an on-skin sensor control unit 254…”.
See column 54, lines 38-45: “…sensor 252 produces signals correlated to the level of the drug or analyte in the patient. The level of the analyte will depend on the amount of drug delivered by the drug administration system. A processor 262 in the on-skin sensor control unit 254, as illustrated in FIG. 25, or in the receiver/display unit 256 determines the level of the analyte, and possibly other information, such as the rate or acceleration of the rate in the increase or decrease in analyte level. This information is then transmitted to the data storage and controller module 252 [sic, 258] using a transmitter 264 in the on-skin sensor control unit 254…”.
Hence, the controller module 258 was in communication with sensor control unit 254, and sensor control unit 254 was electrically connected to analyte sensor 252, which sensor was configured for insertion into a body fluid (interstitial fluid in the subcutaneous tissue) to monitor an analyte level.
wherein the controller module is configured to receive a rate of change in the monitored analyte level as determined by one or more processors of the sensor control unit from a communication device of the sensor control unit
See column 54, lines 38-45: “…sensor 252 produces signals correlated to the level of the drug or analyte in the patient. The level of the analyte will depend on the amount of drug delivered by the drug administration system. A processor 262 in the on-skin sensor control unit 254, as illustrated in FIG. 25, or in the receiver/display unit 256 determines the level of the analyte, and possibly other information, such as the rate or acceleration of the rate in the increase or decrease in analyte level. This information is then transmitted to the data storage and controller module 252 [sic, 258] using a transmitter 264 in the on-skin sensor control unit 254…”.
and to determine an initial dose of a drug
See Fig. 25 and column 54, lines 47-55: “If the drug delivery system 250 has two or more sensors 252, the data storage and controller module 258 may verify that the data from the two or more sensors 252 agrees within predetermined parameters before accepting the data as valid. This data may then be processed by the data storage and controller module 258, optionally with previously obtained data, to determine a drug administration protocol. The drug administration protocol is then executed using the drug administration system 260…”. This “drug administration protocol” can be considered an initial dose of a drug. Say also disclosed (column 54, lines 28-32): “The sensor-based drug delivery system 250 uses data form the one or more sensors 252 to provide necessary input for a control algorithm/mechanism in the data storage and controller module 252 to adjust the administration of drugs.” Thus, the adjusted administration of drugs can be considered a new “initial dose of a drug”, which can be subsequently adjusted based on future input from the sensors. That is, each determined “drug administration protocol” can be considered an “initial dose of a drug” relative to future, adjusted doses of the drug.
and wherein the controller module comprises a display screen
See Fig. 25 and column 54, lines 25-28: “In some cases, the receiver/display unit 256, data storage and controller module 258, and drug administration system 260 may be integrated in a single unit.”
configured to show an indication of the rate of change in the monitored analyte level received from the sensor control unit
See column 50, lines 52-57 and Fig. 23: “One example of a receiver/display unit 46, 48 is illustrated in FIG. 23. The display 154 of this particular receiver/display unit 46, 48 includes a portion 164 which displays the level of the analyte, for example, the blood glucose concentration, as determined by the processing circuit 109 and/or the analyzer 152 using signals from the sensor 42.”
See also column 51, lines 4-8: “The display 154 may also be capable of displaying a graph 178 of the analyte level over a period of time, as illustrated in FIG. 24. Examples of other graphs that may be useful include graphs of the rate of change or acceleration in the rate of change of the analyte level over time.”
Note that processing circuit 109 is introduced at column 36, lines 45-64 as a component of the sensor control unit, and that it may process signals from the sensors for transmission to the receiver/display unit: “The electronic components of the on-skin sensor control unit 44 typically include …a processing circuit 109 that…may also partially or completely evaluate the signals from the sensor 42 and convey the resulting data to the optional transmitter 98…for transmitting the sensor signals or processed data from the processing circuit 109 to a receiver/display unit 46, 48…”.
Say also disclosed that one function of processing circuit 109 was to determine the rate of change (column 44, lines 54-62): “The on-skin sensor control unit 44 may include an optional data storage unit 102 which may be used to hold data (e.g., measurements from the sensor or processed data) from the processing circuit 109 permanently or, more typically, temporarily. The data storage unit 102 may hold data so that the data can be used by the processing circuit 109 to analyze and/or predict trends in the analyte level, including, for example, the rate and/or acceleration of analyte level increase or decrease.”
Thus, “processing circuit 109” of “sensor control unit 44” as shown in Fig. 18A/B is analogous in form and function to “processor 262” in the on-skin “sensor control unit 254” as shown in Fig. 25 and discussed above. Taken together, these disclosures reasonably suggest determining rate of change by the processor of the sensor control unit, transmission of that information to the integrated receiver/display unit 256, data storage and controller module 258, and drug administration system 260, and display of that information.
Regarding claims 37 and 42, monitoring an analyte level by an analyte sensor in contact with a body fluid of a user has been discussed above for claim 27. Likewise, determining a rate of change in the monitored analyte level by a processor of a sensor control unit electrically connected to the analyte sensor has been discussed above for claim 27. Regarding the sensor control unit being secured to the skin of the user by an adhesive, Say disclosed this; see column 36, lines 18-20. Likewise, transmitting the analyte level and rate of change to a controller module integrated with a drug administration system as a single unit has been discussed above for claim 27. Likewise, determining an initial dose of a drug by the controller module based on the analyte level received from the sensor control unit has been discussed above for claim 27. Likewise, displaying the analyte level and an indication of the rate of change by a display screen of the controller module has been discussed above for claim 27.
Regarding claim 36, Say disclosed the drug administration system could be an infusion pump; column 54, lines 55-56.
Regarding claims 43 and 46, see column 54, lines 32-34: “As an example, a glucose sensor could be used to control and adjust the administration of insulin.”
Regarding claim 27, Say did not disclose wherein the controller module determines a predicted analyte level based on one or both of the monitored analyte level and the rate of change.
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.”
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 of Say by modifying the controller module to make use of the rate of change data, transmitted by the sensor control unit, 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.
Claims 29-33, 35 and 40 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Say (US 6,175,752, IDS ref) in view of Bequette (Proceedings of the 2004 American Control Conference, vol. 1, pp. 958-962) as applied to claims 27, 36, 37, 42, 43 and 46 above, and further in view of Blomquist (US 2008/0206799, previously cited).
The disclosures of the Say and Bequette have been discussed. These references 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 modify the controller module 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).
Claim 41 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Say (US 6,175,752, IDS ref) in view of Bequette (Proceedings of the 2004 American Control Conference, vol. 1, pp. 958-962) as applied to claims 27, 36, 37, 42, 43 and 46 above, and further in view of Kalatz (US 6,925,393).
The disclosures of Say and Bequette have been discussed, including the display of analyte level and rate of change. Neither Say nor Bequette suggested additionally displaying insulin delivery information.
Kalatz disclosed (column 8, lines 9-21): “A system based on this invention can also include a control unit that controls an insulin infusion device such as an insulin pump. The system can also have a display or another type of output device that is used to suggest an insulin dose to the patient which he then administers himself or has administered. It is especially favorable if the insulin is infused automatically by the device but the patient can control it if necessary. This can be achieved by including a release unit in the system that the patient can use to intentionally release an insulin dose suggested by the system. For instance, the system can display a calculated insulin dose and wait for a key to be pressed before it administers the insulin (e.g., using an insulin pump).”
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 controller module to further include display of insulin delivery information such as disclosed by Kalatz in order to give the patient appropriate information such as a suggested insulin dose to give the patient more control over the administration of insulin.
Claims 44, 45 and 47 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Say (US 6,175,752, IDS ref) in view of Bequette (Proceedings of the 2004 American Control Conference, vol. 1, pp. 958-962) as applied to claims 27, 36, 37, 42, 43 and 46 above, and further in view of Saidara (US 2005/0038332).
The disclosures of Say and Bequette have been discussed. Regarding claim 45, Say disclosed displaying a graphical representation of analyte levels over a period of time; see Fig. 24 and column 51, lines 4-6.
Neither Say nor Bequette disclose indicating rate of change information using an arrow.
Saidara disclosed using an arrow as a graphical indicator of the rate of change of glucose; see paragraph [0052]: “…a fast declining blood glucose rate, e.g. -2.0 mg/dL per minute or greater (which may be indicated by a single down arrow on the graphical display)… an even greater declining rate, e.g. a -4.0 mg/dL or greater (which may be indicated by a double down arrow on the graphical display)…”.
It would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to indicate rate of change information using an arrow as this was already suggested by Saidara.
Conclusion
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
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