DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application is being examined under the pre-AIA first to invent provisions.
Response to Amendment
2. This Office Action is responsive to the Applicant’s amendment filed on January 30, 2026.3. Claims 21-37 and 40-42 are pending , of which claims presented for examination
21, 32, and 40 are in independent form.
4. Claims 1-20 and 38-39 are cancelled by the applicant.
Response to Arguments
5. Applicant’s arguments, see “Objection to the claims”, filed on January 30, 2026 have been carefully considered and based on claim amendments, the claim objections have been withdrawn.
6. Applicant’s argument, see “Rejections under 35 U.S.C. § 103”, filed on January 30, 2026, have been carefully considered and are not considered to be persuasive.
7. Applicant argues that “First, the combination of Rebrin and Gerber do not teach limitations of the “insulin therapy profile” because Gerber is directed to electrical stimulation therapy rather than insulin therapy and allegedly discloses only electrical stimulation therapy parameters.
including “determining a modification based on an insulin therapy profile and at least one of the retrieved insulin delivery information and the monitored glucose levels” as recited in claims 21, 32, and 40. Response: Examiner has carefully considered the argument but respectfully disagrees. This argument is not persuasive. The rejection does not rely on Gerber for teaching insulin delivery therapy. Rather, Gerber is relied upon for teaching individualized therapy profiles comprising therapy-related parameters that are selected, weighted, stored, evaluated, and adjusted for a particular patient. Gerber expressly teaches patient-specific therapy management in which efficacy parameters are selected for a patient, weighting values are assigned to those parameters, and customized efficacy ratings are generated based upon the selected parameters and weighting values. Gerber explains that “efficacy and associated stimulation parameters can be customized to individual patients”. See (Gerber [0011] e.g., “… ach of the multiple multi-axis graphical representations corresponds to efficacy parameter values obtained for different sets of stimulation parameters or to efficacy parameter values obtained at different times”). Gerber further teaches storing multiple sets of efficacy parameter values and therapy-related information for later retrieval, comparison, and analysis. See (Gerber [0011] e.g., “the graphical representation may simultaneously display multiple multi-axis graphical representations of the efficacy parameter values, wherein each of the multiple multi-axis graphical representations corresponds to efficacy parameter values obtained for different sets of stimulation parameters”). Gerber also teaches repeatedly adjusting therapy petameters based upon efficacy results obtained for the patient. See also [0036] e.g., “ The disclosure provides techniques for patient-individualized efficacy rating so that efficacy and associated stimulation parameters can be customized to individual patients”. Accordingly, Gerber teaches a patient-specific collection of therapy settings and associated parameters that reasonably corresponds to a therapy profile. The rejection relies on Rebrin for the insulin therapy environment. Rebrin teaches a glucose-controlled insulin infusion system in which insulin administration is automatically controlled based on sensed glucose information. Rebrin specifically discloses a feedback-controlled insulin administration system in diabetic subjects and discusses adaptation of control parameters to the needs of an individual patient.
Therefore, one of ordinary skill in the art would have found it obvious to apply Gerber’s individualized therapy profile techniques to Rebrin’s insulin therapy system in order to provide patient-specific insulin therapy settings. Applicant’s argument improperly attacks Gerber individually rather than addressing the combined teaching relied upon in the rejection.
8. Applicant argues that “Rebrin does not teach monitoring glucose levels by a continuous glucose monitor”. Applicant argues that Rebrin merely discloses subcutaneous glucose concertation and does not teach a continuous glucose monitor”. Response: Examiner has carefully considered the argument but respectfully disagrees. This argument is not persuasive. Rebrin expressly discloses implanted glucose sensors used to monitor glucose concentration and provide an input signal for automated insulin control. Specifically, Rebrin states that: (Rebrin [Summary] e.g., “Miniaturized glucose electrodes (amperometric glucose oxidase sensors for the measurement of hydrogen peroxide) were implanted in insulin-dependent diabetic dogs” and “The output of these sensors was fed into the controller” for insulin administration). Rebrin further explains that: (Rebrin [page 573, 1st column] e.g., “Thus, implanted subcutaneous glucose electrodes could be employed in combination with telemetric devices to monitor the effectiveness of intracorporal blood glucose control…”) and repeatedly refers to implanted subcutaneous glucose sensors providing glucose measurements for feedback control of insulin delivery. A continuous glucose monitor is broadly understood as a device that repeatedly measures glucose concentration over time and provides glucose information for therapeutic decision making. Rebrin’s implanted glucose sensor performs exactly that function. The fact that Rebrin uses the terminology “implanted glucose sensor” or “subcutaneous glucose electrode” rather than later-developed phrase “continuous glucose monitor” does not meaningful distinguish the disclosed functionality. Moreover, Rebrin’s feedback-control system necessarily relies upon ongoing glucose measurements because the sensor output is continuously supplied to the controller for automated insulin administration. Accordingly, the rejection properly finds that Rebrin teaches or at least renders obvious monitoring glucose levels using a continuous glucose monitoring device.9. Applicant argues that “Third, the combination of references do not teach or suggest “receiving a user input parameter identifying a current context”, and “associating the adjusted insulin therapy profile with the current context” Response: Examiner has carefully considered the argument but respectfully disagrees. This argument is not persuasive. Gerber expressly teaches receiving user input retaining to therapy evaluation and patient-specific conditions. See [Abstract] e.g., “The graphical representation may be modified so that the efficacy parameter values correspond to values relating to a time reference specified by a user”. This is an actual input. The user is providing information (a specified time reference) that changes what information is displayed and evaluated. The abstract also states: [Abstract] e.g., “Each of the multiple multi-axis graphical representations corresponds to efficacy parameter values obtained for different sets of therapy parameters or to efficacy parameter values obtained at different times”. This teaches maintaining multiple parameter sets associated with different conditions. Gerber teaches that efficacy parameter values may correspond to values relating to a time reference specified by a user and that multiple graphical representations corresponding to different therapy parameter sets or different time references may be displayed simultaneously. Rebrin further teaches adapting therapy control parameters to the needs of an individual patient and to characteristics of the monitored glucose system. See Rebrin [page 576, 1st column] e.g., “Therefore, the adaptation of the algorithm both to the needs of an individual patient and to the kinetic properties of the controlled glucose compartment including the sensing system appears necessary. The feasibility of such adaptive steps has previously been shown”. This supports adapting therapy settings according to conditions. In view of these teachings, it would have been obvious to associate a particular therapy parameter set o adjusted therapy profile with the condition, circumstance, or user-specified context under which the parameter set was generated so that the profile could be later be retrieved and reused whin similar circumstances occur.
Claim Rejections - 35 USC § 103
10. 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.
11. 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.
12. Claims 21-25, 32-36, and 40 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Rebrin et al. Automated feedback control of subcutaneous glucose concertation in diabetic dogs” (hereinafter Rebrin) in view of Gerber et al. US 2007/0255321 A1 (hereinafter Gerber).
Regarding claim 21, Rebrin discloses a method for operating an insulin pump, comprising: monitoring glucose levels by a continuous glucose monitor over a predetermined period of time (Rebrin [page 575] e.g., “In the feedback control tests of subcutaneous glucose concentration, stable conditions were achieved both in pre- and post-OGTT basal states, and the glucose load was compensated for without exaggerated hyperglycaemia or oscillations (Fig.2)”, see also [page 574] e.g., “the animals were observed over at least 1.5 h under basal conditions following restoration of normoglycaemia, and for an interval of 4 h following OGTT”. This teaches subcutaneous glucose in monitored over a predetermined period of time), in which the insulin pump is configured to administer insulin according to a first rate specified by an insulin therapy profile (Rebrin [page 574] e.g., “Automated feedback control of glucose concentration was accomplished by a self-designed, laboratory-made bedside-type device. A proportional-differential insulin dosage algorithm was used with the same control constants throughout.” Insulin is delivered according to an algorithm) , wherein the continuous glucose monitor comprises a subcutaneous analyte sensor and a transmitter (Rebrin [page 573 – Summary] e.g., “Miniaturized glucose electrodes (amperometric glucose oxidase sensors for the measurement of hydrogen peroxide) were implanted in insulin-dependent diabetic dogs. The output of these sensors was fed into the controller of a bedside-type artificial B cell” Subcutaneous sensor is used). Rebrin does not explicitly disclose retrieving the insulin therapy profile and a predetermined parameter, wherein the predetermined parameter comprises insulin delivery information during the predetermined period of time; determining a modification based on the insulin therapy profile and at least one of the retrieved insulin delivery information and the monitored analyte levels; and adjusting the insulin therapy profile based on the determined modification to generate an adjusted insulin therapy profile, wherein the adjusted insulin delivery therapy comprises a second rate for administering the insulin. However, Gerber discloses retrieving the insulin therapy profile and a predetermined parameter, wherein the predetermined parameter comprises insulin delivery information during the predetermined period of time (Gerber [0092] e.g., “As a further alternative, programmer 14 may be configured to derive efficacy rating information from patient information. If a patient repeatedly increases stimulation pulse rate, for example, programmer 14 may infer that the original parameter values did not yield acceptable efficacy for the patient. In this case, programmer 14 may reduce the efficacy rating for some or all efficacy parameters by a fixed amount or in proportion to the number or magnitude of the adjustments made by the patient”. This shows deriving a modification based on previously applied therapy parameters (analogous to insulin delivery information). Incorporates monitored feedback over time (analogous to analyte levels). Teaches adjusting therapy parameters based on observed data Indicates data is collected over a period of time, supporting the “predetermined period” aspect); determining a modification based on the insulin therapy profile and at least one of the retrieved insulin delivery information and the monitored glucose levels (Gerber [0092] e.g., “If a patient repeatedly increases stimulation pulse rate, for example, programmer 14 may infer that the original parameter values did not yield acceptable efficacy for the patient. In this case, programmer 14 may reduce the efficacy rating for some or all efficacy parameters by a fixed amount or in proportion to the number or magnitude of the adjustments made by the patient.”); adjusting the insulin therapy profile based on the determined modification to generate an adjusted insulin therapy profile, wherein the adjusted insulin delivery therapy comprises a second rate for administering the insulin (Gerber [0111] e.g., “Also, in some embodiments, programmer 14 or 16 may recommend a best set of stimulation parameters that correlate to a best set of efficacy parameter values, and permit the user to find and accept this best set of stimulation parameters”. Shows adjusting therapy parameters based on determined modifications (analogous to adjusting the insulin therapy profile). It would have been obvious to a person of ordinary skill in the art at the time of the invention to combine Rebrin’s teaching of automated subcutaneous glucose monitoring and dynamic insulin delivery in diabetic dogs with Gerber’s teaching of insulin therapy profiles, retrieval of prior delivery information, and profile adjustment. Such a combination would yield a method of operating an insulin pump as claimed in Claim 21, including monitoring glucose, adjusting insulin delivery based on a therapy profile, and generating an adjusted insulin delivery rate.
Regarding claim 22, the proposed combination of Rebrin and Gerber teaches the method of claim 21, wherein the insulin therapy profile comprises at least one of a current basal profile, a temporary basal profile, or a pre-programmed insulin delivery profile (Rebrin [page 574] e.g., “The non-diabetic animals were studied under identical conditions with the exception that no insulin was infused. In all experiments the animals were observed over at least 1.5 h under basal conditions following restoration of normoglycaemia, and for an interval of 4 h following OGTT. …Plasma insulin concentration basal b (nmol/1) 0.14 4- 0.07 AUC OGTT…” This clearly describes basal insulin conditions and insulin administration during OGTT (oral glucose tolerance test)).
Regarding claim 23, the proposed combination of Rebrin and Gerber teaches the method of claim 21, further comprising: outputting the adjusted insulin therapy profile to a user device (Gerber [0015] e.g., “the disclosure provides a computer-readable medium comprising instructions to cause a processor to obtain values of a plurality of efficacy parameters associated with therapy delivered to a patient, and control a user interface to display a multi-axis graphical representation of the efficacy parameter values …”, see also [0071] e.g., “… The efficacy output 36 may be presented in a variety of ways, e.g., as a single numeric value, multiple numeric values ranking individual efficacy parameters, symbolic representations, color-based representations or the like”); and receiving, from the user device, an instruction to process the adjusted insulin therapy profile (Gerber [0070] e.g., ““[0070] e.g., “The efficacy input may take a variety of forms, including numeric values, rankings, symbolic selections, color selections, or the like. For example, the input may be entered into efficacy processor 20 by keying in information or selecting or manipulating media such as slider bars, radio buttons, and the like presented via a graphical display”. These passages together show outputting therapy information to the user interface (user device) and receiving user instructions back through that interface).
Regarding claim 24, the proposed combination of Rebrin and Gerber teaches the method of claim 23, wherein the instruction to process the adjusted insulin therapy profile comprises at least one of selecting the adjusted insulin therapy profile, storing the adjusted insulin therapy profile, or ignoring the adjusted insulin therapy profile (Gerber [0111] e.g., “…programmer 14 or 16 may recommend a best set of stimulation parameters that correlate to a best set of efficacy parameter values, and permit the user to find and accept this best set of stimulation parameters for stimulator 12”. This taught the system generated adjusted therapy options, presents them to the user, and the user may either accept (select), implicitly store, or decline (ignore)).
Regarding claim 25, the proposed combination of Rebrin and Gerber teaches the method of claim 24, wherein when the instruction to process the adjusted insulin therapy profile comprises selecting the adjusted insulin therapy profile (Rebrin [page 574] e.g., “Feedback control of subcutaneous glucose concentration by i.v. insulin infusion. The output of the subcutaneously implanted electrodes was fed into the artificial controller”. This demonstrates automatic execution of an insulin delivery rate in response to a control signal), the instruction is configured to cause the insulin pump to operate based on the second rate for administering the insulin (Gerber [0070] e.g., ““[0070] e.g., “The efficacy input may take a variety of forms, including numeric values, rankings, symbolic selections, color selections, or the like. For example, the input may be entered into efficacy processor 20 by keying in information or selecting or manipulating media such as slider bars, radio buttons, and the like presented via a graphical display”).
Claims 32 and 40 incorporate substantially all the limitations of claim 21 in an apparatus (Gerber [col. 6, lines 19] e.g., “…the transmitter processor 204…”) and a memory for storing … (Gerber col. 6, lines 22-23] e.g., “…the transmitter processor 204 also includes a memory…”) and a method and are rejected under the same rationale. The additional element on claim 32 and 40 receiving a user input parameter identifying a current context (Gerber [Abstract] e.g., “The graphical representation may be modified so that the efficacy parameter values correspond to values relating to a time reference specified by a user”. This is an actual input. The user is providing information (a specified time reference) that changes what information is displayed and evaluated); and associating the adjusted insulin therapy profile with the current context (Gerber [Abstract] e.g., “Each of the multiple multi-axis graphical representations corresponds to efficacy parameter values obtained for different sets of therapy parameters or to efficacy parameter values obtained at different times”). Gerber expressly associates a set of therapy parameters with a particular condition (different therapy settings of different times). This is essentially a mapping between a parameter set and an identifying condition. This teaches maintaining multiple parameter sets associated with different conditions. Rebrin, also states: (Rebrin [page 576] e.g., “Therefore, the adaptation of the algorithm both to the needs of an individual patient and to the kinetic properties of the controlled glucose compartment including the sensing system appears necessary. The feasibility of such adaptive steps has previously been shown”.
Regarding claim 33, the proposed combination of Rebrin and Gerber teaches the apparatus of claim 32, wherein the insulin therapy profile comprises at least one of a current basal profile, a temporary basal profile, or a pre-programmed insulin delivery profile (Rebrin [page 574] e.g., “The non-diabetic animals were studied under identical conditions with the exception that no insulin was infused. In all experiments the animals were observed over at least 1.5 h under basal conditions following restoration of normoglycaemia, and for an interval of 4 h following OGTT. …Plasma insulin concentration basal b (nmol/1) 0.14 4- 0.07 AUC OGTT…” This clearly describes basal insulin conditions and insulin administration during OGTT (oral glucose tolerance test)).
Regarding claim 34, the proposed combination of Rebrin and Gerber teaches the apparatus of claim 11, wherein the one or more processing units further: output the adjusted insulin therapy profile to a user device (Gerber [0015] e.g., “the disclosure provides a computer-readable medium comprising instructions to cause a processor to obtain values of a plurality of efficacy parameters associated with therapy delivered to a patient, and control a user interface to display a multi-axis graphical representation of the efficacy parameter values …”, see also [0071] e.g., “… The efficacy output 36 may be presented in a variety of ways, e.g., as a single numeric value, multiple numeric values ranking individual efficacy parameters, symbolic representations, color-based representations or the like”); and receive, from the user device, an instruction to process the adjusted insulin therapy profile (Gerber [0070] e.g., ““[0070] e.g., “The efficacy input may take a variety of forms, including numeric values, rankings, symbolic selections, color selections, or the like. For example, the input may be entered into efficacy processor 20 by keying in information or selecting or manipulating media such as slider bars, radio buttons, and the like presented via a graphical display”. These passages together show outputting therapy information to the user interface (user device) and receiving user instructions back through that interface).
Regarding claim 35, the proposed combination of Rebrin and Gerber teaches the apparatus of claim 34, wherein the instruction to process the adjusted insulin therapy profile comprises at least one of selecting the adjusted insulin therapy profile, storing the adjusted insulin therapy profile, or ignoring the adjusted insulin therapy profile (Gerber [0111] e.g., “…programmer 14 or 16 may recommend a best set of stimulation parameters that correlate to a best set of efficacy parameter values, and permit the user to find and accept this best set of stimulation parameters for stimulator 12”. This taught the system generated adjusted therapy options, presents them to the user, and the user may either accept (select), implicitly store, or decline (ignore)).
Regarding claim 36, the proposed combination of Rebrin and Gerber teaches the apparatus of claim 35, wherein when the instruction to process the adjusted insulin therapy profile comprises selecting the adjusted insulin therapy profile (Rebrin [page 574] e.g., “Feedback control of subcutaneous glucose concentration by i.v. insulin infusion. The output of the subcutaneously implanted electrodes was fed into the artificial controller”. This demonstrates automatic execution of an insulin delivery rate in response to a control signal), the instruction is configured to cause the insulin pump to operate based on the second rate for administering the insulin (Gerber [0070] e.g., ““[0070] e.g., “The efficacy input may take a variety of forms, including numeric values, rankings, symbolic selections, color selections, or the like. For example, the input may be entered into efficacy processor 20 by keying in information or selecting or manipulating media such as slider bars, radio buttons, and the like presented via a graphical display”).
13. Claims 26-31 and 37 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Rebrin et al. Automated feedback control of subcutaneous glucose concertation in diabetic dogs” (hereinafter Rebrin) in view of Gerber et al. US 2007/0255321 A1 (hereinafter Gerber) as applied to claims 21-25, 32-36, and 40 above, and further in view of Sloan et al. U.S. Patent 7,766,829 B2 (hereinafter Sloan).
Regarding claim 26, the proposed combination of Rebrin and Gerber does not explicitly teach the method of claim 21, wherein the second rate for administering the insulin comprises a temporary basal rate. However, Sloan discloses wherein the second rate for administering the insulin comprises a temporary basal rate (Sloan [col. 8, lines 40-48] e.g., “…the current basal profile modification may be performed at different times during the time that the patient is using an infusion device. For example, the patient may perform the current basal profile modification procedure… the current basal profile modification procedure may be performed each time a bolus is administered”. This teaches modifying a basal profile for specific time periods base on patient glucose measurements). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include the method and system for providing basal profile modification in analyte monitoring and management systems as being disclosed and taught by Sloan in the proposed combination of Rebrin and Gerber to yield the predictable results of implement these time-limited basal adjustments as temporary basal rates, because temporary basal rates are known mechanism in insulin therapy (Sloan [col. 2, lines 29-35]).
Regarding claim 27, the proposed combination of Rebrin, Gerber, and Sloan teaches the method of claim 21, wherein the adjusted insulin therapy profile further comprises a new bolus amount determined based on the user input parameter (Solan [col. 8, line…] e.g., “..the modification to the current basal profile may include several factors… patient's activities during the monitored time period, patient's diet, insulin sensitivity, level of insulin on board, and the insulin type”. This describes calculating correction boluses based on patient-specific factors). One of ordinary skill would recognize that such patient-specific adjustment constitute a new bolus amount determined based on user input parameters
Regarding claim 28, the proposed combination of Rebrin, Gerber, and Sloan teaches the method of claim 27, wherein the user input parameter comprises at least one of an amount of carbohydrate to ingest, a type of exercise to perform, and a current time of day information (Solan [col. 8, line…] e.g., “..the modification to the current basal profile may include several factors… patient's activities during the monitored time period, patient's diet…frequency of bolus dosing during the time period…”). It would have been obvious to use these parameters as inputs for determining insulin dosing.
Regarding claim 29, the proposed combination of Rebrin, Gerber, and Sloan teaches the method of claim 27, further comprising storing the new bolus amount in a database, and wherein the database further includes a plurality of previously determined medication dosage levels and one or more associated parameters for each of the plurality of the previously determined medication dosage levels (Sloan [col. 10, lines…] e.g., “…a consistent pattern in the monitored analyte levels of bolus delivery versus time of day is determined... an increase in the insulin level… may be proposed to the current basal profile using equation (1)…”). Storing previous bolus data and using it for calculations would have been an obvious implementation for a skilled artisan.
Regarding claim 30, the proposed combination of Rebrin, Gerber, and Sloan teaches the method of claim 29, wherein one or more of the plurality of the previously determined medication dosage levels stored in the database includes administered medication dosage information (Sloan [col. 10, line …44] e.g., “Table 2 below shows one example of such pattern: … each shown in Table 2 with a “1” entry)”). Recording actual administered doses to inform basal modifications would have been routine and obvious.
Regarding claim 31, the proposed combination of Rebrin, Gerber, and Sloan teaches the method of claim 29, further including performing statistical analysis based on the one or more parameters, wherein the statistical analysis includes one or more of mean deviation analysis, standard deviation analysis (Sloan [col. 10, lines …] e.g., “…a consistent pattern in the monitored analyte levels of bolus delivery versus time of day is determined… an increase in the insulin level… may be proposed to the current basal profile using equation (1)…”) Basic statistical processing of prior doses to calculate basal modifications would have been obvious; additional analyses (mean deviation, regression, forecasting) are routine data processing extensions), estimation analysis, forecasting analysis, correlation of the one or more parameters, modeling of one or more relationships among the one or more parameters, regression analysis, time series analysis (Sloan [col. 11, lines 50-54] e.g., “…a 24 hour profile may be determined based on time-of-day averages over a predetermined number of days. The correction factor may then be based on maintaining the time-of-day averages within a predetermined target range value), autoregressive modeling, integrated modeling, moving average modeling, data mining (Sloan [col. 7, lines 49-55] e.g., “…the monitored analyte levels are retrieved and, based on one or more patterns from the analyte levels monitored and factoring in the current basal profile(s), a recommendation or modification to the current basal profile(s) is determined. Thereafter, the recommendation or modification to the current basal profiles(s) determined at step 304 is provided to the patient visually on a display or audibly”. This process considered as data mining or knowledge discovery. It involves the core steps of collecting data, searching for patterns, and applying the discovered knowledge to drive action), or probability analysis.).
Regarding claim 37, the proposed combination of Rebrin, Gerber, and Sloan teaches the method of claim 32, wherein the second rate for administering the insulin comprises a temporary basal rate (Sloan [col. 8, lines 40-48] e.g., “…the current basal profile modification may be performed at different times during the time that the patient is using an infusion device. For example, the patient may perform the current basal profile modification procedure… the current basal profile modification procedure may be performed each time a bolus is administered”. This teaches modifying a basal profile for specific time periods base on patient glucose measurements).
14. Claims 26-31 and 37 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Rebrin et al. Automated feedback control of subcutaneous glucose concertation in diabetic dogs” (hereinafter Rebrin) in view of Gerber et al. US 2007/0255321 A1 (hereinafter Gerber) as applied to claims 21-25, 32-36, and 40 above, and further in view of Pacione et al. U.S. Patent 8,398,546 B2 (hereinafter Sloan).
Regarding claim 41, the proposed combination of Rebrin and Gerber does not explicitly teach the method of claim 21, further comprising: receiving a second user input parameter; and
querying based on the second user input parameter, the database to identify the adjusted insulin therapy profile. Pacione discloses receiving a second user input parameter (Pacione [col. 23, lines 61-67] e, g., “The user logs meals on a daily basis by selecting individual food items from the food database”. See also [col. 22, lines 66-67 and col. 23, line 4] e.g., “The user may enter as many enter specific information including: … physical activity level, bedtime and wake time”. These are explicit user input parameters); and
querying based on the second user input parameter, the database to identify the adjusted insulin therapy profile (Pacione [col. 25, line13-35] e.g., “The food input screen is the front end to the food database. The user interface provides the capability to search the food database. … The user begins a search by entering at least three characters in the input box. The search should be case insensitive and order independent…”. This is a very clear: use input – database query – retrieve matching information workflow). It would have been obvious to a person of ordinary skill in the art at the time of the invention to combine Pacione’s teaching of system for monitoring and managing body weight and other physiological conditions including iterative and personalized planning, intervention and reporting capability with Rebrin, Gerber’s teaching. Such a combination would yield the expected result of improving personalization of insulin therapy and provide therapy profiles associated with recurring user condition.
Regarding claim 42, the proposed combination of Rebrin, Gerber, and Pacione teach the method of claim 32, wherein the current context comprises at least one of meal or an exercise (Pacione [col. 16, lines 7-13] e.g., “The data relating to life activities may relate to the eating, sleep, exercise … habits, patterns and/or activities of the individua. ... what did you have for lunch today? … How long did you run on the treadmill today?” see also [col. 14, lines 51-61] e.g., “Sensor device 10 may be provided with a button to be used to time stamp events such as … time of meals”. These disclosure show that the system explicitly recognizes meal events and exercise events as conditions associate with the user).
Conclusion
15. THIS ACTION IS MADE FINAL. 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.
13. Any inquiry concerning this communication or earlier communications from the examiner should be directed to BERHANU MITIKU whose telephone number is (571)270-1983. The examiner can normally be reached Monday – Friday 8:30AM – 4:00PM.
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/BERHANU MITIKU/Examiner, Art Unit 2156
/AJAY M BHATIA/Supervisory Patent Examiner, Art Unit 2156
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