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 amendment to the claims filed 18 July 2025 has been entered. Claim(s) 1-5 and 7-8 is/are currently amended. Claim(s) 1-12 is/are pending.
Rejections Withdrawn
Rejections under 35 U.S.C. 112(a) (or pre-AIA 35 U.S.C. 112, first paragraph) and/or 35 U.S.C. 112(b) (or pre-AIA 35 U.S.C. 112, second paragraph) not reproduced below has/have been withdrawn in view of Applicant's amendments to the claims and/or submitted remarks.
Claim Rejections - 35 USC § 112
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 pre-AIA 35 U.S.C. 112, 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.
Claim(s) 1-12 is/are rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, 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 pre-AIA the applicant regards as the invention.
Regarding claims 1-4 and claims dependent thereon, the relationship between the newly-added "glucose measurement data" (claim 1) and the "glucose level excursion data" used in a generating the recommended residual insulin infusion signal (claim 1), and the "data related to a single, processed glucose sample at a specific time, a history of glucose samples up to a specific time, or a statistic computed from glucose samples up to a specific time" (claims 3 and/or 4) is unclear. It is unclear if these all refer to the same glucose data, a plurality of different types of glucose data is required, etc. This is further made unclear by the fact that Applicant appears to use "input data" interchangeably with external source data (e.g., pg. 10, lines 26-30; pg. 8, lines 1-18; etc.).
Regarding claim 1 and claims dependent thereon, the limitation "coordinating distribution of the input data, via the system coordinator device to a daily profile controller device, a meal controller device, and/or a compensation control-to-target controller device" is indefinite, as none of the controller devices clearly utilize any of the recited input data in generating their respective insulin signals. For example, while the claim recites the daily profile controller device generates a reference insulin infusion signal based on "a metabolic state," there is no clear indication said "metabolic state" corresponds to the "metabolic state estimate data" that may be included in the input data. Similarly, there is no clear indication "glucose level excursion data caused by non-meal occurrences" utilized by the compensation control-to-target controller device corresponds to the glucose measurement data that may be included in the input data.
Regarding claim 2 and claims dependent thereon, it is unclear what the difference in scope between "distribution" and "routing" of data is intended to be or if any such difference is intended.
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 pre-AIA 35 U.S.C. 112, first paragraph:
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(s) 1-12 is/are rejected under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claim 1 and claims dependent thereon, Applicant discloses CGM and insulin pump data are "mandatory" input/external source data required by the disclosed system in executing the disclosed method(s) and/or algorithm(s) (pg. 8, lines 7-9). The pending claims only require the input data to include any one of "glucose measurement data," "metabolic measurement data," and "metabolic state estimate data." Applicant discloses "metabolic measurement data" may include one or more of continuous glucose measurements, and insulin measurements (pg. 22, lines 15-16). The specification does not describe what measurements are encompassed by "insulin measurements." For example, there is no indication as to whether "insulin measurements," in the context of the above-noted sentence refers to a direct measurement of insulin from the patient (e.g., serum insulin level), to insulin pump data/measurements, etc. Accordingly, while the pending claims recite the input data may include "glucose measurement data," and/or may arguably include some type of insulin measurement data, the claim does not require the input data to include both CGM and insulin pump data despite encompassing generating each of a reference insulin infusion signal, a recommended meal insulin infusion signal, a recommended residual insulin infusion signal, and a total insulin infusion signal. Since Applicant fails to sufficiently disclose an algorithm for computing the total insulin infusion signal based only on the input data required by the claims, said claims lack sufficient support in the application as filed.
Further, Applicant discloses only one observer module with any specificity that generates "metabolic state estimate data" to be received by a system coordinator. Specifically, Applicant discloses the system includes observers of patients' metabolic state, daily profiles and behavior, which provide information to the central system coordinator, which in tum directs the actions and the interactions of an array of control modules (pg. 5, lines 10-14). Applicant discloses a short-term observer module that generates a vector of estimates of the key metabolic states of the patient, including possibly plasma glucose and plasma insulin (pg. 9, line 23 - pg. 10, line 9), that is output to and/or received by the system coordinator (Fig. 4). "The short-term observer module may be configured to output one of the following: a vector of estimates of key metabolic states of an individual; a single, processed glucose sample at a specific time, or a history of glucose samples up to a specific time, or a statistic computed from glucose samples up to a specific time; or both the vector of estimates of key metabolic states and the sample or history of processed glucose samples. The vector of estimates may include plasma glucose and plasma insulin" (pg. 22, line 31 - pg. 23, line 3). Applicant discloses, when said short-term observer is not active, a "default state estimate" is simply a pass-through of the glucose sample (pg. 10, lines 10-14). However, Applicant does not sufficiently disclose any embodiment(s) in which the system coordinator routes and/or feeds the output of the short-term observer module (i.e., metabolic state estimate data, or x(t)) to either a meal controller device, or a compensation control-to-target controller device. Rather, the daily profile controller device is the only of the disclosed control modules that is adequately described as receiving the output of the short-term observer module (e.g., Fig. 4). Specifically, Applicant discloses, "The inputs to the Daily Profile Control Module are the outputs of the system observers: (1) the metabolic state vector estimate […] (produced by the Short Term Observer Module) and (2) the behavioral profiles […] (produced by the Long Term Observer Module)" (pg. 12, lines 13-16); "The inputs to the Meal Controller are […] the meal data process (from the Data Module) [,…] insulin allowed at time t by the Safety Supervisor as a part of the response to meals (produced by Safety Supervision Module) [,…and] the meal behavioral profile (produced by the Long Term Observer Module)" (pg. 12, lines 26-30); and "The inputs to the Compensation Controller are […] an estimate of glucose excursions away from [a target glucose] that are not due to meals (computed by the System Coordinator) [,…] the insulin allowed at time t by the Safety Supervisor (computed by the Safety Supervisor) [,…] the exercise data process from the Data Module [,…] the exercise behavioral profile (produced by the Long Term Observer Module) [,…and] the circadian insulin profile (produced by the Long Term Observer Module)" (pg. 14, lines 9-16). Accordingly, the limitation "coordinating distribution of the input data," which encompasses the metabolic state estimate data, "via the system coordinator device to a daily profile controller device, a meal controller device, and/or a compensation control-to-target controller device" of claim 1, and the comparable limitations of claims 3-4 encompass new matter.
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 negatived 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:
Determining the scope and contents of the prior art.
Ascertaining the differences between the prior art and the claims at issue.
Resolving the level of ordinary skill in the pertinent art.
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).
Claim(s) 1-7 and 9-11 is/are rejected under pre-AIA 35 U.S.C. 103(a) as obvious over US 2009/0006061 A1 (previously cited, Thukral) in view of US 6,923,763 B1 (previously cited, Kovatchev).
Regarding claims 1, 5-7 and 10, Thukral teaches/suggests a method for managing diabetes of a patient, the method comprising:
receiving, at a system coordinator controller device (Figs. 6-7, means/programming of APS 502 for receiving and communicating data to appropriate compensators, controllers, predictors, etc.), input data including glucose measurement data (¶ [0160] glucose measurements), metabolic measurement data (¶ [0160] delivered insulin information), and/or metabolic state estimate data (¶¶ [0204]-[0209] predicted glucose), wherein the input data, i.e., metabolic state estimate data or vector of state estimate, is generated by one or more external sources (e.g., past insulin delivery information, glucose measurements, etc.) and one or more observer modules (e.g., glucose prediction module 838) (e.g., ¶¶ [0204]-[0209] glucose prediction module 838 makes predictions using past insulin delivery information, the glucose measurements, and using insulin pharmaco-dynamics);
coordinating distribution of the input data, via the system coordinator device to a daily profile controller device, a meal controller device, and/or a compensation control-to-target controller device (Fig. 6, insulin delivered is distributed/routed to at least insulin dose nullifier 636; glucose measurements are distributed/routed to at least glucose predictor; predicted glucose is distributed/routed to at least basal controller 628; etc.);
generating:
a reference insulin infusion signal, by the daily profile controller device, based on a metabolic state (¶ [0205] outputs from glucose predictor 626 and setpoint 603 providing basal control together forms the feedback part of the basal controller 628; ¶¶ [0217]-[0223] basal insulin recommendation, or at least the portion thereof based on current/predicted glucose);
a recommended meal insulin infusion signal, by the meal controller device, based on meal intake data (Fig. 6, meal-related boluses; ¶ [0145] insulin bolus distribution for a meal event); and/or
a recommended residual insulin infusion signal, by the compensation control-to-target controller device, based on glucose level excursion data caused by non-meal occurrences (Fig. 6, intervention-related bolus; ¶ [0160] triggering the appropriate modules to handle the known disturbances, which may include high glucose intervention module 618; ¶¶ [0217]-[0223] the basal insulin recommendation is further based on glucose set point and a glucose push, e.g., ¶¶ [0188]-[0192] reducing basal insulin in anticipation of exercise by adjusting a glucose set point and determining an associated glucose push in anticipation of exercise, and/or normalizing basal rate during exercise; and/or ¶ [0194] low glucose intervention module produces more conservative insulin recommendations by adjusting the glucose set point);
receiving, at a safety supervision module: the reference insulin infusion signal, the recommended meal insulin infusion signal, and/or the recommended residual insulin infusion signal; and metabolic measurement data and/or metabolic state estimate data from the observer module; and generating, by the safety supervision module, an adjusted total insulin infusion signal by adjusting the reference insulin infusion signal, the recommended meal insulin infusion signal, and/or the recommended residual insulin infusion signal (¶¶ [0188]-[0192] and ¶¶ [0217]-[0223] as noted above; ¶ [0223] basal insulin recommendation output by basal controller 628 may be modified by glucose satisfying a target zone and a minimum basal requirement; closed-loop bucket management block 630 determining and/or managing a net insulin recommendation based at least in part on the insulin recommended by the basal controller, e.g., ¶¶ [0224]-[0225] a final insulin recommendation is made from combination of basal control and open loop insulin requirements due to various events triggered); and
administering insulin by an insulin delivery device based on the adjusted insulin infusion signal (¶ [0136] medication delivery unit, such as a programmable insulin pump, automatically operates to the recommended therapy of the system; ¶ [0162] administering insulin boluses; etc.).
As discussed above, Thukral discloses the safety supervision module receives the reference insulin infusion signal, the recommended meal insulin infusion signal, and/or the recommended residual insulin infusion signal, and metabolic measurement data and/or metabolic state estimate data from the observer module to generate an adjusted total insulin infusion signal. Thukral further discloses the system is capable of operating in an open-loop advisory mode (e.g., Fig. 7, mode 700). Alternatively/Additionally, Kovatchev teaches and/or suggests a safety supervision module configured to receive metabolic measurement data and/or metabolic state estimate data (e.g., Abstract, estimate blood glucose in the near future); assess risk of hyper- or hypoglycemia based on the received metabolic data (e.g., Abstract, estimate of the risk of the onset of hypoglycemia); generate a total insulin infusion signal is based on the assessed risk (col. 5, line 59 - col. 6, line 12, adjusting delivered insulin based on the predicted near future BG profile and the assessment of the risk of hypoglycemia) and/or a signal warning of the assessed risk when operating in an open-loop advisory mode (col. 5, line 59 - col. 6, line 12, device may contain a mechanism by which it will warn the individual of the onset of hypoglycemia). It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the method of Thukral with the safety supervision module further receiving metabolic measurement and/or state estimate data, assessing risk of hypoglycemia based on the received data; and generating the total insulin infusion signal by adjusting the reference insulin infusion signal, the recommended meal insulin infusion signal, and/or the recommended residual insulin infusion signal based on the assessed risk; or generating a signal warning of the assessed risk when operating in an open-loop advisory mode as taught and/or suggested by Kovatchev in order to facilitate preventing occurrence of glucose excursions (Kovatchev, col. 9, lines 4-18) and/or as a simple substitution of one means and/or method for compensating for low glucose and/or adjusting recommended insulin based thereon for another to yield no more than predictable results. See MPEP 2143(I)(B).
Regarding claims 2-4, Thurkal as modified teaches/suggests coordinating routing of external source data to the daily profile controller device, the meal controller device, and/or the compensation control-to-target controller device, the external source data a single, processed glucose sample at a specific time, a history of glucose samples up to a specific time, or a statistic computed from glucose samples up to a specific time (Figs. 6-7, glucose data received from glucose sensor 604 distributed/routed to glucose predictor 626 for use by at least basal controller 628); data related to a most recent actual insulin pump command, a history of recent insulin pump commands up to a specific time, or a statistic computed from recent commands (Figs. 6-7, insulin data received from insulin pump 606 indicating insulin delivered 632 distributed/routed to insulin dose nullifier for use by at least basal controller 628); and exercise process data at a specific time and meal data at a specific time (Figs. 6-7, input known events 612 distributed/routed by event handler; ¶ [0067] patient meal intake data, patient exercise data; etc.).
Regarding claim 9, Thukral as modified teaches/suggests the limitations of claim 1, but does not expressly disclose generating the reference insulin infusion signal occurs once per day; generating the recommended residual insulin infusion signal occurs every fifteen to thirty minutes; and generating the recommended meal insulin infusion signal occurs more than once per day. However, Thukral discloses continuously monitoring glucose and implementing intensive therapy rules at frequent, regular intervals, disclosing/suggesting the frequency of assessing the insulin to be provided a user provides a quality that can be optimized (e.g., ¶ [0154] reliability and/or timely providing of insulin doses). Since the frequency of generating the insulin signal(s) is a result-effective variable for at least the reasons noted above, the specific frequency ranges for generating the insulin signals as claimed would have been obvious because it has been held that the discovery of optimum or workable ranges by routine experimentation is not inventive. See MPEP 2144.05(II).
Alternatively/Additionally, at the time the invention was made, it would have been an obvious matter of design choice to a person of ordinary skill in the art to modify the method of Thukral with the claimed time periods for generating the insulin signals because Applicant has not disclosed that said time periods provide an advantage, are used for a particular purpose, or solve a stated problem. Rather, Applicant expressly discloses the frequency of generating each component insulin signal "may be greater or less as desired or required" than the frequency range(s) claimed (¶ [0140]). As no evidence has been provided to the contrary, one of ordinary skill in the art, furthermore, would have expected Applicant's invention to perform equally well with the time period(s) disclosed/suggested by Thukral as modified (e.g., sufficiently frequent updates the insulin signals to provide timely therapy) because either configuration enables modifying the insulin recommendations to facilitate maintaining the patient in a desired/target glucose range.
Regarding claim 11, Thukral as modified teaches the limitations of claim 7, as discussed above, but does not expressly teach the vector of state estimate is based on data assessed at X times per hour, where 0<X≤7200. However, Thukral discloses control cycles occur at periodic intervals, TC (e.g., ¶ [0151]), and discloses monitoring glucose and implementing intensive therapy rules at "frequent regular intervals" (e.g., ¶ [0154]). Accordingly, at the time the invention was made, it would have been an obvious matter of design choice to a person of ordinary skill in the art to modify the method of Thukral with the vector of state estimate being based on data assessed at X times per hour, where 0<X≤7200, because Applicant has not disclosed that the claimed range provides an advantage, is used for a particular purpose, or solves a stated problem. Rather, Applicant expressly discloses, "It should be appreciated that the frequency may be greater or less as desired or required" (¶ [0137]). As no evidence has been provided to the contrary, one of ordinary skill in the art would have expected Applicant's invention to perform equally well with the vector of state estimate frequency reasonably suggested by Thukral because either arrangement provides a sufficiently frequent metabolic state, or vector of state, estimate data for implementing therapy (e.g., administering recommended insulin) expected to keep glucose of the patient in a target range.
Claim(s) 8 and 12 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Thukral in view of Kovatchev as applied to claim(s) 7 above, and further in view of WO 2009/059187 A1 (previously cited, Magni) and US 2010/0160740 A1 (previously cited, Cohen).
Regarding claim 8, Thukral as modified teaches and/or suggests the limitations claim 7, as discussed above, but does not expressly disclose generating, by one or more observer modules (e.g., a second observer module), a behavioral profile. However, Thukral at least suggests capturing patient behavior, such as meal timing distribution, physical activity, insulin distribution, etc. (¶ [0110]). Additionally, Magni discloses an observer module, e.g., short-term observer, configured to generate and/or output metabolic measurement data and/or metabolic state estimate data, such as a vector of state estimate, based on external source data including continuous glucose monitoring data, insulin pump data, and disturbance data (pg. 17, line 15 - pg. 18, line 26, state vector determined as a function of measured glucose, insulin and disturbance data), such as exercise and/or meal data (pg. 1, lines 17-23), wherein future glucose disturbances (e.g., exercise and/or meals) may be inferred from patient behavioral data (e.g., pg. 17, line 15 - pg. 18, line 26). Similarly, Cohen discloses an observer module, e.g., long-term observer, configured to generate and/or output a behavioral profile (e.g., ¶¶ [0058]-[0060] average daily meal, exercise, etc., pattern(s)).
It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the method of Thukral with at least one observer module for generating a behavioral profile to be received by the system coordinator controller as taught and/or suggested by Magni and Cohen in order to facilitate calculating an optimal insulin injection necessary to safely regulate blood glucose (Magni, Abstract); provide more accurate treatment and delivery of insulin to better keep a user within a preferred glucose level range and/or minimize occurrences of severe adverse events (Cohen, ¶ [0061]); etc.
*Regarding claim 12, Thukral as modified teaches and/or suggests the limitations of claim 8, as discussed above, but does not expressly teach the behavioral profile is based on data assessed at X times per month, where 0<X≤60. However, at the time the invention was made, it would have been an obvious matter of design choice to a person of ordinary skill in the art to modify the method of Thukral with the behavioral profile being based on data assessed at X times per month, wherein 0<X≤60, because Applicant has not disclosed that the claimed data assessment frequency provides an advantage, is used for a particular purpose, or solves a stated problem. Rather, Applicant expressly discloses, "It should be appreciated that the frequency may be greater or less as desired or required" (¶ [0138]). As no evidence has been provided to the contrary, one of ordinary skill in the art, furthermore, would have expected Applicant's invention to perform equally well with the data collection frequency reasonably suggested by Cohen (or Thukral as modified thereby) because either arrangement provides a sufficient amount of data for generating a behavioral profile.
Alternatively/Additionally, Thukral further discloses assessing changes in patient lifestyle (e.g., ¶ [0113]), suggesting the behavior profile(s) are, or should be, assessed at least periodically. Cohen teaches/suggests assessing behavior profile(s) using days, weeks, months, etc. of collected data (¶ [0057]), such that it would have been obvious to one of ordinary skill in the art at the time of the invention to modify the method of Thukral with the behavioral profile being based on data assessed at X times per month, where 0<X≤60, as taught/suggested by Cohen (e.g., assessing data collected every three days, one week, two weeks, three weeks, one month, etc. for patterns/trends) in order to access data over a useful period of interest for assessing profile(s)/pattern(s) (Cohen, ¶ [0057]).
Response to Arguments
Applicant's arguments have been fully considered but they are not persuasive.
With respect to the prior art rejections, Applicant contends, the Thukral modules may use certain input data they receive, there is no disclosure that any coordinated distribution of the input values occurs. Contrary to Thukral, Applicant's coordinator is an algorithmic module that is responsible for controlling the integration and the interactions of the modular system (Remarks, pg. 9).
The examiner respectfully disagrees. Firstly, the examiner notes the "coordinating distribution" limitation is indefinite for at least the reasons noted above. Secondly, the comparable "coordinator" of Thukral is the means/algorithm by which the disclosed modules receive the "certain input data" necessary to perform their various disclosed functions. As to Applicant's contention that this distribution of data by Thukral is not "coordinated," the examiner respectfully disagrees. The algorithm of Thukral ensures necessary input data, if available, is "distributed to," or used by, the correct control function(s), and therefore coordinates distribution of the input data, as required by the claim. For example, Applicant discloses the system coordinator "decouple[s] different control functions, and…coordinate[s] the control module action with separate modules responsible for different aspect of diabetes management, such as meals, exercise, basal pattern, and hypo/hyperglycemia avoidance (pg. 6, lines 27-30). This is comparable to the core control actions modules for providing glycemic control disclosed by Thukral, including modules for glucose prediction, insulin recommendation, exercise and meal compensation, etc. (e.g., ¶ [0144], etc.). Thukral discloses input data, including external source data (e.g., delivered insulin data, glucose measurements, event data) and/or data generated by the modules (e.g., glucose predictor or metabolic state estimate data) is appropriately communicated to and/or distributed to the various modules in order to provide glycemic control by determining the appropriate amount of insulin to administer.
With respect to Applicant contention that, contrary to Thukral, "Applicant's coordinator is an algorithmic module that is responsible for controlling the integration and the interactions of the modular system" (Remarks, pg. 9), the pending claims neither require a modular system, nor a system coordinator for "controlling the integration and the interactions." Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Alternatively or additionally, Thukral discloses the disclosed control algorithm is structured modularly to allow the treatment of complex problem in a structured manner, focusing in breaking down the problem into functional units which specialize in the given task (¶¶ [0141]-[0146]), thereby indicating and/or suggesting input data for said tasks is distributed and/or input to said functional units.
Applicant further contends the mapping of various portions of Thukral to the plurality of claimed infusion signals is unclear (Remarks, pgs. 10-11). The examiner respectfully disagrees for at least the reasons noted in the rejection of record above. Specifically, Thukral expressly discloses the basal controller utilizes metabolic state (metabolic state estimate/vector, or predicted glucose) at least in part to generate a basal insulin recommendation. Thukral further discloses the meal compensator (and/or carbohydrate rectification module 834) utilizes external source data as input data (i.e., meal intake data, such as occurrence of a meal, meal type, etc.) to calculate insulin bolus distribution (see, e.g., Fig. 16). Lastly, with respect to the residual insulin infusion signal, though Applicant submits "a residual insulin infusion is not the same or similar to reducing basal insulin" (pg. 10), this statement appears inconsistent with Applicant's own disclosure. For example, Applicant discloses "Control Module 2 will calculate and suggest compensation of the basal delivery (up or down) in case of non-meal related deviations, such as drops or rise due to exercise, or residual dawn phenomenon not covered by module 1" (pg. 6, lines 5-7); and similarly, "a second control module to calculate and suggest compensation of the basal delivery in case of non-meal-related deviations…The second control module may compensate for a basal delivery up or down" (pg. 24, line 22 - pg. 25, line 18). Accordingly, contrary to Applicant's assertions, an adjustment to basal insulin determined based on glucose level excursion data caused by non-meal occurrences, as disclosed by Thukral, is consistent with Applicant's disclosure of generating a recommended residual insulin infusion signal. Lastly, the examiner notes, in light of the "and/or" language, the pending claims only require any one of the infusion signals to be generated.
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Meredith Weare whose telephone number is 571-270-3957. The examiner can normally be reached Monday - Friday, 9 AM - 5 PM.
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/Meredith Weare/Primary Examiner, Art Unit 3791