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 03 March 2026 has been entered. Claim(s) 10, 12, 16-17, 20, 25-26, 28, 30, 35-36 and 38 is/are currently amended. Claim(s) 1-9, 11, 21 and 31 has/have been canceled. New claim(s) 40-42 has/have been added. Claim(s) 10, 12-20, 22-30 and 32-42 is/are pending.
Rejections Withdrawn
Rejections under 35 U.S.C. 112(a) (pre-AIA 35 U.S.C. 112, first paragraph) and/or 35 U.S.C. 112(b) (pre-AIA 35 U.S.C. 112, second paragraph) not reproduced below has/have been withdrawn in view of Applicant's amendments to the claims and/or submitted remarks.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) 10, 12-20, 22-30 and 32-42 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 claim 10, claim 20, claim 30 and claims dependent thereon, the limitation "in a first control function, a first reference insulin infusion based, at least in part, on an estimate of a metabolic state derived, at least in part, from the metabolic measurement data, the metabolic treatment data, and a first profile descriptive of a statistical insulin utilization for the patient" of claim 10 and the comparable limitation(s) of claims 20 and 30 are indefinite are indefinite. It is unclear in what calculation (computation, derivation, etc.) "the metabolic treatment data, and a first profile descriptive of a statistical insulin utilization for the patient" are used. Is the estimate of metabolic state derived from the metabolic measurement data, the metabolic treatment data, and a first profile descriptive of a statistical insulin utilization for the patient? Is the estimate of metabolic state derived from the metabolic measurement data, which is then used in combination with the metabolic treatment data, and a first profile descriptive of a statistical insulin utilization for the patient to compute the first reference insulin?
Further, if the above-noted limitations are intended to indicate the estimate of a metabolic state is derived from at least the metabolic measurement data and the metabolic treatment data, it is unclear what "input data" is/may be distributed to the first control module since there is no clear indication in the claims that the estimate of metabolic state is derived by the first control function. To the contrary, Applicant discloses an "estimate of metabolic state" is derived by a short-term observer module based on, inter alia, metabolic measurement and treatment data (e.g., ¶¶ [0062]-[0063]), rather than being derived by any of the disclosed control functions/modules.
Similarly, the limitation(s) "coordinating distribution of the input data to one or more control functions; computing: […] in a second control function, a first residual insulin infusion based, at least in part, on an estimate of a glucose concentration and a second profile descriptive of patient behavior for the patient that is at least a function of time of day" of claim 10 and the comparable limitation(s) of claims 20 and 30 are indefinite. As there is no clear indication in the claims that any of the recited received input data (i.e., metabolic measurement data, metabolic disturbance data, and/or metabolic treatment data) is utilized by the second control function in computing the first residual insulin infusion, it is unclear what "input data" is/may be distributed to the second control module.
The limitation(s) "coordinating distribution of the input data to one or more control functions; computing: in a first control function…based on the metabolic measurement data, the metabolic treatment data…; in a third control function…based at least in part of the metabolic disturbance data" of claim 10 and the comparable limitation(s) of claims 20 and 30 are indefinite. Each of the first, second, and third control functions is recited as being required to be computed by the claim, with at least one reasonable interpretation of each of at least the first and third control function computations utilizing at least one type of the received input data (metabolic measurement data, metabolic disturbance data and/or metabolic treatment data). The claim additionally indicates that distribution of the input data is only required to be coordinated to one control function (to "one or more control functions," which requires one, and encompasses at least two, etc.). Accordingly, it is unclear how computing each of the first reference insulin infusion, the first residual insulin infusion, and the first meal-accommodation insulin infusion is achieved when the input data is only distributed to only one or two control functions commensurate in scope with the "coordinating distribution" limitation.
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) 10, 12-20, 22-30 and 32-42 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 10, claim 20, claim 30 and claims dependent thereon, as discussed above, the limitation "in a first control function, a first reference insulin infusion based, at least in part, on an estimate of a metabolic state derived, at least in part, from the metabolic measurement data, the metabolic treatment data, and a first profile descriptive of a statistical insulin utilization for the patient" of claim 10 and the comparable limitations of claims 20 and 30 are indefinite, as noted above. Applicant discloses an estimate of metabolic state may be derived by a short-term observer module based, at least in part, on metabolic measurement and metabolic treatment data (¶¶ [0062]-[0063]; Fig. 4; etc.); and further discloses a first (daily profile) control module for computing a reference insulin signal based, at least in part, on the estimate of metabolic state from the short-term observer module and a first profile descriptive of a statistical insulin utilization for the patient (e.g., γ(τ)) (¶¶ [0075]-[0076]; Fig. 4; etc.). Applicant fails to disclose an estimate of a metabolic state may be derived from the metabolic measurement data, the metabolic treatment data, and a first profile descriptive of a statistical insulin utilization for the patient, or a first reference insulin infusion may be computed based on an estimate of a metabolic state, the metabolic treatment data and the claimed first profile. To the best of the examiner's understanding in view of the above-noted citations of Applicant's application as published, Applicant discloses the first reference insulin infusion is computed by the first control function based, at least in part, on a first profile descriptive of a statistical insulin utilization for the patient, and on an estimate of a metabolic state derived, at least in part, from the metabolic measurement data and the metabolic treatment data. Amendments commensurate in scope with this understanding would overcome at least the above-noted rejection(s).
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:
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) 10, 12-17, 19-20, 22-30 and 32-42 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over US 2009/0006061 A1 (previously cited, Thukral) in view of US 2010/0160740 A1 (previously cited, Cohen) and/or WO 2009/059187 A1 (previously cited, Magni); or alternatively, over Thukral in view of Cohen and/or Magni, and US 2008/0183060 A1 (previously cited, Steil).
Regarding claims 10, 12, 20, 28-30 and 38-39, Thukral teaches/suggests a system for diabetes control, the system comprising at least one processor; and a non-transitory computer-usable medium, or memory, having control logic stored thereon that is executable by the at least one processor (e.g., ¶ [0150] APTS program 500 running on a computer) to perform operations/a method including:
receiving input data including:
metabolic measurement data including a first glucose input reflective of glucose sample processing of a patient by a CGM sensor (Fig. 6, data from glucose sensor 604 is received via RF link 608);
metabolic disturbance data (e.g., ¶¶ [0169]-[0170]; Table 3; etc.);
metabolic treatment data including a first insulin delivery command, the first insulin delivery command representing a most recent command to an insulin delivery device relative to a time of the first glucose input (Fig. 6, data from insulin pump 606 is received via RF link 608);
coordinating distribution of the input data to one or more control functions (e.g., ¶¶ [0218]-[0223] where determining basal insulin recommendation requires certain input data, e.g., current glucose, indicating the algorithm is configured to acquire/distribute said input data for performing said function(s); ¶¶ [0141]-[0146] the 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, thereby indicating/suggesting necessary input data for said tasks is distributed to said functional units);
computing, in a first control function, a first reference insulin infusion based, at least in part, on an estimate of a metabolic state derived, at least in part, from the metabolic measurement data, the metabolic treatment data and a first profile descriptive of a statistical insulin utilization for the patient (¶ [0171] user-specific basal insulin profile, e.g., ALGO-defined profile or basal set) (¶¶ [0217]-[0223] determining a basal insulin recommendation based on, inter alia, a current glucose value, which is derived at least based on glucose measurements and past insulin delivery information (e.g., ¶ [0204]), and the pre-defined basal insulin determined from the basal set);
computing, in a second control function, a first residual insulin infusion based, at least in part, on an estimate of a glucose concentration and a second profile descriptive of the patient's behavior that is at least a function of time of day (¶¶ [0188]-[0193] reducing basal insulin in anticipation of exercise by adjusting a glucose set point and determining an associated glucose push in anticipation of exercise, which may be preprogrammed (e.g., known to the algorithm) as a function of time of day, as described in ¶¶ [0138]-[0140], and/or normalizing basal rate during exercise);
computing, in a third control function, a first meal-accommodation insulin infusion based on meal data (¶ [0145] computing insulin boli distribution for a meal event); and
determining a first total insulin infusion based on the first reference insulin infusion, the first residual insulin infusion, and the first meal-accommodation insulin infusion (Fig. 6; closed-loop bucket management block 630 receives basal and bolus information to determine and manage net insulin recommendation, as described in ¶ [0160]).
Thukral further discloses disturbance data or events, which includes meals (¶ [0134]), can be generated based on an algorithm (e.g., ¶ [0136]), and further discloses assessing a profile of meal behavior (i.e., third profile of the patient's meal behavior), such as a day-to-day pattern of meal activities, based on collected user data, including meal time range, meal bolus range, average bolus magnitude with respect to meal size, etc. (¶ [0111]), such that it would have been obvious to one of ordinary skill in the art at the time of the invention to modify the system of Thukral with computing a first meal-accommodation insulin infusion based in part on such a profile (i.e., a third profile of the patient's meal behavior) in order to enhance the knowledge of the anticipated physiological load which is used by algorithm to address therapy needs (Thukral, ¶ [0138]) without requiring manual entry of each event.
Alternatively/Additionally, Cohen teaches and/or suggests a method comprising, inter alia, assessing a second profile descriptive of patient behavior, such as exercise, as a function of time of day (¶ [0058] identifying a pattern of periodically occurring events, e.g., exercise); computing, in a second control function, a first residual insulin infusion based on a glucose concentration and the second profile (¶ [0060] based on the pattern and trend, taking proactive measures to adjust insulin; ¶ [0106] adjusting basal rate based on exercise, etc.); assessing a third profile of the patient's meal behavior (¶ [0058] identifying a pattern of events, such as meals, that occur each day and around the same time of day); and computing, in a third control function, a first meal-accommodation insulin infusion based on the third profile (¶ [0060] based on the pattern and trend, taking proactive measures to adjust insulin; ¶ [0106] a particular bolus type that can mitigate the undesired event or pattern may be recommended based on past data from the user; etc.). Magni similarly discloses a method comprising assessing a profile(s) of glucose disturbances from patient behavioral data in order to calculate an optimal insulin injection to safely regulate blood glucose (pg. 17, line 15 - pg. 18, line 26), disclosing such disturbances include at least meals and exercise (e.g., 22, lines 25-27).
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 computing the first residual insulin infusion based at least in part on a second profile descriptive of the patient's behavior as a function of time of day (e.g., assessed or inferred exercise events/disturbances as a function of time of day based on observed behavioral data) and computing the first meal-accommodation insulin infusion based on a third profile of the patient's meal behavior (e.g., assessed or inferred meal events/disturbances based on observed behavioral data) as taught/suggested by Cohen and/or Magni in order to enable taking proactive measures in delivering or recommending an insulin adjustment(s) (Cohen, ¶ [0060]) to provide more accurate treatment, to keep more stable glucose levels within a desired range, etc. (Cohen, ¶ [0064]); to algorithmically identify events (Thukral, ¶ [0136]; Magni, pg. 17, line 15 - pg. 18, line 26), such as exercise and meal events, to enhance the knowledge of the anticipated physiological load which is used by algorithm to address therapy needs (Thukral, ¶ [0138]) without requiring manual entry of each event; etc.
Thukral as modified further teaches and/or suggests commanding the insulin delivery device to deliver the determined first total insulin infusion via a second insulin delivery command (¶ [0021] Fig. 6 is a closed-loop system; ¶ [0051]; etc.), wherein the system is a personal device external to the insulin delivery device, the personal device comprising a display, an interface for wireless communication and an interface for cellular communication (e.g., ¶ [0150] smart phone), and commanding the insulin delivery device to deliver the determined first total insulin infusion comprises sending the second insulin delivery command to the insulin delivery device over a wireless communications channel via the interface (¶ [0068] system and insulin pump 606 communicate wirelessly, e.g., via an RF link). As "closed-loop control," by definition, indicates the system is automatically regulated without human interaction, one of ordinary skill in the art would at once envisage that, in such closed-loop systems, the total insulin infusion signal is a control signal configured to command the insulin delivery device to deliver insulin (i.e., without requiring any human interaction).
Alternatively/Additionally, Steil teaches and/or suggests a method comprising determining an insulin infusion signal by a device (control 12; e.g., ¶ [0058] controller 12 has its own housing or is included in a supplemental device) having a display and interface for wireless communication (¶ [0058] controller 12, or housing thereof, may comprise wireless (e.g., RF, IR, etc.) transmitters and receivers; a display; etc.); commanding a separate, external insulin delivery device (insulin delivery system 14) to deliver the insulin infusion signal via an insulin delivery command; and sending the second insulin delivery command to the insulin delivery device over a wireless communications channel (¶ [0054] controller 12 generates commands 22 that are communicated to insulin delivery system 14, which receives the commands 22 and infuses insulin 24 into body 20 in response to commands 22). It would have been obvious to one of ordinary skill in the art at the time of the invention to modify the system of Thukral with the personal device having interface for cellular communication (e.g., smart phone) to further comprise a display and an interface for wireless communication, and to further modify the method of Thukral with commanding the insulin delivery device to deliver the determined first total insulin infusion via a second insulin delivery command by sending the second insulin delivery command to the insulin delivery device over a wireless communication channel via the wireless communication interface as taught and/or suggested by Steil in order to automatically administer an optimized insulin delivery profile (Steil, ¶ [0011]), increasing patient convenience (Steil, ¶ [0059]), etc.
Regarding claims 13, 22, and 32, Thukral as modified teaches/suggests computing a first residual insulin infusion comprises managing, in the second control function, a blood glucose excursion not accounted for by the third control function (¶¶ [0217]-[0222] recommended basal insulin is determined based on a glucose set point, glucose push, etc., which are determined and/or adjusted in anticipation or, or during, exercise, as described in ¶¶ [0189]-[0192]).
Regarding claims 14, 23 and 33, Thukral as modified teaches/suggests estimating, in the third control function, a first glucose excursion from a target due to at least one of a meal or a response to a meal (e.g., ¶ [0183] insulin dose distribution is determined so as to best minimize a glucose rise due to a meal, and to bring the glucose to the target glucose level as quickly as possible with minimal undershoot); and estimating, based on the estimated first glucose excursion, a second glucose excursion from the target that is not due to the at least one of a meal or a response to a meal, wherein the first residual insulin infusion is computed based on the estimated second glucose excursion (¶ [0183] glucose predictor 626 used by the basal controller 628 as an action input does not account for glucose changes due to a meal; ¶ [0203] all feed-forward components, including meal-related boluses, are removed; ¶ [0219]; etc.).
Regarding claims 15, 24 and 34, Thukral as modified teaches/suggests the first reference insulin infusion comprises a suggested basal delivery (¶ [0211], ¶ [0221] "would be basal insulin" in a no disturbance/event scenario), wherein the first residual insulin infusion compensates the suggested basal delivery either upward to correct hyperglycemia or downward to reduce a likelihood of hypoglycemia (e.g., ¶¶ [0189]-[0192] where glucose set point, glucose push, etc., which are used to determine recommended insulin, as discussed above, elevates glucose in anticipation of exercise by increasing a glucose set point, or the expected glucose drop due to exercise is used to compute basal insulin needed (i.e., glucose push), as described in ¶¶ [0217]-[0222]).
Regarding claims 16-17, 25-26, 35-36, Thukral as modified teaches/suggests assessing at least one of the first profile (Thukral, ¶ [0171]), the second profile (Thurkal, ¶¶ [0138]-[0140]; Cohen, ¶ [0058]; Magni, Real-Time Closed-Loop Control), or the third profile (Cohen, ¶ [0058]; Magni, Real-Time Closed-Loop Control) and, subsequent to the assessing, receiving a second glucose input reflective of glucose sample processing by the CGM sensor; receiving the second insulin delivery command, the received second insulin delivery command representing a most recent command to the insulin delivery device relative to a time of the second glucose input; repeating the calculations with the new data to determine a second total insulin infusion (Thukral, ¶ [0152] acquiring the new sensor data and data for net insulin dispensed to an provide an updated insulin recommendation); and commanding the insulin delivery device to deliver the determined second total insulin infusion via a third insulin delivery command (Thukral, ¶ [0051]; Steil, ¶ [0054]; etc.).
Regarding claims 19, 27 and 37, Thukral as modified teaches and/or suggests assessing at least one of the first profile (Thukral, ¶ [0171]), the second profile (Thurkal, ¶¶ [0138]-[0140]; Cohen, ¶ [0058]; Magni, Real-Time Closed-Loop Control), or the third profile (Cohen, ¶ [0058]; Magni, Real-Time Closed-Loop Control). Thukral further discloses assessing changes in patient lifestyle (e.g., ¶ [0113]), suggesting the behavior profile(s) are, or at least should be, assessed at least periodically, but does not expressly teach assessing the first profile, the second profile, and the third profile at least monthly. 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 assessing the profiles at least monthly because Applicant has not disclosed that the claimed arrangement provides an advantage, is used for a particular purpose, or solves a stated problem. Rather, Applicant expressly discloses behavior profiles may be assess more or less frequency as desired or required (pg. 23, lines 8-9). 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 assessing the profiles sufficiently frequently to monitor changes in patient behavior/lifestyle as taught and/or suggested by Thukral because either arrangement facilitates evaluating a therapy (Thukral, ¶ [0130]), increasing accuracy of proactive insulin delivery/compensation (Cohen, ¶ 0064).
Alternatively/Additionally, 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 assessing the first, second, and third profile at least monthly 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 provide a useful period of interest for assessing profile(s)/pattern(s) (Cohen, ¶ [0057]) ensuring said profiles are and/or remain up-to-date, accurate, etc.
Regarding claims 40-42, Thukral as modified discloses/suggests the estimate of the glucose concentration is based, at least in part, on an estimate of a metabolic state offset by an estimate of a glucose excursion due to a meal (¶ [0193] the glucose push vector is updated due to an ingestion of fast-acting carbohydrates if so indicated by the patient on the user interface 512).
Claim(s) 18 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over the combination(s) of references applied to claim(s) 10 above, and further in view of US 2007/0173761 A1 (previously cited, Kanderian).
Regarding claim 18, Thukral as modified teaches/suggests the limitations of claim 10, as discussed above, but does not expressly disclose the first residual insulin infusion is computed via at least one of: a model predictive control (MPC) technique; a dynamic model of interactions of a glucose target and residual insulin; a linear quadratic Gaussian (LQG) control methodology; a learning model predictive control (LMPC) methodology; and a proportional-integral-derivative (PID) control methodology.
Kanderian teaches/suggests a comparable method comprising computing a residual insulin for compensating an insulin value upward or downward to reduce a likelihood of hypoglycemia based on, e.g., patient behavior, such as exercise, wherein the residual insulin is computed via a model predictive control (MPC) technique and/or a proportional-integral-derivative (PID) control methodology (¶ [0300] a MPC feature assists a PID controller to use the supplemental information, such as exercise, to anticipate changes in glucose concentration and modify the output commands accordingly).
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 residual insulin infusion being computed via at least one a MPC technique and/or a PID control methodology as taught/suggested by Kanderian in order to facilitate compensating/adjusting a recommended/delivered insulin amount in anticipation of an expected and/or typical event, e.g., exercise (Kanderian, ¶ [0300]) and/or as a simple substitution of one known algorithm/control method for calculating a recommended insulin amount for another to yield no more than predictable results. See MPEP 2143(I)(B).
Response to Arguments
Applicant's arguments have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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.
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/Meredith Weare/Primary Examiner, Art Unit 3791
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