DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Claims 14, 15, 17-21, 24 and 26 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected method, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 5/4/26.
Claim Rejections - 35 USC § 112
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 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.
Claims 1-5 and 7-12 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the limitation "the glucose compart" in line 17. There is insufficient antecedent basis for this limitation in the claim.
Claim 1 recites the limitation "the initial rise, maximum rate, or fall" in line 19. There is insufficient antecedent basis for each of these limitations in the claim.
Claim 1 recites the limitation "the meal" in lines 19-20. There is insufficient antecedent basis for this limitation in the claim.
Claim 9 recites the limitation "the fixed moving time window" in lines 2-3. There is insufficient antecedent basis for this limitation in the claim.
Claim 11 recites the limitation "the fixed time window" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 12 recites the limitation "the subject’s caregiver" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 12 recites the limitation "the time interval of interest" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Dependent claims inherit the deficiencies of the claims from which they depend.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-3, 5 and 7-12 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hayter et al. (US 2010/0298685 A1), hereafter “Hayter”.
As to claim 1, Hayter discloses a method of predicting a blood glucose level of a subject (purpose of handheld controller 12, which contains computer components such as processor 14 and memory 16, is to process sensor data in real-time and provide a prediction of future glucose levels; see para 0058), the method comprising:
(1) receiving and storing a plurality of historical data records representing one or more predicting factors of the subject and a corresponding blood glucose level of the subject for a past period of time (medical device 30, 32 for receiving a plurality of physiological and supplied historical information from the user; Fig. 2, para 0051, 0065, 0069);
(2) inputting into a data processing engine the plurality of historical data records (system receives information regarding external influences and/or various physiological mechanisms associated with the user; see para 0068, 0069), and determining a set of parameters corresponding to the historical data records (optimal control parameters 65 generated from historical data; para 0069);
(3) inputting into the data processing engine the set of parameters and a current data record representing one or more predicting factors of the subject, thereby predicting a blood glucose level of the subject corresponding to the current data record (predictive model based control systems for estimating current glucose based on inputted user data and predicting future glucose values; see para 0057, 0058, 0076, 0078);
(4) outputting information indicative of the predicted blood glucose level corresponding to the current data record (para 0081-0083 teach various glucose control information intended to be outputted to the user after analysis of user data; also see para 0033 mentioning displaying information representative of future insulin delivery); and
(5) administering a dose to the subject via an insulin pump adjusted using an adaptive model predictive bolus (MPB) algorithm upon receiving the information indicative of the predicted blood glucose level (see at least para 0042 and 0052-0058 which disclose closed-loop control and administering doses to a subject based on sensor feedback, also see para 0013, 0017, 0057, 0065, 0068, 0071-0075 disclosing administering to a subject based on adaptive model predictive bolus (MPB)), wherein execution of the MPB algorithm comprises applying a metabolic model comprising one or more of the following parameters: insulin PK/PD rate constants, volume of the glucose compartment, a glucose effectiveness rate constant, insulin sensitivity normalized to insulin clearance, and parameters characterizing the initial rise, maximum rate, or fall in glucose appearance following the meal (see at least para 0013, 0017, 0070, describing monitoring of levels of glucose after a meal including characterizing safe levels).
As to claim 2, Hayter discloses the method of claim 1, wherein the blood glucose level is nighttime nadir glucose (NNG), morning fasting glucose (MFG), 2-hour postprandial glucose (PPG2HR), 5-hour postprandial glucose (PPG5HR), or 5 hour nadir postprandial glucose (NPP5HR) (see para 0082 disclosing a proactive “glycemia exposure avoidance” system that predicts and attempts to regular post-prandial glucose 1 to 2 hours after a meal (PPG2HR)).
As to claim 3, Hayter discloses the method of claim 1, wherein the historical data records representing one or more predicting factors comprise a data record of a level of physical activity (see para 0066, 0074, 0075 mentioning exercise level).
As to claim 5, Hayter discloses the method of claim 1, wherein the historical data records representing one or more predicting factors comprise a data record of the fat content of a meal and/or the carbohydrate content of a meal (see para 0071, 0073).
As to claim 7, Hayter discloses the method of claim 1, wherein the historical data records representing one or more predicting factors comprise a data record of a rate of change of a blood glucose level over a specific time interval (continuous glucose value readings are used to determine rate of change of the user’s blood glucose level; para 0090).
As to claim 8, Hayter discloses the method of claim 1, wherein the historical data records representing one or more predicting factors comprise historical data records that are observed over a prior window of time (see para 0023-0027, 0030, 0117, 0123 disclosing taking data measurements over a variety of time windows including which can be considered a “prior” window of time).
As to claim 9, Hayter discloses method of claim 8, wherein the data processing engine determines the parameters based on historical data records that are received within the fixed moving time window (as noted in the above rejections under 35 USC 112, these limitations are unclear however see para 0023-0027, 0030, 0117, 0123 disclosing taking data measurements over a variety of time windows).
As to claim 10, Hayter discloses the method of claim 8, wherein during the step of determining the parameters, the data processing engine gives less weight to historical data records that were received at points further in the past with a forgetting factor configured to define how long in the past before weight becomes equal to e-1 (see para 0132 disclosing adaptive methods to continuously changing metrics including the use of Exponential Forgetting).
As to claim 11, Hayter discloses the method of claim 9, wherein the fixed moving time window is 1 month, 3 months, 6 months, or 12 months (para 0137 and 0138 discussing a 3 month fixed time window).
As to claim 12, Hayter discloses the method of claim 1, wherein the method further comprises: Application No.FiledPage5of7sending an alert to the subject or a caregiver of the subject when the blood glucose level of the subject for a time interval of interest is outside a predetermined range (para 0115 disclosing an example of an alert that involves informing the user to reduce the basal rate of their insulin pump; also see para 0010, 0026, 0027).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102 of this title, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hayter in view of Knobbe et al. (US 2002/0099282 A1, cited previously and hereafter 'Knobbe').
As to claim 4, Hayter discloses the method of claim 3 as described above, but is silent to wherein the level of physical activity is measured by a continuous activity monitor.
Knobba disclose using a continuous activity monitor to acquire physical activity level data (see para 0018 describing a closed-loop system for continuously regulating cardiovascular functions using sensors to detect physical activity; also see para 0057, 0065).
It would have been obvious to one having ordinary skill in the art to modify Hayter in view of Knobbe such that the level of physical activity is measured by a continuous activity monitor. One would have been motivated to do so in order to provide closed-loop feedback using continuously measured activity levels in order to provide an optimal treatment to a subject (see para 0018, 0057, 0065 of Knobbe).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to James D Ponton whose telephone number is (571)272-1001. The examiner can normally be reached M-F 9am-5pm.
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/James D Ponton/Primary Examiner, Art Unit 3783
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