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 .
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, 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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 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.
Claim(s) 1, 2, 3, 8-11, 13, 15, and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2010/0298764 (“Yodfat ‘764”) in view of U.S. Publication No. 2012/0277667 (“Yodfat ‘667), U.S. Patent No. 6,254,586 (“Mann”), U.S. Publication No. 2016/0339175 (“Yan”), and U.S. Publication No. 2014/0066886 (“Roy”).
Regarding Claim 1, Yodfat ‘764 discloses an integrated, closed-loop artificial pancreas (Par. 1, 4, 36), comprising:
A detection module (1006), configured to continuously detect a real-time blood glucose level (Abstract; Par. 5, 36 , 46, 64);
A program module (1007), connected to the detection module (see Fig. 3A), configured to monitor and control insulin dosing by a user (Par. 1, 36); and
An infusion module (1005), connected to the program module (see Fig. 3A), comprising an infusion tube (6) which is used as an insulin infusion channel (see Fig. 6A, 7 – at 65; Par. 118), and wherein a tube wall of the infusion tube (see the outer wall which defines 75 and the inner wall which defines 65 – Fig. 7) can be used in sensing analyte levels in association with the detection module (see Fig. 6A; Par. 118) with the infusion module infuses insulin required according to a data of the current insulin infusion dose (Par. 118; Par. 1, 36);
Wherein the infusion tube comprises an inner layer tube (i.e. the tubing defining 65 – see Fig. 7) and at least one outer layer tube (i.e. the tubing defining 75 – see Fig. 7), at wherein the at least one outer layer tube is disposed outside and continuously surrounds the inner layer tube (see Fig. 6A), with the inner layer tube being used for insulin infusion (see Fig. 6A; Par. 118) and the outer tube is used in association with analyte sensing (see Fig. 6A; Par. 118), the outer layer tube forming an outermost layer tube (see Fig. 6A, Fig. 7), such that the outermost tube layer surrounds and covers, in whole, the sampling space defined between the inner layer tube and the outer layer tube (see Fig. 6A, 7), the material of the at least one outer layer tube comprising a permeable or semi-permeable membrane (Par. 117, 118, 70) which allows selective entry of analyte molecules, e.g. glucose to assist in sampling.
Yodfat ‘’764 discloses the invention substantially as claimed except that the detection module comprises at least two electrodes located, locally, within the sampling space defined between the inner layer tube and the outer layer tube. Rather, Yodfat discloses that the sampling space is used to convey the sampled analytes remotely to the sensor arrangement in the detection module. However, such configurations are well-known in the art. For example, Yodfat ‘667 discloses a related artificial pancreas (Par. 151) which like Yodfat ‘764 includes an invasive cannula/tube (e.g. 305b) which is used for infusing insulin (Par. 170) via an inner channel (355) defined by an inner layer tube (Fig. 34c) and an outer channel (356) defined between the inner layer tube and an outer layer (see Fig. 34c), the cannula including an analyte sensing arrangement configured to locally sense the analyte level within the sampling space directly (Par. 179, 180) and comprising at least two electrodes, wherein the electrodes are provided on/in a tube wall of the infusion tube, wherein at least one of the electrodes is located on an outer wall surface of the inner layer tube, located between the outer wall surface of the inner layer tube and an outermost tube of the at least one outer layer tube (see Figs. 34 – Par. 228). It would have been obvious for one having ordinary skill in the art at the time the invention was made to configure the sampling space of the cannula of Yodfat ‘764 to include sampling electrodes therein, as disclosed by Yodfat ‘667, in order to allow for the analyte to measured directly in the cannula thereby eliminating the need to remotely convey the analyte through the cannula thereby ensuring that the sensing arrangement can be exposed to a maximal level of bodily fluids for sampling with the semi-permeable outer layer of Yodfat ‘764 allowing for selective passage of the analyte into the sampling space, filtering out other agents or fluids which might otherwise obscure the sensing electrode arrangement. The prior art of Mann establishes a reasonable expectation of success for implementing arrangements wherein the open window of Yodfat ‘667 are replaced with a semi-permeable membrane for permitting the entry of an analyte into an interior sampling space of such a local, electrode sampling probe (Fig. 7, 12; Col 11).
Yodfat ‘764 discloses the invention substantially as claimed except that except for the particulars of the program module by which the system calculates and tracks the insulin dosing. However, Yodfat ‘667 discloses a program module (130), connected to the detection module, configured to obtain an insulin dose infused per day by a user (Par. 205) and a total daily dose algorithm (see 1002) and a current infusion algorithm (Par. 4 – i.e. the combination of the programmed basal rate in addition to any bolus infusions). It would have been obvious for one having ordinary skill in the art at the time the invention was made to configure the program module of Yodfat ‘764 to track insulin dose infused per day by a user and provide a total daily dose algorithm alongside a current infusion algorithm, as disclosed by Yodfat ‘667, in order to allow for accurate insulin management to ensure efficacious and safe results.
Yodfat ‘764, as modified, discloses the invention substantially as claimed except that that total daily dose algorithm is used to calculate the total daily dose according to the insulin dose infused per day by users. Rather Yodfat ‘667 merely describes a “daily basal profile” without particularly disclosing how the profile algorithm is created. However, Yan discloses that in a closed-loop system a total daily dose (i.e. the daily dose for current day used to determine the proper basal delivery profile – Par. 20) can be dynamically calculated using an algorithm which operates in accordance with the insulin dose infused per day in prior history (Par. 66) importing this value into the predictive algorithms. It would have been obvious for one having ordinary skill in the art at the time the invention was made to calculate the total daily dose in the invention of Yodfat ‘764 as used to determine the proper basal rate for a given day using prior insulin dose infused per day data, as disclosed by Yan, in order to allow for past insulin usage to be accounted for to determine trends which can be used to create a more accurate daily basal profile.
Yodfat ‘764, in view of Yan, discloses the invention substantially as claimed except that that the insulin dose is considered “over a plurality of previous days” using “a weighted average with a sliding data frame of the insulin dose infused per day by the user, wherein the insulin doses infused per day by the user from the previous days are assigned different weights”. However, Roy discloses a related closed-loop artificial pancreas system which uses a weighted history of past insulin doses to compensate for insulin delivery delay and insulin clearance, wherein the most recent data is provided with more weight, i.e. a sliding data frame, to thereby permit the weighted history to be considered in the PID to yield a compensated control output. It would have been obvious for one having ordinary skill in the art at the time the invention was made to configure the algorithm of Yodfat ‘764 to consider the insulin dose infused over a period of previous days as a weighted sliding scale with more recent data being provided with more weight than earlier data, as disclosed by Roy, in order to evaluate for trends in insulin delivery delay and clearance pursuant to changes in a patient’s routine and physiology over time with more recent data being more closely predictive of current predictions.
Regarding Claim 2, Yodfat ‘764, as modified in view of Yodfat ‘667, provides for at least another one of the electrodes to be located on an outer surface of the tube wall or inside the tube wall (Par. 179; see Fig. 34 – Yodfat ‘667).
Regarding Claim 3, Yodfat ‘764, as modified in view of Yodfat ‘667, discloses the tube wall to be provided with electrode leads electrically connecting the electrodes and processing hardware (Par. 228 – Yodfat ‘667).
Regarding Claim 8, Yodfat ‘764, as modified by Yodfat ‘667, provides that the electrodes include at least one working electrode and at least one auxiliary electrode (Par. 171 – Yodfat ‘667).
Regarding Claim 9, Yodfat ‘764, as modified by Yodfat ‘667, provides that the plurality of the electrodes form one or more electrode combinations, each of the electrode combinations comprises the working electrode and the auxiliary electrode (Par. 171 – Yodfat ‘667), the detection module choosing the one or more electrode combinations to detect glucose data in body fluid.
Regarding Claim 10, Yodfat ‘764, as modified by Yodfat ‘667, discloses the program module includes a manual input interface (40 – Yodfat ‘667) or an automatic detection sub-module (Par. 57 – Yodfat ‘667), and the method for the program module to obtain the insulin dose infused per day by users comprises: the insulin dose infused per day by users is manually input into the program module through the manual input interface or the insulin dose infused per day by users is automatically detected, stored and calculated by the automatic detection sub-module (Par. 57, 159 – Yodfat ‘667).
Regarding Claim 11, Yodfat ‘764, as modified by Yodfat ‘667 and Yan, discloses the insulin dose infused per day by users comprises a total amount of daily infusion dose data or bolus and basal data infused in different time periods, or temporary basal data and correction bolus data, or infusion data after different events (Par. 205 – Yodfat ‘667).
Regarding Claim 13, Yodfat ‘764, as modified by Yan, discloses variable factors of the total daily dose algorithm include one or more of [user's physical activity status, physiological status, psychological status, and meal status (Par. 3, 21, 57 – Yan).
Regarding Claim 15, Yodfat ‘764, as modified by Yan, discloses physical activity status includes general body stretching, exercise, or sleep, and the physical activity status is one of the variable factors of the total daily dose algorithm or the current insulin infusion algorithm (Par. 3, 21, 57 – Yan).
Regarding Claim 18, Yodfat discloses the detection module, the program module and the infusion module are connected together configured to form a single structure which is attached on only one position on a skin (see Fig. 2, 3).
Claim(s) 12 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2010/0298764 (“Yodfat ‘764”) in view of U.S. Publication No. 2012/0277667 (“Yodfat ‘667), U.S. Patent No. 6,254,586 (“Mann”), U.S. Publication No. 2016/0339175 (“Yan”), and U.S. Publication No. 2014/0066886 (“Roy”) as applied above, and further in view of U.S. Publication No. 2008/0234663 (“Yodfat 3”).
Regarding Claim 12, Yodfat ‘764, as modified by Yodfat ‘667 and Yan, discloses the invention substantially as claimed except that the total daily dose is obtained by calculating the total amount of the daily infusion dose data in the previous two or more days according to the total daily dose algorithm, and the total daily dose is an average or median of the insulin dose infused per day by users, and the total daily dose is one variable factor of the current insulin infusion algorithm. Rather, Yan only explicitly contemplates relying upon the previous day daily infusion dose data (Par. 20, 66). However, Yodfat 3 discloses that average total daily dose may be considered using up to a week’s worth of data (Par. 93). It would have been obvious for one having ordinary skill in the art at the time the invention was made to utilize two or more days daily infusion dose data in determining the proper total daily dose by considering the average over that extended time period, as disclosed by Yodfat 3, in order to increase sample size and decrease variability due to a single day of higher or lower than normal insulin usage.
Regarding Claim 14, Yodfat ‘764, as modified by Yodfat ‘667 and Yan, discloses the invention substantially as claimed except that the physiological status includes one or more factors of weight, gender, age, disease, and menstrual period. However, Yodfat 3 discloses that corrective factors can include menstrual cycle and disease (re: “stress and fever”) to better adapt the predictive capabilities of the models. It would have been obvious for one having ordinary skill in the art at the time the invention was made to incorporate various physiological status factors such as menstrual cycle and disease status into the algorithms of modified Yodfat ‘764, as disclosed by Yodfat 3, thereby increasing accuracy of the algorithms by controlling for known factors.
Claim(s) 16 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2010/0298764 (“Yodfat ‘764”) in view of U.S. Publication No. 2012/0277667 (“Yodfat ‘667), U.S. Patent No. 6,254,586 (“Mann”), U.S. Publication No. 2016/0339175 (“Yan”), and U.S. Publication No. 2014/0066886 (“Roy”) as applied above, and further in view of WO 2018/120104 (“Yang”).
Regarding Claims 16 and 17, Yodfat ‘764, as modified, discloses the invention substantially as claimed except that that the device comprises a motion sensor, wherein the motion sensor which is provided in the detection module, the program module or the infusion module, is used to automatically sense the user's physical activity status. Rather, in view of Yan the system is understood to require self-reporting of physical activity. However, Yang discloses that such closed-loop artificial pancreas devices may comprise motion sensors, which may comprise a gyroscope of a three-axis accelerometer, which automatically determine and track physical activity in order to update insulin requirements (see Summary of Invention). It would have been obvious for one having ordinary skill in the art at the time the invention was made to include a motion sensor as part of the detection module of Yodfat ‘764, as disclosed by Yang, in order to allow physical activity data to be automatically gathered for the algorithms thereby eliminating the need for users to self-report.
Response to Arguments
Applicant’s arguments with respect to the claim(s) 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 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM R CARPENTER whose telephone number is (571)270-3637. The examiner can normally be reached Mon. to Thus. - 7:00AM to 5:00PM (EST/EDT).
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/WILLIAM R CARPENTER/Primary Examiner, Art Unit 3783
06/01/2026
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