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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 17 November 2025 has been entered.
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 35 U.S.C. 112 (pre-AIA ), 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) 1-6 and dependents is/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.
Regarding Claim 1, Applicant recites the limitation “the outer wall surface of the inner layer tube… the outer layer tubes…” [emphasis added]. However, this limitation creates confusion inasmuch as no “inner layer tube” or “outer layer tubes” or “outer wall surface” have been previously introduced and therefore use of the definite article “the” is improper. “Inner layer tube” and “outer layer tubes” are later introduced in dependent Claim 4 using the indefinite article “a”, but with additional limitations (see “outer layer tubes are disposed outside the inner layer tube, and the inner layer tube is used for insulin infusion”). It is unclear if these are the same “tubes” or different tubes and if any or all of these limitations should also be inferred with respect to the “tubes” recited in Claim 1 – e.g. are the tubes necessarily part of the “infusion tube” and are the tubes layered with respect to one another such that the outer layer tube(s) are disposed “outside” the inner layer tube.
Regarding Claim 1, Applicant recites the limitation “the electrodes are provided on/in a tube wall of the infusion tube…” [emphasis added] in combination with the new limitation “the electrode located on the outer wall surface of the inner layer tube is covered in whole by the outer layer tubes…” Here the limitations particularly locating the electrode outer to the inner layer tube and inner to the outer layer tube would appear to be contradictory with the “on” alternative limitation as understood in light of the specification.
Regarding Claim 1, Applicant recites the limitation “when the electrode located on the outer wall surface…” However, the use of the conditional “when” creates confusion as it is unclear if Applicant is positively requiring the electrode to be located at the specified location OR is merely limiting a possible location, but where the claim could be satisfied by other locations as well.
Regarding Claim 2, Applicant recites the limitation “wherein the electrodes are located on an outer surface of the tube wall or inside the tube wall”. However, the alternative (re: “on an outer surface of the tube wall”) would appear to contradict the new limitations of Claim 1 which appear to require the electrodes to be disposed between inner and outer layer, where “an outer surface of the tube wall” (in light of the specification) would appear to be understood as an exterior surface of the outer layer. Although the alternative (re: “inside the tube wall”) would appear to be compatible with the new limitations of Claim 1, this limitation would not appear to further limit Claim 1 (as understood) and the inclusion of the impossible alternative renders the claim indefinite.
Regarding Claim 3, Applicant recites the limitation “the electrodes are located on a subcutaneous part of the outer surface of the tube wall”, which would appear to contradict Claim 1 as currently amended. Because this case is now positively recited, and not presented as a mere impossible alternative (like in Claims 1 or 2), this claim is unexaminable because it is unclear how the electrode can simultaneously be covered by the outer layer AND disposed on an outer surface of the tube wall.
Regarding Claim 4, as discussed above, this claim includes subject matter which would appear to have been previously introduced in Claim 1 (albeit using the definite articles “the”), but uses the indefinite article “a” implying that these are different structures.
Regarding Claim 5, Applicant recites “at least one of the electrodes is provided between an outer wall surface of the inner layer tube…” However, this limitation, introduces “an outer wall surface” using the indefinite article “an”, when Claim 1 previously recites limitations toward “the outer wall surface”. Therefore there is confusion as to whether this is the same “outer wall surface”, particularly because Claim 1 already appears to require ALL of the electrodes to be provided between the outer wall surface of the inner layer and outer layer tubes.
Regarding Claim 6, Applicant recites limitations “configured to be entirely exposed in subcutaneous tissue fluid, or covered in whole or in part by the outer layer tubes”. Limitations which appear to contradict (through the inclusive of the alternative cases) limitations in Claim 1 which require the electrodes to be covered, in whole, by the outer layer tubes.
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, 4-6, 8-11, 13, 15, and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2012/0277667 (“Yodfat”) in view of U.S. Publication No. 2016/0339175 (“Yan”), U.S. Publication No. 2014/0066886 (“Roy”), and U.S. Patent No. 6,254,586 (“Mann”).
Regarding Claim 1, Yodfat discloses an integrated, closed-loop (Par. 151) artificial pancreas, comprising:
a detection module (e.g. 1777), configured to continuously detect a real-time blood glucose level (Par. 159), comprising at least two electrodes (321, 322, 323);
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); and
an infusion module (1888), connected to the program module, comprising an infusion tube (300) which is used as an insulin infusion channel (Par. 170), wherein the detecting electrodes are provided on/in a tube wall of the infusion tube (see e.g. Fig. 6B – see also Par. 179, 180; Figs. 9, 12, 20A, 25B, 32 detailing various arrangements of the electrodes in/on the tubing wall), and the infusion module infuses insulin required according to a data of the current insulin infusion dose (Par. 159), said current insulin infusion dose being a product of at least the blood glucose detected (Par. 159).
Yodfat 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 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 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, 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 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.
In some embodiments Yodfat discloses that the infusion tube may comprise an inner layer tube and at least one outer layer tubes, with the outer layer tubes being disposed outside the inner layer tube such that the electrode lies on an outer wall surface of the inner layer tube and below the outer layer tube (see Figs. 34).
Yodfat discloses the invention substantially as claimed except that the electrode is covered in whole by the outer layer tubes with a material of the outer layer tubes being a permeable or semi-permeable membrane. Rather, Yodfat discloses that the system only partially covers the electrode and with outer layer utilizing windows (36) to permit the passage of the fluids/analytes past the outer layer to reach the electrodes (Par. 228). However, Mann discloses a related electrode sensor arrangement (18, 20) wherein the electrode is provided between an inner layer and an outer layer (Fig. 7; Fig. 12) with the outer layer covering the electrode, wherein instead of open windows (22, Fig. 7) the outer layer may comprise a membrane material (23) which is permeable to the agent (re: semi-permeable) to permit passage of the agent/analyte/fluid of interest through the outer layer to the electrode, wherein the because of the inclusion of the semi-permeable membrane the electrode is covered in whole by the outer layer (see Fig. 12; Col. 11). It would have been obvious for one having ordinary skill in the art at the time the invention was made to extend the outer layer of modified Yodfat to include as a part thereof a material formed of a semi-permeable membrane covering the window such that the outer layer wholly covers the electrode, as disclosed by Mann, in order to ensure that only the fluid containing the agent of interest is able to enter the sensing area for monitoring by the electrode, thereby filtering out agents and fluids that might disrupt or obscure the sensing electrode.
Regarding Claim 2, Yodfat discloses the electrodes may be located on an outer surface of the tube wall or inside the tube wall (Par. 179; see Fig. 34).
Regarding Claim, 4, Yodfat discloses the infusion tube includes an inner layer tube and at least one outer layer tubes, and the outer layer tubes are disposed outside the inner layer tube, and the inner layer tube is used for insulin infusion (see e.g. Figs. 34).
Regarding Claim 5, Yodfat discloses at least one of the electrodes is provided between an outer wall surface of the inner layer tube and an outermost tube of the outer layer tubes (see e.g. Figs. 34).
Regarding Claim 6, Yodfat discloses the electrode provided between the outer wall surface of the inner layer tube and the outermost tube is located on the outer wall surface of the inner layer tube and is configured to be entirely exposed in subcutaneous tissue fluid or covered in whole or in part by the outer layer tubes (see Figs. 34).
Regarding Claim 8, Yodfat discloses the electrodes include at least one working electrode and at least one auxiliary electrode (Par. 171).
Regarding Claim 9, Yodfat discloses 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), the detection module choosing the one or more electrode combinations to detect glucose data in body fluid.
Regarding Claim 10, Yodfat discloses the program module includes a manual input interface (40) or an automatic detection sub-module (Par. 57), 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).
Regarding Claim 11, Yodfat, as modified by 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).
Regarding Claim 13, Yodfat, 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, 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. 3).
Claim(s) 12 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Publication No. 2012/0277667 (“Yodfat”) in view of U.S. Publication No. 2016/0339175 (“Yan”), U.S. Publication No. 2014/0066886 (“Roy”), and U.S. Patent No. 6,254,586 (“Mann”) as applied above, and further in view of U.S. Publication No. 2008/0234663 (“Yodfat 3”).
Regarding Claim 12, Yodfat, as modified by 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, as modified by 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, 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. 2012/0277667 (“Yodfat”) in view of U.S. Publication No. 2016/0339175 (“Yan”), U.S. Publication No. 2014/0066886 (“Roy”), and U.S. Patent No. 6,254,586 (“Mann”) as applied above, and further in view of WO 2018/120104 (“Yang”).
Regarding Claims 16 and 17, Yodfat, 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, 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
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/WILLIAM R CARPENTER/Primary Examiner, Art Unit 3783 01/28/2026