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 .
Response to Amendment
The amendment filed on 11/21/2025 has been entered. Claims 1-3 and 6-13 are pending in the application. Claims 4-5 are cancelled. The amendments to the claims overcome each and every objection and 112(b) rejection previously set forth in the Non-Final Office Action mailed on 10/1/2025.
Claim Objections
Claims 1 and 12 are objected to because of the following informalities:
-Claim 1, line 14: please correct “the plurality” to “a plurality”
-Claim 12, line 3: please correct “detection modules” to “detection module”
-Claim 12, line 3: please correct “and” to “or”
-Claim 12, line 6: please correct “and” to “or”
Appropriate correction is required.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 1-3, 6-8, and 10-13 are rejected under 35 U.S.C. 103 as being unpatentable over Yang (CN 108261591 A, see copy previously filed on 2/22/2023 and translation filed with the Office Action of 10/1/2025 for citations; hereinafter referred to as "Yang '591") in view of Grosman et al. (US 2019/0321553 A1; hereinafter referred to as "Grosman") and further in view of Yang (CN 108261585 A, see copy previously filed on 2/22/2023 and translation filed with the Office Action of 10/1/2025 for citations; hereinafter referred to as "Yang '585").
Regarding claim 1, Yang '591 discloses a closed-loop artificial pancreas insulin infusion control system (see Figs. 1-2, page 1 of translation, "the present invention relates to artificial pancreas, in particular to a closed-loop algorithm for controlling insulin infusion"), comprising:
a detection module (glucose sensor 1) configured to continuously detect a real-time blood glucose level (see page 2 of translation, "a glucose sensor 1 continuously measuring blood glucose values at discrete time intervals");
a program module (controller 302), connected to the detection module (glucose sensor 1), is configured to obtain an insulin dose infused per day by users, and is also imported into a current insulin infusion algorithm (see page 2 of translation, "the glucose sensor 1 measures the blood glucose level of the patient and sends the blood glucose information to the controller 302 to automatically implement the steps shown in Fig. 4 to obtain the required insulin infusion amount and generate a corresponding infusion instruction; see page 4 of translation which shows that daily insulin demand and standard daily basal insulin value are obtained for the user to be used in the algorithm for determining the insulin dose), wherein,
according to the real-time blood glucose level detected or the insulin dose infused per day by the users, the current insulin infusion algorithm is used to calculate a current insulin infusion dose (see page 2 of translation, "the glucose sensor 1 measures the blood glucose level of the patient and sends the blood glucose information to the controller 302 to automatically implement the steps shown in Fig. 4 to obtain the required insulin infusion amount and generate a corresponding infusion instruction; see page 4 of translation which shows that daily insulin demand and standard daily basal insulin value are obtained for the user to be used in the algorithm for determining the insulin dose);
an infusion module (insulin pump 2), connected to and controlled by the program module (controller 302), is configured to infuse insulin required according to the current insulin infusion dose (see page 2 of translation, "the glucose sensor 1 measures the blood glucose level of the patient and sends the blood glucose information to the controller 302 to automatically implement the steps shown in Fig. 4 to obtain the required insulin infusion amount and generate a corresponding infusion instruction. The instruction is sent by the controller 302 to the processor 202 of the insulin pump 2, and insulin infusion is performed on the patient to realize closed-loop control of the artificial pancreas.").
However, Yang '591 fails to expressly state the program module is also imported into a total daily dose algorithm, wherein, according to the insulin dose infused per day by the users, the total daily dose algorithm is used to calculate a total daily dose by calculating the total amount of the daily infusion dose data in two or more previous days according to the total daily dose algorithm, and the total daily dose is an average or a median of the insulin dose infused per day by the users, wherein the average includes an arithmetic average or a weighted average; wherein the total daily dose is one of the plurality of variable factors of the current insulin infusion algorithm; and the system further comprises a motion sensor configured to sense a physical activity status of the users which is sent to the program module and is one of a plurality of variable factors of the total daily dose algorithm or the current insulin infusion algorithm.
Grosman teaches a closed-loop artificial pancreas insulin infusion control system (see Figs. 1 and 4-5, par. [0010]) comprising a program module imported into a total daily dose algorithm, wherein, according to the insulin dose infused per day by the users, the total daily dose algorithm is used to calculate a total daily dose (see par. [0010], [0046], [0114], and [0128]) by calculating the total amount of the daily infusion dose data in two or more previous days according to the total daily dose algorithm (see Fig. 4, par. [0114], [0125], [0128]), and the total daily dose is an average or a median of the insulin dose infused per day by the users (see par. [0128]), wherein the average includes an arithmetic average or a weighted average (see par. [0128]-[0129]); wherein the total daily dose is one of the plurality of variable factors of the current insulin infusion algorithm (see Fig. 5, par. [0114], [0125], [0128], [0137]).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the control system of Yang '591 to include that the program module is also imported into a total daily dose algorithm, wherein, according to the insulin dose infused per day by the users, the total daily dose algorithm is used to calculate a total daily dose by calculating the total amount of the daily infusion dose data in two or more previous days according to the total daily dose algorithm, and the total daily dose is an average or a median of the insulin dose infused per day by the users, wherein the average includes an arithmetic average or a weighted average; wherein the total daily dose is one of the plurality of variable factors of the current insulin infusion algorithm, as taught by Grosman, in order to further update and refine the parameters of the control algorithms for determining the infusion parameters (see Grosman par. [0053] and [0063]).
However, modified Yang '591 still fails to expressly state that the system further comprises a motion sensor configured to sense a physical activity status of the users which is sent to the program module and is one of a plurality of variable factors of the total daily dose algorithm or the current insulin infusion algorithm.
Yang '585 teaches a closed-loop artificial pancreas insulin infusion control system (see Figs. 1 and 4, page 1 of translation, "a system and method for implementing closed-loop control in an artificial pancreas") comprising a motion sensor (motion sensor 101) configured to sense a physical activity status of the users which is sent to the program module (processor 302) and is one of a plurality of variable factors of the total daily dose algorithm or the current insulin infusion algorithm (see page 4 of translation, "a motion sensor 101 is provided for detecting the patient's activity level and sending a corresponding signal and adjusts the relevant algorithm based in part on the signal. The processor 302 further processes the data to determine whether the patch pump 2 needs to be operated").
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the control system of modified Yang '591 to include a motion sensor configured to sense a physical activity status of the users which is sent to the program module and is one of a plurality of variable factors of the total daily dose algorithm or the current insulin infusion algorithm, as taught by Yang '585, because Yang '585 teaches that the combination of sensing a user's physical activity status and adjusting the relevant algorithms is crucial to implementing a closed-loop algorithm in an artificial pancreas (see Yang '585 page 2 of translation, "in order to implement a closed-loop algorithm in an artificial pancreas, the combination of sensing the patient's activity level and adjusting the relevant algorithms is crucial").
Regarding claim 2, modified Yang '591 teaches the closed-loop artificial pancreas insulin infusion control system of claim 1 substantially as claimed. Yang '591 further teaches wherein the program module (controller 302) includes an automatic detection sub-module, and wherein the insulin dose infused per day by the users is configured to be automatically detected, stored, and calculated by the automatic detection sub-module (see page 4 of translation "the required amount of insulin infusion is calculated with the autoregressive model. The calculation results of the insulin infusion volume are compared with the PID controller to optimize the parameters of the PID controller. When the autoregressive model is used to calculate the insulin infusion required at the current moment, the controller executes the PID algorithm at the same time to calculate the insulin infusion required at the current moment"; see page 4 of translation which shows that daily insulin demand and standard daily basal insulin value are obtained for the user to be used in the algorithm for determining the insulin dose).
Regarding claim 3, modified Yang '591 teaches the closed-loop artificial pancreas insulin infusion control system of claim 2 substantially as claimed. Yang '591 further teaches wherein the insulin dose infused per day by the users includes a total amount of a daily infusion dose data (see page 4 of translation which shows that daily insulin demand and standard daily basal insulin value are obtained for the user to be used in the algorithm for determining the insulin dose).
Regarding claim 6, modified Yang '591 teaches the closed-loop artificial pancreas insulin infusion control system of claim 3 substantially as claimed. Modified Yang '591 further teaches wherein the plurality of variable factors of the total daily dose algorithm include one or more of the physical activity status of the users, a physiological status, a psychological status, or a meal status (see Grosman par. [0049], [0125], [0128], see previous modifications in rejection of claim 1 above).
Regarding claim 7, modified Yang '591 teaches the closed-loop artificial pancreas insulin infusion control system of claim 6 substantially as claimed. Modified Yang '591 further teaches wherein the physiological status includes one or more factors of weight, gender, age, disease, or menstrual period (see Grosman par. [0049], [0125], [0128], see previous modifications in rejection of claim 1 above).
Regarding claim 8, modified Yang '591 teaches the closed-loop artificial pancreas insulin infusion control system of claim 6 substantially as claimed. Modified Yang '591 further teaches wherein the physical activity status includes general body stretching, exercise, or sleep (see Yang '585 page 4 of translation, "a motion sensor 101 is provided for detecting the patient's activity level and sending a corresponding signal and adjusts the relevant algorithm based in part on the signal The processor 302 further processes the data to determine whether the patch pump 2 needs to be operated", see previous modifications in rejection of claim 1 above).
Regarding claim 10, modified Yang '591 teaches the closed-loop artificial pancreas insulin infusion control system of claim 1 substantially as claimed. Modified Yang '591 further teaches wherein the motion sensor (Yang '585, motion sensor 101) is provided in the detection module (see Yang '585 translation page 4, "a motion sensor 101 is provided in a dynamic blood glucose monitoring system"), the program module (see Yang '585 page 3 of translation, "at least one motion sensor is provided in one, two, or all three devices of the dynamic blood glucose monitoring system 1, the patch pump 2, and the handheld device 3"), or the infusion module (see Yang '585 translation page 4, "the patch pump 2 also includes a motion sensor") (see previous modifications in rejection of claim 1 above).
Regarding claim 11, modified Yang '591 teaches the closed-loop artificial pancreas insulin infusion control system of claim 10 substantially as claimed. Modified Yang '591 further teaches wherein the motion sensor (Yang '585, motion sensor 101) includes a three-axis acceleration sensor (see Yang '585 translation page 4, "the motion sensor 101 in this embodiment is a three-axis acceleration sensor") or a gyroscope (see Yang '585 translation page 2, "the motion sensor includes one or more of a gyroscope") (see previous modifications in rejection of claim 1 above).
Regarding claim 12, modified Yang '591 teaches the closed-loop artificial pancreas insulin infusion control system of claim 1 substantially as claimed. Yang '591 further teaches wherein any two of the detection module (glucose sensor 1), the program module (controller 302), and the infusion module (insulin pump 2) are connected to each other to form a single structure whose attached position on a skin is different from the other of the detection module (glucose sensor 1), the program module (controller 302), and the infusion module (insulin pump 2) (see translation page 2, "the controller may also be a processor in a glucose sensor or an insulin pump").
Regarding claim 13, modified Yang '591 teaches the closed-loop artificial pancreas insulin infusion control system of claim 1 substantially as claimed. However, modified Yang '591 fails to expressly state wherein the detection module, the program module, and the infusion module are connected together to form a single structure which is attached on only one position on a skin.
Yang '585 teaches a closed-loop artificial pancreas insulin infusion control system (see Figs. 1 and 4, page 1 of translation, "a system and method for implementing closed-loop control in an artificial pancreas") wherein the detection module (dynamic blood glucose monitoring system 1), the program module (processor), and the infusion module (patch pump 2) are connected together to form a single structure which is attached on only one position on a skin (see Fig. 3, pages 3-4 of translation, "the single needle integrated artificial pancreas is integrated with a patch pump 2 and a dynamic blood glucose monitoring system 1 built into the patch pump 2. The patch pump 2 includes a processor for receiving signals, processing and displaying data, and sending instructions. The patch pump 2 also includes a motion sensor").
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the control system of modified Yang '591 to include wherein the detection module, the program module, and the infusion module are connected together to form a single structure which is attached on only one position on a skin, as taught by Yang '585, in order to provide an integrated system that only requires a single needle (see Yang '585 pages 3-4 of translation, "the single needle integrated artificial pancreas is integrated with a patch pump 2 and a dynamic blood glucose monitoring system 1 built into the patch pump 2. The patch pump 2 includes a processor for receiving signals, processing and displaying data, and sending instructions. The patch pump 2 also includes a motion sensor").
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Yang (CN 108261591 A, see copy previously filed on 2/22/2023 and translation filed with the Office Action of 10/1/2025 for citations; hereinafter referred to as "Yang '591") in view of Grosman et al. (US 2019/0321553 A1; hereinafter referred to as "Grosman") and further in view of Yang (CN 108261585 A, see copy previously filed on 2/22/2023 and translation filed with the Office Action of 10/1/2025 for citations; hereinafter referred to as "Yang '585"), as applied to claim 6 above, further in view of Patek et al. (US 2015/0190098 A1; hereinafter referred to as "Patek").
Regarding claim 9, modified Yang '591 teaches the closed-loop artificial pancreas insulin infusion control system of claim 6 substantially as claimed. However, modified Yang '591 fails to expressly state wherein meal information, exercise information, sleep information, or physical condition information is manually input into the program module through the manual input interface.
Patek teaches an insulin infusion control system (see Figs. 11 and 16) wherein meal information, exercise information, sleep information, or physical condition information is manually input into the program module (processor 138) through the manual input interface (input device 132) (see Figs. 11 and 16, par. [0089], [0091]).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the control system of modified Yang '591 to include wherein meal information, exercise information, sleep information, or physical condition information is manually input into the program module through the manual input interface, as taught by Patek, in order to present an opportunity for inputting meals and physical activity by time and amount into the algorithm (see Patek par. [0091]).
Response to Arguments
Applicant's arguments filed 11/21/2025 have been fully considered but they are not persuasive.
Applicant argues that incorporating the features of Grosman and Yang ‘585 into the invention of Yang ‘591 would require substantial redesign and thus is not obvious. However, the test for obviousness is not whether experimentation would be necessary to combine the features of the secondary reference into the invention of the primary reference. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See MPEP 2145. In the instant case, it is not clear how or why incorporating the features of Grosman and Yang ‘585 into the invention of Yang ‘591 would “disrupt Yang ‘591’s carefully calibrated parameter optimization balance” as argued by the Applicant (see Remarks page 11), as it appears an ordinary artisan would still be able to calibrate and optimize the system algorithms. The Examiner interprets that the proposed combination would not change the principle of operation of the primary reference, since the proposed modifications would merely add additional features to the invention, and thus the proposed combination would also not render the primary reference inoperable for its intended purposes.
Applicant argues that “obtain” refers to a dynamic calculation process and not taught by Yang ‘591. It is noted that the features upon which applicant relies (i.e., that “obtain” in “a program module…configured to obtain an insulin dose…” requires that the program module automatically detects/stores/calculates the insulin dose) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See MPEP 2145. Further, the Specification does not provide a special definition for the term “obtain” and par. [0050]-[0052] of the Specification supports that “obtain” can mean that the insulin dose is entered manually by the user or that the insulin dose is automatically detected/stored/calculated (which is also supported by dependent claim 2). Thus, the broadest reasonable interpretation of the claim, in light of the specification, can include, but is not limited to, that the insulin dose can be “obtained” by a manual input or an automatic input. Should Applicant desire that the aforementioned “obtain” limitation be limited to an automatic detection/storage/calculation of the insulin dose, this limitation should be amended in the claim.
Applicant argues that the “weighted average” mentioned in Grosman par. [0128]-[0129] does not pertain to the total daily dose as required by the claim. It is noted that the claim limitation states “the total daily dose is an average or a median of the insulin dose infused per day by the users, wherein the average includes an arithmetic average or a weighted average”. Paragraph [0128] states that “the process 400 calculates an expected value of total daily dose of insulin (TDD, which is usually expressed in units of insulin per day) delivered to the user during the number of days under consideration…a median TDD value can be calculated from the N days under consideration, a mean TDD value can be calculated, or other statistical representations, measures, or weighted values may also be utilized” (see Grosman, [0128]). These citations appear to teach each of the median, arithmetic average, and weighted average alternative limitations as recited in the claim.
Applicant argues that Yang ‘585 fails to distinguish between algorithms for total daily dose, current infusion, or activity status. While Applicant states that the present invention includes two distinct algorithms for the total daily dose and the current infusion algorithm (see Remarks pages 12-13), the Examiner understands that both algorithms communicate with each other within the same insulin control program/software. It is not apparent what the separation/distinction between the algorithms must entail. Thus, the broadest reasonable interpretation of the total daily dose algorithm and the current insulin infusion algorithm includes that the total daily dose algorithm can be considered any algorithm or portion(s) of an algorithm which are related to calculating/determining/receiving the total daily dose and that the current insulin infusion algorithm can be considered an algorithm or portion(s) of an algorithm which are related to calculating/determining/receiving the current insulin infusion information. Should Applicant desire that the claim be limited to a more specific distinction between the two algorithms, this limitation should be amended in the claim.
Conclusion
THIS ACTION IS MADE FINAL. 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 AVERY SMALE whose telephone number is (571)270-7172. The examiner can normally be reached Mon.-Fri. 8-4 ET.
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/AVERY SMALE/Examiner, Art Unit 3783
/KAMI A BOSWORTH/Primary Examiner, Art Unit 3783