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 filed on 06/11/26 has been entered in the case. Claims 2-31 are pending for examination and claim 1 is cancelled.
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 the first paragraph of pre-AIA 35 U.S.C. 112:
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 31 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), 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 applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Nowhere in the original specification has described the limitation that: a recommendation message related to attention of insulin delivery based on the evaluation of the assessed risk of hypoglycemia. The original specification of the current application states in lines 24-26 of page 3 that: a red/yellow/green light hypoglycemia alarm providing to the patient an indication of the risk of hypoglycemia. Having said that, Examiner acknowledges that the signal provides an indication, i.e., alarm or visual alert, i.e., light color (but not a recommendation message, as recited in the claim 31).
Claim Rejections - 35 USC § 102
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 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
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 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.
I) Prior art Jeannewine
Claims 2-12, 14-26, 28-31 are rejected under pre-AIA 35 U.S.C. 102 (b) as anticipated by or, in the alternative, under pre-AIA 35 U.S.C. 103(a) as obvious over Jeannewine et al. (US 2007/0213657).
Regarding claims 2 & 17, Jeannewine discloses non-transient computer-readable media comprising instructions for causing a computing environment to perform a method, the method for preventing or mitigating hypoglycemia in a patient, the instructions comprising:
non-transient computer-readable media comprising instructions for causing a computing environment to perform a method, in Figs. 1-6, the method for preventing or mitigating hypoglycemia in a patient, the instructions comprising:
receiving, from sensor electronics of a glucose monitor 110 (Fig. 1), data related to a glucose concentration;
assessing a risk of hypoglycemia based on at least the data related to the glucose concentration, steps #420-440 in Fig. 4;
evaluating the assessed risk of hypoglycemia (para [0043], at step 4440, it is determined that each of the predetermined number of consecutive glucose readings is lower or equal to the predetermined target low glucose level) to determine of the following outcomes: 1) no action is needed, 2) attenuation of insulin delivery is needed (para [0043], a suggestion or recommendation to modify the existing basal rate of the insulin delivery device 120) 3) additional intervention is needed (para [0043], alert and/or notifications include one or more of a visual, audible, or tactile notification of the measured consecutive low glucose level, and a suggestion or recommendation to modify the existing basal rate of the insulin delivery device, also see para [0073]), or 4) attention of insulin delivery and additional intervention are needed (see #2 & #3 above), and
outputting to an output device 120 (including 230 & 250) a result of said evaluation, (e.g., para [0043], at step 440 in Fig. 4, if the low glucose level is below a target low glucose level, then at step 450, an alert and/or notification is generated and output to the patient to take certain predefined and appropriate corrective actions and device status verification. Examples of such alerts and/or notifications include one or more of a visual, audible, or tactile notification of the measured consecutive low glucose level, also see para [0073]), wherein the result includes a recommendation signal (para [0043], via a visual, audible, or tactile notification) or a control signal (e.g., para [0043], modify the existing basal rate of the insulin delivery device 120. Note: in order to prevent the risk of hypoglycemia, a person skilled in the art would recognize that the step of modifying the existing basal rate must be reduced the rate of the insulin delivery device) related to attenuation of insulin delivery when the evaluating indicates that the assessed risk of hypoglycemia has passed or is predicted to pass a threshold, see paras [0052-0057].
Note: with aspect to claim 17, the claim 17 is being rejected by using same analysis as noted in the claim 2 above. Jeannewine further discloses that: a processor 210 of the insulin delivery device 120 administers insulin based on the recommendation signal or a control signal, paras [0021, 0024 & 0043].
Regarding claim 3, wherein the output device 120 is an insulin delivery device 120.
Regarding claim 4, wherein the output device 120 is operatively associated with the media and the control signal causes the output device to deliver an attenuated dose of insulin, para [0043].
Regarding claims 5 & 19, wherein the recommendation signal or the control signal relates to reducing a commanded dose of insulin set to be delivered by an insulin delivery device, para [0043].
Regarding claims 6-7 & 20-21, wherein the recommendation signal or the control signal related to attenuation of insulin delivery is generated by multiple a basal rate by an attenuation factor (e.g., basal adjustment, para [0043, 0046]; wherein the basal rate is pre-programmed.
Regarding claims 8 & 22, wherein the sensor electronics 110 includes a transmitter or a dedicated receiver, (paras [0015, 0078-0079], a medication delivery unit operatively for wireless receiving data associated with the monitored analyte level from the analyte monitoring system).
Regarding claims 9 & 23, wherein the assessing is further based on one or more of the group selected from: meal data, exercise data, glucose rate of change data, and delivery of insulin data.
Regarding claims 10 & 24, wherein a level of attenuation (reduce the insulin delivery) is proportional to the assessed risk (of hypoglycemia).
Regarding claims 11 & 25, as best as understood, wherein the outputting the result of said evaluation to the output device is performed in accordance with a safety supervision function (e.g. the processing unit is configured to generate one or more of alerts or a notification for output via the interface unit, i.e., audible alert, visual alert, or a tactile alert, paras [0067, 0072-0074]).
Regarding claims 12 & 26, further comprising generating a metabolic state (e.g., cholesterol, chorionic… hormone, … , para [0017], blood glucose concentration, meal, physical activity, para [0027]) based on at least the data related to the glucose concentration.
Regarding claims 14-15 & 28-29, wherein a level of attenuation is further based on an aggressiveness factor, wherein the aggressiveness factor is based on one or more of the group selected from insulin sensitivity, total daily insulin, and correction factor.
Regarding claims 16 & 30, as seen in Figs. 1-2, as best as understood, the instruction from the programmer 210 is separate component with external data (from the glucose sensor 110, display 230, or output unit 260), and wherein the assessing the risk and/or the evaluating the assessed risk is further based on the received external data 110/230/260.
Regarding claim 18, wherein the computing environment is a smart phone 140.
Regarding claim 31, Jeannewine discloses that non-transient computer-readable media in Figs. 1-6 comprising instructions for causing a computing environment to perform a method, the method for preventing or mitigating hypoglycemia in a patient, the instructions comprising:
receiving, from sensor electronics of a glucose monitor 110 (Fig. 1), data related to a glucose concentration;
assessing a risk of hypoglycemia based on at least the data related to the glucose concentration, steps #420-440 in Fig. 4;
evaluating the assessed risk of hypoglycemia (para [0043], at step 4440, it is determined that each of the predetermined number of consecutive glucose readings is lower or equal to the predetermined target low glucose level) to determine of the following outcomes: 1) no action is needed, 2) attenuation of insulin delivery is needed (para [0043], a suggestion or recommendation to modify the existing basal rate of the insulin delivery device 120) 3) additional intervention is needed (para [0043], alert and/or notifications include one or more of a visual, audible, or tactile notification of the measured consecutive low glucose level, and a suggestion or recommendation to modify the existing basal rate of the insulin delivery device, also see para [0073]), or 4) attention of insulin delivery and additional intervention are needed (see #2 & #3 above), and
outputting to an output device 120 (including 230 & 250) a result of said evaluation, (e.g., para [0043], at step 440 in Fig. 4, if the low glucose level is below a target low glucose level, then at step 450, an alert and/or notification is generated and output to the patient to take certain predefined and appropriate corrective actions and device status verification. Examples of such alerts and/or notifications include one or more of a visual, audible, or tactile notification of the measured consecutive low glucose level, also see para [0073]), wherein the result includes a recommendation signal (para [0043], via a visual, audible, or tactile notification) or a control signal (e.g., para [0043], modify the existing basal rate of the insulin delivery device 120. Note: in order to prevent the risk of hypoglycemia, a person skilled in the art would recognize that the step of modifying the existing basal rate must be reduced the rate of the insulin delivery device) related to attenuation of insulin delivery when the evaluating indicates that the assessed risk of hypoglycemia has passed or is predicted to pass a threshold, see paras [0052-0057]; and
wherein the signal to manage insulin delivery includes:
a recommendation message (via a visual, audible, or tactile notification, para [0043]) related to attenuation of insulin delivery based on the evaluation of the assessed risk of hypoglycemia; and/or
a control signal to cause attenuation of insulin delivery based on the evaluation of the assessed risk of hypoglycemia (e.g., modify the existing basal rate of the insulin delivery device 120, para [0043]. Note: in order to prevent the risk of hypoglycemia, a person skilled in the art would recognize that the step of modifying the existing basal rate must be reduced the rate of the insulin delivery device).
II) Prior art Kovatchev et al. (US 6,923,763)
Claims 2-12, 14-26, 28-31 are rejected under pre-AIA 35 U.S.C. 102 (b) as anticipated by or, in the alternative, under pre-AIA 35 U.S.C. 103(a) as obvious over Kovatchev et al. (US 6,923,763).
Regarding claims 2 & 17, Kovatchev discloses non-transient computer-readable media (a system includes portable device incorporates another device such as BG monitoring, infusion device, col. 5, lines 30-35) comprising instructions for causing a computing environment (from a portable device, i.e., infusion device) to perform a method, the method for preventing or mitigating hypoglycemia in a patient, the instructions comprising:
receiving, from sensor electronics of a glucose monitor (BG monitoring device, col. 4, line 13), data related to a glucose concentration (col. 3, lines 11-12);
assessing a risk of hypoglycemia based on at least the data related to the glucose concentration (BG level below 70 mg/dl, see Fig. 1, col. 3, lines 19-23, 25-30, col. 9, line 25-36);
evaluating the assessed risk of hypoglycemia (col. 9, line 25-36) to determine one of the following outcomes:
1) no action is needed,
2) attenuation of insulin delivery is needed (e.g. insulin depresses BG level, col. 6, lines 59-62, col. 9, lines 15-18),
3) additional intervention is needed (e.g., food intake, col. 6, line 59; warning to the patent and reduce the insulin infusion rate, col. 9,lines 13-18) , or
4) attenuation of insulin delivery and additional intervention are needed, (see #2 & 3 above) and
outputting to an output device (an interface, i.e. Graphs as shown in Figs. 4-14) a result of said evaluation, wherein the result includes a recommendation signal or a control signal related to attenuation of insulin delivery when the evaluating indicates that the assessed risk of hypoglycemia has passed or is predicted to pass a threshold (see Figs. 4-7, 10, 13-14, the graphs show that the blood glucose concentration at hypoglycemia level and then back to the normal, target value).
Note: with aspect to claim 17, the claim 17 is being rejected by using same analysis as noted in the claim 2 above. Kovatchev discloses an infusion device includes: a processor of the insulin delivery device (col. 20, lines 38-39) administers insulin based on the recommendation signal or a control signal, (col. 6, lines 8-10; col. 64-col. 12, line 2).
Regarding claim 3, wherein the output device is an insulin delivery device.
Regarding claim 4, wherein the output device is operatively associated with the media (insulin) and the control signal causes the output device to deliver an attenuated dose of insulin.
Regarding claims 5 & 19, wherein the recommendation signal or the control signal relates to reducing a commanded dose of insulin set to be delivered by an insulin delivery device, col. 9, lines 15-18, see Figs. 13-14.
Regarding claims 6 & 20, wherein the recommendation signal or the control signal related to attenuation of insulin delivery is generated by multiplying a basal rate by an attenuation factor, see Figs. 13-14.
Regarding claims 7 & 21, wherein the basal rate is pre-programmed, col. 9, lines 15-18, see Figs. 13-14.
Regarding claims 8 & 22, wherein the sensor electronics (BG monitoring device) includes a transmitter or a dedicated receiver (e.g. BG monitoring device is separate unit with the insulin pump; where the portable device, i.e. infusion pump includes an interface for receiving data input (blood glucose concentration from the BG monitoring device, col. 4, lines 59-62; col. 5, lines 30-45),
Regarding claims 9 & 23, wherein the assessing is further based on one or more of the group selected from: meal data, exercise data, glucose rate of change data, and delivery of insulin data (food intake, insulin delivery rate, col. 6, lines 59-62, col. 9, lines 12-18, see Figs. 11, 13-14).
Regarding claims 10 & 24, wherein a level of attenuation (warning to a patient of low blood glucose concentration) is proportional to the assessed risk (of hypoglycemia).
Regarding claims 11 & 25, wherein the outputting the result of said evaluation to the output device is performed in accordance with a safety supervision function (e.g., recommend having a food intake or reduce the insulin to prevent hypoglycemia).
Regarding claims 12 & 26, further comprising generating a metabolic state (carbohydrates, food intake or insulin) based on at least the data related to the glucose concentration.
Regarding claims 14-15 & 28-29, wherein a level of attenuation is further based on an aggressiveness factor, wherein the aggressiveness factor is based on one or more of the group selected from insulin sensitivity, total daily insulin, and correction factor.
Regarding claims 16 & 30, comprising receiving external data (input data is received by manually input form an external source, such as a patient or medical care giver, or by automated data acquisition from a monitoring device or mechanism, col. 4, lines 59-62), and wherein the assessing the risk and/or evaluating the assessed risk is further based on the received external data (from the BG value from the BG monitoring device)
Regarding claim 18, the infusion device is automatically- electronic device (computing environment) and therefore, it is considered as a smart phone
Regarding claim 31, Kovatchev discloses non-transient computer-readable media (a system includes portable device incorporates another device such as BG monitoring, infusion device, col. 5, lines 30-35) comprising instructions for causing a computing environment (portable device, i.e. infusion device) to perform a method, the method for preventing or mitigating hypoglycemia in a patient, the instructions comprising:
receiving, from sensor electronics of a glucose monitor (BG monitoring device, col. 4, line 13), data related to a glucose concentration (col. 3, lines 11-12);
assessing a risk of hypoglycemia based on at least the data related to the glucose concentration (BG level below 70 mg/dl, see Fig. 1, col. 3, lines 19-23, 25-30, col. 9, line 25-36);
outputting a result to an output device (an interface, i.e. Graphs as shown in Figs. 4-14), the result including a signal to manage insulin delivery (Figs. 13-14), the signal based on an evaluation of the assessed risk of hypoglycemia (col. 9, line 25-36) to determine one of the following outcomes:
1) no action is needed,
2) attenuation of insulin delivery is needed (e.g. insulin depresses BG level, col. 6, lines 59-62, col. 9, lines 15-18),
3) additional intervention is needed (e.g., food intake, col. 6, line 59; warning to the patent and reduce the insulin infusion rate, col. 9, lines 13-18) , or
4) attenuation of insulin delivery and additional intervention are needed, (see #2 & 3 above), and
Wherein the signal to manage insulin delivery include:
A recommendation message related to attenuation of insulin delivery based on the evaluation of the assessed risk of hypoglycemia (Figs. 1, 4-10, 13-14); and/or
A control signal to cause attention of insulin delivery based on the evaluation of the assessed risk of hypoglycemia (e.g., food intake or reduce the insulin infusion rate).
Claims 13 & 27 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Kovatchev et al. (US 6,923,763) in view of Knobbe et al. (US 2002/0111547).
Regarding claims 13 & 27, Kovatchev discloses the invention substantially as claimed invention. Keith does not disclose that generating the metabolic state involves a Kalman filter technique.
Knobbe discloses a system using Kalman filter to estimate or track’s patient’s metabolic state, i.e., concerning glucose and insulin levels for diabetes management, see abstract, Figs. 1 & 8.
It would have been obvious at the time the invention was made to a person having ordinary skill in the art to modify the device system of Kovatchev with using a Kalman filter technique to track a patient’s metabolic state, as taught by Knobbe, in order to make optimal estimates of physiological parameter, i.e., glucose level in real time to prevent hypoglycemia or hyperglycemia to a patient.
III) Prior art Keith et al. (US 2004/0152622).
Claims 2-5, 9-12, 14-19, 23-24, 26, 28-30 are rejected under pre-AIA 35 U.S.C. 102 (b) as anticipated by or, in the alternative, under pre-AIA 35 U.S.C. 103(a) as obvious over Keith et al. (US 2004/0152622).
Regarding claims 2 & 17, Keith discloses in Figs. 2 & 6, non-transient computer-readable media comprising instructions for causing a computing environment to perform a method, the method for preventing or mitigating hypoglycemia in a patient, the instructions comprising:
receiving, from sensor electronics of a glucose monitor 206, data related to a glucose concentration;
assessing a risk of hypoglycemia based on at least the data related to the glucose concentration, paras [0070 & 0074, 0076] & Fig. 14;
Note #1: the para [0074] states that: A MPC algorithm evaluates, at specific time intervals, current and past glucose levels, as well as recent insulin delivery history to compute an insulin dose which will bring the patient to a target glucose level. ... The embodiments of the present invention use the MPC algorithm to set the future glucose target in such a way that the controller (e.g., controller 202 shown in FIG. 6) can be initiated when the patient's blood glucose is arbitrarily far away from the target while minimizing the occurrence of hypoglycemia. Having said in the para [0074] above, based on the current, and past glucose level, and by using the MPC algorithm, the controller 202 predicts (estimate, assess or evaluate) the occurrence of hypoglycemia. The assessment of the risk of hypoglycemia can be used or based on MPC to predict the future glucose concentration, or using the sensor for measuring the current glucose concentration
Note #2: the para [0074] states: The controller 206 generates the highest permissible delivery rates, which cause in this case a hypoglycemic episode. Based on the statement in para [0074], the controller 206 acknowledges the current condition, i.e., risk of hypoglycemia.
Note #3: the para [0076] states that: An alternative use of the embodiments of the present invention discussed above is to limit the potential for hypoglycemia after a meal... Reduction of hypoglycemia can also be achieved by resetting the target value to at or near to the glucose level reached during a hyperglycemic episode. This will cause the controller 206 to significantly reduce insulin delivery rates, and thereby avoid creating hypoglycemia. In other words, the controller is configured to assess (evaluate or by predicting) that the risk of hypoglycemia is to be happened after a meal and the controller is configured to adjust the insulin rate to avoid hypoglycemia.
Note #4: in addition, the Fig. 14 shows that the glucose concentration (in solid line) is gradually decline below 70 mg/dl or reaching to 60mg/dl which is in progress of hypoglycemic condition.
For all the reasons in the Notes #1-4 above, Kieth clearly discloses the limitation of assessing a risk of hypoglycemia based on at least the data related to the glucose concentration, as required in the claimed invention.
evaluating the assessed risk of hypoglycemia to determine one of the following outcomes:
#2) attenuation of insulin delivery is needed (via a display or graph shows in Fig. 14)
#3) additional intervention is needed (e.g., para [0022], adjust the model based on the comparison of the post-delivery glucose concentration and the target or predicted glucose concentration; para [0040], the controller 102 can adjust the control signal to adjust the amount of the drug; para [0051], smaller insulin rate commands, and smaller rate command variations, which will improve reliability and longevity of the delivery device, along with reduced occurrence of hypoglycemia; para [0070], A MPC algorithm evaluates at specific time intervals, current and past glucose levels, as well as recent insulin delivery history to compute an insulin dose to bring the patient to target glucose level to avoid hypoglycemia; para [0074], A controller (e.g., controller 206) is initiated with a target value of 160 mg/dl in this example. The initial glucose value was 246 mg/dl. The controller 206 generates the highest permissible delivery rates, which cause in this case a hypoglycemic episode; para [0076], ... A "naive" controller will ultimately keep average glucose levels at the target value, so any hyperglycemia will be followed by a period of hypoglycemia. This effect can be greatly reduced by limiting the maximum rate of insulin delivery as discussed above. Reduction of hypoglycemia can also be achieved by resetting the target value to at or near to the glucose level reached during a hyperglycemic episode. This will cause the controller 206 to significantly reduce insulin delivery rates, and thereby avoid creating hypoglycemia),
#4) attenuation of insulin delivery and additional intervention (as mentioned in #2 & #3), or as mentioned in paras [0070, 0074, 0076] & Fig. 14 above.
Note #5: the para [0074] states that: the controller 206 generates the highest permissible delivery rate, which cause in this case a hypoglycemic episode;
Note #6: the system in Fig. 2 includes model predictive control (MPC) principle into the controller 202, paras [0047 & 0049]. In other words, based on the current data of glucose concentrate to predict a future glucose concentration or to predict a result in hypoglycemia (below a typical target glucose concentrate value, i.e. below 70 mg/dl) or hyperglycemic (above a typical target glucose concentrate vale, i.e. above 150-180 mg/dl). The MPC is instructed to bring a patient blood glucose from a hyperglycemic value or hypoglycemia value to a typical target value. In addition, the para [0022] states: The controller can employ an algorithm to compare a pre-delivery concentration of the glucose present prior to delivery to the insulin to a target or predicted glucose concentration. In order to deliver a right amount of the insulin to the target/predicted glucose concentration value, the system or the instruction, software, algorithm in the MPC includes the assessing and evaluating a risk of hypoglycemia to determine the attenuation of insulin delivery and additional intervention are needed.
outputting to an output device 204 a result of said evaluation, wherein the result includes a recommendation signal or a control signal related to attenuation of insulin delivery when the evaluating indicates that the assessed risk of hypoglycemia has passed or is predicted to pass a threshold, paras [0049, 0051 & 0075].
Note #7: As seen in Figs. 14-15, outputting to an output device (via graph as shown in Figs. 14-15) a result of said evaluation (via glucose concentration that below or above the target values). The para [0076] states that: … reduction of hypoglycemia can be achieved by resetting the target value to at or near to the glucose level reached during a hyperglycemic episode. This will cause the controller 206 to significantly reduce insulin delivery rates, and thereby avoid creating hypoglycemia.
Note #8: In para [0047], Keith explicitly discloses: “… The controller 202 generates a control command (i.e., insulin rate or volume to be delivered) based on the current state of the patient 208 and the expected future behavior of the patient 208 (i.e., a model response). For each proceeding control step, the patient response is compared to the modeled response, and control commands are adjusted accordingly.” The para [0051 states that: “… Furthermore, smaller insulin rate commands, and smaller rate command variations, which will improve reliability and longevity of the delivery device, are also realized, along with reduced occurrence of hypoglycemia, in terms of both minimum glucose excursions and time below any threshold value, which will minimize the risk of adverse conditions for the patient.”
Based on the above teachings, the system discloses by Keith assesses the risk of hypoglycemia and evaluates such risk of hypoglycemia; and recommendation signal or a control signal related to attenuation of insulin delivery when the evaluating indicates that the assessed risk of hypoglycemia has passed or is predicted to pass a threshold; As for claims 17 & 19, wherein the process of the insulin delivery device administers insulin based on the recommendation signal or a control signal, see paras [0051, 0070].
Note #9: the claims 17 & 19 include all the limitations in the claim 2. Therefore, the claims 17 & 19 are being rejected with using same analysis as noted in the claim 2 above.
Regarding claim 3, Keith discloses that wherein the output device is an insulin delivery device 204, see Fig. 2.
Regarding claims 4-5, Keith discloses in Fig. 2, a feedback closed-loop system for monitoring glucose. The closed loop system in Fig. 2 is operatively associated with the instructions (algorithm) in the controller 202 and increases or decreases the amount/dose of insulin to be infused based on the feedback from the sensor 206 and the reference signal 216. Therefore, Keith discloses wherein the output device is operatively associated with the media and the control signal causes the output device to deliver an attenuated dose of insulin; wherein the recommendation signal or the control signal relates to reducing (if the result will be a rapid input of insulin, which may in turn result in hypoglycemia, para [0013]) a commanded dose of insulin set to be delivered by an insulin delivery device.
Regarding claims 9 & 23, Keith discloses in Fig. 2, a feedback closed-loop system for monitoring glucose, having a sensor 206 that provides feedback comprising increases or decreases rate of change of glucose of levels in the body of a user. In other words, Keith discloses that the assessing is further based on one or more of the group selected from: meal data, exercise data, glucose rate of change data, and delivery of insulin data.
Regarding claim 10 & 24, Keith discloses in Fig. 2, a feedback closed-loop system for monitoring glucose, having a sensor 206 that provides feedback comprising increases or decreases rate of change of glucose of levels in the body of a user. In other words, Keith discloses that a level of attenuation is proportional to the assessed risk.
Regarding claim 12 & 26, Keith discloses in Fig. 2, a feedback closed-loop system for monitoring glucose, based on the glucose feedback, changing the amount of insulin infused into the body of a user. Concerning changes in metabolism, for example, the liver exhibits a decrease in gluconeogenesis and increases in glycogenesis in response to the presence of insulin. Insulin’s effect stretches to lipid and protein metabolism as well. It stimulates lipogenesis and protein synthesis and conversely inhibits lipolysis and protein degradation. Therefore, the feedback signal representing changes in glucose concentration in the boy of a user effects changes in the insulin dose infused into the body which as a metabolic effect in the body of the user. Therefore, Keith discloses that generating a metabolic state based on at least the data related to the glucose concentration.
Regarding claims 14-15 & 28-29, having said the above, Keith discloses in Fig. 2, a feedback closed-loop system for monitoring glucose, having a sensor 206 that provides feedback comprising increases or decreases (rate of change) of glucose levels in the body of the user. The extent of change in the glucose level represented by the feedback signal (correction factor) from the sensor determines the level of aggressiveness factor in the dosing changes. Therefore, the feedback signal from the sensor is aggressiveness factor that based on one or more of the group selected from insulin sensitivity, total daily insulin, and correction factor.
Regarding claims 16 & 30, having said the above, Keith discloses in Fig. 2, a feedback closed-loop system for monitoring glucose, having a sensor 206 that provides feedback comprising increases or decreases (rate of change) of glucose levels in the body of the user. The feedback signal from the sensor is considered external data since the sensor 206 is a separate structure from the controller 202, as shown in Fig. 2. Therefore, Keith discloses that: receiving external data, and wherein the assessing the risk and/or the evaluating the assessed risk is further based on the received external data.
Regarding claim 18, Keith discloses in para [0045] that: “[t]he system 200 can also be configured to communicate with a health care provider and/or non-local system manager, either via a telephone (modem or wireless) or the Internet, for example.” Therefore, Keith discloses that the computing environment is a smart phone.
Claims 8 & 22 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Keith et al. (US 2004/0152622) in view of Say et al. (US 2005/0121322).
Regarding claims 8 & 22, Keith discloses all claimed subject matter as required. Keith discloses in para [0021] that:
[0021] … The system can also be portable and wearable by the patient, and at least a portion of communications between the controller, the sensor and the delivery device include wireless communications.”
Keith does not disclose that the sensor includes a transmitter and a receiver. However, designing a glucose or analyte sensor with a transmitter and receiver to communicate with a controller or external device would have been considered conventional the art at the time of the invention based on the teachings of Say.
Say discloses an analyte sensor, in the abstract, Say states: “…The sensor control unit typically has a housing adapted for placement on skin and is adapted to receive a portion of an electrochemical sensor. The sensor control unit also includes two or more conductive contacts disposed on the housing and configured for coupling to two or more contact pads on the sensor. A transmitter is disposed in the housing and coupled to the plurality of conductive contacts for transmitting data obtained using the sensor. The display unit has a receiver for receiving data transmitted by the transmitter of the sensor control unit and a display coupled to the receiver for displaying an indication of a level of an analyte…”
Accordingly, for an artisan skilled in the art, modifying the sensor disclosed by Keith with a transmitter and receiver, as taught by Say, would have been considered obvious in view of the demonstrated conventionality of this communication enhancement. Moreover, the artisan would have been motivated to make the modification because designing the sensor with a transmitter and receiver would have enabled wireless communications between the sensor, the controller, and the infusion pump, facilitating the functions of the closed loop system to determine an accurate insulin dose.
Claims 11 & 25 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Keith et al. (US 2004/0152622) in view of Bengtsson et al. (US 2010/0145262).
Regarding claims 11 & 25, Keith discloses the invention substantially as claimed invention. Keith does not disclose that the outputting the result of the evaluation is performed in accordance with a safety supervision function.
Bengtsson discloses a closed loop control system for an infusion pump comprising: a control algorithm or processor comprises dynamic safety limits via model predictive dataset to evaluate the assessed risk of hypoglycemic to the output device (display message or alarm, as shown in Fig. 11) is performed in accordance with a safety supervision function (safe-mode function), paras [0109-0117, 0129-0130]).
It would have been obvious at the time the invention was made to a person having ordinary skill in the art to modify the device of Keith with providing an output device being performed with a safety supervision function, as taught by Bengtsson, in order to detect and prevent of hypoglycemia to a patient.
Claims 13 & 27 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Keith et al. (US 2004/0152622) in view of Knobbe et al. (US 2002/0111547).
Regarding claims 13 & 27, Keith discloses the invention substantially as claimed invention. Keith does not disclose that generating the metabolic state involves a Kalman filter technique.
Knobbe discloses a system using Kalman filter to estimate or track’s patient’s metabolic state, i.e., concerning glucose and insulin levels for diabetes management, see abstract, Figs. 1 & 8.
It would have been obvious at the time the invention was made to a person having ordinary skill in the art to modify the device system of Keith with using a Kalman filter technique to track a patient’s metabolic state, as taught byKnobbe, in order to make optimal estimates of physiological parameter, i.e., glucose level in real time to prevent hypoglycemia or hyperglycemia to a patient.
Claim 31 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Keith et al. (US 2004/0152622) in view of Moreman (US 2004/0248204).
Regarding claim 31, Keith discloses the invention substantially as claimed (please see the rejections in claim 2 above). Keith does not disclose the limitations that: a recommendation message related to attenuation of insulin delivery based on the assessed risk of hypoglycemia.
Moreman discloses a health monitoring device comprising: a non-transient computer-readable media, i.e. programming or software comprising instructions; wherein the instruction comprising: a signal to manage insulin delivery includes: a recommendation message 44-45 (on a display in Fig. 5) related to attenuation of insulin delivery based on the assessed risk of hypoglycemia; the recommendation message is the signal to manage insulin delivery or the signal to manage insulin delivery comprises the recommendation message 44-45. For example: the device 10 concludes that the patient should reduce evening insulin to avoid hypoglycemia, para [0078]; the device provides recommendations to the patients in the messages 44-45.
It would have been obvious at the time the invention was made to a person having ordinary skill in the art to modify the device of Keith with providing a signal with including a recommendation message related to attenuation of insulin delivery, and including a recommendation message being signaled to manage insulin delivery, as taught by Moreman, in order to alert a patient pay attention the risk of hypoglycemia and preventing a risk of hypoglycemia.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the claims at issue are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
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Claims 2-31 are rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-28 of U.S. Patent No. 11,986,294. Although the conflicting claims are not identical, they are not patentably distinct from each other because they are not structurally distinguishable from the claims in the patent.
Regarding claim 2, US’294 discloses non-transient computer-readable media comprising instructions for causing a computing environment to perform a method, the method for preventing or mitigating hypoglycemia in a patient, see lines 1-4 in claim 1 of US’294, the instructions comprising:
receiving, from sensor electronics of a glucose monitor, data related to a glucose concentration, see lines 5-6 in claim 1 of US’294;
assessing a risk of hypoglycemia based on at least the data related to the glucose concentration, see lines 7-8 in claim 1 of US’294;
evaluating the assessed risk of hypoglycemia, see line 9 in claim 1 of US’294; and
outputting to an output device a result of said evaluation, wherein the result includes a recommendation signal or a control signal related to attenuation of insulin delivery when the evaluating indicates that the assessed risk of hypoglycemia has passed or is predicted to pass a threshold, see lines 10-15 in claim 1 of US’294.
Regarding claim 3, wherein the output device is an insulin delivery device, see claim 2 in US’294.
Regarding claim 4, wherein the output device is operatively associated with the media and the control signal causes the output device to deliver an attenuated dose of insulin, see claim 3 in US’294.
Regarding claim 5, wherein the recommendation signal or the control signal relates to reducing a commanded dose of insulin set to be delivered by an insulin delivery device, see claim 4 in US’294.
Regarding claim 6, wherein the recommendation signal or the control signal related to attenuation of insulin delivery is generated by multiplying a basal rate by an attenuation factor, see lines 16-18 in claim 1 in US’294.
Regarding claim 7, wherein the basal rate is pre-programmed, see claim 5 in US’294.
Regarding claim 8, wherein the sensor electronics includes a transmitter or a dedicated receiver, see claim 6 in US’294.
Regarding claim 9, wherein the assessing is further based on one or more of the group selected from: meal data, exercise data, glucose rate of change data, and delivery of insulin data, see claim 7 in US’294.
Regarding claim 10, wherein a level of attenuation is proportional to the assessed risk, see claim 8 in US’294.
Regarding claim 11, wherein the outputting the result of said evaluation to the output device is performed in accordance with a safety supervision function, see claim 9 in US’294.
Regarding claim 12, further comprising generating a metabolic state based on at least the data related to the glucose concentration, see claim 10 in US’294.
Regarding claim 13, wherein the generating the metabolic state involves a Kalman filter technique, see claim 11 in US’294.
Regarding claim 14, wherein a level of attenuation is further based on an aggressiveness factor, see claim 12 in US’294.
Regarding claim 15, wherein the aggressiveness factor is based on one or more of the group selected from insulin sensitivity, total daily insulin, and correction factor, see claim 13 in US’294.
Regarding claim 16, further comprising receiving external data, and wherein the assessing the risk and/or the evaluating the assessed risk is further based on the received external data, see claim 14 in US’294.
Regarding claim 17, US’294 discloses an insulin delivery device, see line 1 in claim 15 of US’294, comprising:
a processor configured to receive a signal from a computing environment, the computing environment including a non-transient computer-readable medium having instructions for causing the computing environment to, see lines 2-6 in claim 15 of US’294:
receive, from sensor electronics of a glucose monitor, data related to a glucose concentration, see lines 7-8 in claim 15 of US’294;
assess a risk of hypoglycemia based on at least the data related to the glucose concentration, see lines 9-10 in claim 15 of US’294;
evaluate the assessed risk of hypoglycemia, see line 11 in claim 15 of US’294and
output a result of said evaluation to the processor of the insulin delivery device, wherein the result includes a recommendation signal or a control signal related to attenuation of insulin delivery if the evaluating indicates that the assessed risk of hypoglycemia has passed or is predicted to pass a threshold, see lines 12-17 in claim 15 of US’294;
wherein the processor of the insulin delivery device administers insulin based on the recommendation signal or a control signal, see lines 21-23 in claim 15 of US’294.
Regarding claim 18, wherein the computing environment is a smart phone, see claim 16 in US’294.
Regarding claim 19, wherein the processor of the insulin delivery device administers insulin by injecting an amount of insulin based on recommendation signal or a control signal and/or adjusting an amount of insulin to be injected based on the recommendation signal or a control signal, see claim 17 in US’294.
Regarding claim 20, wherein the recommendation signal or the control signal related to attenuation of insulin delivery is generated by multiplying a basal rate by an attenuation factor, see lines 17-20 in claim 15 of US’294.
Regarding claim 21, wherein the basal rate is pre-programmed, see claim 18 in US’294.
Regarding claim 22, wherein the sensor electronics includes a transmitter or a dedicated receiver, see claim 19 in US’294.
Regarding claim 23, wherein the assessing is further based on one or more of the group selected from: meal data, exercise data, glucose rate of change data, and delivery of insulin data, see claim 20 in US’294.
Regarding claim 24, wherein a level of attenuation is proportional to the assessed risk, see claim 21 in US’294.
Regarding claim 25, wherein the outputting the result of said evaluation is performed in accordance with a safety supervision function, see claim 22 in US’294.
Regarding claim 26, further comprising generating a metabolic state based on at least the data related to the glucose concentration, see claim 23 in US’294.
Regarding claim 27, wherein the generating the metabolic state involves a Kalman filter technique, see claim 24 in US’294.
Regarding claim 28, wherein a level of attenuation is further based on an aggressiveness factor, see claim 25 in US’294
Regarding claim 29, wherein the aggressiveness factor is based on one or more of the group selected from insulin sensitivity, total daily insulin, and correction factor, see claim 26 in US’294.
Regarding claim 30, further comprising receiving external data, and wherein the assessing the risk and/or the evaluating the assessed risk is further is based on the received external data, see claim 27 in US’294.
Regarding claim 31, US’294 discloses non-transient computer-readable media comprising instructions for causing a computing environment to perform a method, the method for preventing or mitigating hypoglycemia in a patient, the instructions comprising, see lines 1-4 in claim 28 of US’294:
receiving, from sensor electronics of a glucose monitor, data related to a glucose concentration, see lines 5-6 in claim 28 of US’294;
assessing a risk of hypoglycemia based on at least the data related to the glucose concentration, see lines 7-8 in claim 28 of US’294;
outputting a result to an output device, the result including a signal to manage insulin delivery, the signal based on the assessed risk of hypoglycemia, see lines 9-11 in claim 28 of US’294, and
wherein the signal to manage insulin delivery includes, see line 12 in claim 28 of US’294:
a recommendation message related to attenuation of insulin delivery based on the assessed risk of hypoglycemia, see lines 13-15 in claim 28 of US’294; and/or
a control signal to cause attenuation of insulin delivery based on the assessed risk of hypoglycemia, see lines 16-17 in claim 28 of US’294;
wherein, see line 18 in claim 28 of US’294:
the recommendation message is the signal to manage insulin delivery or the signal to manage insulin delivery comprises the recommendation message, see lines 19-22 in claim 28 of US’294; and/or
the control signal to cause attenuation of insulin delivery is the signal to manage insulin delivery or the signal to manage insulin delivery comprises the control signal to cause attenuation of insulin delivery, see lines 23-26 in claim 28 of US’294.
Response to Arguments
Applicant's arguments filed 06/11/26 have been fully considered but they are not persuasive.
Prior art Jennewine:
1) Applicant argues that Jennewine does not disclose assessing a risk of hypoglycemic, evaluating the assessed risk of hypoglycemia, and outputting a recommendation signal or a control signal related to attenuation of insulin delivery.
In response, Jennewine clearly discloses the limitations of assessing a risk of hypoglycemic (step #440, are received predetermined number of consecutive glucose readings < = target low glucose level?), evaluating the assessed risk of hypoglycemia (e.g., Y in Fig. 4, the controller is configured to determine if the number of consecutive glucose readings is/are lower or equal to the predetermined target low glucose level, then at step 450, an alert and/or notification is generated and output to the patient), and outputting a recommendation signal (e.g., para [0043], at step 450, an alert and/or notification is generated and output to the patient to take certain predefined and appropriate corrective actions and device status verifications. Examples of such alerts and/or notifications may include one or more of a visual, audible, or tactile notification of the measured consecutive low glucose levels, and a suggestion or recommendation to ingest a snack and or modify the existing basal rate of the insulin delivery device 120)
or a control signal related to attention of insulin delivery (e.g., para [0043] Examples of such alerts and/or notifications may include one or more of a visual, audible, or tactile notification of the measured consecutive low glucose levels, and a suggestion or recommendation to ingest a snack and or modify the existing basal rate of the insulin delivery device 120). A person skilled in the art would recognize that the controller is configured to modify the existing basal rate by reducing or temporary pause of delivery to prevent or stop hypoglycemia condition).
Prior art Keith:
1) Applicant argues that Kieth considers hypoglycemia only within a glucose-target MPC control framework, not through the claimed formal assessment of hypoglycemia risk evaluated against a threshold to determine whether to output an attention-related recommendation or control signal.
In response, Examiner would like to ask that how does applicant define “the formal assessment of hypoglycemic risk being evaluated”? The claimed invention does not require any specifically method of instruction of assessing a risk of hypoglycemia. A person skilled in the art would recognize that the “hypoglycemia” needs to be prevented rather than waiting until it happens to adjust the insulin. Therefore, a preferred method for preventing hypoglycemic involves utilizing a Model Predictive Control (MPC) algorithm to forecast or assess the risk of a hypoglycemic event. In this case, Keith applies the MPC algorithm to assessing a risk of hypoglycemic based on the current blood glucose concentration and the expected future behaviors of the patient (i.e., a model response) to reduce occurrence of hypoglycemia, see paras [0070, 0074, 0076] & Fig. 14 as discussed in the rejection in claim 2 above.
2) Applicant states that Keith states in para [0049] only that the controller generates an insulin command based on the patient’s current state and expected future behavior, while Keith states on paras [0074-0076] explain that hypoglycemia is reduced by using a ramped or reset glucose target and/or limiting maximum delivery rate.
In response, Applicant should read the entire of the document in Keith as a whole rather pick and choose in certain paragraph in Keith. The para [0049] in Keith states that: the controller 202 generates a control command (i.e. insulin rate or volume to be delivered) based on the current state of the patient. A closed loop therapy system in Keith for controlling a glucose concentration to prevent hyperglycemic and hypoglycemic. As mentioned earlier, the system in Keith is configured to detect/assess, or evaluate an occurrence of hypoglycemia, also see Fig. 14. Therefore, a person skilled in the art would recognize that the controller 202 generates a control command by reducing insulin rate or reducing volume to be delivered based on the current state, i.e. hypoglycemia of the patient. A person skilled in the art would have recognized that if the infusion therapy must be stopped or reduced when occurrence of hypoglycemia otherwise it can cause a death to a patient.
Examiner Notes
Examiner cites particular columns and line numbers in the references as applied to the claims above for the convenience of the applicant. Although the specified citations are representative of the teachings in the art and are applied to the specific limitations within the individual claim, other passages and figures may apply as well. It is respectfully requested that, in preparing responses, the applicant fully consider the references in entirety as potentially teaching all or part of the claimed invention, as well as the context of the passage as taught by the prior art or disclosed by the examiner.
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.
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/QUYNH-NHU H. VU/ Primary Examiner, Art Unit 3783
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