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 and Request for Continued Examination (RCE) filed on 01/27/26 have been entered in the case. Claims 1-2, 10-11, 14-16, 19-23, 25-27, 29 -32 are pending for examination and claims 3-9, 12-13, 17-18, 24, 28 are cancelled.
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.
Claims 1-2, 10-11, 14, 21-23, 27, 29-32 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Steil et al. (US 2008/0183060) in view of John (US 7,811,279) and Mastrototaro (US 7,785,313).
Regarding claim 1, Steil discloses a system, Figs. 1-17 comprising:
a glucose sensor 10 or 26 configured to provide a sensor glucose measurement signal 16 representative of sensed glucose level 18 in a body a patient;
a controller 12, in Fig. 1, programmed to:
determine a sensed glucose level 18 based on the sensor glucose measurement 16 and sensor error parameter of the glucose sensor 209a (in Fig. 15b), also see para [0142] states that: the sensor has failed and must be replaced; and
provide an insulin delivery control signal (e.g., a software/programming to generate commands 22 for the insulin delivery system, para [0055-0056]) as a function of the received sensor glucose measurement signal 16, (e.g., an infusion system for regulating the rate of fluid infusion, i.e., insulin delivery parameter, into a body of a user based on glucose concentration measurement taken from the body, para [0045]; the sensor signal 16 is provided directly to the user, who then determines based on the blood glucose level 18, the amount and timing of insulin delivery to the body, para [0059]; the delivery system is controlled automatically based on sensor reading, col. 16, lines 64-65), in accordance with a model predictive control (a model predictive -MP), step 220 in Fig. 14 or solid curved line 205 in Fig. 15b);
Note: in addition, the insulin delivery information 203 (in Fig. 15a) correlates to the sensed glucose level 207 & 209 and a model predictive control value 205. Therefore, Steil clearly discloses the limitation that the controller programmed to provide an insulin delivery control signal as a function of the sensed glucose level in accordance with a model predictive control.
wherein the model predictive control forecasts glucose levels over a prediction horizon (e.g., block 330, the metabolic model of the MPC algorithm is used to generate a predicted glucose concentration profile over a prediction horizon based on the current glucose concentration, para [0144], & Fig. 16); and
wherein the delivery control signal is further based on a patient parameter (e.g., measured glucose concentration, and/or historical meal); and
a medication delivery device (infusion pump) in communication with the controller 12 and configured to deliver insulin in accordance with the insulin delivery control signal (a commands 22); wherein the controller is further configured to adjust delivery of insulin based on a safety check (e.g., adjusting an amount of insulin when the glucose concentration is high or low).
Steil does not disclose that: a) the controller is configured to adjust delivery of insulin based on a detecting occlusion of the medication delivery device; b) wherein the controller is further configured to cap delivery of insulin to a maximum delivery rate that is based on a pre-programmed basal rate.
John discloses a drug delivery system comprising: a controller unit 22 is configured to detecting a safety check of occlusion of the medication delivery device DDS, col. 19, lines 25-28; wherein the DDS can automatically modify/adjust a previous delivery regimen based upon recent trends in the history of the implantee in order to compensate for variations in the implantee’s schedule, col. 19, lines 30-34. Based on the statement above, a person skilled in the art would recognize that the controller is configured to adjust delivery of insulin based on the occlusion. For example: when the occlusion happens in the medication delivery device, the amount of insulin being delivered into a patient in zero or very little amount and therefore, it will be affecting of high blood glucose, i.e., hyperglycemic in the patient. As mentioned in the above, the controller of the DDS can automatically modify the previous delivery regimen (can modify the insulin doses into the patient) to compensate with the occlusion to prevent the hyperglycemic symptom.
Giving the teaching from John, it would have been obvious to one of ordinary skill in the art, prior to the effective filling date of the claimed invention to modify the device system of Steil with providing a function of adjusting delivery of insulin when detecting occlusion of the medication delivery device, as taught by John, in order to prevent of hyperglycemia because of lacking amount injected insulin into a patient during occlusion.
Steil (or Steil in view of John) does not disclose that: the controller is further configured to cap delivery of insulin to a maximum delivery rate that is based on a pre-programmed basal rate.
Mastrototaro discloses a system 14 comprising: a glucose sensor 10 configured to provide a sensor glucose measurement signal 16 representative of sensed glucose level 18 in a body of a patient, see S500 (Fig. 12) or S600 (Fig. 13); determined a sensor error parameter of the glucose sensor (e.g., detection of a sensor failure and a request for sensor replacement should be initiated..., col. 10, line 25-32; real-time calibration adjustment can be performed to account for changes in sensor sensitivity during the lifespan of the glucose sensor 26 and to detect when a sensor fails, col. 14, lines 5-8; if the Target is not achieved or maintained, then the insulin delivery system must account for: 1) an inaccurate blood glucose level is detected, 2) the sensitivity of the glucose sensor 26 is changed, or 3) the glucose sensor 26 is faulty before changing insulin delivery parameters, col. 14, lines 34-39; the supervisory model may be able to detect not only sensor error, but catheter problems as well, col. 18, lines 7-8);
a medication delivery device 34 in communication with a controller 12 and configured to deliver insulin in accordance with the insulin delivery control signal; where in the controller is configured to adjust delivery of insulin, col. 13, lines 15-17; wherein the controller is further configured to cap delivery of insulin to a maximum delivery rate that is based on a pre-programmed basal rate, col.13, lines 15-19 & lines 33-45.
Giving the teaching from Mastrototaro, it would have been obvious to one of ordinary skill in the art, prior to the effective filling date of the claimed invention to modify the device system of Steil in view of John with providing a controller being configured to cap delivery of insulin to a maximum delivery rate that is based on a pre-programmed basal rate, as taught by Mastrototaro, in order to prevent of hypoglycemia because of over amount injected insulin into a patient.
Regarding claim 2, Steil in view of John and Mastrototaro discloses all the claimed subject matter as required. Steil further discloses that wherein the model predictive control is based on a glucoregulatory model (e.g., various insulin delivery patterns, para [0139], total insulin amount delivered, para [0146]).
Regarding claim 10, Steil in view of John and Mastrototaro discloses all the claimed subject matter as required. Steil further discloses that wherein the insulin delivery comprises at least an insulin basal rate, paras [0128-0129].
Regarding claim 11, Steil in view of John and Mastrototaro discloses all the claimed subject matter as required. Steil further discloses that wherein the insulin delivery control signal comprises at least an insulin bolus amount, see abstract, paras [0007-0008].
Regarding claim 14, Steil in view of John and Mastrototaro discloses all the claimed subject matter as required. Steil shows in Figs. 15a-15b that the safety check comprises reducing delivery of insulin (see line 203 in Fig. 15a) when the sensed glucose levels 209 (in Fig. 15b) are decreasing. For example: the dotted lines 207 (sensor glucose values) or dots 209 (meter values) are decreasing from 11-12hrs in Fig. 15b, at this time periods, the amount of insulin delivery 203 is also decreasing, in Fig. 15a.
Regarding claim 21, Steil in view of John and Mastrototaro discloses all the claimed subject matter as required. Mastrototaro also discloses that the insulin delivery parameter or the patient parameter comprises a total daily dose of insulin, col. 11, lines 24-35.
Regarding claims 22 & 27, Steil in view of John and Mastrototaro discloses all the claimed subject matter as required. As mentioned in the claim 1, Mastrototaro discloses that the controller being configured to cap delivery of insulin to a maximum delivery rate that is based on a pre-programmed basal rate. In other words, if the basal rate is adjusted and consistently reaches the maximum boundary. In this case the controller does not automatically allow the insulin delivery system 14 to deliver insulin to the patient at the adjusted basal . The action will be performed at S 560 (e.g., perform safety action). Therefore, Steil in view of John and Mastrototaro discloses that the adjustment of the delivery of insulin based on the safety check comprises limiting the delivery of insulin to a pre-programmed basal rate when occlusion is detected.
It is noted that the claim 27 is rejected used the same analysis as noted in the claims 1 & 22 above.
Regarding claim 23, Steil in view of John and Mastrototaro discloses all the claimed subject matter as required. Steil shows in Figs. 15a-15b that the safety check comprises stopping insulin delivery when the sensed glucose level is below a low glucose level. The Fig. 15b shows that the glucose concentration (dotted line 27 or dot 29) is about 60-70 at around 11:45 hr-12:30 hr, during this time period, the insulin delivery is zero, see lines 203 in Fig. 15a.
Regarding claim 28, as discussed in the rejection claim1 above, Steil in view of John and Mastrototaro discloses the limitation that using the model predict control algorithm to forecast glucose levels; and the safety check comprises detecting occlusion of the medication delivery device. As we know that when the occlusion happens, the amount of insulin is delivered either zero or less than the programmed insulin amount into a patient. Therefore, during the occlusion stage, the blood glucose level will be raised up into the patient. Thus, a person skilled in the art would recognize that using the MPC method is to be inferred occlusion. For example: Steil shows in Fig. 15b that: x-axis, at time (hr) from 0-11, or 15-16 hr, the glucose concentration values are above 130 mg/dl (by using MPC to forecast the glucose levels). During these time period, a person skilled in the art would recognize that the occlusion is possibly inferred based on the forecast- high glucose levels via the MPC.
Regarding claim 29, Steil in view of John and Mastrototaro discloses all the claimed subject matter as required. Mastrototaro further states in col. 13, lines 20-32 that: For example, a predefined boundary may be set at 25% above or below the preset basal rate for any given time interval. In the preferred embodiment, 25% is chosen so that the amount of insulin makes only small changes to the blood glucose value over a longer period of time. However, this boundary can be defined at any percentage or value above or below a preset basal rate. Therefore, a person skilled in the art would recognize that the maximum delivery rate is being in a range of two to five times the pre-programmed basal rate, since it has been held that discovering this value of a result effective variable involves only routine skill in the art., e.g., for example: depending on each of condition of patient who needs to consume in certain amount of insulin per day.
Regarding claim 30, Steil in view of John and Mastrototaro discloses all the claimed subject matter as required. Steil further discloses in para [0067] that: the digital sensor values Dsig are calibrated with respect to one or more glucose reference values (fingerstick reference, see Fig. 15b). The glucose reference values are entered into the calibrator and compared to the digital sensor values Dsig. The calibrator applies a calibration algorithm to convert the digital sensor values Dsig, which are typically in counts into blood glucose values. In particular embodiments, the calibration method is of the type described in U.S. patent application Ser. No. 09/511,580, filed on Feb. 23, 2000, entitled "GLUCOSE MONITOR CALIBRATION METHODS", which is incorporated by reference herein.
Based on the statement in para [0067] above, the Fig. 15b in Steil shows the different between a plasma glucose level 209 and the sensor glucose measurement signal sensor 207 (Dsig value) at 209a or at 20-21hrs (sensor failure). In other words, the calibration error is at 209a (or at 20-21hrs as shown in Fig. 15b).
Note: The application No. ‘580 (US 6424847) as mentioned in the para [0067] in Steil, incorporated with the device in Steil, the US’847 discloses a sensor error parameter comprises calibration error; the calibration error is indicative of a different between a plasma glucose level (reference glucose values, col. 11, lines 39-45 in US847) and the sensor glucose measurement signal (Valid ISIG value); wherein the different in between the two values (plasma glucose and ISIG) are out of range limit to determine a calibration error, col. 10, line 26-col. 15, line 36, also claim 1 in US’847.
In addition, Mastrototaro’313 states that: real-time calibration adjustment can be performed to account for changes in sensor sensitivity during the lifespan of the glucose sensor 26 and to detect when a sensor fails, col. 14, lines 5-8; the infusion system wishes to immediately calibrate the glucose sensor 26 after determining that the Target is not achieved, col. 14, lines 42-44, also see claim 2 in Mastrototaro).
Regarding claim 31, Steil in view of John and Mastrototaro discloses all the claimed subject matter as required. Steil further discloses that the calibration error is indicative of a different between a plastic glucose sensor (meter value-fingerstick reference 209) and the sensor glucose measurement signal 207 at 20hrs-22hrs in Fig. 15b.
Regarding claim 32, Steil in view of John and Mastrototaro discloses all the claimed subject matter as required. Steil further discloses that the sensor error parameter comprises glucose sensor drop out information 209a & line 207 after 20hrs in Fig. 15b.
Claims 15-16, 19-20, 25-26 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Steil et al. (US 2008/0183060) in view of John (US 7,811,279).
Regarding claim 15, Steil discloses a method in Figs. 1-17 comprising:
Sensing with a glucose sensor 10/26, a glucose level and providing a sensor glucose measurement signal 16 representative of sensed glucose level 18 to a controller 12, in Fig. 1;
determining a sensed glucose level 18 based on the sensor glucose measurement signal 16 and sensor error parameter of the glucose sensor 209a (in Fig. 15b), (also see para [0142] states that: the sensor has failed and must be replaced); and
providing, with the controller, an insulin delivery control signal (e.g., a software/programming to generate commands 22 for the insulin delivery system, para [0055-0056]) as a function of the sensed glucose level (e.g., an infusion system for regulating the rate of fluid infusion, i.e., insulin delivery parameter, into a body of a user based on glucose concentration measurement taken from the body, para [0045]; the sensor signal 16 is provided directly to the user, who then determines based on the blood glucose level 18, the amount and timing of insulin delivery to the body, para [0059]; the delivery system is controlled automatically based on sensor reading, col. 16, lines 64-65), in accordance with a model predictive control (a model predictive -MP), step 220 in Fig. 14 or solid curved line 205 in Fig. 15b);
Note: in addition, the insulin delivery information 203 (in Fig. 15a) correlates to the sensed glucose level 207 & 209 and a model predictive control value 205. Therefore, Steil clearly discloses the limitation that the controller programmed to provide an insulin delivery control signal as a function of the sensed glucose level in accordance with a model predictive control.
wherein the model predictive control forecasts glucose levels over a prediction horizon (e.g., block 330, the metabolic model of the MPC algorithm is used to generate a predicted glucose concentration profile over a prediction horizon based on the current glucose concentration, para [0144], & Fig. 16); and
delivering insulin, by a medication delivery device 14/34 in communication with the controller 12, in accordance with the insulin delivery control signal via commands 22, see Fig. 1, para [0054]
wherein the controller is further configured to adjust delivery of insulin based on a safety check (e.g., adjusting an amount of insulin when the glucose concentration is high or low).
Steil does not disclose a method of adjusting delivery of insulin based on the safety check; wehrien the safety check comprising detecting occlusion of the medication delivery device.
John discloses a drug delivery system comprising: a controller unit 22 is configured to detecting a safety check of occlusion of the medication delivery device DDS, col. 19, lines 25-28; wherein the DDS can automatically modify/adjust a previous delivery regimen based upon recent trends in the history of the implantee in order to compensate for variations in the implantee’s schedule, col. 19, lines 30-34. Based on the statement above, a person skilled in the art would recognize that the controller is configured to adjust delivery of insulin based on the occlusion. For example: when the occlusion happens in the medication delivery device, the amount of insulin being delivered into a patient in zero or very little amount and therefore, it will be affecting of high blood glucose, i.e., hyperglycemic in the patient. As mentioned in the above, the controller of the DDS can automatically modify the previous delivery regimen (can modify the insulin doses into the patient) to compensate with the occlusion to prevent the hyperglycemic symptom.
Giving the teaching from John, it would have been obvious to one of ordinary skill in the art, prior to the effective filling date of the claimed invention to modify the device system of Steil with providing a function of adjusting delivery of insulin when detecting occlusion of the medication delivery device, as taught by John, in order to prevent of hyperglycemia because of lacking amount injected insulin into a patient during occlusion.
Regarding claim 16, Steil in view of John discloses all the claimed subject matter as required. Steil further discloses that wherein the model predictive control is based on a glucoregulatory model (e.g., various insulin delivery patterns, para [0139], total insulin amount delivered, para [0146]).
Regarding claim 19, Steil in view of John discloses all the claimed subject matter as required. Steil further discloses that wherein the insulin delivery comprises at least an insulin basal rate, paras [0128-0129].
Regarding claim 20, Steil in view of John discloses all the claimed subject matter as required. Steil further discloses that wherein the insulin delivery control signal comprises at least an insulin bolus amount, see abstract, paras [0007-0008].
Regarding claim 25, Steil in view of John discloses all the claimed subject matter as required. Steil shows in Figs. 15a-15b that the safety check comprises stopping insulin delivery when the sensed glucose level is below a low glucose level. The Fig. 15b shows that the glucose concentration (dotted line 27 or dot 29) is about 60-70 at around 11:45 hr-12:30 hr, during this time period, the insulin delivery is zero, see lines 203 in Fig. 15a.
Regarding claim 26, Steil in view of John discloses all the claimed subject matter as required. Steil shows in Figs. 15a-15b that the safety check comprises reducing delivery of insulin (see line 203 in Fig. 15a) when the sensed glucose levels 209 (in Fig. 15b) are decreasing. For example: the dotted lines 207 (sensor glucose values) or dots 209 (meter values) are decreasing from 11-12hrs in Fig. 15b, at this time periods, the amount of insulin delivery 203 is also decreasing, in Fig. 15a.
Claim 21 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Steil et al. (US 2008/0183060) in view of John (US 7,811,279) & Mastrototaro (US 7,785,313) and further in view of Blomquist (US 7,751,907).
In case Applicant disagrees with the rejectin of claim 21 above, the claim 21 is alternatively rejected as below.
Steil in view of John & Mastrototaro discloses the invention substantially as claimed. Assuming that Steil in view of John & Mastrototaro fails to disclose the limitation that the patient parameter comprises a total daily dose of insulin.
Blomquist discloses a drug delivery device system comprising: a glucose sensor configured to provide a sensor glucose measurement signal representative of sensed glucose level in a body of a patient, a controller programmed to receive the sensor glucose measurement signal and to provide an insulin delivery control signal (e.g., the insulin pump setting is a basal rate, col. 4, line 11); wherein the delivery control signal is based on a patient parameter, such as total daily dose of insulin, col. 4, lines 11-30.
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 Steil in view of John & Mastrototaro with providing a delivery control signal being based on total daily dose of insulin, as taught by Blomquist, in order to keep the glucose level in a control level without overdose of insulin being injected into the patient.
Claims 1-2, 10-11, 14, 22-23, 29-32 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Steil et al. (US 2008/0183060) in view of Sparks et al. (US 7,879,241) and Mastrototaro (US 7,785,313).
Regarding claim 1, Steil discloses a system, Figs. 1-17 comprising:
a glucose sensor 10 or 26 configured to provide a sensor glucose measurement signal 16 representative of sensed glucose level 18 in a body a patient;
a controller 12, in Fig. 1, programmed to:
determine a sensed glucose level 18 based on the sensor glucose measurement 16 and sensor error parameter of the glucose sensor 209a (in Fig. 15b), also see para [0142] states that: the sensor has failed and must be replaced; and
provide an insulin delivery control signal (e.g., a software/programming to generate commands 22 for the insulin delivery system, para [0055-0056]) as a function of the received sensor glucose measurement signal 16, (e.g., an infusion system for regulating the rate of fluid infusion, i.e., insulin delivery parameter, into a body of a user based on glucose concentration measurement taken from the body, para [0045]; the sensor signal 16 is provided directly to the user, who then determines based on the blood glucose level 18, the amount and timing of insulin delivery to the body, para [0059]; the delivery system is controlled automatically based on sensor reading, col. 16, lines 64-65), in accordance with a model predictive control (a model predictive -MP), step 220 in Fig. 14 or solid curved line 205 in Fig. 15b);
Note: in addition, the insulin delivery information 203 (in Fig. 15a) correlates to the sensed glucose level 207 & 209 and a model predictive control value 205. Therefore, Steil clearly discloses the limitation that the controller programmed to provide an insulin delivery control signal as a function of the sensed glucose level in accordance with a model predictive control.
wherein the model predictive control forecasts glucose levels over a prediction horizon (e.g., block 330, the metabolic model of the MPC algorithm is used to generate a predicted glucose concentration profile over a prediction horizon based on the current glucose concentration, para [0144], & Fig. 16); and
wherein the delivery control signal is further based on a patient parameter (e.g., measured glucose concentration, and/or historical meal); and
a medication delivery device (infusion pump) in communication with the controller 12 and configured to deliver insulin in accordance with the insulin delivery control signal (a commands 22); wherein the controller is further configured to adjust delivery of insulin based on a safety check (e.g., adjusting an amount of insulin when the glucose concentration is high or low).
Steil does not disclose that: a) the controller is configured to adjust delivery of insulin based on a detecting occlusion of the medication delivery device; b) wherein the controller is further configured to cap delivery of insulin to a maximum delivery rate that is based on a pre-programmed basal rate.
Sparks discloses a drug delivery system 10 comprising: a control unit 80; a sensor unit 12, a safety limits can also be programmed into the system 10 to prevent overdose or warn if occlusions... The control interface can also receive inputs from other sensors integrated into the system 10 to sense bodily responses, such as glucose…, and then adjust or halt the medication delivery rate if necessary, see col. 7, lines 47-55. In other words, the controller 80 in Sparks is configured to adjust delivery of insulin based on a safety check, i.e., occlusion.
Giving the teaching from Sparks, it would have been obvious to one of ordinary skill in the art, prior to the effective filling date of the claimed invention to modify the device system of Steil with providing a function of adjusting delivery of insulin when detecting occlusion of the medication delivery device, as taught by Sparks, in order to prevent of hyperglycemia because of lacking amount injected insulin into a patient during occlusion.
Steil in view of Sparks does not disclose that the controller is further configured to cap delivery of insulin to a maximum delivery rate that is based on a pre-programmed basal rate.
Mastrototaro discloses a system 14 comprising: a glucose sensor 10 configured to provide a sensor glucose measurement signal 16 representative of sensed glucose level 18 in a body of a patient, see S500 (Fig. 12) or S600 (Fig. 13); determined a sensor error parameter of the glucose sensor (e.g., detection of a sensor failure and a request for sensor replacement should be initiated..., col. 10, line 25-32; real-time calibration adjustment can be performed to account for changes in sensor sensitivity during the lifespan of the glucose sensor 26 and to detect when a sensor fails, col. 14, lines 5-8; if the Target is not achieved or maintained, then the insulin delivery system must account for: 1) an inaccurate blood glucose level is detected, 2) the sensitivity of the glucose sensor 26 is changed, or 3) the glucose sensor 26 is faulty before changing insulin delivery parameters, col. 14, lines 34-39; the supervisory model may be able to detect not only sensor error, but catheter problems as well, col. 18, lines 7-8);
a medication delivery device 34 in communication with a controller 12 and configured to deliver insulin in accordance with the insulin delivery control signal; where in the controller is configured to adjust delivery of insulin, col. 13, lines 15-17; wherein the controller is further configured to cap delivery of insulin to a maximum delivery rate that is based on a pre-programmed basal rate, col.13, lines 15-19 & lines 33-45.
Giving the teaching from Mastrototaro, it would have been obvious to one of ordinary skill in the art, prior to the effective filling date of the claimed invention to modify the method and device system of Steil in view of Sparks with providing a controller being configured to cap delivery of insulin to a maximum delivery rate that is based on a pre-programmed basal rate, as taught by Mastrototaro, in order to prevent of hypoglycemia because of over amount injected insulin into a patient.
Regarding claim 2, Steil in view of Sparks and Mastrototaro discloses all the claimed subject matter as required. Steil discloses that wherein the model predictive control is based on a glucoregulatory model (e.g., various insulin delivery patterns, para [0139], total insulin amount delivered, para [0146]).
Regarding claim 10, Steil in view of Sparks and Mastrototaro discloses all the claimed subject matter as required. Steil discloses that wherein the insulin delivery comprises at least an insulin basal rate, paras [0128-0129].
Regarding claim 11, Steil in view of Sparks and Mastrototaro discloses all the claimed subject matter as required. Steil discloses that wherein the insulin delivery control signal comprises at least an insulin bolus amount, see abstract, paras [0007-0008].
Regarding claim 14, Steil in view of Sparks and Mastrototaro discloses all the claimed subject matter as required. Steil shows in Figs. 15a-15b that the safety check comprises reducing delivery of insulin (see line 203 in Fig. 15a) when the sensed glucose levels 209 (in Fig. 15b) are decreasing. For example: the dotted lines 207 (sensor glucose values) or dots 209 (meter values) are decreasing from 11-12hrs in Fig. 15b, at this time periods, the amount of insulin delivery 203 is also decreasing, in Fig. 15a.
Regarding claim 22, Steil in view of Sparks and Mastrototaro discloses all the claimed subject matter as required. As mentioned in the claim 1 above, Sparks discloses a drug delivery system 10 comprising: a control unit 80; a sensor unit 12, a safety limits can also be programmed into the system 10 to prevent overdose or warn if occlusions... The control interface can also receive inputs from other sensors integrated into the system 10 to sense bodily responses, such as glucose…, and then adjust or halt the medication delivery rate if necessary, see col. 7, lines 47-55. In other words, the method of adjusting or halting the medication delivery rate is equivalent to the claimed limitation, i.e., limiting the delivery of insulin to a pre-programmed basal rate when occlusion is detected.
In addition, Mastrototaro discloses that the controller being configured to cap delivery of insulin to a maximum delivery rate that is based on a pre-programmed basal rate. In other words, if the basal rate is adjusted and consistently reaches the maximum boundary. In this case the controller does not automatically allow the insulin delivery system 14 to deliver insulin to the patient at the adjusted basal . The action will be performed at S 560 (e.g., perform safety action). In addition, Spark also states that safety limits are programmed into the system 10 to preven overdose, col. 7, lines 47-49. Therefore, Steil in view of John and Mastrototaro discloses that the adjustment of the delivery of insulin based on the safety check comprises limiting the delivery of insulin to a pre-programmed basal rate to prevent overdose even when occlusion is detected.
Regarding claim 23, Steil in view of Sparks and Mastrototaro discloses all the claimed subject matter as required. Steil shows in Figs. 15a-15b that the safety check comprises stopping insulin delivery when the sensed glucose level is below a low glucose level. The Fig. 15b shows that the glucose concentration (dotted line 27 or dot 29) is about 60-70 at around 11:45 hr-12:30 hr, during this time period, the insulin delivery is zero, see lines 203 in Fig. 15a.
Regarding claim 29, Steil in view of Sparks and Mastrototaro discloses all the claimed subject matter as required. Mastrototaro further states in col. 13, lines 20-32 that: For example, a predefined boundary may be set at 25% above or below the preset basal rate for any given time interval. In the preferred embodiment, 25% is chosen so that the amount of insulin makes only small changes to the blood glucose value over a longer period of time. However, this boundary can be defined at any percentage or value above or below a preset basal rate. Therefore, a person skilled in the art would recognize that the maximum delivery rate is being in a range of two to five times the pre-programmed basal rate, since it has been held that discovering this value of a result effective variable involves only routine skill in the art., e.g., for example: depending on each of condition of patient who needs to consume in certain amount of insulin per day.
Regarding claim 30, Steil in view of Sparks and Mastrototaro discloses all the claimed subject matter as required. Steil further discloses in para [0067] that: the digital sensor values Dsig are calibrated with respect to one or more glucose reference values (fingerstick reference, see Fig. 15b). The glucose reference values are entered into the calibrator and compared to the digital sensor values Dsig. The calibrator applies a calibration algorithm to convert the digital sensor values Dsig, which are typically in counts into blood glucose values. In particular embodiments, the calibration method is of the type described in U.S. patent application Ser. No. 09/511,580, filed on Feb. 23, 2000, entitled "GLUCOSE MONITOR CALIBRATION METHODS", which is incorporated by reference herein.
Based on the statement in para [0067] above, the Fig. 15b in Steil shows the different between a plasma glucose level 209 and the sensor glucose measurement signal sensor 207 (Dsig value) at 209a or at 20-21hrs (sensor failure). In other words, the calibration error is at 209a (or at 20-21hrs as shown in Fig. 15b).
Note: The application No. ‘580 (US 6424847) as mentioned in the para [0067] in Steil, incorporated with the device in Steil, the US’847 discloses a sensor error parameter comprises calibration error; the calibration error is indicative of a different between a plasma glucose level (reference glucose values, col. 11, lines 39-45 in US847) and the sensor glucose measurement signal (Valid ISIG value); wherein the different in between the two values (plasma glucose and ISIG) are out of range limit to determine a calibration error, col. 10, line 26-col. 15, line 36, also claim 1 in US’847.
In addition, Mastrototaro’313 states that: real-time calibration adjustment can be performed to account for changes in sensor sensitivity during the lifespan of the glucose sensor 26 and to detect when a sensor fails, col. 14, lines 5-8; the infusion system wishes to immediately calibrate the glucose sensor 26 after determining that the Target is not achieved, col. 14, lines 42-44, also see claim 2 in Mastrototaro’313).
Regarding claim 31, Steil in view of Sparks and Mastrototaro discloses all the claimed subject matter as required. Steil further discloses that the calibration error is indicative of a different between a plastic glucose sensor (meter value-fingerstick reference 209) and the sensor glucose measurement signal 207 at 20hrs-22hrs in Fig. 15b.
Regarding claim 32, Steil in view of Sparks and Mastrototaro discloses all the claimed subject matter as required. Steil further discloses that the sensor error parameter comprises glucose sensor drop out information 209a & line 207 after 20hrs in Fig. 15b.
Claim 21 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Steil et al. (US 2008/0183060) in view of Sparks et al. (US 7,879,241) & Mastrototaro (US 7,785,313) and further in view of Blomquist (US 7,751,907).
Steil in view of Sparks and Mastrototaro discloses the invention substantially as claimed except for the limitations that the patient parameter comprises a total daily dose of insulin.
Blomquist discloses a drug delivery device system comprising: a glucose sensor configured to provide a sensor glucose measurement signal representative of sensed glucose level in a body of a patient, a controller programmed to receive the sensor glucose measurement signal and to provide an insulin delivery control signal (e.g., the insulin pump setting is a basal rate, col. 4, line 11); wherein the delivery control signal is based on a patient parameter, such as total daily dose of insulin, col. 4, lines 11-30.
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 Steil in view of Sparks and Mastrototaro with providing a delivery control signal being based on total daily dose of insulin, as taught by Blomquist, in order to keep the glucose level in a control level without overdose of insulin being injected into the patient.
Claims 15-16, 19-20, 25-27 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Steil et al. (US 2008/0183060) in view of Sparks et al. (US 7,879,241).
Regarding claim 15, Steil discloses a method in Figs. 1-17 comprising:
sensing with a glucose sensor 10/26, a glucose level and providing a sensor glucose measurement signal 16 representative of sensed glucose level 18 to a controller 12, in Fig. 1;
determining a sensed glucose level 18 based on the sensor glucose measurement signal 16 and sensor error parameter of the glucose sensor 209a (in Fig. 15b), (also see para [0142] states that: the sensor has failed and must be replaced); and
providing, with the controller, an insulin delivery control signal (e.g., a software/programming to generate commands 22 for the insulin delivery system, para [0055-0056]) as a function of the sensed glucose level (e.g., an infusion system for regulating the rate of fluid infusion, i.e., insulin delivery parameter, into a body of a user based on glucose concentration measurement taken from the body, para [0045]; the sensor signal 16 is provided directly to the user, who then determines based on the blood glucose level 18, the amount and timing of insulin delivery to the body, para [0059]; the delivery system is controlled automatically based on sensor reading, col. 16, lines 64-65), in accordance with a model predictive control (a model predictive -MP), step 220 in Fig. 14 or solid curved line 205 in Fig. 15b);
Note: in addition, the insulin delivery information 203 (in Fig. 15a) correlates to the sensed glucose level 207 & 209 and a model predictive control value 205. Therefore, Steil clearly discloses the limitation that the controller programmed to provide an insulin delivery control signal as a function of the sensed glucose level in accordance with a model predictive control.
wherein the model predictive control forecasts glucose levels over a prediction horizon (e.g., block 330, the metabolic model of the MPC algorithm is used to generate a predicted glucose concentration profile over a prediction horizon based on the current glucose concentration, para [0144], & Fig. 16); and
delivering insulin, by a medication delivery device 14/34 in communication with the controller 12, in accordance with the insulin delivery control signal via commands 22, see Fig. 1, para [0054]
wherein the controller is further configured to adjust delivery of insulin based on a safety check (e.g., adjusting an amount of insulin when the glucose concentration is high or low).
Steil does not disclose a method of adjusting delivery of insulin based on the safety check; wehrien the safety check comprising detecting occlusion of the medication delivery device.
Sparks discloses a drug delivery system 10 comprising: a control unit 80; a sensor unit 12, a safety limits can also be programmed into the system 10 to prevent overdose or warn if occlusions... The control interface can also receive inputs from other sensors integrated into the system 10 to sense bodily responses, such as glucose…, and then adjust or halt the medication delivery rate if necessary, see col. 7, lines 47-55. In other words, the controller 80 in Sparks is configured to adjust delivery of insulin based on a safety check, i.e., occlusion.
Giving the teaching from Sparks, it would have been obvious to one of ordinary skill in the art, prior to the effective filling date of the claimed invention to modify the method and device system of Steil with providing a function of adjusting delivery of insulin when detecting occlusion of the medication delivery device, as taught by Sparks, in order to prevent of hyperglycemia because of lacking amount injected insulin into a patient during occlusion.
Regarding claim 16, Steil in view of Sparks discloses all the claimed subject matter as required. Steil discloses that wherein the model predictive control is based on a glucoregulatory model (e.g., various insulin delivery patterns, para [0139], total insulin amount delivered, para [0146]).
Regarding claim 19, Steil in view of Sparks discloses all the claimed subject matter as required. Steil discloses that wherein the insulin delivery comprises at least an insulin basal rate, paras [0128-0129].
Regarding claim 20, Steil in view of Sparks discloses all the claimed subject matter as required. Steil discloses that wherein the insulin delivery control signal comprises at least an insulin bolus amount, see abstract, paras [0007-0008].
Regarding claim 25, Steil in view of Sparks discloses all the claimed subject matter as required. Steil shows in Figs. 15a-15b that the safety check comprises stopping insulin delivery when the sensed glucose level is below a low glucose level. The Fig. 15b shows that the glucose concentration (dotted line 27 or dot 29) is about 60-70 at around 11:45 hr-12:30 hr, during this time period, the insulin delivery is zero, see lines 203 in Fig. 15a.
Regarding claim 26, Steil in view of Sparks discloses all the claimed subject matter as required. Steil shows in Figs. 15a-15b that the safety check comprises reducing delivery of insulin (see line 203 in Fig. 15a) when the sensed glucose levels 209 (in Fig. 15b) are decreasing. For example: the dotted lines 207 (sensor glucose values) or dots 209 (meter values) are decreasing from 11-12hrs in Fig. 15b, at this time periods, the amount of insulin delivery 203 is also decreasing, in Fig. 15a.
Regarding claim 27, Steil in view of Sparks discloses all the claimed subject matter as required. As mentioned in the claim 15 above, Sparks discloses a drug delivery system 10 comprising: a control unit 80; a sensor unit 12, a safety limits can also be programmed into the system 10 to prevent overdose or warn if occlusions... The control interface can also receive inputs from other sensors integrated into the system 10 to sense bodily responses, such as glucose…, and then adjust or halt the medication delivery rate if necessary, see col. 7, lines 47-55. In other words, the method of adjusting or halting the medication delivery rate is equivalent to the claimed limitation, i.e., limiting the delivery of insulin to a pre-programmed basal rate when occlusion is detected.
Note: incase Applicant disagrees with the rejection 27 above, the claim 27 is alternatively being rejected using same analysis as noted in the claim 22 above (e.g. Steil in view of Sparks and Mastrototaro).
Response to Arguments
Applicant's arguments filed 12/26/25 have been fully considered but they are not persuasive.
1) Applicant argues that Steil fails to disclose or suggest determining a sensed glucose level based on sensor glucose measurement signal from a glucose sensor and a sensor error parameter.
In response, Steli clearly discloses the limitations that: sensing with a glucose sensor 10/26, a glucose level and providing a sensor glucose measurement signal 16 representative of sensed glucose level 18 to a controller 12, in Fig. 1; determining a sensed glucose level 18 based on the sensor glucose measurement signal 16 and sensor error parameter of the glucose sensor 209a (in Fig. 15b), (also see para [0142] states that: the sensor has failed and must be replaced).
2) Applicant argues that Steil’s error function does not relate to a sensor error parameter such as calibration error or sensor dropout as recited in new dependent claims 30 & 32.
In response, Steil further discloses in para [0067] that: the digital sensor values Dsig are calibrated with respect to one or more glucose reference values (fingerstick reference, see Fig. 15b). The glucose reference values are entered into the calibrator and compared to the digital sensor values Dsig. The calibrator applies a calibration algorithm to convert the digital sensor values Dsig, which are typically in counts into blood glucose values.
The calibration error is indicative of a different between a plasma glucose level and the sensor glucose measurement signal (as mentioned in claim 31). In this case, the Fig. 15b in Steil clearly shows that the different between a plasma glucose level 209 and the sensor glucose measurement signal sensor 207 at 209a or at 20-21hrs. In other words, the calibration error is at 209a (or at 20-21hrs as shown in Fig. 15b). The Fig. 15b also shows that the sensor error parameter (line 207) comprises glucose sensor dropout information (at 20-22hrs).
Note: The application No. ‘580 (US 6424847) as mentioned in the para [0067] in Steil, incorporated with the device in Steil, the US’847 discloses a sensor error parameter comprises calibration error; the calibration error is indicative of a different between a plasma glucose level (reference glucose values, col. 11, lines 39-45 in US847) and the sensor glucose measurement signal (Valid ISIG value); wherein the different in between the two values (plasma glucose and ISIG) are out of range limit to determine a calibration error, col. 10, line 26-col. 15, line 36, also claim 1 in US’847.
In addition, Mastrototaro’313 states that: real-time calibration adjustment can be performed to account for changes in sensor sensitivity during the lifespan of the glucose sensor 26 and to detect when a sensor fails, col. 14, lines 5-8; the infusion system wishes to immediately calibrate the glucose sensor 26 after determining that the Target is not achieved, col. 14, lines 42-44, also see claim 2 in Mastrototaro’313).
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
Any inquiry concerning this communication or earlier communications from the examiner should be directed to QUYNH-NHU HOANG VU whose telephone number is (571)272-3228. The examiner can normally be reached on M-F 7:30 am-4:00 pm.
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/Quynh-Nhu H. Vu/
Quynh-Nhu H Vu
Primary Examiner, Art Unit 3783
Prosecution Insights