DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application is being examined under the pre-AIA first to invent provisions.
Response to Amendment
2. According to the Amendment, filed 26 March 2025, the status of the claims is as follows:
Claims 21-40 are new; and
Claims 1-20 are cancelled.
Claim Interpretation
3. The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
4. The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
5. This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
“a data transmitter unit” in claims 21 and 33; and
“an insulin delivery device” in claims 21 and 33.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 102
6. 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.
7. Claims 21-40 are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Steil et al., U.S. Patent No. 6,558,351 B1 (“Steil”).
As to Claim 21, Steil teaches the following:
A system (“closed loop drug delivery system”, not labeled) for automatically updating a basal insulin profile (see “This invention relates to closed loop drug delivery systems and more specifically to systems for controlling the infusion rate of insulin based on continuously monitored body glucose levels.” in col. 1, ll. 16-19, and see fig. 1), the system comprising:
a glucose monitoring system (“glucose sensor system”) 10 (see “Generally, the glucose sensor system 10 includes a glucose sensor, sensor electrical components to provide power to the sensor and generate the sensor signal 16, a sensor communication system to carry the sensor signal 16 to the controller 12, and a sensor system housing for the electrical components and the sensor communication system.” in col. 8, ll. 17-22), comprising:
a glucose sensor (“sensor”) 26 comprising a portion (“sensing end”) 40 configured to be placed subcutaneously in contact with a bodily fluid of a user (see “Preferred embodiments of the invention include a sensor 26, a sensor set 28, … all worn on the body 20 of a user, as shown in FIG. 2. … A sensing end 40 of the sensor 26 has exposed electrodes 42 and is inserted through skin 46 into a subcutaneous tissue 44 of a user's body 20, as shown in FIG. 3 (d) and 4. The electrodes 42 are in contact with interstitial fluid (ISF) that is present throughout the subcutaneous tissue 44. The sensor 26 is held in place by the sensor set 28, which is adhesively secured to the user's skin 46, as shown in FIGS. 3(c) and 3(d).” in col. 8, l. 57, to col. 9, l. 5), and
a data transmitter unit (“telemetered characteristic monitor”) 30 configured to receive signals from the glucose sensor 26 and to transmit information corresponding to real-time glucose levels (see “The telemetered characteristic monitor 30 includes a monitor housing 31 that supports a printed circuit board 33, batteries 35, antenna (not shown), and a sensor cable connector (not shown), as seen in FIG. 3(a) and 3(b). … The electrical components 39 sample the sensor signal 16 and store digital sensor values (Dsig) in a memory and then periodically transmit the digital sensor values Dsig from the memory to the controller 12, which is included in the infusion device.” in col. 8, l. 61, to col. 9, l. 14); and
an insulin delivery device (“controller 12” and “infusion device 34”) 12/34 in wireless communication with the glucose monitoring system 10 and configured to deliver insulin to the user (see “The glucose sensor system 10 generates a sensor signal 16 representative of blood glucose levels 18 in the body 20, and provides the sensor signal 16 to the controller 12. The controller 12 receives the sensor signal 16 and generates commands 22 that are communicated to the insulin delivery system 14. The insulin delivery system 14 receives the commands 22 and infuses insulin 24 into the body 20 in response to the commands 22.” in col. 8, ll. 9-16), wherein the insulin delivery device 12/34 comprises a processor (“controller”) 12 coupled to a memory storing instructions that, when executed by the processor, cause the processor to (see “Typically, the controller 12 includes controller electrical components and software to generate commands for the insulin delivery system 14 based on the sensor signal 16, and a controller communication system to receive the sensor signal 16 and carry commands to the insulin delivery system 14.” in col. 8, ll. 23-29):
retrieve a basal insulin profile and one or more insulin therapy parameters from the memory, wherein the one or more insulin therapy parameters comprise an insulin absorption rate (“insulin clearance rate k”) and an insulin sensitivity factor (“insulin sensitivity S.sub.I”) (see “In particular embodiments, two parameters, the insulin sensitivity S.sub.I and the insulin clearance rate k, are measured for each individual. In other embodiments, the insulin clearance rate k is estimated from literature given the individual's body weight. In other particular embodiments, longer or shorter insulin clearance times are used. In still other embodiments, all of the parameters are estimated. In additional embodiments, one or more parameters are measured, while at least one parameter is estimated from literature.” in col. 13, ll. 56-64; and see “In particular embodiments, the controller gains for a user are selected based on measurements of insulin sensitivity, insulin clearing time, insulin appearance time, insulin concentration, body weight, body fat percentage, body metabolism, or other body characteristics such as pregnancy, age, heart conditions, or the like.” in col. 14, ll. 12-18),
determine a rate of change of the glucose levels over a predetermined time period (see “After the digital sensor values Dsig are evaluated, and if necessary, modified by the pre-filter 400, the digital sensor values Dsig are passed to the filter 402. The filter 402 may be used to reduce noise in particular frequency bands. Generally the body's blood glucose level 18 changes relatively slowly compared to a rate at which digital sensor values Dsig are collected.” in col. 24, ll. 16-22),
adjust at least one of the one or more insulin therapy parameters (see “In alternative embodiments, a post-controller lead-lag compensator 522 is used to modify the commands (U.sub.PID) to compensate for the insulin delivery delay and/or the insulin clearance rate k, as shown in FIG. 37. The greater of the delay time constants, P.sub.3, may be compensated for using the post-controller lead-lag compensator.” in col. 20, ll. 20-24),
determine an updated basal insulin profile based on the adjusted insulin therapy parameter, real-time glucose levels, and the rate of change of the glucose levels (see “The PID controller generates commands (U.sub.PID) for a desired insulin delivery rate into the blood plasma. The commands U.sub.PID are calculated and issued periodically depending on the update rate for the control loop, which is selected based on a maximum anticipated rate of change of the blood glucose level, an insulin delivery system minimum insulin dosage, insulin sensitivity, a maximum and a minimum acceptable glucose concentration, or the like. The commands U.sub.PID are used as inputs to the post-controller lead-lag compensator 522.” in col. 20, ll. 24-33), and
cause administration of the updated basal insulin profile (see “In particular embodiments, the insulin delivery system provides finite insulin doses into the body in response to commands from the controller. The smallest amount of insulin that the insulin delivery system can deliver is the minimum finite insulin dose. The controller may generate commands for a dose of insulin to be delivered that is not a whole number multiple of the minimum finite insulin dose.” in col. 20, ll. 61-65).
As to Claim 22, Steil teaches the following:
wherein the insulin delivery device 34 comprises an infusion pump (not labeled) (see “Preferably, the infusion device 34 responds to the commands 22 and actuates a plunger 48 that forces insulin 24 out of a reservoir 50 located inside the infusion device 34, as shown in FIG. 5.” in col. 9, ll. 17-20, and see fig. 5).
As to Claim 23, Steil teaches the following:
wherein the infusion pump (not labeled) comprises an infusion set (“infusion set”) 38 and a cannula (“cannula”) 56 configured to be placed through a skin of the user (see “A second end 53 of the infusion tube 36 connects to the infusion set 38. Insulin 24 is forced through the infusion tube 36 into the infusion set 38 and into the body 16. … As part of the infusion set 38, a cannula 56 extends through the skin 46 and terminates in the subcutaneous tissue 44 completing fluid communication between the reservoir 50 and the subcutaneous tissue 44 of the user's body 16.” in col. 9, ll. 23-31).
As to Claim 24, Steil teaches the following:
wherein the insulin delivery device is in wireless communication with the glucose monitoring system by a Bluetooth communication protocol (see “In further embodiments, the glucose reference values are entered into a supplemental device where the calibration is executed. In alternative embodiments, a blood glucose meter is in communication with the infusion device 34, telemetered characteristic monitor transmitter 30 or supplemental device so that glucose reference values may be transmitted directly into the device that the blood glucose meter is in communication with. In additional alternative embodiments, the blood glucose meter is part of the infusion device 34, telemetered characteristic monitor transmitter 30 or supplemental device such as that shown in U.S. patent application Ser. No. 09/334,996, filed on Jun. 17, 1999, entitled "CHARACTERISTIC MONITOR WITH A CHARACTERISTIC METER AND METHOD OF USING THE SAME", which is incorporated by reference herein.” in col. 27, ll. 17-31).
As to Claim 25, Steil teaches the following:
wherein the glucose monitoring system 10 comprises a strip port (“test interface”) 302 configured to receive a test strip (“test strip”) 350 for testing blood glucose levels (see “In additional alternative embodiments, the blood glucose meter is part of the infusion device 34, telemetered characteristic monitor transmitter 30 or supplemental device such as that shown in U.S. patent application Ser. No. 09/334,996, filed on Jun. 17, 1999, entitled "CHARACTERISTIC MONITOR WITH A CHARACTERISTIC METER AND METHOD OF USING THE SAME", which is incorporated by reference herein.” in col. 27, ll. 17-31, which incorporates by reference U.S. patent application no. 09/334,996, which discloses “As shown in Fig. 2, a test strip 350 for holding an analyte sample is inserted into the test interface 302. This activates the characteristic test meter 304 and the microprocessor 216. The characteristic test meter 304 analyzes the characteristics and sends the analysis results to the microprocessor 216, which displays the results on the display 208 and stores the results in the RAM 206 for later review.” in page 12).
As to Claim 26, Steil teaches the following:
wherein the blood glucose levels are used to calibrate the glucose sensor 26 (see “In further embodiments, the glucose reference values are entered into a supplemental device where the calibration is executed. In alternative embodiments, a blood glucose meter is in communication with the infusion device 34, telemetered characteristic monitor transmitter 30 or supplemental device so that glucose reference values may be transmitted directly into the device that the blood glucose meter is in communication with. In additional alternative embodiments, the blood glucose meter is part of the infusion device 34, telemetered characteristic monitor transmitter 30 or supplemental device such as that shown in U.S. patent application Ser. No. 09/334,996, filed on Jun. 17, 1999, entitled "CHARACTERISTIC MONITOR WITH A CHARACTERISTIC METER AND METHOD OF USING THE SAME", which is incorporated by reference herein.” in col. 27, ll. 17-31).
As to Claim 27, Steil teaches the following:
wherein the processor 12 is configured to cause administration of the updated basal insulin profile upon receipt of an input from the user to execute the updated basal insulin profile (see “In other alternative embodiments, the user or another individual may manually override the control system or select a different controller algorithm. For instance, in particular alternative embodiments, an individual may select to normalize to a basal glucose level immediately, and instead of using the .beta.-cell emulating PID controller another controller would take over such as a PID controller with different gains, a PD controller for rapid glucose adjustment, or the like. Additional alternative embodiments allow an individual to turn off the integral component of the PID controller once the glucose level is normalized and no meals are anticipated. In other particular alternative embodiments, the user may select to turn off the controller entirely, therefore disengaging the closed loop system. Once the closed loop system is not controlling insulin dosing, the user may program the infusion device with a basal rate, variable basal rates, boluses, or the like, or the user may manually enter each individual dosage when it is needed.” in col. 31, l. 55, to col. 32, l. 5).
As to Claim 28, Steil teaches the following:
wherein the at least one insulin therapy parameter is updated based on the rate of change of the glucose levels (see “The PID controller generates commands (U.sub.PID) for a desired insulin delivery rate into the blood plasma. The commands U.sub.PID are calculated and issued periodically depending on the update rate for the control loop, which is selected based on a maximum anticipated rate of change of the blood glucose level, an insulin delivery system minimum insulin dosage, insulin sensitivity, a maximum and a minimum acceptable glucose concentration, or the like. The commands U.sub.PID are used as inputs to the post-controller lead-lag compensator 522.” in col. 20, ll. 24-33).
As to Claim 29, Steil teaches the following:
wherein the processor 12 is further caused to determine a projected glucose level based on the rate of change of the glucose levels (see “The PID controller generates commands (U.sub.PID) for a desired insulin delivery rate into the blood plasma. The commands U.sub.PID are calculated and issued periodically depending on the update rate for the control loop, which is selected based on a maximum anticipated rate of change of the blood glucose level, an insulin delivery system minimum insulin dosage, insulin sensitivity, a maximum and a minimum acceptable glucose concentration, or the like. The commands U.sub.PID are used as inputs to the post-controller lead-lag compensator 522.” in col. 20, ll. 24-33).
As to Claim 30, Steil teaches the following:
wherein the one or more insulin therapy parameters that are adjusted comprises the insulin absorption rate and the insulin sensitivity factor (see “In alternative embodiments, a post-controller lead-lag compensator 522 is used to modify the commands (U.sub.PID) to compensate for the insulin delivery delay and/or the insulin clearance rate k, as shown in FIG. 37. The greater of the delay time constants, P.sub.3, may be compensated for using the post-controller lead-lag compensator.” in col. 20, ll. 20-24).
As to Claim 31, Steil teaches the following:
wherein the predetermined period of time is 15 minutes to 6 hours (see “In particular embodiments, the amount of time dt over which the derivative of the sensor resistance Rs is taken is the entire time since the last calibration. In other embodiments, the amount of time dt over which the derivative is taken is fixed, for example over the last hour, 90 minutes, 2 hours, or the like.” in col. 34, ll. 19-24).
As to Claim 32, Steil teaches the following:
wherein the basal insulin profile is a pre-programmed basal insulin profile (see “In preferred embodiments, the controller 12 is designed to model a pancreatic beta cell (.beta.-cell). In other words, the controller 12 commands the infusion device 34 to release insulin 24 into the body 20 at a rate that causes the insulin concentration in the blood to follow a similar concentration profile as would be caused by fully functioning human .beta.-cells responding to blood glucose concentrations in the body 20.” in col. 9, ll. 42-49).
As to Claim 33, Steil teaches the following:
A method for automatically updating a basal insulin profile (see “This invention relates to closed loop drug delivery systems and more specifically to systems for controlling the infusion rate of insulin based on continuously monitored body glucose levels.” in col. 1, ll. 16-19, and see fig. 1), the method comprising:
collecting signals by a glucose monitoring system (“glucose sensor system”) 10 (see “Generally, the glucose sensor system 10 includes a glucose sensor, sensor electrical components to provide power to the sensor and generate the sensor signal 16, a sensor communication system to carry the sensor signal 16 to the controller 12, and a sensor system housing for the electrical components and the sensor communication system.” in col. 8, ll. 17-22) comprising a glucose sensor (“sensor”) 26 having a portion (“sensing end”) 40 placed subcutaneously in contact with a bodily fluid of a user (see “Preferred embodiments of the invention include a sensor 26, a sensor set 28, … all worn on the body 20 of a user, as shown in FIG. 2. … A sensing end 40 of the sensor 26 has exposed electrodes 42 and is inserted through skin 46 into a subcutaneous tissue 44 of a user's body 20, as shown in FIG. 3 (d) and 4. The electrodes 42 are in contact with interstitial fluid (ISF) that is present throughout the subcutaneous tissue 44. The sensor 26 is held in place by the sensor set 28, which is adhesively secured to the user's skin 46, as shown in FIGS. 3(c) and 3(d).” in col. 8, l. 57, to col. 9, l. 5);
transmitting information corresponding to real-time glucose levels by a data transmitter unit (“telemetered characteristic monitor”) 30 that receives signals from the glucose sensor 26 (see “The telemetered characteristic monitor 30 includes a monitor housing 31 that supports a printed circuit board 33, batteries 35, antenna (not shown), and a sensor cable connector (not shown), as seen in FIG. 3(a) and 3(b). … The electrical components 39 sample the sensor signal 16 and store digital sensor values (Dsig) in a memory and then periodically transmit the digital sensor values Dsig from the memory to the controller 12, which is included in the infusion device.” in col. 8, l. 61, to col. 9, l. 14);
retrieving, by a processor (“controller”) 12 of an insulin delivery device (“controller 12” and “infusion device 34”) 12/34 in wireless communication with the glucose monitoring system 10 (see “The glucose sensor system 10 generates a sensor signal 16 representative of blood glucose levels 18 in the body 20, and provides the sensor signal 16 to the controller 12. The controller 12 receives the sensor signal 16 and generates commands 22 that are communicated to the insulin delivery system 14. The insulin delivery system 14 receives the commands 22 and infuses insulin 24 into the body 20 in response to the commands 22.” in col. 8, ll. 9-16), a basal insulin profile and one or more insulin therapy parameters from a memory coupled to the processor 12 (see “Typically, the controller 12 includes controller electrical components and software to generate commands for the insulin delivery system 14 based on the sensor signal 16, and a controller communication system to receive the sensor signal 16 and carry commands to the insulin delivery system 14.” in col. 8, ll. 23-29), wherein the one or more insulin therapy parameters comprise an insulin absorption rate (“insulin clearance rate k”) and an insulin sensitivity factor (“insulin sensitivity S.sub.I”) (see “In particular embodiments, two parameters, the insulin sensitivity S.sub.I and the insulin clearance rate k, are measured for each individual. In other embodiments, the insulin clearance rate k is estimated from literature given the individual's body weight. In other particular embodiments, longer or shorter insulin clearance times are used. In still other embodiments, all of the parameters are estimated. In additional embodiments, one or more parameters are measured, while at least one parameter is estimated from literature.” in col. 13, ll. 56-64; and see “In particular embodiments, the controller gains for a user are selected based on measurements of insulin sensitivity, insulin clearing time, insulin appearance time, insulin concentration, body weight, body fat percentage, body metabolism, or other body characteristics such as pregnancy, age, heart conditions, or the like.” in col. 14, ll. 12-18),
determining, by the processor 12, a rate of change of the glucose levels over a predetermined time period (see “After the digital sensor values Dsig are evaluated, and if necessary, modified by the pre-filter 400, the digital sensor values Dsig are passed to the filter 402. The filter 402 may be used to reduce noise in particular frequency bands. Generally the body's blood glucose level 18 changes relatively slowly compared to a rate at which digital sensor values Dsig are collected.” in col. 24, ll. 16-22);
adjusting, by the processor 12, at least one of the one or more insulin therapy parameters (see “In alternative embodiments, a post-controller lead-lag compensator 522 is used to modify the commands (U.sub.PID) to compensate for the insulin delivery delay and/or the insulin clearance rate k, as shown in FIG. 37. The greater of the delay time constants, P.sub.3, may be compensated for using the post-controller lead-lag compensator.” in col. 20, ll. 20-24); and
determining, by the processor 12, an updated basal insulin profile based on the adjusted insulin therapy parameter, the real-time glucose levels, and the rate of change of the glucose levels (see “The PID controller generates commands (U.sub.PID) for a desired insulin delivery rate into the blood plasma. The commands U.sub.PID are calculated and issued periodically depending on the update rate for the control loop, which is selected based on a maximum anticipated rate of change of the blood glucose level, an insulin delivery system minimum insulin dosage, insulin sensitivity, a maximum and a minimum acceptable glucose concentration, or the like. The commands U.sub.PID are used as inputs to the post-controller lead-lag compensator 522.” in col. 20, ll. 24-33); and
causing, by the processor 12, administration of the update basal insulin profile (see “In particular embodiments, the insulin delivery system provides finite insulin doses into the body in response to commands from the controller. The smallest amount of insulin that the insulin delivery system can deliver is the minimum finite insulin dose. The controller may generate commands for a dose of insulin to be delivered that is not a whole number multiple of the minimum finite insulin dose.” in col. 20, ll. 61-65).
As to Claim 34, Steil teaches the following:
wherein the insulin delivery device 34 comprises an infusion pump (not labeled) (see “Preferably, the infusion device 34 responds to the commands 22 and actuates a plunger 48 that forces insulin 24 out of a reservoir 50 located inside the infusion device 34, as shown in FIG. 5.” in col. 9, ll. 17-20, and see fig. 5).
As to Claim 35, Steil teaches the following:
wherein the information corresponding to real-time glucose levels is transmitted by the data transmitter unit 30 to the insulin delivery device 12/34 via a Bluetooth communication protocol (see “In further embodiments, the glucose reference values are entered into a supplemental device where the calibration is executed. In alternative embodiments, a blood glucose meter is in communication with the infusion device 34, telemetered characteristic monitor transmitter 30 or supplemental device so that glucose reference values may be transmitted directly into the device that the blood glucose meter is in communication with. In additional alternative embodiments, the blood glucose meter is part of the infusion device 34, telemetered characteristic monitor transmitter 30 or supplemental device such as that shown in U.S. patent application Ser. No. 09/334,996, filed on Jun. 17, 1999, entitled "CHARACTERISTIC MONITOR WITH A CHARACTERISTIC METER AND METHOD OF USING THE SAME", which is incorporated by reference herein.” in col. 27, ll. 17-31).
As to Claim 36, Steil teaches the following:
wherein the one or more insulin therapy parameters that are adjusted comprises the insulin absorption rate and the insulin sensitivity factor (see “In alternative embodiments, a post-controller lead-lag compensator 522 is used to modify the commands (U.sub.PID) to compensate for the insulin delivery delay and/or the insulin clearance rate k, as shown in FIG. 37. The greater of the delay time constants, P.sub.3, may be compensated for using the post-controller lead-lag compensator.” in col. 20, ll. 20-24).
As to Claim 37, Steil teaches the following:
receiving a test strip (“test strip”) 350 in a strip port (“test interface”) 302 of the glucose monitoring system 10, and measuring a blood glucose level using the test strip 350 (see “In additional alternative embodiments, the blood glucose meter is part of the infusion device 34, telemetered characteristic monitor transmitter 30 or supplemental device such as that shown in U.S. patent application Ser. No. 09/334,996, filed on Jun. 17, 1999, entitled "CHARACTERISTIC MONITOR WITH A CHARACTERISTIC METER AND METHOD OF USING THE SAME", which is incorporated by reference herein.” in col. 27, ll. 17-31, which incorporates by reference U.S. patent application no. 09/334,996, which discloses “As shown in Fig. 2, a test strip 350 for holding an analyte sample is inserted into the test interface 302. This activates the characteristic test meter 304 and the microprocessor 216. The characteristic test meter 304 analyzes the characteristics and sends the analysis results to the microprocessor 216, which displays the results on the display 208 and stores the results in the RAM 206 for later review.” in page 12).
As to Claim 38, Steil teaches the following:
calibrating the glucose sensor 26 using the blood glucose level measured using the test strip (see “In further embodiments, the glucose reference values are entered into a supplemental device where the calibration is executed. In alternative embodiments, a blood glucose meter is in communication with the infusion device 34, telemetered characteristic monitor transmitter 30 or supplemental device so that glucose reference values may be transmitted directly into the device that the blood glucose meter is in communication with. In additional alternative embodiments, the blood glucose meter is part of the infusion device 34, telemetered characteristic monitor transmitter 30 or supplemental device such as that shown in U.S. patent application Ser. No. 09/334,996, filed on Jun. 17, 1999, entitled "CHARACTERISTIC MONITOR WITH A CHARACTERISTIC METER AND METHOD OF USING THE SAME", which is incorporated by reference herein.” in col. 27, ll. 17-31).
As to Claim 39, Steil teaches the following:
receiving an input from the user to execute the updated basal insulin profile prior to causing administration of the updated basal insulin profile (see “In other alternative embodiments, the user or another individual may manually override the control system or select a different controller algorithm. For instance, in particular alternative embodiments, an individual may select to normalize to a basal glucose level immediately, and instead of using the .beta.-cell emulating PID controller another controller would take over such as a PID controller with different gains, a PD controller for rapid glucose adjustment, or the like. Additional alternative embodiments allow an individual to turn off the integral component of the PID controller once the glucose level is normalized and no meals are anticipated. In other particular alternative embodiments, the user may select to turn off the controller entirely, therefore disengaging the closed loop system. Once the closed loop system is not controlling insulin dosing, the user may program the infusion device with a basal rate, variable basal rates, boluses, or the like, or the user may manually enter each individual dosage when it is needed.” in col. 31, l. 55, to col. 32, l. 5).
As to Claim 40, Steil teaches the following:
outputting an alert based on the rate of change of the glucose levels (see “In particular embodiments, the rate of change of the sensor resistance dRs/dt may be compared to two thresholds as shown in FIG. 32. If dRs/dt exceeds a `replacement` threshold then a warning is provided to the user to replace the sensor. If dRs/dt exceeds a `recalibrate` threshold then a warning is provided to the user to recalibrate the sensor.” in col. 33, ll. 56-65).
Conclusion
8. Any inquiry concerning this communication or earlier communications from the examiner should be directed to NAVIN NATNITHITHADHA whose telephone number is (571)272-4732. The examiner can normally be reached Monday - Friday 8:00 am - 8:00 am - 4:00 pm.
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/NAVIN NATNITHITHADHA/Primary Examiner, Art Unit 3791 02/19/2026