DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
The amendment filed June 11, 2026 has been entered. Claims 1-23 remain pending in the application. Applicant’s amendments to the claims and associated remarks have overcome the objections and rejections under 35 U.S.C. 101 and 35 USC 112 previously set forth in the Non-Final Office Action mailed March 11, 2026.
Claim Objections
Claim 1 is objected to because there is a lack of antecedent basis for “the process” in lines 17-18 as opposed to “the iterative process”. Appropriate correction is required.
Claim 18 is objected to because there is a lack of antecedent basis for “the respective time window” in line 13. Appropriate correction is required.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1-6 and 11-13 are rejected under 35 U.S.C. 103 as being unpatentable over Sloan et al. (US 20120232520) in view of Patek et al. (US 20230338654).
Regarding claim 1, Sloan discloses a medicament delivery device (“the health monitor devices disclosed herein may be included in and/or integrated with, a medication delivery device and/or system, e.g., an insulin pump module, such as an insulin pump or controller module thereof” [0265]) configured for delivering basal medicament doses to a type two diabetes patient (“the long-acting insulin dosage calculation function may be based upon Levemir.RTM. insulin, available from Novo Nordisk. Levemir.RTM. is a long-acting insulin indicated for once- or twice-daily subcutaneous administration for the treatment of adult and pediatric patients with type 1 diabetes mellitus or adult patients with type 2 diabetes mellitus who require basal (long-acting) insulin for the control of hyperglycemia” [0119]), comprising:
a non-transitory computer-readable storage medium (memory device 670; [0082]) storing computer programming instructions (“The instructions for a long-acting medication dosage calculation function may be in the form of software stored on the memory device 670” [0117]); and
a processor (processor 660) configured for executing the computer programming instructions (“The instructions for a long-acting medication dosage calculation function may be in the form of software stored on the memory device 670 (FIG. 6B) and executed by the processor 660 (FIG. 6B) of the health monitor device 600.” [0117]), wherein executing the computer programming instructions causes the processor to (method described in Figure 39 and paragraphs [0494-0495]):
establish an initial basal medicament delivery rate for a type two diabetes patient (“Based on the information the user entered, the health monitor device determines suggested initial insulin doses for the user for various times of day (e.g., morning, breakfast, lunch and dinner) (3904).” [0494]; “The health monitor device may also display the previous basal insulin dosage amount.” [0495]);
receive glucose level readings of the type two diabetes patient over an initial time window (“the previous week” [0494]) since establishing the initial basal medicament delivery rate (“the health monitor device may display the average of the user's fasting blood glucose values over a preceding time period and the user's target blood glucose range (3910).” [0495]);
as part of a titration, adjust the initial basal medicament delivery rate to a new delivery rate for the type two diabetes patient based on the received glucose level readings (“the health monitor device may suggest that the user decrease their dose of insulin if more than one-half of the mealtime blood glucose measurements for the previous week were below their target blood glucose level…the health monitor device may suggest that the user increase their dose of insulin if more than one-half of the mealtime blood glucose measurements for the previous week were above their target blood glucose level.” [0494]; “Next, the health monitor device may display the suggested new dose of basal insulin for the user (3912).” [0495]; Figure 39); and
cause delivery of basal medicament to the type two diabetes patient at the new delivery rate for a next time window (“The medication delivery device may be configured to administer a dose of medication, such as insulin, into a patient based on a prescribed medication dosage, and may be automatically updated with medication dosage information and/or determined analyte concentration received from the analyte monitoring device” [0367]; “Next, the health monitor device may display the suggested new dose of basal insulin for the user (3912)…The user may then confirm whether the user wants to use the suggested basal insulin dosage amount as the user's new basal insulin dosage amount by pressing the yes or the no button (3913).” [0495]).
Sloan fails to explicitly disclose the titration is an iterative process in which adjustments in the initial basal medicament delivery rate and the new delivery rate are made until the process settles on an ongoing basal medicament rate that provides a predetermined level of glucose level control for the type two diabetes patient.
Patek teaches a medicament delivery device (Figure 10) configured for delivering basal medicament doses to a type two diabetes patient (“a CGM-driven basal insulin titration system and method for patients with Type 2 Diabetes.” [0050]), comprising a processor (processor 130) configured to execute computer programming instructions that cause the processor to: as part of a titration, adjust an initial basal medicament delivery rate to a new delivery rate; wherein the titration is an iterative process in which adjustments in the initial basal medicament delivery rate and the new delivery rate are made until the process settles on an ongoing basal medicament rate that provides a predetermined level of glucose level control for the type two diabetes patient (via Termination Checker 180 [0157-0171]: “a CGM-driven basal insulin titration system and method for patients with Type 2 Diabetes. The system and method can be adapted to the needs and concerns of subjects just starting on basal insulin therapy. As explained in more detail below, the method uses an inputs historical CGM, basal insulin dose information, reports of hypoglycemia, and past recommendations and generates an adjusted insulin dose along with a report advising whether to continue the titration process, or to stop. The method can generate a new recommendation on a regular basis (e.g., each day) until it determines an adequate, consistent dose size.” [0050]; “the Termination Checker Submodule 410 checks what elements in a given list of termination criteria are verified…three different criteria can terminate the titration process: a. The seven past elements of the Estimated Fasting Blood Glucose History are all within the desired target range and the seven past elements of Time Below 70 Indicator History are all below a desired target and the seven past elements of Time Below 54 Indicator History are all below a desired target and there are no elements in the Hypo Event History with a timestamp within the past seven days. b. The seven past Adjusted Doses obtained from the last elements of Recommendation History are equal to zero.” [0167-0169]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the titration process of Patek to include the titration is an iterative process in which adjustments in the initial basal medicament delivery rate and the new delivery rate are made until the process settles on an ongoing basal medicament rate that provides a predetermined level of glucose level control for the type two diabetes patient based on the teachings of Patek to allow for automatic determination of a stable, safe and effective dosage of medication to manage type two diabetes in a manner that limits human error (Patek [0005]).
Regarding claim 2, Sloan discloses the medicament delivery device of claim 1, wherein processor is further configured to receive input and establish the initial basal medicament delivery rate based at least in part on the received input (Figures 39, see all of [0494-0495]).
Regarding claim 3, Sloan discloses the medicament delivery device of claim 2, wherein the input includes at least one of an age of the patient, a weight of the patient (“To set up the insulin dose titration feature of the health monitor device a user, a health care professional, or a user under the direction of a health care professional may begin by entering the user's weight” [0494]), a gender of the patient, a starting medicament dose (“After pressing the dose they want to adjust, the health monitor device will display a screen showing the suggested dose, and the user may increase or decrease the suggested dose by pressing the up or down arrow buttons (3905)” [0494]), or a titration frequency (“the adjusted dose level may be determined according to a predetermined schedule. For instance, a patient may determine an adjusted dose level every 3 days, or every 4 days, or every 5 days, or every 6 days, or once a week, or every ten days, or every 14 days, or every 16 days, or every two weeks, or every three weeks, or every month, and the like. In some instances, the predetermined schedule is determined by a health care professional and/or a patient and stored in a memory 670 of the health monitor device 600.” [0135]; “the health monitor device may suggest that the user decrease their dose of insulin if more than one-half of the mealtime blood glucose measurements for the previous week were below their target blood glucose level.” [0494]).
Regarding claim 4, Sloan discloses the medicament delivery device of claim 3, wherein the input includes a titration frequency and the titration frequency determines a length of the initial time window and the next time window (“the adjusted dose level may be determined according to a predetermined schedule. For instance, a patient may determine an adjusted dose level every 3 days, or every 4 days, or every 5 days, or every 6 days, or once a week, or every ten days, or every 14 days, or every 16 days, or every two weeks, or every three weeks, or every month, and the like. In some instances, the predetermined schedule is determined by a health care professional and/or a patient and stored in a memory 670 of the health monitor device 600.” [0135]; “the health monitor device may suggest that the user decrease their dose of insulin if more than one-half of the mealtime blood glucose measurements for the previous week were below their target blood glucose level.” [0494].
Regarding claim 5, Sloan discloses the medicament delivery device of claim 2, wherein the input is received wirelessly from a management device that manages the medicament delivery device (“the health monitor device is configured to wirelessly communicate with a server device via the communication interface…The server device could be another portable device, such as a smart phone” [0272]).
Regarding claim 6, Sloan discloses the medicament delivery device of claim 5, wherein the management device is a smartphone (“the health monitor device is configured to wirelessly communicate with a server device via the communication interface…The server device could be another portable device, such as a smart phone” [0272]).
Regarding claim 11, Sloan discloses the medicament delivery device of claim 1, wherein the processor is further configured to adjust the new delivery rate based on time of day (“Based on the information the user entered, the health monitor device determines suggested initial insulin doses for the user for various times of day (e.g., morning, breakfast, lunch and dinner) (3904). The user may adjust the suggested initial insulin doses by pressing the dose they want to adjust…the health monitor device may suggest that the user decrease their dose of insulin if more than one-half of the mealtime blood glucose measurements for the previous week were below their target blood glucose level. In addition, the user may set the number of units the health monitor device will suggest that the user increase the initial insulin dose by if the user's blood glucose measurements are above their target blood glucose level (3908). For instance, the health monitor device may suggest that the user increase their dose of insulin if more than one-half of the mealtime blood glucose measurements for the previous week were above their target blood glucose level.” [0494], wherein the new delivery rate is based in part on a mealtime blood glucose measurement from a specific time of day).
Regarding claim 12, Sloan discloses the medicament delivery device of claim 1, wherein the processor is further configured to remove an impact of meal consumption on the received glucose level readings in setting the new delivery rate (“the health monitor device may display the average of the user's fasting blood glucose values over a preceding time period and the user's target blood glucose range (3910)…the health monitor device may display the suggested new dose of basal insulin for the user (3912).” [0495], wherein using fasting blood glucose values would remove an impact of meal consumption).
Regarding claim 13, Sloan discloses the medicament delivery device of claim 1, wherein the basal medicament is insulin, a glucagon- like peptide-1 (GLP-1) receptor agonist, a glucose-dependent insulinotropic polypeptide (GIP) receptor agonist, a dual GLP-1 and GIP receptor agonist, an antihyperglycemic, or a co- formulation thereof (“the medication delivery device is configured to deliver a drug (e.g., insulin) to a patient (e.g., a patient with diabetes) based on the analyte (e.g., glucose) level measured by the health monitor device.” [0367]).
Claims 7-8 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Sloan et al. (US 20120232520) in view of Patek et al. (US 20230338654) as applied in claim 1 above, and further in view of El-Khatib et al. (US 20220189604), herein after El-Khatib(US).
Regarding claim 7, modified Sloan discloses the medicament delivery device of claim 1.
Modified Sloan fails to explicitly disclose the processor is further configured to receive a request to pause medicament delivery and to pause delivery of medicament in response to receipt of the request.
El-Khatib(US) discloses a medicament delivery device (ambulatory medical device 4402) comprising a processor configured for executing programming instructions (“signal processing component 4404 includes a processor, memory, and storage” [0646]) that cause the processor to be configured to receive a request to pause medicament delivery and to pause delivery of medicament in response to receipt of the request (“When the user 3214 has made a duration selection on the pause screen 3404, the pause screen 3406 shows the user 3214 the duration 3414 that the user 3214 selected (e.g., in the figure the user 3214 selected 1 hour. Thus the medicament delivery is suspended for 1 hour after the suspension begins).” [0489], see also [0488] and Figure 34).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the processor of the medicament delivery device of Sloan to be configured to receive a request to pause medicament delivery and to pause delivery of medicament in response to receipt of the request based on the teachings of El-Khatib(US) to prevent hypoglycemia by suspending medicament delivery when the patient has lower insulin needs, such as when exercising (El-Khatib(US) [0471]).
Regarding claim 8, modified Sloan discloses the medicament delivery device of claim 1.
Modified Sloan fails to explicitly disclose the processor is further configured to receive an indication that the patient will be in a state that will require less medicament during a portion of the next time window and is further configured to reduce the new medicament delivery rate during the portion.
El-Khatib(US) discloses a medicament delivery device (ambulatory medical device 4402) comprising a processor configured for executing programming instructions (“signal processing component 4404 includes a processor, memory, and storage” [0646]) that cause the processor to receive an indication that the patient will be in a state that will require less medicament during a portion of the next time window and is further configured to reduce the new medicament delivery rate during the portion (“the ability to suspend delivery of insulin during situations such as exercise, which has a blood glucose lowering effect. Suspension of insulin delivery can prevent a subject from entering a hypoglycemic state” [0471]; “When the user 3214 has made a duration selection on the pause screen 3404, the pause screen 3406 shows the user 3214 the duration 3414 that the user 3214 selected (e.g., in the figure the user 3214 selected 1 hour. Thus the medicament delivery is suspended for 1 hour after the suspension begins).” [0489], see also [0488] and Figure 34).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the processor of the medicament delivery device of Sloan to be configured to receive an indication that the patient will be in a state that will require less medicament during a portion of the next time window and is further configured to reduce the new medicament delivery rate during the portion based on the teachings of El-Khatib(US) to prevent hypoglycemia by suspending medicament delivery when the patient has lower insulin needs, such as when exercising (El-Khatib(US) [0471]).
Regarding claim 10, modified Sloan discloses the medicament delivery device of claim 1.
Modified Sloan fails to explicitly disclose the processor is further configured to receive input indicating that the type two diabetes patient is about to sleep or about to begin an activity that will lower their glucose level and to adjust the new delivery rate to a lower delivery rate to compensate.
El-Khatib(US) discloses a medicament delivery device (ambulatory medical device 4402) comprising a processor configured for executing programming instructions (“signal processing component 4404 includes a processor, memory, and storage” [0646]) that cause the processor to receive input indicating that the diabetes patient is about to sleep or about to begin an activity that will lower their glucose level and to adjust the new delivery rate to a lower delivery rate to compensate (“the ability to suspend delivery of insulin during situations such as exercise, which has a blood glucose lowering effect. Suspension of insulin delivery can prevent a subject from entering a hypoglycemic state” [0471]; “When the user 3214 has made a duration selection on the pause screen 3404, the pause screen 3406 shows the user 3214 the duration 3414 that the user 3214 selected (e.g., in the figure the user 3214 selected 1 hour. Thus the medicament delivery is suspended for 1 hour after the suspension begins).” [0489], see also [0488] and Figure 34; wherein the “input” is the user selection on the pause screen 3404 and suspending delivery is considered to be adjusting the new delivery rate).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the processor of the medicament delivery device of Sloan to be configured to receive input indicating that the type two diabetes patient is about to sleep or about to begin an activity that will lower their glucose level and to adjust the new delivery rate to a lower delivery rate to compensate based on the teachings of El-Khatib(US) to prevent hypoglycemia by suspending medicament delivery when the patient has lower insulin needs, such as when exercising (El-Khatib(US) [0471]).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Sloan et al. (US 20120232520) in view of El-Khatib et al. (WO 2022235714), herein after El-Khatib(WO).
Regarding claim 9, Sloan discloses the medicament delivery device of claim 1.
Sloan fails to explicitly disclose the processor is further configured to detect that a glucose level for the patient is below a threshold and to suspend delivery of medicament in response to the detecting.
El-Khatib(WO) discloses a medicament delivery device (glucose level control system 200) comprising a processor (processor 204) configured to detect that a glucose level for the patient is below a threshold and to suspend delivery of medicament in response to the detecting (“At block 3712, the system determines that at least one hypoglycemic event criterion is satisfied, such as a hypoglycemic event criterion described herein. At block 3716, the system instructs the medicament pump to suspend delivery of at least one of the basal doses and/or the correction doses of medicament.” [0586]; Figure 29; “where determining that at least one hypoglycemic event criterion is satisfied includes determining that the glucose level is equal to or less than a critical low threshold level” [0047]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the processor of the medicament delivery device of Sloan to be configured to detect that a glucose level for the patient is below a threshold and to suspend delivery of medicament in response to the detecting based on the teachings of El-Khatib(WO) to prevent hypoglycemia by suspending medicament delivery (El-Khatib(WO) [0586]).
Claims 14-15 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Mensinger et al. (US 20190392937) in view of Simpson et al. (US 20090299156) in further view of Sloan et al. (US 20120232520).
Regarding claim 14, Mensinger discloses a management device (companion device 5) for a medicament delivery device (pen device 10; “The system 100 includes a pen device 10 in wireless communication with a mobile computing and communication device 5 of a patient user, also referred to as the user's companion device.” [0027]), said management device comprising:
a non-transitory computer-readable storage medium storing computer programming instructions (“the memory can include and store processor-executable code” [0036]);
a display (“display unit of the companion device 5” [0036]); and
a processor configured for executing the computer programming instructions (“the memory can include and store processor-executable code, which when executed by the processor, configures the data processing unit to perform various operations, e.g., such as receiving information, commands, and/or data, processing information and data, and transmitting or providing information/data to another device.” [0036]), wherein executing the computer programming instructions causes the processor to:
transmit a command signal to the medicament delivery device (pen device 10), wherein the command signal causes the medicament delivery device to initiate an iterative, time-windowed basal medicament delivery rate titration protocol (“method 500 for adjusting an insulin dose calculation using a basal titration protocol in accordance with the present technology. In various implementations, the method 500 can be implemented by the app associated with the pen device 10” [0102], see all of [0102] and Figure 5; see also additional iterative basal titration protocols in [0048]).
Mensinger fails to explicitly disclose display on the display a user interface to obtain input regarding gender, age and weight of the patient; obtain the input regarding gender, age and weight of the patient; initiate the iterative time-windowed based medicament delivery rate titration protocol using the obtained input regarding gender, age, and weight of the patient; receive, from the medicament delivery device, a proposed adjusted basal medicament delivery rate generated by the medicament delivery device as part of the iterative, time-windowed basal medicament delivery rate titration protocol; and prompt the patient, via the user interface displayed on the display, to accept or reject the proposed adjusted basal medicament delivery rate.
Simpson teaches a management device (system 10) for a medicament delivery device (“the system 10 is operably connected to and/or integrated with a secondary medical device 120 configured to deliver the medicament to the host, such as an infusion pump, for example (see FIG. 1).” [0126]), said management device comprising: a display (user interface 216 having LCD 216e); and a processor (processor module 206) configured for executing computer programming instructions (“a processor module 206 (see FIG. 2) configured to process the signal from the continuous analyte sensor 100 and the titration parameters, to obtain titration information associated with titration of the medicament.” [0095]), wherein executing the computer programming instructions causes the processor to (see method shown in Figure 3, detailed [0122-0130]): display on the display a user interface to obtain input regarding gender, age and weight of the patient and obtain the input regarding gender, age and weight of the patient (“At block 304, titration parameters are input into the system 10, such as via the user interface 216. Titration parameters include, but are not limited to information related to how the titration procedure is to be performed…the system is configured for selection of host information (e.g., name, weight, age, height, etc.) via a scroll menu on an LCD screen 216e.” [0125]); “the communication device 110 includes an input module configured to receive titration parameters, which can be input via a user interface 216. Titration parameters can include any information needed to perform the medicament titration, such as but not limited to…host data (e.g., identification, height, weight, age, sex, a physical aspect/attribute of the host).” [0094]); initiate an iterative time-windowed based medicament delivery rate titration protocol using the obtained input regarding gender, age, and weight of the patient (“At block 312, the system is configured to process the first signal, an optional second signal and the titration parameters to obtain titration information…the system is configured to at least intermittently process the data and provide updated titration information. For example, in some embodiments, the processor module is configured to process the incoming data every 5, 10, 15, or 30 minutes” [0129]); receive, from the medicament delivery device, a proposed adjusted basal medicament delivery rate generated by the medicament delivery device as part of the iterative, time-windowed basal medicament delivery rate titration protocol (“At block 314, the system is configured to provide the titration information. In some embodiments, the titration information is provided via the user interface 216…the titration information can be displayed on the user interface of a secondary medical device, such as but not limited to a patient monitor or an Infusion pump.” [0130]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the management device of Mensinger to include that executing the computer programming instructions causes the processor to display on the display a user interface to obtain input regarding gender, age and weight of the patient; obtain the input regarding gender, age and weight of the patient; initiate the iterative time-windowed based medicament delivery rate titration protocol using the obtained input regarding gender, age, and weight of the patient; and receive, from the medicament delivery device, a proposed adjusted basal medicament delivery rate generated by the medicament delivery device as part of the iterative, time-windowed basal medicament delivery rate titration protocol based on the teachings of Simpson to determine an effective dose of the medicament specific to the patient that maintains the therapeutic window while minimizing side effects (Simpson [0094], [0123]).
Modified Mensinger fails to explicitly disclose that executing the computer programming instructions causes the processor to prompt the patient, via the user interface displayed on the display, to accept or reject the proposed adjusted basal medicament delivery rate.
Sloan discloses a management device (Figure 39: “a health monitor device (e.g., blood glucose monitor)” [0494]; health monitor device 600, for example) for a medicament delivery device, said management device comprising a processor (processor 660) that executes computer programming instructions that cause the processor to prompt the patient, via a user interface displayed on a display (display unit 620), to accept or reject the proposed adjusted basal medicament delivery rate (“the health monitor device may display the suggested new dose of basal insulin for the user (3912)…The user may then confirm whether the user wants to use the suggested basal insulin dosage amount as the user's new basal insulin dosage amount by pressing the yes or the no button (3913).” [0495]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to further modify the management device of Mensinger to include that executing the computer programming instructions causes the processor to prompt the patient, via the user interface displayed on the display, to accept or reject the proposed adjusted basal medicament delivery rate based on the teachings of Sloan to provide the user direct control over their diabetes management (Sloan [0494-0495]).
Regarding claim 15, modified Mensinger discloses the management device of claim 14, wherein the obtained input also includes an identification of a starting medicament dose at which the titration is to begin (“utilize a dose calculation module of the software application to assist the patient regarding dose setting information on the size of the next dose to be delivered. For example, the patient could enter carbohydrates to be eaten, current blood sugar, and the companion device 5 would already know insulin on board. Using these parameters, a suggested medicine dose (e.g., such as insulin dose), calculated by the dose calculation module, may be determined.” [0038]) and an indication of how often to titrate (“(a) titrating a fixed amount per a fixed period (1 U/day) until glucose levels are stable and/or until A1C levels (or average glucose values) are as desired; or (b) titrating a variable amount per a fixed period (e.g., +1 U per 50 mg/dL above target every 3 days)” [0048]).
Regarding claim 17, modified Mensinger discloses the management device of claim 14, wherein the medicament delivery device delivers insulin (“an intelligent medicine administering system includes a smart insulin injection pen…which provides dose calculator and decision support modules that calculate and recommend a time- and context-sensitive dose of medicine (e.g., insulin)” [0005]; “an insulin dose calculation” [0102]), a glucagon-like peptide-1 (GLP-1) receptor agonist, a glucose-dependent insulinotropic polypeptide (GIP) receptor agonist, a dual GLP-1 and GIP receptor agonist, an antihyperglycemic, or a co- formulation thereof.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Mensinger et al. (US 20190392937) in view of Simpson et al. (US 20090299156) in further view of Sloan et al. (US 20120232520) as applied in claim 14 above, and further in view of El-Khatib et al. (US 20220189604), hereinafter El-Khatib(US).
Regarding claim 16, Mensinger discloses the management device of claim 14.
Modified Mensinger fails to explicitly discloses the processor is further configured to display another user interface to receive an indication that the patient is about to sleep or is about to exercise and the processor is further configured to forward the indication to the medicament delivery device.
El-Khatib(US) discloses a management device (therapy change delivery system 4400 and input components 4412) for a medicament delivery device (therapy delivering component 4408), said management device comprising a display (input components 4412 having display 4428) and a processor configured for executing programming instructions (“signal processing component 4404 includes a processor, memory, and storage” [0646]) that cause the processor to display a user interface to receive an indication that the patient is about to sleep or is about to exercise and the processor is further configured to forward the indication to the medicament delivery device (“the user may provide input using the input components 4412 that the user is about to perform exercise that may lower their blood sugar…Upon receiving the activity change from the input components 4412, the activity change component 4414 offers the user the option via the mode controller 4420 to select between the automated delivery system 4418 or the manual delivery component 4422.” [0657]).
Before the effective filing date of the claimed invention, it would have been obvious to one having ordinary skill in the art to modify the processor of the management device of Mensinger to be configured to processor to display another user interface to receive an indication that the patient is about to sleep or is about to exercise and the processor is further configured to forward the indication to the medicament delivery device based on the teachings of El-Khatib(US) to prevent and manage hypoglycemic events (El-Khatib(US) [0657]).
Claims 18-23 are rejected under 35 U.S.C. 103 as being unpatentable over Sloan et al. (US 20120232520) in view of Bengtsson et al. (WO 2022234032).
Regarding claim 18, Sloan discloses a medicament delivery device (“the health monitor devices disclosed herein may be included in and/or integrated with, a medication delivery device and/or system, e.g., an insulin pump module, such as an insulin pump or controller module thereof” [0265]) configured for delivering basal medicament doses to a type two diabetes patient (“the long-acting insulin dosage calculation function may be based upon Levemir.RTM. insulin, available from Novo Nordisk. Levemir.RTM. is a long-acting insulin indicated for once- or twice-daily subcutaneous administration for the treatment of adult and pediatric patients with type 1 diabetes mellitus or adult patients with type 2 diabetes mellitus who require basal (long-acting) insulin for the control of hyperglycemia” [0119]), comprising:
a non-transitory computer-readable storage medium (memory device 670; [0082]) storing computer programming instructions (“The instructions for a long-acting medication dosage calculation function may be in the form of software stored on the memory device 670” [0117]); and
a processor (processor 660) configured for executing the computer programming instructions (“The instructions for a long-acting medication dosage calculation function may be in the form of software stored on the memory device 670 (FIG. 6B) and executed by the processor 660 (FIG. 6B) of the health monitor device 600.” [0117]), wherein executing the computer programming instructions causes the processor to:
perform a titration (“Referring to FIGS. 25, 6A and 6B, after measuring several fasting blood glucose measurements and storing those measurements in a memory 670 of the health monitor device 600, the health monitor device 600 may analyze the stored data to titrate the patient's long acting insulin dose level.” [0144]) by:
establishing an initial basal delivery rate of a medicament for delivery to the patient by the medicament delivery device over an initial time window (“Based on the information the user entered, the health monitor device determines suggested initial insulin doses for the user for various times of day (e.g., morning, breakfast, lunch and dinner) (3904).” [0494]; “The health monitor device may also display the previous basal insulin dosage amount.” [0495]);
for the initial time window, calculating an average glucose level of the glucose level readings received from the patient over the respective time window (“The health monitor device 600 then determines the average of the fasting blood glucose measurements over the preceding time period (2545).” [0144]), and compare the average glucose level to a target glucose level (“The health monitor device 600 then compares the average of the fasting blood glucose measurements to a series of threshold ranges (2550), where each range corresponds to a recommended dose adjustment amount.” [0144], wherein a “threshold range” is the patient’s blood glucose target range: “below a threshold amount (e.g., below the patient's blood glucose target range for that meal)” [0159], “above a threshold amount (e.g., above the patient's blood glucose target range for that meal)” [0160]);
increasing the initial basal delivery rate in the one or more subsequent time windows to establish an increased basal delivery rate based on a difference between the average glucose level and the target glucose level (“The health monitor device 600 then compares the average of the fasting blood glucose measurements to a series of threshold ranges (2550), where each range corresponds to a recommended dose adjustment amount. The health monitor device 600 may then recommend (e.g., display) the appropriate corresponding dose adjustment amount and/or the adjusted dose level to the patient (2555). For instance, if the average is greater than 180 mg/dL, then the health monitor device 600 may recommend that the long acting insulin dosage amount be increased by 10% of the current dose amount. If the average is 140-180 mg/dL, then the health monitor device 600 may recommend that the long acting insulin dosage amount be increased by 7% of the current dose amount. If the average is 100-139 mg/dL, then the health monitor device 600 may recommend that the long acting insulin dosage amount be increased by 4% of the current dose amount.” [0144]).
Modified Sloan fails to explicitly teach the titration is an iterative titration, and performing the iterative titration by: for each of the initial time window and one or more subsequent time windows, calculating an average glucose level of the glucose level readings received from the patient over the respective time window, and compare the average glucose level to a target glucose level; decreasing the increased basal delivery rate to a decreased basal rate for a later time window after the subsequent time windows where the initial basal delivery rate is increased; and conclude the iterative titration by setting the decreased basal rate as an ongoing basal delivery rate for the patient when the average glucose level for the later time window in which the increased basal delivery rate is decreased exhibits a predetermined level of glucose level control.
Bengtsson teaches a medicament delivery system configured for delivering medicament doses to a type two diabetes patient (“the algorithm may also be used as part of an overall diabetes dose guidance system that helps people with diabetes by generating recommended insulin doses based on estimated FPG values. In such a system a given algorithm is used to generate recommended insulin doses and treatment advice for diabetes patients based on BG data, insulin dosing history” [Page 8, lines 10-15]) that performs an iterative titration (“a titration process can be performed requiring less fasting and less finger pricks to obtain SMPG values” [Page 2, lines 15-21]; shown in Figure 1) by: for each of the initial time window and one or more subsequent time windows, calculating an average glucose level of the glucose level readings received from the patient over the respective time window, and compare the average glucose level to a target glucose level (“a predicted FPG is calculated using a mathematical model using FPG history data and insulin injection history data. Based on the predicted FPG and a current measured FPG an updated estimated FPG can be calculated which can then be used to calculate a dose recommendation.” [Page 9, lines 9-12]; “As the FPG is then measured the following week and thus added to the historical data, the algorithm can improve the modelling accuracy and gradually adapt the parameters of the model to fit the specific individual’s response to the drug better and better.” [Page 9, lines 16-18]; “The updated estimated FBG may be calculated as a weighted average of the predicted FBG and the current measured FBG.” [Page 4, lines 10-11]; averages detailed on [Page 10, lines 19-27]; “If the value is above the target area, the dose should be increased and if it is below, the dose should be decreased. This process continues until the weekly measurements becomes stabile and within target range.” [Page 2, lines 26-29]; see also Figure 1); establishing an initial dose of a medicament for delivery of the patient by the medicament delivery device over an initial time window (Figure 1, at week 0, see also Table 1 in page 10); increasing the initial dose in a subsequent time window to establish an increased dose based on the difference between the average glucose level and the target glucose level (Figure 1, between weeks 1-8; see also Table 1 in pages 10-11; “If the value is above the target area, the dose should be increased and if it is below, the dose should be decreased. This process continues until the weekly measurements becomes stabile and within target range.” [Page 2, lines 26-29]); decreasing the increased dose to a decreased dose for a later time window after the subsequent time windows where the initial dose is increased (Figure 1, at weeks 9; see also Table 1 in pages 10-11); and conclude the iterative titration by setting the decreased basal rate as an ongoing basal delivery rate for the patient when the average glucose level for the later time window in which the increased basal delivery rate is decreased exhibits a predetermined level of glucose level control (“This process continues until the weekly measurements becomes stabile and within target range.” [Page 2, line 29]; Figure 1).
Before the effective filing date of the claimed invention, it would have been obvious to modify the titration of the medicament delivery device of Sloan to be an iterative titration, and performing the iterative titration by: for each of the initial time window and one or more subsequent time windows, calculating an average glucose level of the glucose level readings received from the patient over the respective time window, and compare the average glucose level to a target glucose level; decreasing the increased basal delivery rate to a decreased basal rate for a later time window after the subsequent time windows where the initial basal delivery rate is increased; and conclude the iterative titration by setting the decreased basal rate as an ongoing basal delivery rate for the patient when the average glucose level for the later time window in which the increased basal delivery rate is decreased exhibits a predetermined level of glucose level control based on the teachings of Bengtsson to provide improved estimates of dosage adjustments in order to reduce both glucose variation and the amount of time necessary to determine a stable glucose control for the patient (Bengtsson [Col 3, lines 5-10]).
Regarding claim 19, modified Sloan discloses the medicament delivery device of claim 18, wherein executing the computer programming instructions causes the processor to calculate average glucose levels for glucose readings of the time windows (“The health monitor device 600 then determines the average of the fasting blood glucose measurements over the preceding time period (2545).” [0144]).
Regarding claim 20, modified Sloan discloses the medicament delivery device of claim 19, wherein executing the computer programming instructions causes the processor, for the time windows, to calculate differences between the average glucose levels of the time windows and target glucose levels (“The health monitor device 600 then compares the average of the fasting blood glucose measurements to a series of threshold ranges (2550), where each range corresponds to a recommended dose adjustment amount.” [0144], see all of [0144])
Regarding claim 21, modified Sloan discloses the medicament delivery device of claim 20, wherein increasing the initial basal delivery rate are based on the calculated differences (“The health monitor device 600 may then recommend (e.g., display) the appropriate corresponding dose adjustment amount and/or the adjusted dose level to the patient (2555). For instance, if the average is greater than 180 mg/dL, then the health monitor device 600 may recommend that the long acting insulin dosage amount be increased by 10% of the current dose amount. If the average is 140-180 mg/dL, then the health monitor device 600 may recommend that the long acting insulin dosage amount be increased by 7% of the current dose amount. If the average is 100-139 mg/dL, then the health monitor device 600 may recommend that the long acting insulin dosage amount be increased by 4% of the current dose amount.” [0144]).
Regarding claim 22, modified Sloan discloses the medicament delivery device of claim 21, wherein the medicament delivery device is an insulin pump (“the health monitor devices disclosed herein may be included in and/or integrated with, a medication delivery device and/or system, e.g., an insulin pump module, such as an insulin pump or controller module thereof” [0265]).
Regarding claim 23, modified Sloan discloses the medicament delivery device of claim 18, wherein the medicament is insulin, a glucagon-like peptide-1 (GLP-1) receptor agonist, a glucose-dependent insulinotropic polypeptide (GIP) receptor agonist, a dual GLP-1 and GIP receptor agonist, an antihyperglycemic, or a co-formulation thereof (“the medication delivery device is configured to deliver a drug (e.g., insulin) to a patient (e.g., a patient with diabetes) based on the analyte (e.g., glucose) level measured by the health monitor device.” [0367]).
Response to Arguments
Applicant’s arguments with respect to claims 1-23 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
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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/LEAH J SWANSON/ Examiner, Art Unit 3783
/KEVIN C SIRMONS/ Supervisory Patent Examiner, Art Unit 3783
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