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 .
Information Disclosure Statement
The information disclosure statement noted below filed 01/19/24 (18 pages) fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. It has been placed in the application file, but the information referred to therein has not been considered.
IDS filed 01/19/24 (18 pages) - No copy has been provided for NPL Document Cite No. 12.
IDS filed 01/19/24 (28 pages) - No copy has been provided for NPL Documents Cite No. 11 and Cite No. 14.
IDS filed 01/19/24 (37 pages) - No copy has been provided for NPL Document Cite No. 17.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 14-23 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Regarding claim 14, the claim is directed to a management device for a medicament delivery device (a machine), and thus falls into at least one of the four statutory categories of invention deemed to be appropriate subject matter of a patent. However, the claim is also directed toward an abstract idea because the limitations “wherein 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; and forward the input regarding gender, age and weight of the user to the medicament delivery device for the patient to initiate titration of a medicament delivery rate to the patient” are steps that, under the broadest reasonable interpretation, covers performance of these limitations in the human mind but for the recitation of generic computer components. The steps themselves can reasonably be carried out in the mind and/or by pen and paper by a person: a user can manually input their gender, age, and weight into a medicament delivery device and manually press a button to initiate titration. If a claim, under its broadest reasonable interpretation, covers performances of the limitations in the human mind, then it falls within the “mental processes” grouping of abstract ideas. This judicial exception is not integrated into a practical application. The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional elements recited by the claim (“management device”, “non-transitory computer-readable storage medium”, “computer programming instructions”, “a display” “a processor”) are recited in a high-level of generality (i.e. as a generic processor performing a generic computer function of displaying a user interface and forwarding data) such that it amounts to no more than mere instructions to apply the exception using a generic computer component. Accordingly, these additional elements do not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the idea. The claim as currently presented does not require or positively recite any delivery of a medicament or that the processor causes delivery of the medicament at the titrated medicament delivery rate. The dependent claims 15-17 do not add significantly more to the abstract idea, and amount to insignificant extra-solution activity, such as displaying and forwarding additional information and further defining the type of medication to be delivered. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception.
Regarding claim 18, the claim is directed to a medicament delivery device (a machine), and thus falls into at least one of the four statutory categories of invention deemed to be appropriate subject matter of a patent. However, the claim is also directed toward an abstract idea because the limitations “executing the computer programming instructions causes the processor to: establish an initial basal delivery rate of medicament for delivery to the patient by the medicament delivery device over an initial time window; increase the basal delivery rate in subsequent time windows based on glucose level readings for the patient; decrease the basal delivery rate to a decreased basal rate for a time window after the time windows where the basal delivery rate is increased; and where the glucose level readings of the patient for the later time window exhibit good glucose level control, conclude the titration by setting the decreased basal rate as the basal delivery rate for the patient” are steps that, under the broadest reasonable interpretation, covers performance of these limitations in the human mind but for the recitation of generic computer components. The steps themselves can reasonably be carried out in the mind and/or by pen and paper by a person: manually input an initial basal delivery rate into the medicament delivery device, manually increasing and decreasing the basal delivery rate based on observed glucose measurements, and mentally determining, based on observed glucose measurements, that the decreased basal delivery rate provides good glucose control. If a claim, under its broadest reasonable interpretation, covers performances of the limitations in the human mind, then it falls within the “mental processes” grouping of abstract ideas. This judicial exception is not integrated into a practical application. The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional elements recited by the claim (“non-transitory computer-readable storage medium”, “computer programming instructions”, “a processor”) are recited in a high-level of generality (i.e. as a generic processor performing a generic computer function of setting a value, obtaining data, and adjusting the value based on that data) such that it amounts to no more than mere instructions to apply the exception using a generic computer component. Accordingly, these additional elements do not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the idea. The claim as currently presented does not require or positively recite any delivery of the medicament or that the processor causes delivery of the medicament at the discussed basal delivery rates. The dependent claims 19-23 do not add significantly more to the abstract idea, and amount to insignificant extra-solution activity, such as further defining the mathematical relationship between the glucose level reading and the basal delivery rate and further defining the type of medication to be delivered. The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception.
Therefore, claims 14-23 are not patent eligible.
Claim Objections
Claim 1 is objected to because there is lack of antecedent basis for “the basal medicament delivery rate” in line 10, “the received glucose level readings” in line 11, and “the delivery of basal medicament” in line 12. Appropriate correction is required.
Claim 1 is further objected to because there appears to be a typo regarding “…to new delivery rate” as opposed to “…to a new delivery rate” in line 10. Appropriate correction is required.
Claim 9 is objected to because there is lack of antecedent basis for “the glucose level” in line 2. Appropriate correction is required.
Claim 10 is objected to because there is lack of antecedent basis for “the patent” in line 2 as opposed to “the type two diabetes patient”. Appropriate correction is required.
Claim 13 is objected to because there is lack of antecedent basis for “the medicament” in line 1. Appropriate correction is required.
Claim 14 is further objected to because there appears to be a typo regarding “an medicament delivery device” as opposed to “a medicament delivery device” in line 1. Appropriate correction is required.
Claim 16 is objected to because there is lack of antecedent basis for “the received indication” in line 3. Appropriate correction is required.
Claim 17 is objected to because there is lack of antecedent basis for “the medicament” in line 1. Appropriate correction is required.
Claim 18 is objected to because there is lack of antecedent basis for “the basal delivery rate” in lines 9, 11, and 15, “the time windows” in line 12, and “the later time window” in line 13. Appropriate correction is required.
Claim 21 is objected to because there is lack of antecedent basis for “the increases of basal delivery rate” in line 1. Appropriate correction is required.
Claim 22 is objected to because there is lack of antecedent basis for “the device” in line 1 as opposed to “the medicament delivery device”. Appropriate correction is required.
Claim 23 is objected to because there is lack of antecedent basis for “the medicament” in line 1. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 18-23 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 18 recites the limitation "the titration" in line 14. There is insufficient antecedent basis for this limitation in the claim. Therefore, the limitation “conclude the titration” is unclear. It is unclear if “the titration” refers to “increase the basal delivery rate” and “decrease the basal delivery rate” of lines 9-12, or if “the titration” in reference to another, separate titration. For examination purposes, "the titration" has been interpreted as being in reference to “increase the basal delivery rate” and “decrease the basal delivery rate” of lines 9-12.
Claims 19-23 are rejected for being dependent upon claim 18.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 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 –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-6 and 11-13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sloan et al. (US 20120232520).
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 titration, adjusting the basal medicament delivery rate to 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
causing the 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]).
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 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 14-15 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Simpson et al. (US 20090299156).
Regarding claim 14, Simpson discloses a management device (system 10) for an 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 non-transitory computer-readable storage medium (program member 208 and RAM 210) storing computer programming instructions (“memory storage components such as program memory 208 (e.g., code for running algorithms), RAM 210, dynamic-RAM, static-RAM, non-static RAM, rewritable ROMs, non-volatile memory (e.g., EEPROM, flash memory, etc.), and the like.” [0100]);
a display (user interface 216 having LCD 216e); and
a processor (processor module 206) configured for executing the 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 (“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]);
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]); and
forward the input regarding gender, age and weight of the user to the medicament delivery device for the patient to initiate titration of a medicament delivery rate to the patient (“the titration information includes a therapy recommendation and/or a therapy instruction… In some embodiments, the recommendation/instruction is directed to a secondary medical device. For example, if the medicament is being delivered by an Infusion pump, the system can intelligently instruct the pump to increase and/or decrease the rate of medicament delivery. In some embodiments, the titration information can be used to intelligently process incoming data from the continuous analyte sensor 100 and any secondary medical devices, such as to optimize medicament delivery/titration.” [0121]; “At optional block 306… 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). In some embodiments, the secondary medical device is configured to deliver the medicament at a predetermined, programmable and/or selectable rate…the processor is configured to evaluate the sensor information, the titration parameters, input information such as but not limited to information related to the medicament's effect, and the like, and to intelligently provide a therapy instruction to the secondary medical device.” [0126]; “At block 312, the system is configured to process the first signal, an optional second signal and the titration parameters to obtain titration information.” [0129]; “At block 314, the system is configured to provide the titration information” [0130]).
Regarding claim 15, Simpson 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 (“Titration parameters include, but are not limited to information related to how the titration procedure is to be performed. For example, titration parameters can include information related to the host, the medicament to be titrated, to the procedural steps to be followed, and the like. In another example, in some embodiments, the system is configured for entry of the medicament's identity, initial concentration and rate of delivery via a keyboard 216a or buttons 216g” [0125]) and an indication of how often to titrate (“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. In some embodiments, the processor module is configured to process the data every 1, 2 or 3-hours, or to wait even longer periods between processing. In some embodiments, the frequency with which the data are processed is a titration parameter that is entered/selected by the user.” [0129]; “At block 314, the system is configured to provide the titration information…titration information can be used as a titration parameter when the system performs subsequent processing of data being received” [0130]).
Claims 18-23 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mensinger et al. (US 20190392937).
Regarding claim 18, Mensinger discloses a medicament delivery device (pen device 10 and companion device 5 of system 100) configured for delivering basal medicament doses to a type two diabetes patient (“an intelligent medicine administering system provides medicine dose recommendation and management capabilities for Type I and Type II diabetes patients and their caregiver” [0023]; “the system 100 may automatically or semi-automatically implement the insulin dose calculation adjustment method (e.g., a titration protocol) and adjust/update parameters associated with basal dosing, accordingly.” [0047]), comprising:
a non-transitory computer-readable storage medium storing computer programming instructions (“The data processing unit of the companion device 5 includes a processor to process data, a memory in communication with the processor…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], see memory detailed in [0036]); and
a processor (“The data processing unit of the companion device 5 includes a processor” [0036]) configured for executing the computer programming instructions, wherein 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” [0036]; “FIG. 5 shows a diagram of an example 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, which can include the modules of software architecture 200.” [0102]) causes the processor to:
establish an initial basal delivery rate of medicament for delivery to the patient by the medicament delivery device over an initial time window (“The method 500 includes a process 510 to aggregate glucose data, insulin data, and carbohydrates data associated with a patient user…The determined basal insulin dose recommendation (adjustment or non-adjustment) data can be feedback to the process 510 in implementations of the method 500.” [0102]);
increase the basal delivery rate in subsequent time windows based on glucose level readings for the patient (“The method 500 includes a process 550 to adjust (or not adjust) a basal insulin dose recommendation based on the calculated average slope…where the slope is an upward slope that is above a threshold, a process 555 is implemented to generate a recommendation to increase the basal dose” [0102]);
decrease the basal delivery rate to a decreased basal rate for a time window after the time windows where the basal delivery rate is increased (“The method 500 includes a process 550 to adjust (or not adjust) a basal insulin dose recommendation based on the calculated average slope. In implementations where the slope is a downward slope that is below a threshold, a process 551 is implemented to generate a recommendation to decrease the basal dose.” [0102], wherein the titration method 500 is a loop and was repeated with the increased basal rate: “The determined basal insulin dose recommendation (adjustment or non-adjustment) data can be feedback to the process 510 in implementations of the method 500.” [0102]), followed by decreasing the basal rate); and
where the glucose level readings of the patient for the later time window exhibit good glucose level control, conclude the titration by setting the decreased basal rate as the basal delivery rate for the patient (“In implementations where the slope is between a high threshold and a low threshold, a process 553 is implemented to generate a recommendation to not change the basal dose…The determined basal insulin dose recommendation (adjustment or non-adjustment) data can be feedback to the process 510 in implementations of the method 500.” [0102], wherein the slope falling between the thresholds indicates good glucose level control, and the wherein the titration method 500 is a loop and was repeated with the decreased basal rate: “The determined basal insulin dose recommendation (adjustment or non-adjustment) data can be feedback to the process 510 in implementations of the method 500.” [0102]), followed by maintaining this decreased rate).
Regarding claim 19, Mensinger 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 method 500 includes a process 510 to aggregate glucose data, insulin data, and carbohydrates data associated with a patient user…a process 540 to calculate the average slope of glucose levels over time.” [0102]).
Regarding claim 20, Mensinger 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 (Comparison of differences of average slope of glucose to threshold: “The method 500 includes a process 550 to adjust (or not adjust) a basal insulin dose recommendation based on the calculated average slope. In implementations where the slope is a downward slope that is below a threshold…In implementations where the slope is between a high threshold and a low threshold…In implementations where the slope is an upward slope that is above a threshold [0102]).
Regarding claim 21, Mensinger discloses the medicament delivery device of claim 20, wherein the increases of the basal delivery rate are based on the calculated differences (“The method 500 includes a process 550 to adjust (or not adjust) a basal insulin dose recommendation based on the calculated average slope…In implementations where the slope is an upward slope that is above a threshold, a process 555 is implemented to generate a recommendation to increase the basal dose.” [0102]).
Regarding claim 22, Mensinger discloses the medicament delivery device of claim 21, wherein the device is an insulin pump (“the IOB data can additionally or alternatively be provided by an insulin pump being used by the patient user, e.g., as some diabetic patient users may choose to alternate insulin pump use with an insulin pen for a time being and/or use an insulin pen as a supplement medication delivery device to the insulin pump.” [0045]).
Regarding claim 23, Mensinger 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 (“intelligent medicament delivery system 100 includes a report generator, an adaptive dose calculator and decision support modules to determine and recommend a time- and circumstance-relevant dose of a medicine (e.g., insulin) for the patient” [0045]).
Claim Rejections - 35 USC § 103
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 7-8 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Sloan et al. (US 20120232520) in view of El-Khatib et al. (US 20220189604), herein after El-Khatib(US).
Regarding claim 7, Sloan discloses the medicament delivery device of claim 1.
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, Sloan discloses the medicament delivery device of claim 1.
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, Sloan discloses the medicament delivery device of claim 1.
Sloan fails to explicitly disclose the processor is further configured to receive input indicating that the 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 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 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 the 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 the 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 the 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 16 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Simpson et al. (US 20090299156) in view of El-Khatib et al. (US 20220189604), hereinafter El-Khatib(US).
Regarding claim 16, Simpson discloses the management device of claim 14.
Simpson 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 received 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 received 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 Simpson 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 received indication to the medicament delivery device based on the teachings of El-Khatib(US) to prevent and manage hypoglycemic events (El-Khatib(US) [0657]).
Regarding claim 17, Simpson discloses the management device of claim 14.
Simpson fails to explicitly disclose 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.
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]), wherein a medicament delivered by the medicament delivery device is insulin (“the ambulatory medical device 4402 infuses insulin or glucagon into the user 4406” [0647]).
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 Simpson to include the medicament is insulin based on the teachings of El-Khatib(US) treat a user that has diabetes by assisting in maintaining healthy blood glucose levels (El-Khatib(US) [0647]).
Conclusion
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/LEAH J SWANSON/Examiner, Art Unit 3783 /KEVIN C SIRMONS/Supervisory Patent Examiner, Art Unit 3783