DETAILED ACTION
Notices to Applicant
This communication is a Final Office Action on the merits. Claims 1-8, 10, 12-13, 15-21, and 23 as filed 08/21/2025, are currently pending and have been considered below.
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Priority
The present application claims priority benefit to U.S. Provisional Application No. 62/914,399, filed on 10/11/2019.
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 19-21 and 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 19 recites the limitation "the memory" in line 18. There is insufficient antecedent basis for this limitation in the claim.
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 1-8, 10, 12-13, 21, and 23 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., an abstract idea) without significantly more.
Claims 1-8, 10, and 12-13 are drawn to a method of adjusting insulin therapy settings of a portable drug delivery device for a person with diabetes, which is within the four statutory categories (i.e. method).
Independent Claim 1 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. Claim 1 recites:
A method of adjusting insulin therapy settings of a portable drug delivery device for a person with diabetes that treats the diabetes by administering first and second types of insulin, the method comprising:
storing, in a non-transitory storage medium of the portable drug delivery device, a first-type insulin dosage suggestion for a person with diabetes regarding a first type of insulin having an active time that is longer than an active time for a second type of insulin;
receiving, via a communication link between a blood glucose sensor and a processor of the portable drug delivery device, blood glucose data obtained by the blood glucose sensor for the person with diabetes, the blood glucose data including blood glucose values for a plurality of days;
determining, by the processor of the portable drug delivery device, a first variability of the blood glucose values for a selected first period of time during the plurality of days, wherein the first variability is based on a mean value of the blood glucose values for the selected first period of time with respect to a predefined mean value and the selected first period of time includes multiple time segments from the plurality of days that correspond to each other;
modifying, by the processor of the portable drug delivery device, the first-type insulin dosage suggestion in the non-transitory storage medium using only the determined first variability; and
administering the first type of insulin to the person with diabetes according to the modified first-type insulin dosage suggestion.
The above limitations, as drafted, is a method that, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components. That is, other than reciting the above bolded limitations, such as “storing, in a non-transitory storage medium of the portable drug delivery device,” “receiving, via a communication link between a blood glucose sensor and a processor of the portable drug delivery device, blood glucose data obtained by the blood glucose sensor for the person with diabetes,” and “administering the first type of insulin to the person with diabetes according to the modified first-type insulin dosage suggestion,” nothing in the claim precludes the steps from practically being performed in the mind. For example, but for the “storing, in a non-transitory storage medium of the portable drug delivery device,” “receiving, via a communication link between a blood glucose sensor and a processor of the portable drug delivery device, blood glucose data obtained by the blood glucose sensor for the person with diabetes,” and “administering the first type of insulin to the person with diabetes according to the modified first-type insulin dosage suggestion,” language, a first-type insulin dosage suggestion for a person with diabetes regarding a first type of insulin having an active time that is longer than the active time for a second type of insulin, receiving blood glucose data for the person with diabetes including blood glucose values for a plurality of days, determining a first variability of the blood glucose values for a selected first period of time during the plurality of days, and modifying the first-type insulin dosage suggestion based on the determined first variability in the context of this claim encompasses the user manually collecting and analyzing blood glucose values to determine a suggested insulin dosage through observation, evaluation, judgment, and opinion. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components, then it falls within the “Mental Processes” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
This judicial exception is not integrated into a practical application. In particular, the claim only recites additional elements of using “storing, in a non-transitory storage medium of the portable drug delivery device,” and “receiving, via a communication link between a blood glucose sensor and a processor of the portable drug delivery device, blood glucose data obtained by the blood glucose sensor for the person with diabetes,” to perform the claim limitations. The elements in each of these steps are recited at a high-level of generality (i.e., a non-transitory storage medium such as a memory and/or a hard drive holding executable instructions by one or more processors for operating the mobile communication device such as a mobile phone, smart phone, a tablet, a laptop computer, a portable computer and similar devices, the system includes an insulin injection pen, a glucose monitor, and a remote user interface device which are in wireless communication as they relate to general purpose computer components (Application Specification [0027], [0031]-[0033])). As such, the limitations amount to no more than mere instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea. See MPEP 2106.05(f). Further, the limitation of “administering the first-type insulin dosage to the person with diabetes based on the modified first-type insulin dosage suggestion” amounts to adding insignificant extra‐solution activity to the judicial exception. See MPEP 2106.05(g). Accordingly, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. The claim is directed to an abstract idea.
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional elements of using “storing, in a non-transitory storage medium of the portable drug delivery device,” and “receiving, via a communication link between a blood glucose sensor and a processor of the portable drug delivery device, blood glucose data obtained by the blood glucose sensor for the person with diabetes,” to perform the claim limitations amounts to no more than mere instructions to apply the exception using a generic computer component. (i.e., a non-transitory storage medium such as a memory and/or a hard drive holding executable instructions by one or more processors for operating the mobile communication device such as a mobile phone, smart phone, a tablet, a laptop computer, a portable computer and similar devices, the system includes an insulin injection pen, a glucose monitor, and a remote user interface device which are in wireless communication as they relate to general purpose computer components (Application Specification [0027], [0031]-[0033])). Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept. See MPEP 2106.05(f). Further, the limitation of “administering to a person with diabetes, via the portable drug delivery device the second type of insulin according to the modified second-type insulin dosage suggestion” amounts to adding insignificant extra‐solution activity to the judicial exception that is well-understood, routine, and conventional activity. See MPEP 2106.05(d)(g) (e.g. Immunizing a patient against a disease, Classen Immunotherapies, Inc. v. Biogen IDEC, 659 F.3d 1057, 1063, 100 USPQ2d 1492, 1497 (Fed. Cir. 2011) (U.S. 2019/0175833 A1 “An external biologically effective drug (e.g., insulin or its analog) is commonly administered by means of daily injections. In some cases, multiple, daily injections (MDI) of a mixture of rapid- and long-acting insulin via a reusable transdermal liquid dosing device ( commonly referred to as an "insulin pen") or a hypodermic syringe. The injections are typically administered by a person with diabetes (PWD), and so require self-monitoring of blood glucose and the self-administration of insulin;. As a result, the abstract idea is not integrated into a practical application.”)). The claim is not patent eligible.
Dependent claims 2-8, 10, and 12-13 include limitations of the independent claim and are directed to the same abstract idea as discussed above and incorporated herein. The dependent claims are rejected under 35 U.S.C. § 101 because they are directed to non-statutory subject matter. These additional claims recite what the blood glucose and insulin data is and how it is analyzed. These information characteristics do not integrate the judicial exception into a practical application, and, when viewed individually or as a whole, they do not add anything substantial beyond collecting and analyzing blood glucose and insulin data. Dependent claim 12 recites the additional elements of “a cap sensor of a pen cap,” however, this elements is recited at a high level and (i.e. the insulin injection pen is a LantusTM pen, a LevemirTMpen,a ToujeoTM pen, or a TresibaTM pen, wherein, the system includes a glucose monitor (e.g., a CGM) or another glucose sensor) (Application Specification at [0031])), such that limitation, when viewed individually as with the claim as a whole, amounts to generally linking the use of the abstract idea to a particular technological environment or field of use. See MPEP 2106.05(h). Furthermore, the combination of elements does not indicate a significant improvement to the functioning of a computer or any other technology. Therefore the dependent claims are rejected under 35 U.S.C. § 101.
Claims 15-18 are drawn to a method of adjusting insulin therapy settings for a person with diabetes, which is within the four statutory categories (i.e. method).
Independent Claim 15 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. Claim 15 recites:
A method of adjusting insulin therapy settings for a person with diabetes that treats the diabetes by administering first and second types of insulin via a portable drug delivery device, the method comprising:
storing, in a non-transitory storage medium of an electronic the portable drug delivery device, a second-type insulin dosage suggestion for a person with diabetes regarding a second type of insulin having an active time that is shorter than an active time for a first type of insulin;
receiving, via a communication link between a blood glucose sensor and the portable drug delivery device, blood glucose data for the person with diabetes, the blood glucose data including blood glucose values for a plurality of days;
receiving, by a processor of the portable drug delivery device, second-type insulin dosage times for the person with diabetes regarding the plurality of days;
determining, by the processor of the portable drug delivery device, a first variability of the blood glucose values for a selected first period of time during the plurality of days based on a selected metric;
modifying the second-type insulin dosage suggestion in the non-transitory storage medium based on only the determined first variability;
administering to a person with diabetes, via the portable drug delivery device the second type of insulin according to the modified second-type insulin dosage suggestion; and
applying the selected metric to blood glucose data received after the administering of the second type of insulin to the person with diabetes according to the modified second-type insulin dosage suggestion to enable determining of whether the modified second-type insulin dosage suggestion was successful.
The above limitations, as drafted, is a method that, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components. That is, other than reciting “storing, in a non-transitory storage medium of an electronic the portable drug delivery device,” “via a communication link between a blood glucose sensor and the portable drug delivery device,” “by a processor of the portable drug delivery device,” and “administering, via the portable drug delivery device the second type of insulin according to the modified second-type insulin dosage suggestion,” nothing in the claim precludes the steps from practically being performed in the mind. For example, but for the “storing, in a non-transitory storage medium of an electronic the portable drug delivery device,” “via a communication link between a blood glucose sensor and the portable drug delivery device,” “by a processor of the portable drug delivery device,” and “administering, via the portable drug delivery device the second type of insulin according to the modified second-type insulin dosage suggestion,” language, a second-type insulin dosage suggestion for a person with diabetes regarding a second type of insulin having an active time that is shorter than an active time for a first type of insulin, receiving blood glucose data for the person with diabetes including blood glucose values and second-type insulin dosage times for a plurality of days, receiving second-type insulin dosage times for the person with diabetes regarding the plurality of days, determining a first variability of the blood glucose values for a selected first period of time during the plurality of days based on a selected metric, modifying the second-type insulin dosage suggestion based on the determined first variability, and enable determining whether the modified second-type insulin dosage suggestion was successful by applying the selected metric to blood glucose data received after administering of the second type of insulin according to the modified second-type insulin dosage suggestion in the context of this claim encompasses the user manually collecting and analyzing blood glucose values to determine a suggested insulin dosage through observation, evaluation, judgment, and opinion. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components, then it falls within the “Mental Processes” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
This judicial exception is not integrated into a practical application. In particular, the claim only recites additional elements of using “storing, in a non-transitory storage medium of an electronic the portable drug delivery device,” “via a communication link between a blood glucose sensor and the portable drug delivery device,” and “by a processor of the portable drug delivery device,” to perform the collecting and analyzing limitations. The elements in each of these steps are recited at a high-level of generality (i.e., a non-transitory storage medium such as a memory and/or a hard drive holding executable instructions by one or more processors for operating the mobile communication device such as a mobile phone, smart phone, a tablet, a laptop computer, a portable computer and similar devices, the system includes an insulin injection pen, a glucose monitor, and a remote user interface device which are in wireless communication as they relate to general purpose computer components (Application Specification [0027], [0031]-[0033])). As such, the limitations amount to no more than mere instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea. See MPEP 2106.05(f). Further, the limitation of “administering, via the portable drug delivery device the second type of insulin according to the modified second-type insulin dosage suggestion” amounts to adding insignificant extra‐solution activity to the judicial exception. See MPEP 2106.05(g). Accordingly, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. The claim is directed to an abstract idea.
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional elements of using “storing, in a non-transitory storage medium of an electronic the portable drug delivery device,” “via a communication link between a blood glucose sensor and the portable drug delivery device,” and “by a processor of the portable drug delivery device,” to perform the collecting and analyzing limitations amounts to no more than mere instructions to apply the exception using a generic computer component. (i.e., a non-transitory storage medium such as a memory and/or a hard drive holding executable instructions by one or more processors for operating the mobile communication device such as a mobile phone, smart phone, a tablet, a laptop computer, a portable computer and similar devices, the system includes an insulin injection pen, a glucose monitor, and a remote user interface device which are in wireless communication as they relate to general purpose computer components (Application Specification [0027], [0031]-[0033])). Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept. See MPEP 2106.05(f). Further, the limitation of “administering to a person with diabetes, via the portable drug delivery device the second type of insulin according to the modified second-type insulin dosage suggestion” amounts to adding insignificant extra‐solution activity to the judicial exception that is well-understood, routine, and conventional activity. See MPEP 2106.05(d)(g) (e.g. Immunizing a patient against a disease, Classen Immunotherapies, Inc. v. Biogen IDEC, 659 F.3d 1057, 1063, 100 USPQ2d 1492, 1497 (Fed. Cir. 2011) (U.S. 2019/0175833 A1 “An external biologically effective drug (e.g., insulin or its analog) is commonly administered by means of daily injections. In some cases, multiple, daily injections (MDI) of a mixture of rapid- and long-acting insulin via a reusable transdermal liquid dosing device ( commonly referred to as an "insulin pen") or a hypodermic syringe. The injections are typically administered by a person with diabetes (PWD), and so require self-monitoring of blood glucose and the self-administration of insulin;. As a result, the abstract idea is not integrated into a practical application.”)).The claim is not patent eligible.
Dependent claims 16-18 include limitations of the independent claim and are directed to the same abstract idea as discussed above and incorporated herein. The dependent claims are rejected under 35 U.S.C. § 101 because they are directed to non-statutory subject matter. These additional claims recite what the blood glucose and insulin data is and how it is analyzed. These information characteristics do not integrate the judicial exception into a practical application, and, when viewed individually or as a whole, they do not add anything substantial beyond collecting and analyzing blood glucose and insulin data. such that limitation, when viewed individually as with the claim as a whole, amounts to generally linking the use of the abstract idea to a particular technological environment or field of use. See MPEP 2106.05(h). Furthermore, the combination of elements does not indicate a significant improvement to the functioning of a computer or any other technology. Therefore the dependent claims are rejected under 35 U.S.C. § 101.
Claims 19-21 and 23 are drawn to a machine for adjusting insulin therapy settings for a person with diabetes, which is within the four statutory categories (i.e. machine).
Independent Claim 19 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. Claim 19 recites:
19. A portable diabetes management device comprising:
a processor;
and a non-transitory storage medium having stored therein:
a first-type insulin dosage suggestion for a person with diabetes regarding a first type of insulin having an active time that is longer than an active time for a second type of insulin;
blood glucose data for the person with diabetes, the blood glucose data including blood glucose values for a plurality of days; and
instructions that when executed cause the processor to:
determine a first variability of the blood glucose values for a selected first period of time during the plurality of days, wherein the first variability is based on a mean value of the blood glucose values for the selected first period of time with respect to a predefined mean value;
assess a first-type insulin dosage suggestion stored in the memory with respect to only the determined first variability;
modify the first-type insulin dosage suggestion stored in the non-transitory storage medium based on the assessment of the first variability indicating the first-type insulin dosage suggestion led to an undesirable blood glucose level; and
administer to a person with diabetes, via a pump mechanism, the first-type insulin dosage based on the modified first-type insulin dosage suggestion.
The above limitations, as drafted, is a machine that, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components. That is, other than reciting “a processor; and a non-transitory storage medium having stored therein,” “instructions that when executed cause the processor to,” “the memory,” and “administer, via a pump mechanism, the first-type insulin dosage based on the modified first-type insulin dosage suggestion,” nothing in the claim precludes the steps from practically being performed in the mind. For example, but for the “a processor; and a non-transitory storage medium having stored therein,” “instructions that when executed cause the processor to,” “the memory,” and “administer, via a pump mechanism, the first-type insulin dosage based on the modified first-type insulin dosage suggestion,” language, a first-type insulin dosage suggestion for a person with diabetes regarding a first type of insulin having an active time that is longer than the active time for a second type of insulin, and blood glucose data for the person with diabetes including blood glucose values for a plurality of days, determine a first variability of the blood glucose values for a selected first period of time during the plurality of days, assess a first-type insulin dosage suggestion with respect to the determined first variability, and modify the first-type insulin dosage suggestion based on the assessment of the first variability indicating the first-type insulin dosage suggestion led to an undesirable blood glucose level in the context of this claim encompasses the user manually collecting and analyzing blood glucose values to determine a suggested insulin dosage through observation, evaluation, judgment, and opinion. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components, then it falls within the “Mental Processes” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
This judicial exception is not integrated into a practical application. In particular, the claim only recites additional elements of using “a processor; and a non-transitory storage medium having stored therein,” “instructions that when executed cause the processor to,” and “the memory,” to perform the collecting and analyzing limitations. The elements in each of these steps are recited at a high-level of generality (i.e., a non-transitory storage medium such as a memory and/or a hard drive holding executable instructions by one or more processors for operating the mobile communication device such as a mobile phone, smart phone, a tablet, a laptop computer, a portable computer and similar devices, the system includes an insulin injection pen, a glucose monitor, and a remote user interface device which are in wireless communication as they relate to general purpose computer components (Application Specification [0027], [0031]-[0033])). As such, the limitations amount to no more than mere instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea. See MPEP 2106.05(f). Further, the limitation of “administer, via a pump mechanism, the first-type insulin dosage based on the modified first-type insulin dosage suggestion” amounts to adding insignificant extra‐solution activity to the judicial exception. See MPEP 2106.05(g). Accordingly, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. The claim is directed to an abstract idea.
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional elements of using “a processor; and a non-transitory storage medium having stored therein,” “instructions that when executed cause the processor to,” and “the memory,” to perform the collecting and analyzing limitations amounts to no more than mere instructions to apply the exception using a generic computer component. (i.e., a non-transitory storage medium such as a memory and/or a hard drive holding executable instructions by one or more processors for operating the mobile communication device such as a mobile phone, smart phone, a tablet, a laptop computer, a portable computer and similar devices, the system includes an insulin injection pen, a glucose monitor, and a remote user interface device which are in wireless communication as they relate to general purpose computer components (Application Specification [0027], [0031]-[0033])). Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept. See MPEP 2106.05(f). Further, the limitation of “administering to a person with diabetes, via the portable drug delivery device the second type of insulin according to the modified second-type insulin dosage suggestion” amounts to adding insignificant extra‐solution activity to the judicial exception that is well-understood, routine, and conventional activity. See MPEP 2106.05(d)(g) (e.g. Immunizing a patient against a disease, Classen Immunotherapies, Inc. v. Biogen IDEC, 659 F.3d 1057, 1063, 100 USPQ2d 1492, 1497 (Fed. Cir. 2011) (U.S. 2019/0175833 A1 “An external biologically effective drug (e.g., insulin or its analog) is commonly administered by means of daily injections. In some cases, multiple, daily injections (MDI) of a mixture of rapid- and long-acting insulin via a reusable transdermal liquid dosing device ( commonly referred to as an "insulin pen") or a hypodermic syringe. The injections are typically administered by a person with diabetes (PWD), and so require self-monitoring of blood glucose and the self-administration of insulin;. As a result, the abstract idea is not integrated into a practical application.”)).The claim is not patent eligible.
Dependent claims 20-21 and 23 include limitations of the independent claim and are directed to the same abstract idea as discussed above and incorporated herein. The dependent claims are rejected under 35 U.S.C. § 101 because they are directed to non-statutory subject matter. These additional claims recite what the blood glucose and insulin data is and how it is analyzed. These information characteristics do not integrate the judicial exception into a practical application, and, when viewed individually or as a whole, they do not add anything substantial beyond collecting and analyzing blood glucose and insulin data. such that limitation, when viewed individually as with the claim as a whole, amounts to generally linking the use of the abstract idea to a particular technological environment or field of use. Dependent claim 20 recites the additional elements of “a cap sensor of a pen cap,” however, this elements is recited at a high level and (i.e. the insulin injection pen is a LantusTM pen, a LevemirTMpen,a ToujeoTM pen, or a TresibaTM pen, wherein, the system includes a glucose monitor (e.g., a CGM) or another glucose sensor) (Application Specification at [0031])). See MPEP 2106.05(h). Furthermore, the combination of elements does not indicate a significant improvement to the functioning of a computer or any other technology. Therefore the dependent claims are rejected under 35 U.S.C. § 101.
Claim Rejections - 35 USC § 102
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-5, 8-9, 13-19, and 22-23 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by U.S. Patent Application Pub. No. 2019/0272912 A1 (hereinafter “Van Orden et al.”).
RE: Claim 1 (Currently Amended) Van Orden et al. teaches the claimed:
1. A method of adjusting insulin therapy settings of a portable drug delivery device for a person with diabetes that treats the diabetes by administering first and second types of insulin, the method comprising: storing, in a non-transitory storage medium of the portable drug delivery device, a first-type insulin dosage suggestion for a person with diabetes regarding a first type of insulin having an active time that is longer than an active time for a second type of insulin ((Van Orden et al., [0018], [0098], [0114], [0115], [0119], [0341]) (an exemplary basal titration adjustment device for obtaining a basal rate titration schedule for a subject comprises one or more processing units, a network or other communication interface, a memory, one or more magnetic disk storage and/or persistent devices optionally accessed by one or more controllers, one or more communication busses for interconnecting the aforementioned components; a second dataset associated with a standing insulin regimen for a subject over the first time course; if a pen is used, at least some of the administration events are for the administration of a basal (long acting) insulin medicament. For instance, in some embodiments, some of the administration events represent injection of a basal insulin medicament while other injection events in the second dataset represent injection of a bolus (short acting) insulin medicament; a computer program product that comprises a computer program mechanism embedded in a non-transitory computer readable storage medium));
receiving, via a communication link between a blood glucose sensor and a processor of the portable drug delivery device, blood glucose data obtained by the blood glucose sensor for the person with diabetes, the blood glucose data including blood glucose values for a plurality of days ((Van Orden et al., [0107], [0114], [0153]) (receives glucose measurements originating from one or more glucose sensors attached to a subject during a first time course; an exemplary basal titration adjustment device for obtaining a basal rate titration schedule for a subject comprises one or more processing units, a network or other communication interface, a memory, one or more magnetic disk storage and/or persistent devices optionally accessed by one or more controllers, one or more communication busses for interconnecting the aforementioned components; a plurality of autonomous glucose measurements taken over a period of a day or more, two days or more, a week or more, two weeks or more, etc.));
determining, by the processor of the portable drug delivery device, a first variability of the blood glucose values for a selected first period of time during the plurality of days, wherein the first variability is based on a mean value of the blood glucose values for the selected first period of time with respect to a predefined mean value and the selected first period of time includes multiple time segments from the plurality of days that correspond to each other ((Van Orden et al., [0034], [0040], [0087], [0165], [0169], [0171], [0191], [0192], [0193])) (determining a total glucose level variability observed across the plurality of autonomous glucose measurements; the mean profile and standard deviation of the glucose measurements made during the first time course are used to determine glycemic risk of the subject during the first time; The mean value of the glucose in the four hour period, can also be evaluated against the mean glucose value of the preceding 24 hours, the 24 hours of the previous calendar day, or another period providing a reference level enabling the identification of a relatively low glucose level in the four hour period; the second data set comprises a first plurality of insulin medicament records comprising: i) a respective insulin medicament infusion event including the amount of insulin medicament infused into the subject; … iii) a respective type of insulin medicament infused into the subject, and the respective type of insulin medicament being a bolus insulin medicament; the first dataset and the second data set are used to calculate a first glycemic risk measure and an insulin sensitivity factor of the subject during the first time course in order to transition to the second time course; successive measurements in the plurality of autonomous glucose measurements in the second dataset are taken at an interval rate of one day, two days, three days, four days, five days, six days, or seven days; using the first dataset and the second dataset to calculate the first glycemic risk measure of the subject during the first time course comprises determining (i) a total glucose level variability observed across the plurality of autonomous glucose measurements));
modifying, by the processor of the portable drug delivery device, the first-type insulin dosage suggestion in the non-transitory storage medium using only the determined first variability ((Van Orden et al., [0213) (The suggested frequency of titration and SMPG measurements are looked up in Table 4 i.e. BG variability Low: Titation TW SMPG 2/week; BG variability Medium: Titration OW SMPG 3/week; BG variability High: Titration OW SMPG 5/week)); and
administering the first type of insulin to the person with diabetes according to the modified first-type insulin dosage suggestion ((Van Orden et al., [0162], [0209]) (The subject adjusts treatment in accordance with these recommendations and the health care practitioner follows progress until the blood glucose is under control; the measurement of fasting blood glucose before as the resulting basal insulin dose adjustments may either be performed by the patient him/herself for by a doctor/nurse based on BG values supplied by the patient)).
RE: Claim 2 (Previously Presented) Van Orden et al. teaches the claimed:
2. The method of claim 1, further comprising: storing, in the non-transitory storage medium, a second-type insulin dosage suggestion for the person with diabetes regarding the second type of insulin ((Van Orden et al., [0192], [0193]) (the first dataset and the second data set are used to calculate a first glycemic risk measure and an insulin sensitivity factor of the subject during the first time course in order to transition to the second time course; obtain a corresponding basal rate titration schedule, which is based on or matches a corresponding bolus insulin medicament titration schedule for the second time course of the subject, where the second time course occurs subsequent to the first time course));
receiving second-type insulin dosage times for the person with diabetes regarding the plurality of days ((Van Orden et al., [0153]) (a plurality of autonomous glucose measurements taken over a period of a day or more, two days or more, a week or more, two weeks or more, etc.));
determining a second variability of the blood glucose values for the selected second period of time during the plurality of days, the second period of time not overlapping the first period of time ((Van Orden et al., [0165]) (determining a total glucose level variability observed across the plurality of autonomous glucose measurements)); and
modifying the second-type insulin dosage suggestion in the non-transitory storage medium based on the determined second variability ((Van Orden et al., [0173]) (by using at least the first glycemic risk measure and the insulin sensitivity factor of the subject to obtain a corresponding basal rate titration schedule, which is based on or matches a corresponding basal insulin medicament titration schedule (or bolus insulin medicament titration schedule, if an insulin pump with a basal rate is used) for a second time course for the subject, where the second time course occurs subsequent to the first time course)).
RE: Claim 3 (Original) Van Orden et al. teaches the claimed:
3. The method of claim 1, wherein determining the first variability comprises determining a measure of dispersion for the blood glucose values for the selected first period of time ((Van Orden et al., [0165]) (determining a percentage of the time glucose level of the subject are below the first target range across the plurality of autonomous glucose measurements)).
RE: Claim 4 (Original) Van Orden et al. teaches the claimed:
4. The method of claim 3, wherein determining the measure of dispersion comprises determining a percentage of the blood glucose values for the selected first period of time that fall below a threshold blood glucose level ((Van Orden et al., [0165]) (determining a percentage of the time glucose level of the subject are below the first target range across the plurality of autonomous glucose measurements)).
RE: Claim 5 (Original) Van Orden et al. teaches the claimed:
5. The method of claim 4, wherein modifying the first-type insulin dosage suggestion comprises: in response to the percentage exceeding a threshold percentage, decreasing the first-type insulin dosage suggestion; and in response to the percentage being less than the threshold percentage, increasing the first-type insulin dosage suggestion ((Van Orden et al., [0165], [0197]) (determining a percentage of the time glucose level of the subject are below the first target range across the plurality of autonomous glucose measurements; after a time period, e.g. 24 hours, when enough glucose data is available, the basal infusion rate with the bolus insulin medicament is changed; The change is in this case an increase, but the change is dependent on the used algorithm and patient response measured in the glucose level)).
RE: Claim 8 (Original) Van Orden et al. teaches the claimed:
8. The method of claim 3, wherein determining the measure of dispersion includes evaluating a mean value of a distribution of the blood glucose values for the selected first period of time, and a standard deviation of the distribution of the blood glucose values for the selected first period of time ((Van Orden et al., [0087], [0165]) (the mean profile and standard deviation of the glucose measurements made during the first time course are used to determine glycemic risk of the subject during the first time)).
RE: Claim 13 (Original) Van Orden et al. teaches the claimed:
13. The method of claim 1, wherein the first period of time is selected as being at least one of fasting time or sleeping time for the person with diabetes ((Van Orden et al., [0022]) (obtaining a third dataset representing all or a portion of the second time course, wherein the third dataset comprises a plurality of fasting blood glucose values from the subject and, for each respective fasting glucose measurement in the plurality of fasting glucose measurements, a time of measurement)).
RE: Claim 15 (Currently Amended) Van Orden et al. teaches the claimed:
15. A method of adjusting insulin therapy settings for a person with diabetes that treats the diabetes by administering first and second types of insulin via a portable drug delivery device, the method comprising: storing, in a non-transitory storage medium of the portable drug delivery device, a second-type insulin dosage suggestion for a person with diabetes regarding a second type of insulin having an active time that is shorter than an active time for a first type of insulin ((Van Orden et al., [0018], [0098], [0114], [0115], [0119], [0341]) (an exemplary basal titration adjustment device for obtaining a basal rate titration schedule for a subject comprises one or more processing units, a network or other communication interface, a memory, one or more magnetic disk storage and/or persistent devices optionally accessed by one or more controllers, one or more communication busses for interconnecting the aforementioned components; a second dataset associated with a standing insulin regimen for a subject over the first time course; if a pen is used, at least some of the administration events are for the administration of a basal (long acting) insulin medicament. For instance, in some embodiments, some of the administration events represent injection of a basal insulin medicament while other injection events in the second dataset represent injection of a bolus (short acting) insulin medicament; a computer program product that comprises a computer program mechanism embedded in a non-transitory computer readable storage medium));
receiving, via a communication link between a blood glucose sensor and the portable drug delivery device, blood glucose data for the person with diabetes, the blood glucose data including blood glucose values for a plurality of days ((Van Orden et al., [0107], [0114], [0153]) (an exemplary basal titration adjustment device for obtaining a basal rate titration schedule for a subject comprises one or more processing units, a network or other communication interface, a memory, one or more magnetic disk storage and/or persistent devices optionally accessed by one or more controllers, one or more communication busses for interconnecting the aforementioned components; receives glucose measurements originating from one or more glucose sensors attached to a subject during a first time course; a plurality of autonomous glucose measurements taken over a period of a day or more, two days or more, a week or more, two weeks or more, etc.));
receiving, by a processor of the portable drug delivery device, second-type insulin dosage times for the person with diabetes regarding the plurality of days ((Van Orden et al., [0096], [0098]) (each insulin medicament record comprises a timestamped even specifying an amount of administered insulin medicament that the subject received as part of the standing insulin medicament dosage regimen; if a pen is used, at least some of the administration events are for the administration of a basal (long acting) insulin medicament. For instance, in some embodiments, some of the administration events represent injection of a basal insulin medicament while other injection events in the second dataset represent injection of a bolus (short acting) insulin medicament));
determining, by the processor of the portable drug delivery device, a first variability of the blood glucose values for a selected first period of time during the plurality of days based on a selected metric((Van Orden et al., [0165], [0191], [0192], [0193])) (determining a total glucose level variability observed across the plurality of autonomous glucose measurements; the second data set comprises a first plurality of insulin medicament records comprising: i) a respective insulin medicament infusion event including the amount of insulin medicament infused into the subject; … iii) a respective type of insulin medicament infused into the subject, and the respective type of insulin medicament being a bolus insulin medicament; the first dataset and the second data set are used to calculate a first glycemic risk measure and an insulin sensitivity factor of the subject during the first time course in order to transition to the second time course; obtain a corresponding basal rate titration schedule, which is based on or matches a corresponding bolus insulin medicament titration schedule for the second time course of the subject, where the second time course occurs subsequent to the first time course))
modifying the second-type insulin dosage suggestion in the non-transitory storage medium based on only the determined first variability ((Van Orden et al., [0173], [0213]) (by using at least the first glycemic risk measure and the insulin sensitivity factor of the subject to obtain a corresponding basal rate titration schedule, which is based on or matches a corresponding basal insulin medicament titration schedule (or bolus insulin medicament titration schedule, if an insulin pump with a basal rate is used) for a second time course for the subject, where the second time course occurs subsequent to the first time course; The suggested frequency of titration and SMPG measurements are looked up in Table 4 i.e. BG variability Low: Titation TW SMPG 2/week; BG variability Medium: Titration OW SMPG 3/week; BG variability High: Titration OW SMPG 5/week)); and
administering to a person with diabetes, via the portable drug delivery device, the first type of insulin according to the modified first-type insulin dosage suggestion ((Van Orden et al., [0162], [0209]) (The subject adjusts treatment in accordance with these recommendations and the health care practitioner follows progress until the blood glucose is under control; the measurement of fasting blood glucose before as the resulting basal insulin dose adjustments may either be performed by the patient him/herself for by a doctor/nurse based on BG values supplied by the patient)); and
applying the selected metric to blood glucose data received after administering of the second type of insulin to the person with diabetes according to the modified second-type insulin dosage suggestion to enable determining of whether the modified second-time dosage suggestion was successful ((Van Orden et al., [0162], [0209]) (The subject adjusts treatment in accordance with these recommendations and the health care practitioner follows progress until the blood glucose is under control; the measurement of fasting blood glucose before as the resulting basal insulin dose adjustments may either be performed by the patient him/herself for by a doctor/nurse based on BG values supplied by the patient)).
RE: Claim 16 (Original) Van Orden et al. teaches the claimed:
16. The method of claim 15, wherein determining the first variability comprises determining a measure of dispersion for the blood glucose values for the selected first period of time ((Van Orden et al., [0165]) (determining a percentage of the time glucose level of the subject are below the first target range across the plurality of autonomous glucose measurements)).
RE: Claim 17 (Previously Presented) Van Orden et al. teaches the claimed:
17. The method of claim 15, further comprising: storing, in the non-transitory storage medium, a first-type insulin dosage suggestion for the person with diabetes regarding the first type of insulin ((Van Ord