DETAILED ACTION
Notices to Applicant
This communication is a First Action Non-Final on the merits. Claims 1-20 as filed 10/22/2025, 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 is a 371 of PCT/US2024/027205 filed 05/01/2024, which claims benefit priority to PRO 63/571,570 filed 03/29/2024 and PRO 63/499,796 filed 05/03/2023.
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 1-21 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 1-10 are drawn to a system, which is within the four statutory categories (i.e. machine).
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:
1. (Original) A system comprising: a computing system programmed to calculate a final insulin dose using an operation comprising:
calculating a proposed insulin dose;
iteratively adjusting the proposed insulin dose until a predicted first level is greater than a first threshold;
iteratively adjusting the proposed insulin dose until a predicted second level is less than a predetermined maximum threshold; and
determining the final insulin dose after the iteratively adjusting steps.
The claim limitations, as drafted, is a machine that, under its broadest reasonable interpretation, covers managing personal behavior or interactions between people through rules or instructions but for the recitation of generic computer components. That is, other than reciting the above bolded limitation, such as “a computing system,” nothing in the claim precludes the steps from being directed to rules or instructions for managing personal behavior or interactions between people to calculate a final insulin dose. For example, but for the “a processor,” and “a repository,” language, calculating a proposed insulin dose; iteratively adjusting the proposed insulin dose until a predicted first level is greater than a first threshold; iteratively adjusting the proposed insulin dose until a predicted second level is less than a predetermined maximum threshold; and determining the final insulin dose after the iteratively adjusting steps in the context of this claim encompasses rules or instructions for managing personal behavior or interactions between people to calculate a final insulin dose. If a claim, under broadest reasonable interpretation, covers performance managing personal behavior or interactions between people through rules or instructions but for the recitation of generic computer components, then it falls within the “Certain Methods of Organizing Human Activity” grouping of abstract ideas. See MPEP § 2106.04(a)(2)(II)(C) (iii. a mental process that a neurologist should follow when testing a patient for nervous system malfunctions, In re Meyer, 688 F.2d 789, 791-93, 215 USPQ 193, 194-96 (CCPA 1982)). The claim limitations of calculating a proposed insulin dose and determining the final insulin dose after the iteratively adjusting steps cover performance of the limitations in the mind but for the recitation of generic computer components, such that the claim also recites 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 the above bolded additional elements of using “a computing system,” to perform the claim limitations. The elements in each of these steps are recited at a high-level of generality (i.e., a computing system including a graphical user interface, computer device including a tablet or server computer including a processor, memory, display/user-interface, and communication device as they relate to a general purpose computers (Application Specification [0044], [00156]-[00158])). 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). 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 above bolded additional elements of using “a computing system” to perform the claim limitations amounts to no more than mere instructions to apply the exception using a generic computer component (i.e., a computing system including a graphical user interface, computer device including a tablet or server computer including a processor, memory, display/user-interface, and communication device as they relate to a general purpose computers (Application Specification [0044], [00156]-[00158])). Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept. See MPEP 2106.05(f). The claim is not patent eligible.
Dependent claims 2-10 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 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 the abstract ideas. 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 11-21 are drawn to a method, which is within the four statutory categories (i.e. method).
Independent Claim 11 is rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. Claim 11 recites:
11. (Original) A method comprising: calculating a proposed insulin dose;
iteratively adjusting the proposed insulin dose until a predicted first level is greater than a first threshold;
iteratively adjusting the proposed insulin dose until a predicted second level is less than a predetermined maximum threshold; and
determining a final insulin dose after the iteratively adjusting steps.
The claim limitations, as drafted, is a method that, under its broadest reasonable interpretation, covers managing personal behavior or interactions between people through rules or instructions but for the recitation of generic computer components. That is, nothing in the claim precludes the steps from being directed to rules or instructions for managing personal behavior or interactions between people to calculate a final insulin dose. For example, calculating a proposed insulin dose; iteratively adjusting the proposed insulin dose until a predicted first level is greater than a first threshold; iteratively adjusting the proposed insulin dose until a predicted second level is less than a predetermined maximum threshold; and determining the final insulin dose after the iteratively adjusting steps in the context of this claim encompasses rules or instructions for managing personal behavior or interactions between people to calculate a final insulin dose. If a claim, under broadest reasonable interpretation, covers performance managing personal behavior or interactions between people through rules or instructions, then it falls within the “Certain Methods of Organizing Human Activity” grouping of abstract ideas. See MPEP § 2106.04(a)(2)(II)(C) (iii. a mental process that a neurologist should follow when testing a patient for nervous system malfunctions, In re Meyer, 688 F.2d 789, 791-93, 215 USPQ 193, 194-96 (CCPA 1982)). The claim limitations of calculating a proposed insulin dose and determining the final insulin dose after the iteratively adjusting steps cover performance of the limitations in the mind, such that the claim also recites 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 does not recite any additional elements. Accordingly, abstract idea is not integrated into a practical application because the claim does 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 claim fails to recite any additional elements. The claim is not patent eligible.
Dependent claims 12-21 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 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 the abstract ideas. Therefore the dependent claims are rejected under 35 U.S.C. § 101.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 4-5, 7-11, 16-17, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over US 2022/0211944 A1 (hereinafter “Mensinger et al.”) in view of US 2012/0232520 A1 (hereinafter “Sloan et al.”).
RE: Claim 1 Mensinger et al. teaches the claimed:
1. (Original) A system comprising: a computing system programmed to calculate a final insulin dose using an operation comprising ((Mesinger et al., [0056]) (provide a dose calculator and/or decision support modules that can calculate and recommend a dose of the medicine for the patient user to administer using the pen device)):
calculating a proposed insulin dose ((Mesinger et al., [0093]) (The primary dose calculation may be run using the traditional mathematical formula presented above to achieve target BG));
iteratively adjusting the proposed insulin dose until a predicted first level is greater than a first threshold ((Mesinger et al., [0093]) (The secondary dose calculation may be run concurrently to predict the worst-case low BG if all carbs were fast, and if the predicted worst-case value falls below an unacceptable threshold));
determining the final insulin dose after the iteratively adjusting steps ((Mesinger et al., [0093]) (The secondary dose calculation may be run concurrently to predict the worst-case low BG if all carbs were fast, and if the predicted worst-case value falls below an unacceptable threshold then adjust the final dose recommendation conservatively to assure safety)).
Mensinger et al. fails to explicitly teach, but Sloan et al. teaches the claimed:
iteratively adjusting the proposed insulin dose until a predicted second level is less than a predetermined maximum threshold ((Sloan et al., [0133]-[0134]) (the dose level of medication has a maximum dose level. If the adjusted dose level (e.g., the current dose level plus the predetermined dose adjustment amount) would be greater than the maximum dose level, then health monitor device 600 may display information and/or a message to the user if an analyte concentration is below a threshold level, if an analyte concentration is above a threshold level, if an analyte concentration is greater than a predetermined amount below a threshold level, if an analyte concentration is greater than a predetermined amount above a threshold level, if a post-meal analyte concentration is above a threshold level, if a postmeal analyte concentration is above a threshold level more than a predetermined number of times, if a pre-meal analyte concentration is above a threshold level, or if a pre-meal analyte concentration is above a threshold level more than a predetermined number of times)).
One of ordinary skill in the art at the time of the effective filing date would have found it obvious to combine the threshold levels of medication dose level such as the maximum insulin dose level for a patient as taught by Sloan et al. within the systems and methods for determining a dose of insulin as taught by Mensinger et al. with the motivation of providing a medication dosage calculation function into a health monitor device, such as a blood glucose meter, configured to perform data analysis and management (Sloan et al. [0003]-[0004]).
RE: Claim 4 Mesinger et al. and Sloan et al. teach the claimed:
4. (Original) The system of claim 1, wherein the predicted second level is a maximum insulin activity level, wherein the second threshold is a predetermined maximum threshold ((Mensinger et al., [0030]) (the app may identify the forecasted maximum BG value and/or the forecasted minimum BG value, and then use these values to run a dose recommendation calculation for that future time point marking the identified maximum or minimum to optimize the insulin dose administered)).
RE: Claim 5 Mesinger et al. and Sloan et al. teach the claimed:
5. (Original) The system of claim 4, wherein the proposed insulin dose is iteratively decreased until the proposed insulin dose results in the predicted maximum insulin activity level being less than a predetermined maximum threshold ((Mensinger et al., [0030]) (the app may identify the forecasted maximum BG value and/or the forecasted minimum BG value, and then use these values to run a dose recommendation calculation for that future time point marking the identified maximum or minimum to optimize the insulin dose administered. In some embodiments, the app may include safeguards in such a calculation to prevent hypoglycemia, for example by capping the maximum adjustment, re-running the simulation at least once to confirm forecast and check for a projected hypoglycemic response)).
RE: Claim 7 Mesinger et al. and Sloan et al. teach the claimed:
7. (Original) The system of claim 1, wherein the proposed insulin dose is based, at least in part, on a target insulin activity level ((Mensinger et al., [0024]) (The primary dose calculation may be run using the traditional mathematical formula presented above to achieve target BG)).
RE: Claim 8 Mesinger et al. and Sloan et al. teach the claimed:
8. (Original) The system of claim 7, wherein the target insulin activity level is based, at least in part, on a current insulin activity level and an insulin activity level reduction ((Mensinger et al., [0126]) (the app 40 may increase target BG to provide a safety buffer against hypoglycemia. This may be applied at all times, or only in extreme cases of very large corrections, such as with an extreme high or low BG ( e.g. as measured by the CGM 60), a high rate of change ( e.g. as detected by the CGM 60), or a large meal consumed by the user. The increased target BG may be based on one of these factors or the total net insulin calculation)).
RE: Claim 9 Mesinger et al. and Sloan et al. teach the claimed:
9. (Original) The system of claim 8, wherein the current insulin activity level and the insulin activity level reduction are based, at least in part, on a subject's records ((Mensinger et al., [0128]) (IOB is calculated by the app 40 from objective insulin dose records)).
RE: Claim 10 Mesinger et al. and Sloan et al. teach the claimed:
10. (Original) The system of claim 8, wherein the insulin activity level reduction is based, at least in part, on a number of entries in the subject's records relating to a disease within a predetermined period of time of calculating the proposed insulin dose ((Mensinger et al., [0136]) (the app 40 may prompt the user to perform a BG check at a time when the user is forecasted to exceed a minimum or maximum BG threshold based on past BG level and rate of change. In some embodiments, the app 40 may prompt the user to perform a BG check at a time of day (and/or day of the week) when the user has previously shown a pattern of poor glycemic control, allowing the user to identify a risk in real-time and giving the opportunity to proactively counteract it with a dose of insulin or food intake)).
RE: Claim 11 Mensinger et al. teaches the claimed:
11. (Original) A method comprising: calculating a proposed insulin dose ((Mesinger et al., [0093]) (The primary dose calculation may be run using the traditional mathematical formula presented above to achieve target BG));
iteratively adjusting the proposed insulin dose until a predicted first level is greater than a first threshold ((Mesinger et al., [0093]) (The secondary dose calculation may be run concurrently to predict the worst-case low BG if all carbs were fast, and if the predicted worst-case value falls below an unacceptable threshold));
determining the final insulin dose after the iteratively adjusting steps ((Mesinger et al., [0093]) (The secondary dose calculation may be run concurrently to predict the worst-case low BG if all carbs were fast, and if the predicted worst-case value falls below an unacceptable threshold then adjust the final dose recommendation conservatively to assure safety));.
Mensinger et al. fails to explicitly teach, but Sloan et al. teaches the claimed:
iteratively adjusting the proposed insulin dose until a predicted second level is less than a predetermined maximum threshold ((Sloan et al., [0133]-[0134]) (the dose level of medication has a maximum dose level. If the adjusted dose level (e.g., the current dose level plus the predetermined dose adjustment amount) would be greater than the maximum dose level, then health monitor device 600 may display information and/or a message to the user if an analyte concentration is below a threshold level, if an analyte concentration is above a threshold level, if an analyte concentration is greater than a predetermined amount below a threshold level, if an analyte concentration is greater than a predetermined amount above a threshold level, if a post-meal analyte concentration is above a threshold level, if a postmeal analyte concentration is above a threshold level more than a predetermined number of times, if a pre-meal analyte concentration is above a threshold level, or if a pre-meal analyte concentration is above a threshold level more than a predetermined number of times)).
One of ordinary skill in the art at the time of the effective filing date would have found it obvious to combine the threshold levels of medication dose level such as the maximum insulin dose level for a patient as taught by Sloan et al. within the systems and methods for determining a dose of insulin as taught by Mensinger et al. with the motivation of providing a medication dosage calculation function into a health monitor device, such as a blood glucose meter, configured to perform data analysis and management (Sloan et al. [0003]-[0004]).
RE: Claim 16 Mesinger et al. and Sloan et al. teach the claimed:
16. (Original) The method of claim 11, wherein the predicted second level is a predicted maximum insulin activity level, wherein the second threshold is a predetermined maximum threshold ((Mensinger et al., [0030]) (the app may identify the forecasted maximum BG value and/or the forecasted minimum BG value, and then use these values to run a dose recommendation calculation for that future time point marking the identified maximum or minimum to optimize the insulin dose administered)).
RE: Claim 17 Mesinger et al. and Sloan et al. teach the claimed:
17. (Original) The method of claim 16, wherein the proposed insulin dose is iteratively decreased until the proposed insulin dose results in the predicted maximum insulin activity level being less than a predetermined maximum threshold ((Mensinger et al., [0030]) (the app may identify the forecasted maximum BG value and/or the forecasted minimum BG value, and then use these values to run a dose recommendation calculation for that future time point marking the identified maximum or minimum to optimize the insulin dose administered. In some embodiments, the app may include safeguards in such a calculation to prevent hypoglycemia, for example by capping the maximum adjustment, re-running the simulation at least once to confirm forecast and check for a projected hypoglycemic response)).
RE: Claim 21 Mesinger et al. and Sloan et al. teach the claimed:
21. (Currently Amended) The method of claim 11, wherein the proposed insulin dose is based, at least in part, on a target insulin activity level, wherein the target insulin activity level is based, at least in part, on a current insulin activity level and an insulin activity level reduction ((Mensinger et al., [0126]) (the app 40 may increase target BG to provide a safety buffer against hypoglycemia. This may be applied at all times, or only in extreme cases of very large corrections, such as with an extreme high or low BG ( e.g. as measured by the CGM 60), a high rate of change ( e.g. as detected by the CGM 60), or a large meal consumed by the user. The increased target BG may be based on one of these factors or the total net insulin calculation)).
Claims 2-3, 6, 12-15, 18, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over US 2022/0211944 A1 (hereinafter “Mensinger et al.”) in view of US 2012/0232520 A1 (hereinafter “Sloan et al.”) and further in view of US 2016/0117481 A1 (hereinafter “Booth et al.”).
RE: Claim 2 Mesinger et al. and Sloan et al. teach the claimed:
2. (Original) The system of claim 1.
Mensinger et al. and Sloan et al. fail to explicitly teach, but Roy et al. teaches the claimed:
wherein the predicted first level is a median insulin activity level, wherein the first threshold is a subject's median insulin activity level ((Booth et al., [0012]) (The representative aggregate blood glucose measurement may further include a median blood glucose value for the associated scheduled blood glucose time interval)).
One of ordinary skill in the art at the time of the effective filing date would have found it obvious to combine aggregate blood glucose measurement may include a median blood glucose value as taught by Booth et al. within the systems and methods for determining a dose of insulin as taught by Mensinger et al. and the threshold levels of medication dose level such as the maximum insulin dose level for a patient as taught by Sloan et al. with the motivation of reducing human error in calculating insulin doses for maintaining blood glucose measurements within desired ranges (Booth et al. [0003]).
RE: Claim 3 Mesinger et al., Sloan et al., and Booth et al. teach the claimed:
3. (Original) The system of claim 2, wherein the proposed insulin dose is iteratively increased until the proposed insulin dose results in the predicted median insulin activity level being greater than the subject's median insulin activity level ((Mensinger et al., [0083]) (the app may identify the forecasted maximum BG value and/or the forecasted minimum BG value, and then use these values to run a dose recommendation calculation for that future time point marking the identified maximum or minimum to optimize the insulin dose administered. In some embodiments, the app may include safeguards in such a calculation to prevent hypoglycemia, for example by capping the maximum adjustment, re-running the simulation at least once to confirm forecast and check for a projected hypoglycemic response. Since the goal of an insulin dose calculator is to achieve ( or maintain) target BG in the future, adjusting the dose recommendation based on BG trend may help achieve the target glucose level more accurately than only adjusting for the present BG value)).
RE: Claim 6 Mesinger et al. and Sloan et al. teach the claimed:
6. (Original) The system of claim 1,
Mensinger et al. and Sloan et al. fail to explicitly teach, but Booth et al. teaches the claimed:
wherein the predicted first level is a median insulin activity level, wherein the first threshold is a subject's median insulin activity level, wherein the predicted second level is a maximum insulin activity level, wherein the second threshold is a predetermined maximum threshold ((Booth et al., [0012], [0067]) (The representative aggregate blood glucose measurement may further include a median blood glucose value for the associated scheduled blood glucose time interval; determines if the patient 10 is within a threshold blood glucose value BG TH In some examples, the surveillance module 70 alerts the user 40 if a patient's blood glucose values BG are not within a threshold blood glucose value BG TH)).
One of ordinary skill in the art at the time of the effective filing date would have found it obvious to combine aggregate blood glucose measurement may include a median blood glucose value as taught by Booth et al. within the systems and methods for determining a dose of insulin as taught by Mensinger et al. and the threshold levels of medication dose level such as the maximum insulin dose level for a patient as taught by Sloan et al. with the motivation of reducing human error in calculating insulin doses for maintaining blood glucose measurements within desired ranges (Booth et al. [0003]).
RE: Claim 12 Mesinger et al. and Sloan et al. teach the claimed:
12. (Original) The system of claim 11,
Mensinger et al. and Sloan et al. fail to explicitly teach, but Booth et al. teaches the claimed:
wherein the predicted first level is a predicted median insulin activity level, wherein the first threshold is a subject's median insulin activity level ((Booth et al., [0012]) (The representative aggregate blood glucose measurement may further include a median blood glucose value for the associated scheduled blood glucose time interval)).
One of ordinary skill in the art at the time of the effective filing date would have found it obvious to combine aggregate blood glucose measurement may include a median blood glucose value as taught by Booth et al. within the systems and methods for determining a dose of insulin as taught by Mensinger et al. and the threshold levels of medication dose level such as the maximum insulin dose level for a patient as taught by Sloan et al. with the motivation of reducing human error in calculating insulin doses for maintaining blood glucose measurements within desired ranges (Booth et al. [0003]).
RE: Claim 13 Mesinger et al., Sloan et al., and Booth et al. teach the claimed:
13. (Original) The method of claim 12, wherein the proposed insulin dose is iteratively increased until the proposed insulin dose results in the predicted median insulin activity level being greater than the subject's median insulin activity level ((Mensinger et al., [0083]) (the app may identify the forecasted maximum BG value and/or the forecasted minimum BG value, and then use these values to run a dose recommendation calculation for that future time point marking the identified maximum or minimum to optimize the insulin dose administered. In some embodiments, the app may include safeguards in such a calculation to prevent hypoglycemia, for example by capping the maximum adjustment, re-running the simulation at least once to confirm forecast and check for a projected hypoglycemic response. Since the goal of an insulin dose calculator is to achieve ( or maintain) target BG in the future, adjusting the dose recommendation based on BG trend may help achieve the target glucose level more accurately than only adjusting for the present BG value)).
RE: Claim 14 Mesinger et al. and Sloan et al. teach the claimed:
14. (Original) The method of claim 13, wherein the proposed insulin dose is iteratively increased based, at least in part, on median fasting blood glucose level ((Booth et al., [0012], [0106]) (The representative aggregate blood glucose measurement may further include a median blood glucose value for the associated scheduled blood glucose time interval; Basal insulin is for the fasting insulin-needs of a patient's body. Therefore, the best indicator of the effectiveness of the basal dose is the value of the blood glucose BG after the patient 10 has fasted for a period of time)).
One of ordinary skill in the art at the time of the effective filing date would have found it obvious to combine aggregate blood glucose measurement may include a median blood glucose value and fasting blood glucose as taught by Booth et al. within the systems and methods for determining a dose of insulin as taught by Mensinger et al. and the threshold levels of medication dose level such as the maximum insulin dose level for a patient as taught by Sloan et al. with the motivation of reducing human error in calculating insulin doses for maintaining blood glucose measurements within desired ranges (Booth et al. [0003]).
RE: Claim 15 Mesinger et al. and Sloan et al. teach the claimed:
15. (Original) The method of claim 12, wherein the predicted median insulin activity level is based, at least in part, on solving differential equations ((Booth et al., [0012], [0094]) (The representative aggregate blood glucose measurement may further include a median blood glucose value for the associated scheduled blood glucose time interval; The remaining equations involves a time-dependent, two0compartment model of insulin, Equations SB and SC are simultaneous linear first-order differential equations)).
One of ordinary skill in the art at the time of the effective filing date would have found it obvious to combine aggregate blood glucose measurement may include a median blood glucose value differential equations for determining remaining insulin and as taught by Booth et al. within the systems and methods for determining a dose of insulin as taught by Mensinger et al. and the threshold levels of medication dose level such as the maximum insulin dose level for a patient as taught by Sloan et al. with the motivation of reducing human error in calculating insulin doses for maintaining blood glucose measurements within desired ranges (Booth et al. [0003]).
RE: Claim 18 Mesinger et al. and Sloan et al. teach the claimed:
18. (Original) The method of claim 17, wherein the proposed insulin dose is iteratively decreased based, at least in part, on median fasting blood glucose level ((Booth et al., [0012], [0106]) (The representative aggregate blood glucose measurement may further include a median blood glucose value for the associated scheduled blood glucose time interval; Basal insulin is for the fasting insulin-needs of a patient's body. Therefore, the best indicator of the effectiveness of the basal dose is the value of the blood glucose BG after the patient 10 has fasted for a period of time)).
One of ordinary skill in the art at the time of the effective filing date would have found it obvious to combine aggregate blood glucose measurement may include a median blood glucose value and fasting blood glucose as taught by Booth et al. within the systems and methods for determining a dose of insulin as taught by Mensinger et al. and the threshold levels of medication dose level such as the maximum insulin dose level for a patient as taught by Sloan et al. with the motivation of reducing human error in calculating insulin doses for maintaining blood glucose measurements within desired ranges (Booth et al. [0003]).
RE: Claim 20 Mesinger et al. and Sloan et al. teach the claimed:
20. (Original) The method of claim 11.
Mensinger et al. and Sloan et al. fail to explicitly teach, but Booth et al. teaches the claimed:
wherein the predicted first level is a median insulin activity level, wherein the first threshold is a subject's median insulin activity level, wherein the predicted second level is a maximum insulin activity level, wherein the second threshold is a predetermined maximum threshold ((Booth et al., [0012], [0067]) (The representative aggregate blood glucose measurement may further include a median blood glucose value for the associated scheduled blood glucose time interval; determines if the patient 10 is within a threshold blood glucose value BG TH In some examples, the surveillance module 70 alerts the user 40 if a patient's blood glucose values BG are not within a threshold blood glucose value BG TH)).
One of ordinary skill in the art at the time of the effective filing date would have found it obvious to combine aggregate blood glucose measurement may include a median blood glucose value as taught by Booth et al. within the systems and methods for determining a dose of insulin as taught by Mensinger et al. and the threshold levels of medication dose level such as the maximum insulin dose level for a patient as taught by Sloan et al. with the motivation of reducing human error in calculating insulin doses for maintaining blood glucose measurements within desired ranges (Booth et al. [0003]).
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over US 2022/0211944 A1 (hereinafter “Mensinger et al.”) in view of US 2012/0232520 A1 (hereinafter “Sloan et al.”) and further in view of US 2014/0066886 A1 (hereinafter “Roy et al.”).
RE: Claim 19 Mesinger et al. and Sloan et al. teach the claimed:
19. (Original) The method of claim 16.
Mensinger et al. and Sloan et al. fail to explicitly teach, but Roy et al. teaches the claimed:
wherein the predicted maximum insulin activity level is based, at least in part, on solving differential equations ((Roy et al., [0265], [0637]) (a maximum anticipated rate of change of the blood glucose level, an insulin delivery system minimum insulin dosage, insulin sensitivity, a maximum and a minimum acceptable glucose concentration, or the like; the sensor glucose prediction model is expressed as a fourth order ordinary differential equation that, when solved given the initial conditions, provides model-predicted sensor glucose values)).
One of ordinary skill in the art at the time of the effective filing date would have found it obvious to combine the predicted sensor glucose values with differential equations as taught by Roy et al. within the systems and methods for determining a dose of insulin as taught by Mensinger et al. and the threshold levels of medication dose level such as the maximum insulin dose level for a patient as taught by Sloan et al. with the motivation of providing insulin pumps adopted for the speed of insulin they are using (Roy et al. [0003]-[0004]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US 2018/0296757 A1 teaches determine a total insulin dose based on the modified manual bolus insulin dose and the calculated basal insulin dose ([0044]);
US 2017/0053101 A1 teaches chronologically adjusts the bolus insulin dose one dose adjustment at a time wherein the box associated with the patient's MealBolusGov is selected by iteratively comparing the patient's MealBolusGov to an upper bound of the MealBolusGov attribute ([0108]); and
US 2014/0039383 A1 teaches calculate an insulin therapy (e.g., dose) less than or equal to the maximum total insulin dose associated with the engaged bolus constraint, wherein the evaluation and/or calculation of therapy are performed iteratively ([0185]).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANTHONY BALAJ whose telephone number is (571)272-8181. The examiner can normally be reached 8:00 - 4:00 M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Fonya Long can be reached at (571) 270-5096. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/A.M.B./Examiner, Art Unit 3682
/FONYA M LONG/Supervisory Patent Examiner, Art Unit 3682
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