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 .
Formal Matters
Applicant's response, filed 21 January 2026, has been fully considered. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Status of Claims
Claims 1-5, 8-14, and 17-20 are currently pending and have been examined.
Claims 1, 10, and 18 have been amended.
Claims 6-7 and 15-16 have been canceled.
Claims 1-5, 8-14, and 17-20 have been rejected.
Priority
The instant application claims the benefit of priority under 35 U.S.C 119(e) or under 35 U.S.C. § 120, 121, or 365(c). Accordingly, the effective filing date for the instant application is 19 July 2021 claiming benefit to Provisional Application 63/223429.
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed for No. EP211315203.6 on 07 July 2024.
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 1-5, 8-14, and 17-20 are rejected under 35 U.S.C. § 101 because the claimed invention is directed to a judicial exception (i.e. a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Step 1 – Statutory Categories of Invention:
Claims 1-5, 8-14, and 17-20 are drawn to a system, method, or device, which are statutory categories of invention.
Step 2A – Judicial Exception Analysis, Prong 1:
Independent claim 1 recites a system, independent claim 10 recites a computer-implemented method, and independent claim 18 recites one or more non-transitory computer-readable storage media in part performing the steps of (claim 1 is quoted directly hereinafter): storing a medical prescription specifying a dose plan for stabilizing a blood glucose level of a patient, the dose plan comprising (i) a plurality of dose adjustment rules for adjusting a dose of a first type of insulin, and (ii) a dose maintenance rule for maintaining a dose of a second type of insulin, wherein the plurality of dose adjustment rules define a target range of blood glucose level, the target range comprising a lower limit and an upper limit, a plurality of measurement values of the blood glucose level generated by a blood glucose measurement unit, and a plurality of dose values of the first type of insulin applied before the plurality of measurement values are generated; determine a next dose value of the first type of insulin based on the plurality of measurement values of the blood glucose level, the plurality of dose values of the first type of insulin, and the plurality of dose adjustment rules, comprising: determining, based on a most recently generated measurement value in the plurality of measurement values of the blood glucose level, whether the most recently generated measurement value is below the lower limit or above the upper limit, wherein the most recently generated measurement value was generated after a most recently applied dose value in the plurality of dose values of the first type of insulin was applied, and in response to the determining that the most recently generated measurement value is above the upper limit of the target range, determining the next dose value of the first type of insulin by increasing the most recently applied dose value of the first type of insulin by a predetermined amount of insulin or by a predetermined percentage of the most recently applied dose value, or in response to the determining that the most recently generated measurement value is below the lower limit of the target range, determining the next dose value of the first type of insulin by decreasing the most recently applied dose value of the first type of insulin by a predetermined amount of the first type of insulin or by a predetermined percentage of the most recently applied dose value; display the next dose value of the first type of insulin, determine a next dose value of the second type of insulin based on the dose maintenance rule, and display of the next dose value of the second type of insulin.
These steps of analyzing patient prescription data and analyte levels to output dosage recommendations amount to methods of organizing human activity which includes functions relating to interpersonal and intrapersonal activities, such as managing relationships or transactions between people, social activities, and human behavior (MPEP § 2106.04(a)(2)(II)(C) citing the abstract idea grouping for methods of organizing human activity for managing personal behavior or relationships or interactions between people similar to 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)– also note MPEP § 2106.04(a)(2)(II) stating certain activity between a person and a computer may fall within the “certain methods of organizing human activity” grouping).
Dependent claims 2, 11, & 19 recite, in part, wherein the first type of insulin is basal insulin and the second type of insulin is bolus insulin.
Dependent claims 3, 12, & 20 recite, in part, wherein the plurality of measurement values of the blood glucose level comprises a plurality of fasting blood glucose values.
Dependent claims 4 & 13 recite, in part, wherein the first type of insulin is bolus insulin and the second type of insulin is basal insulin.
Dependent claims 5 & 14 recite, in part, wherein the plurality of measurement values of the blood glucose level comprises a plurality of postprandial blood glucose values.
Dependent claims 8 & 17 recite, in part, determine whether a hypoglycemic event has occurred based on the plurality of measurement values; and in response to the determining that the hypoglycemic event has occurred, display of a prompt to the patient to contact a healthcare provider.
Dependent claim 9 recites, in part, wherein determining whether the hypoglycemic event has occurred comprises determining whether at least one of the plurality of measurement values is below a predetermined hypoglycemic blood glucose threshold.
Each of these steps of the preceding dependent claims only serve to further limit or specify the features of independent claims 1, 10, or 18 accordingly, and hence are nonetheless directed towards fundamentally the same abstract idea as the independent claim and utilize the additional elements analyzed below in the expected manner.
Step 2A – Judicial Exception Analysis, Prong 2:
This judicial exception is not integrated into a practical application because the additional elements within the claims only amount to instructions to implement the judicial exception using a computer [MPEP 2106.05(f)].
Claim 1 recites a data storage, one or more processors, and a display with a user interface of a computing device. Claim 10 recites a data storage and a display with a user interface of a computing device. Claim 18 recites a one or more non-transitory computer-readable storage media coupled to one or more processors, data storage, and a display with a user interface of a computing device.
The above claims, as a whole, are therefore directed to an abstract idea.
Step 2B – Additional Elements that Amount to Significantly More:
The present claims do not include additional elements that are sufficient to amount to more than the abstract idea because the additional elements or combination of elements amount to no more than a recitation of instructions to implement the abstract idea on a computer.
Claim 1 recites a data storage, one or more processors, and a display with a user interface of a computing device. Claim 10 recites a data storage and a display with a user interface of a computing device. Claim 18 recites a one or more non-transitory computer-readable storage media coupled to one or more processors, data storage, and a display with a user interface of a computing device. The specification defines the computer devices and corresponding hardware as “any appropriate type of computing device” with exemplary embodiments in the Detailed Description on p. 9 line 28 – p. 10 line 7. The computer and corresponding hardware is only recited as a tool to apply data to an algorithm and report the results (MPEP § 2106.05(f)(2) see case involving a commonplace business method or mathematical algorithm being applied on a general purpose computer within the “Other examples.. i.”) amounting to instruction to implement the abstract idea using a general purpose computer. Alice Corp. Pty. Ltd. V. CLS Bank Int’l, 134 S. Ct. 2347, 1357 (2014).
Each of these elements is only recited as a tool for performing steps of the abstract idea, such as the use of the storage mediums to store data, the computer and data processing devices to apply the algorithm, and the display device to display selected results of the algorithm. These additional elements therefore only amount to mere instructions to perform the abstract idea using a computer and are not sufficient to amount to significantly more than the abstract idea (MPEP 2016.05(f) see for additional guidance on the “mere instructions to apply an exception”).
Each additional element under Step 2A, Prong 2 is analyzed in light of the specification’s explanation of the additional element’s structure. The claimed invention’s additional elements do not have sufficient structure in the specification to be considered a not well-understood, routine, and conventional use of generic computer components. Note that the specification can support the conventionality of generic computer components if “the additional elements are sufficiently well-known that the specification does not need to describe the particulars of such additional elements to satisfy 35 U.S.C. § 112(a)” (Berkheimer in III. Impact on Examination Procedure, A. Formulating Rejections, 1. on p. 3).
Thus, taken alone, the additional elements do not amount to significantly more than the above-identified judicial exception. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. Their collective functions merely provide conventional computer implementation.
Claims 1-5, 8-14, and 17-20 are therefore rejected under 35 U.S.C. § 101 as being directed to non-statutory subject matter.
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 1-5, 8-14, and 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over Chen et al. (US Patent Application No. 2020/0342974)[hereinafter Chen] in view of Booth et al. (US Patent Application No. 2015/0217053)[hereinafter Booth].
As per claim 1, Chen teaches on the following limitations of the claim:
a system comprising: a data storage configured to store is taught in the Detailed Description in ¶ 0066 and ¶ 0068-69 (teaching on a computer implemented method for controlling dual insulin injections on a processor with a memory and corresponding hardware)
a medical prescription specifying a dose plan for stabilizing a blood glucose level of a patient, the dose plan comprising is taught in the Detailed Description in ¶ 0074-75 (teaching on a model predictive control algorithm for managing basal and bolus dosages for a diabetic patient)
(i) a plurality of dose adjustment rules for adjusting a dose of a first type of insulin, and is taught in the Detailed Description in ¶ 0073 and ¶ 0078 (teaching on a model predictive control algorithm for managing bolus dosages)
(ii) a dose maintenance rule for maintaining a dose of a second type of insulin is taught in the Detailed Description in ¶ 0073 and ¶ 0076 (teaching on a model predictive control algorithm for managing basal dosages)
wherein the plurality of dose adjustment rules define a target range of blood glucose level, the target range comprising a lower limit and an upper limit is taught in the Detailed Description in ¶ 0191 (teaching on determining the insulin dosage when the MMPC predict the blood glucose to be within or above (hyperglycemia) the threshold limits - but suspending insulin delivery when the blood glucose is below the lower threshold (hypoglycemic) )
a plurality of measurement values of the blood glucose level generated by a blood glucose measurement unit, and is taught in the Detailed Description in ¶ 0078, ¶ 0084, and in the Figures at fig. 3 (teaching on receiving continuous interstitial glucose values by an implanted continuous glucose monitor)
a plurality of dose values of the first type of insulin applied before the plurality of measurement values are generated; and is taught in the Detailed Description in ¶ 0078-79 and ¶ 0084 (teaching on a model predictive control algorithm wherein the bolus is delivered, blood glucose is remeasured for a rate of change, and updated state vectors are produced to manage the insulin dosages)
one or more processors operatively coupled to the data storage, the one or more processors configured to is taught in the Detailed Description in ¶ 0066 and ¶ 0068-69 (teaching on a computer implemented method for controlling dual insulin injections on a processor with a memory and corresponding hardware)
determine a next dose value of the first type of insulin based on the plurality of measurement values of the blood glucose level, the plurality of dose values of the first type of insulin, and the plurality of dose adjustment rules, comprising: is taught in the Detailed Description in ¶ 0078-79, ¶ 0084, and in the Figures at fig. 3 (teaching on a model predictive control algorithm wherein the bolus dosage is delivered, blood glucose is remeasured for a rate of change, and updated state vectors are produced to manage the insulin dosages)
determining, based on a most recently generated measurement value in the plurality of measurement values of the blood glucose level, whether the most recently generated measurement value is below the lower limit or above the upper limit, wherein the most recently generated measurement value was generated after a most recently applied dose value in the plurality of dose values of the first type of insulin was applied, and is taught in the Detailed Description in ¶ 0078-79, ¶ 0084, ¶ 0176, ¶ 0195, and in the Figures at fig. 3 (teaching on a model predictive control algorithm (MMPC) wherein after the bolus dosage is delivered, blood glucose is remeasured for a rate of change, and updated state vectors are produced to manage the insulin dosages, the MMPC is optimized continuously to maintain a blood glucose within a particular rage with a upper and lower threshold limits)
in response to the determining that the most recently generated measurement value is above the upper limit of the target range, determining the next dose value of the first type of insulin by increasing the most recently applied dose value of the first type of insulin by a predetermined amount of insulin or by a predetermined percentage of the most recently applied dose value, or in response to the determining that the most recently generated measurement value is below the lower limit of the target range, determining the next dose value of the first type of insulin by decreasing the most recently applied dose value of the first type of insulin by a predetermined amount of the first type of insulin or by a predetermined percentage of the most recently applied dose value is taught in the Detailed Description in ¶ 0191 (teaching on determining the next insulin dosage when the MMPC predict the blood glucose to be within or above (hyperglycemia) the threshold limits - but suspending insulin delivery when the blood glucose is below the lower threshold (hypoglycemic))
determine a next dose value of the second type of insulin based on the dose maintenance rule, and is taught in the Detailed Description in ¶ 0078-79, ¶ 0084, and in the Figures at fig. 3 (teaching on a model predictive control algorithm wherein after bolus dosage is delivered, blood glucose is remeasured for a rate of change, and updated state vectors are produced to determine the corresponding basal dosage)
Chen fails to teach the following limitation of claim 1. Booth, however, does teach the following:
cause a display, on a user interface of a computing device, of the next dose value of the first type of insulin is taught in the Detailed Description in ¶ 0141 (teaching on displaying a bolus dosage recommendation to a user)
cause a display, on the user interface, of the next dose value of the second type of insulin is taught in the Detailed Description in ¶ 0141 (teaching on displaying a basal dosage recommendation to a user)
One of ordinary skill in the art before the effective filing date of the invention would include the display of both recommended basal and bolus insulin dosages on a user interface device of Booth in substitution of the automatic injection of the recommended dosages of Chen since each individual element and its function are shown in the prior art, albeit shown in separate references, the difference between the claimed subject matter and the prior art rests not on any individual element or function but in the very combination itself- that is in the substitution of a display of the recommendations of the secondary reference for the automatic injection means of the primary reference. Thus, the simple substitution of one known element for another producing a predictable result of informing the user of the dosage recommendations renders the claim obvious.
Independent claims 10 and 18 are rejected under the same rational.
As per claim 2, the combination of Chen and Booth discloses all of the limitations of claim 1. Chen also discloses the following:
the system of claim 1, wherein the first type of insulin is basal insulin and the second type of insulin is bolus insulin is taught in the Detailed Description in ¶ 0074-75, ¶ 0076, and ¶ 0078 (teaching on a model predictive control algorithm for managing basal and bolus dosages for a diabetic patient)
Dependent claims 11 and 19 are rejected under the same rational.
As per claim 3, the combination of Chen and Booth discloses all of the limitations of claim 1. Chen also discloses the following:
the system of claim 1, wherein the plurality of measurement values of the blood glucose level comprises a plurality of fasting blood glucose values is taught in the Detailed Description in ¶ 0181 (teaching on the measured blood glucose values including fasting values)
Dependent claims 12 and 20 are rejected under the same rational.
As per claim 4, the combination of Chen and Booth discloses all of the limitations of claim 1. Chen also discloses the following:
the system of claim 1, wherein the first type of insulin is bolus insulin and the second type of insulin is basal insulin is taught in the Detailed Description in ¶ 0074-75 (teaching on a model predictive control algorithm for managing basal and bolus dosages for a diabetic patient - Examiner notes that as the algorithm is continuously updating between basal and bolus dosages the rules adjust to the last injection and are therefore interchangeable in the model predictive control)
Dependent claim 13 is rejected under the same rational.
As per claim 5, the combination of Chen and Booth discloses all of the limitations of claim 1. Chen also discloses the following:
the system of claim 1, wherein the plurality of measurement values of the blood glucose level comprises a plurality of postprandial blood glucose values is taught in the Detailed Description in ¶ 0191 (teaching on the measured blood glucose values including post-prandial glucose patterns)
Dependent claim 14 is rejected under the same rational.
As per claim 8, the combination of Chen and Booth discloses all of the limitations of claim 1. Chen also discloses the following:
the system of claim 1, wherein the one or more processors are further configured to: determine whether a hypoglycemic event has occurred based on the plurality of measurement values; and is taught in the Detailed Description in ¶ 0191 and ¶ 0195 (teaching on determining that a hypoglycemic event has occurred based on the measured blood glucose)
Chen fails to teach the following; Booth, however, does disclose:
in response to the determining that the hypoglycemic event has occurred, cause a display, on the user interface, of a prompt to the patient to contact a healthcare provider is taught in the Detailed Description in ¶ 0081 and ¶ 0091 (teaching on displaying an alert warning message to the patient when the patient's blood glucose is below a lower threshold (hypoglycemic) - Examiner notes that message prompting the patient to contact a health care provider is the intended use of the message and does not carry patentable weight - see MPEP § 2111.05)
One of ordinary skill in the art before the effective filing date of the invention would include the alert display of a hypoglycemic event on a user interface device of Booth with the hypoglycemic event detection algorithm of Chen with the motivation of “provid[ing] a warning message” to the user directly (Booth in the Detailed Description in ¶ 0091).
Dependent claim 17 is rejected under the same rational.
As per claim 9, the combination of Chen and Booth discloses all of the limitations of claim 1. Chen also discloses the following:
the system of claim 8, wherein determining whether the hypoglycemic event has occurred comprises determining whether at least one of the plurality of measurement values is below a predetermined hypoglycemic blood glucose threshold is taught in the Detailed Description in ¶ 0191 and ¶ 0195 (teaching on suspending insulin delivery when the blood glucose is below the lower threshold (hypoglycemic))
Response to Arguments
Applicant's arguments filed 21 January with respect to 35 USC § 101 have been fully considered but they are not persuasive. Applicant asserts that determining a medication dose via a titration to treat a metabolic disease should not be considered an abstract idea, and by reciting an automated logic, amount to automation of specific task using specific rules. Examiner is not persuaded. First, determining a medication dose is not a fundamentally in a closed loop manner disqualify a task from being considered an abstract idea. The use of electronic means for performing the abstract idea is not enough to overcome Step 2A Prong 1 (2019 Revised Patent Subject Matter Eligibility Guidance, 84 FED. REG. 4 (January 7, 2019) at p. 8 footnote 54 further citing Intellectual Ventures I LLC v. Symantec Corp., 838 F.3d 1307, 1316-18 (Fed. Cir. 2016) where the electronic implementation of human activity was not adequate to overcome Step 2A Prong 1). Second, language such as concurrently, automatically, instantly, or simultaneously to describe the automation of a manual process is not enough to overcome a subject matter eligibility rejection (MPEP § 2106.05(a)(I) Examples that the courts have indicated may not be sufficient to show an improvement in computer-functionality no. (iii) mere automation of manual processes). Examiner also notes that language such as this is not restricted to computer processes, humans can automatically/instantly/simultaneously complete different tasks (see MPEP § 2106.04(a)(2)(III) stating that the mental processes may be completely by humans plural – not just a singular human mind).
Next, Applicant asserts that the claims amount to a practical application via an improvement to the technical field of diabetes management systems stating that the instant claims provide “more timely and more accurate next dose recommendations” compared to existing systems. An improvement to the abstract idea of determining a medication dose based on the physiological data of a patient does not amount to an improvement to technology or a technical field (see MPEP § 2106.05(a)(III) stating “it is important to keep in mind that an improvement in the abstract idea itself (e.g. a recited fundamental economic concept) is not an improvement in technology. For example, in Trading Technologies Int’l v. IBG, 921 F.3d 1084, 1093-94, 2019 USPQ2d 138290 (Fed. Cir. 2019), the court determined that the claimed user interface simply provided a trader with more information to facilitate market trades, which improved the business process of market trading but did not improve computers or technology.”). There is no indication in the instant disclosure that the involvement of a computer assists in improving the technology for the outlined problem statement. Here, the improvement is to medication dosing algorithm. The instant application and claim language fail to detail how a computer aids the method, the extent to which the computer aids the method, or the significance of a computer to the performance of the method. Merely adding generic computer components to perform the method is not sufficient.
Applicant's arguments filed 21 January with respect to 35 USC § 103 have been fully considered but they are not persuasive. Applicant asserts that Chen fails to teach on the adjust rules based on range thresholds because Chen relies on a cost function to determine the next dosage. Examiner disagrees. While Chen may rely on additional predictive measures for determining the next dosage, the model predictive control algorithm utilizes the most recent blood glucose measure of the patient to determine a trend. The instant claims recite a “comprising” step wherein the claim is in no way limited to merely the steps and data presented in the claim. Additionally, the claim language says “determining, based on a more recent generated measurement value”.. [emphasis added] and in no way limits the claim to the methodology in which the determination is calculated. Examiner does not make any statement regarding the teachings of Booth as Examiner has not relied on said prior art to teach on the amended limitations. Therefore, the rejection is sustained.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JORDAN LYNN JACKSON whose telephone number is (571)272-5389. The examiner can normally be reached Monday-Friday 8:30AM-4:30PM ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Arleen M Vazquez can be reached at (571) 272-2619. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JORDAN L JACKSON/Primary Examiner, Art Unit 2857