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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 05/26/2026 has been entered.
Formal Matters
Applicant's response, filed 05/26/2026, 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 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, based on the most recently generated measurement value in a 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 the 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, automatically increase the most recently applied dose value of the first type of insulin by a first predetermined percentage of the most recently applied dose value to obtain the next dose value of the first type of insulin, wherein the first predetermined percentage is specified by the plurality of dose adjustment rules, or in response to the determining that the most recently generated measurement value is below the lower limit of the target range, automatically decrease the most recently applied dose value of the first type of insulin by a second predetermined percentage of the most recently applied dose value to obtain the next dose value of the first type of insulin, wherein the second predetermined percentage is specified by the plurality of dose adjustment rules; 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 computer and corresponding hardware are 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).
Claims 1, 10, and 18 recite establish a wireless communication link with a remote data processing system; maintain a synchronized treatment state with a remote data processing system by (a) automatically transmitting, via the wireless communication link, the plurality of measurement values and the plurality of dose values to the remote data processing system, and (b) dynamically updating the data storage in response to receiving a modification to the dose plan from the remote data processing system. The limitations are only recited as a tool which only serves to input data for use by the abstract idea (MPEP § 2106.05(g) - insignificant pre-solution activity that amounts to mere data gathering to obtain input) and is therefore not a practical application of the recited judicial exception.
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).
Claims 1, 10, and 18 recite establish a wireless communication link with a remote data processing system; maintain a synchronized treatment state with a remote data processing system by (a) automatically transmitting, via the wireless communication link, the plurality of measurement values and the plurality of dose values to the remote data processing system, and (b) dynamically updating the data storage in response to receiving a modification to the dose plan from the remote data processing system. The courts have decided that receiving or transmitting data over a network as well-understood, routine, conventional activity when claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity (MPEP § 2106.05(d)(II) other types of activities example i. receiving or transmitting data over a network, OIP Techs., Inc., v. Amazon.com, Inc., 788 F.3d 1359, 1363, 115 USPQ2d 1090, 1093 (Fed. Cir. 2015) (sending messages over a network). Furthermore, the courts have decided that storing and retrieving information in memory as well-understood, routine, conventional activity as a computer function when claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity (MPEP § 2106.05(d)(II)).
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] in view of Raskin et al. (US Patent Application No. 20210213200)[hereinafter Raskin].
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, based on the most recently generated measurement value in a 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 the 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, automatically increase the most recently applied dose value of the first type of insulin by a first predetermined percentage of the most recently applied dose value to obtain the next dose value of the first type of insulin, wherein the first predetermined percentage is specified by the plurality of dose adjustment rules stored in the data storage, or in response to the determining that the most recently generated measurement value is below the lower limit of the target range, automatically decrease the most recently applied dose value of the first type of insulin by a second predetermined percentage of the most recently applied dose value to obtain the next dose value of the first type of insulin, wherein the second predetermined percentage is specified by the plurality of dose adjustment rules stored in the data storage is taught in the Detailed Description in ¶ 0191 and ¶ 0071 (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) wherein an offered embodiment is a deviation is a percentage of the previous basal insulin dose)
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.
Chen and Booth fail to teach the following limitation of claim 1. Raskin, however, does teach the following:
establish a wireless communication link with a remote data processing system; maintain a synchronized treatment state with a remote data processing system by (a) automatically transmitting, via the wireless communication link, the plurality of measurement values and the plurality of dose values to the remote data processing system, and (b) dynamically updating the data storage in response to receiving a modification to the dose plan from the remote data processing system is taught in the Detailed Description in ¶ 0053-56, ¶ 0239-240, and ¶ 0243 (teaching on continuously updating a user dosage data and corresponding response glucose reading and transmitting a new dosage to the delivery device from a remote server and corresponding memory hardware)
One having ordinary skill in the art before the invention was filed would include the continuous exchange and maintenance of data between a remote dosage server and a user insulin management device of Raskin with the insulin dosage device of Chen with the motivation of “performing real - time analysis and optimization of one or more control parameters, maintenance of the subject's diabetes can be improved faster and more accurately compared to delayed analysis that may occur during clinical testing” (Raskin in the Detailed Description in ¶ 0271).
Independent claims 10 and 18 are rejected under the same rational.
As per claim 2, the combination of Chen, Booth, and Raskin 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, Booth, and Raskin 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, Booth, and Raskin 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, Booth, and Raskin 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, Booth, and Raskin 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, Booth, and Raskin 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 05/26/2026 with respect to 35 USC § 101 have been fully considered but they are not persuasive. First, Applicant asserts that the wireless communication between the local and remote data processing system does not recite an abstract idea. Examiner agrees. The transmitting of data between devices has been treated as an additional element under Step 2A Prong 2 and Step 2B.
Next, Applicant asserts that the wireless transmission of data between the devices solves a core technical failure wherein localized clinical titration tools create a significant latency and lack effective data-exchange channels citing “unintentional dosing errors and delays in increasing or decreasing the amount to insulin treatment regimens” in the specification on p. 7. Examiner disagrees. First, the problem presented in the specification is with communicating the titration data between two humans – the doctor and the patient. This is not a problem with technology, this is a problem with the abstract idea of applying the abstract idea of a doctor calculating the titration and applying said abstraction to a computer to automate the process as clearly laid out on p. 7 of the Specification. Second, communicating data between two devices is not an unconventional technical solution. There is no evidence in the claims or the specification that the instant application improves the communication network by transmitting the data in a non-conventional manner. The mere application of specific data – here the titration data – to a known network configuration does not amount to an improvement to technology. Finally, Examiner notes that automatically transmitting and updating of insulin bolus and basal dosages off of interstitial glucose measurements was not an unconventional technical solution at the time the invention was filed. This position is supported by at least Booth et al (US 2016/0117481) in ¶ 0069, ¶ 0077, and ¶ 0113 solving the communication problem presented in the instant application utilizing a similar remote networking methodology.
Applicant’s arguments filed 05/26/2026 with respect to 35 USC § 103 have been considered and are persuasive regarding the some of the newly added limitations. Therefore, the rejection has been withdrawn. However, upon further consideration, a new grounds of rejection is made in view of Raskin, as per the rejection above.
Examiner notes that Applicant relies on one embodiment offered for determining the basal dosage in Chen disclosed in ¶ 0070 and ¶ 0098. Examiner notes that in the proceeding ¶ 0071, the percentage stepwise increase is taught as an alternate embodiment in Chen stating, “[t]he deviation may be an amount or volume of insulin or a percentage of the basal insulin dose”.
Conclusion
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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/JORDAN L JACKSON/Primary Examiner, Art Unit 2857
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