Detailed Action
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 November 11, 2025 has been entered.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 02/07/23 has been considered by the examiner.
Amendment Entered
In response to the amendment filed on November 11, 2025, amended claims 1 and 20 have been entered.
Response to Arguments
Applicant's remarks and amendments with respect to the rejections under U.S.C. 101 have been fully considered, but were not persuasive. Examiner argues that nothing from the claims, accompanying specification, and/or drawings suggest that the method steps cannot be practically performed mentally, or using pen/paper. Applicant argues the invention is not an abstract idea. Examiner notes that although the claims include a display, processor, continuous glucose measurement device, a controller and a memory, no physical aspect of the device mentioned in the claims is novel. The claims merely recite data gathering/outputting steps. Applicant further argues the claims integrate into a practical application. Examiner notes that according to MPEP 2106.04(d)(2), the practical application consists of administering a specific medication in response to the collected data. Alternately, a practical application would consist of incorporating additional structure to the device. Lastly, Applicant argues the invention is significantly more based on the additional elements. Examiner notes there is no special purpose computer and the components of the invention are all well known in the art and conventional. Therefore, as currently claimed, the invention is not an improvement in technology. Accordingly, Examiner maintains that the identified judicial exception recites a mental process that is not integrated into a practical application. As such, the 35 USC 101 rejections are maintained. Examiner notes that incorporating a particular treatment based on the results or more structure to the claims would help move prosecution forward. Please see corresponding rejection heading below for more detailed analysis.
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 1-16, 18, 20, 34, 35 and 37 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Regarding claim 1, the claims recite a method for generating sensor measurements. The claims are directed towards a process, which is one of the statutory categories of invention.
Based on the broadest reasonable interpretation of the claims as a whole, claims 1-16, 18, 20, 34, 35 and 37 are directed to the judicially recognized exception of an abstract idea of a mental process as the skilled artisan is capable of transforming and calculating the data received by the system and making a mental assessment thereafter. These limitations describe a mathematical calculation. Furthermore, nothing from the claims or accompanying specification suggest that the skilled artisan would not be able to perform the judicial exception mentally, or using pen and paper. The following limitations set forth said judicial exception:
“receiving a plurality of glucose measurements for the patient, the plurality of glucose measurements for the subject comprising a time-series collected from the subject;- selecting one or more curve intervals in the plurality of glucose measurements, the one or more curve intervals corresponding to one or more local maxima of the plurality of glucose measurements; - determining a representative curve based on the one or more curve intervals; - determining a reduced set of parameter coefficients based on the representative curve, the reduced set of parameter coefficients comprising: a proportional coefficient A1 for response of a controller u(t) to an error e(t), an integral coefficient A2 for response of the controller u(t) to past values of error e(t), an inverse memory time scale A for decay of an integral term, a steady depletion coefficient A3 for a basic metabolic rate, and a feedback coefficient A4for an approximate mass action rate; - generating the glucose homeostasis model by performing a gradient descent, the glucose homeostasis model comprising the proportional coefficient A1, the integral coefficient A2, the inverse memory time scale A, the steady depletion coefficient A3, and the feedback coefficient A4 wherein the reduced set of parameter coefficients reduces a processing time of the generating the glucose homeostasis model relative to a processing time of generating a model based on a set of non-linear Ordinary Differential Equations (ODEs), and wherein the glucose homeostasis model, when executed by the processor, causes the processor to generate a glucose homeostasis message”
Next, the claim as a whole is analyzed to determine whether any element, or combination of elements, integrates the identified judicial exception into a practical application.
For this part of the 101 analysis, the following additional limitations are considered:
“a processor; a continuous glucose measurement device; a controller, the glucose homeostasis message for display at a display device in communication with the processor”
Claim 20 recites:
“a memory”
A glucose measurement device is a general device for generating glucose measurements and processors, controllers and memory are conventional means for computing and storing data. These appear to be nothing more than components for generating generic computer models that do not add significantly more. Furthermore, generating glucose models do not integrate the judicial exception into a practical application as these limitations amount to mere post-solution activity. See MPEP 2106.05(g). Therefore, these elements do not amount to significantly more than a judicial exception.
Furthermore, the additional limitations recite well-known structural limitations (generically recited measurement device, a processor, a controller, display etc.) and as such, do not amount to significantly more than the identified judicial exception. Examiner takes official notice that the additional limitations are conventional components in prior analyte monitoring systems. Rollins (US 2020/0016337) teaches these additional elements, showing these additional elements are well known and conventional [par. 34, 75].
Independent claim 20 is also not patent eligible for substantially similar reasons.
Dependent claims 2-16, 18, 34, 35 and 37 also fail to add something more to the abstract independent claims as they merely further limit the abstract idea.
Therefore, claims 1-16, 18, 20, 34, 35 and 37 are not patent eligible under 35 USC 101.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GRACE L ROZANSKI whose telephone number is (571)272-7067. The examiner can normally be reached M-F 8:30am-5pm, alt F 8:30am-5pm.
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/GRACE L ROZANSKI/Examiner, Art Unit 3791
/ALEX M VALVIS/Supervisory Patent Examiner, Art Unit 3791