DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections – 35 USC § 101
2. 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 2-21 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. Independent claims 2 and 17 recites a method comprising:
assigning a first classification to a glucose response of a user based at least in part on a plurality of measured glucose values, wherein the first classification comprises at least one of: low variability, moderate variability, or severe variability;
applying a bias correction to the plurality of glucose values based the first classification to generate a bias-corrected plurality of measured glucose values;
receiving input pertaining to a glucose-changing event;
determining a glucose response score based on the bias-corrected plurality of measured glucose values and the input pertaining to the glucose-changing event; and
providing a recommendation relating to the glucose-changing event based on the glucose response score.
The limitations of assigning a classification, applying a bias correction, receiving input, determining a glucose response score, and providing a recommendation, as drafted, constitutes a process that, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components. That is, other than reciting the steps are performed by “one or more hardware processors”, and the providing constitutes outputting “to a display”, nothing in the claim elements precludes the steps from practically being performed in the mind. For example, but for the “hardware processors” and “display” language, “assigning” “applying”, “receiving”, “determining” and “outputting” in the context of this claim encompasses a user manually assigning a classification and applying a bias correction, receiving inputs, making a determination, and providing the recommendation, for example using a pen and paper. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components, then it falls within the “Mental Processes” grouping of abstract ideas. Accordingly, the claims recite an abstract idea.
This judicial exception is not integrated into a practical application. In particular, the claim only recites using one or more hardware processors and a display to perform the claimed steps. The processors and display in these steps are recited at a high-level of generality (i.e., as a generic processor and display performing generic computer functions of receiving input, making determinations, and displaying information) such that they amount to no more than mere instructions to apply the exception using generic computer components. 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 claims further recite measuring, using a glucose sensor, a plurality of blood glucose values of a user, and the processor receiving the values from the sensor. This amounts to no more than insignificant extra-solution activity in the form of pre-solution data gathering, and is not indicative of integration into a practical application. See MPEP 2106.05(g). The claims are directed to an abstract idea.
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional element of using hardware processors and a display to perform the claimed assigning, applying, receiving, determining and outputting steps amounts to no more than mere instructions to apply the exception using generic computer components. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept. Furthermore, as discussed above, measuring, using a glucose sensor, a plurality of blood glucose values of a user amounts to no more than insignificant extra-solution activity in the form of pre-solution data gathering. The claims are not patent eligible.
Dependent claims 3-16 and 18-21 recite the same abstract idea as in their respective parent claims, and only recite additional details of the data being input to the processors and information provided to the user via the display, such as the user inputs, classification measurements, and recommendations and scores. Therefore, these claims do not recite additional limitations sufficient to direct the claimed invention to significantly more.
Response to Arguments
3. Applicant’s arguments filed 30 March 2026 with respect to the section 101 rejection have been fully considered but they are not persuasive. Applicant argues that claims 2 and 17 recite a particular sensor-driven physiological data processing workflow that is more than mere data collection. This is not persuasive. The sensor is a generic glucose sensor that merely provides measurements used for analysis by the processor, and there is no other claimed connection between the sensor and processor. Applicant is directed to 2106.05(g), which states that similar examples such as “performing clinical tests on individuals to obtain input for an equation” in In re Grams constitute mere data gathering. Applicant also points to the assigning of GluScores and argues this represents an improvement to the sensor-processor arrangement. However, this appears to be directed instead to an improvement to the classification of an individual in order to provide more accurate recommendations to the user. This is not an improvement to the sensor or to any technical area. Applicant further argues that the particular series of steps results in an improvement to a technical area through the use of classifying and bias correction. Again, it is noted that the result of this series of steps does not otherwise affect the function of the sensor or the processor, and only results in an improvement to the recommendations provided to the user, which is an abstract idea itself. Applicant further argues that the use of the sensor and processor to perform the claimed steps cannot be performed in the human mind. This is not persuasive. Applicant has not shown how a person could not assign a classification, apply a bias correction, and determine a score, by observing values collected from a glucose sensor and making determinations and/or calculations based on the values.
5. Applicant’s arguments with respect to the section 102 and 103 rejections, in view of the corresponding amendments, have been fully considered and are persuasive. The section 102 and 103 rejections have been withdrawn. Shaya and the other prior art of record does not reasonably disclose or suggest the particular combination of steps performed in claim 2, including assigning a classification, applying a bias correction, and determining a score based on the bias-corrected plurality of values and input pertaining to a glucose-changing event.
Conclusion
6. 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.
7. Any inquiry concerning this communication or earlier communications from the examiner should be directed to PETER EGLOFF whose telephone number is (571) 270-3548. The examiner can normally be reached 9:00 AM – 5:00 PM, Monday through Friday Eastern.
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/Peter R Egloff/
Primary Examiner, Art Unit 3715