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 .
Response to Amendment
In response to amendment filed July 1, 2026, claims 1-4, 7, 10, 14, 16, 18-19 are amended. Claims 6, 8-9, 13, 15, 20, 22-26 are cancelled and new claims 27-39 are added. Claims 1-5, 7, 10-12, 14, 16-19, 21, 27-33, 35-36 and 38-39 are pending.
Response to Arguments
Applicant’s arguments, see Remarks, filed July 1, 2026, with respect to the rejection of claims under 35 U.S.C 112 have been fully considered and are persuasive in view of the amendment. The rejection of claim 12 under 35 U.S.C 112 has been withdrawn.
Applicant’s arguments, see Remarks, filed July 1, 2026, with respect to rejection of claims under 35 U.S.C 102 and 35 U.S.C 103 have been fully considered and are persuasive in view of the amendments. The rejection of claims under 35 U.S.C 102 and 35 U.S.C 103 has been withdrawn.
Claim Objections
The numbering of claims is not in accordance with 37 CFR 1.126 which requires the original numbering of the claims to be preserved throughout the prosecution. When claims are canceled, the remaining claims must not be renumbered. When new claims are presented, they must be numbered consecutively beginning with the number next following the highest numbered claims previously presented (whether entered or not).
Misnumbered claim 35 should be renumbered 34.
Misnumbered claim 36 should be renumbered 35.
Misnumbered claim 38 should be renumbered 36.
Misnumbered claim 39 should be renumbered 37.
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, 7, 10-12, 14, 16-19, 21, 27-33, 35-36 and 38-39 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Claims 1-5, 7, 10-12, 14, 16-19, 21, 27-33, 35-36 and 38-39 are all within at least one of the four categories.
The independent claim 1 recites:
generate sensor data packages including measured analyte concentration levels
receive sensor data packages;
select a combination of features calculated from the measured analyte data, wherein the combination of features is based on a performance metric and a robustness metric;
generate a disease prediction based on the selected combination of features.
The independent claim 11 recites:
generating biased analyte data by adding sensor bias to historical analyte data;
associating the biased analyte data with clinical disease diagnosis associated with the historical analyte data;
extracting features from the biased analyte data;
generate disease predictions based on a different combination of the features extracted from the biased analyte data;
evaluating the disease predictions based on the clinical disease diagnoses associated with the biased analyte data; and
selecting a model and a combination of features based on a performance metric and a robustness metric.
The independent claim 21 recites:
extracting features from historical analyte data having inherent analyte sensor bias;
generating disease predictions based on a different combination of the features extracted from the historical analyte data;
evaluating the disease predictions based on the clinical disease diagnoses associated with the historical analyte data; and
selecting a model and a combination of features based on a performance metric and a robustness metric.
The above claim limitations constitute an abstract idea that is part of the Mathematical Concepts and/or Mental Processes group identified in the 2019 Revised Patent Subject Matter Eligibility Guidance published in the Federal Register (84 FR 50) on January 7, 2019. See footnotes 14 and 15.
“A mathematical relationship is a relationship between variables or numbers. A mathematical relationship may be expressed in words ….” October 2019 Update: Subject Matter Eligibility, II. A. i. “[T]here are instances where a formula or equation is written in text format that should also be considered as falling within this grouping.” Id. at II. A. ii. “[A] claim does not have to recite the word “calculating” in order to be considered a mathematical calculation.” Id. at II. A. iii. See for example, SAP Am., Inc. v. InvestPic, LLC, 898 F.3d 1161, 1163-65 (Fed. Cir. 2018) (performing a resampled statistical analysis to generate a resampled distribution).
The claimed steps of generating; receiving; selecting; associating; extracting and evaluating can be practically performed in the human mind using mental steps or basic critical thinking, which are types of activities that have been found by the courts to represent abstract ideas.
Examples of ineligible claims that recite mental processes include:
a claim to “collecting information, analyzing it, and displaying certain results of the collection and analysis,” where the data analysis steps are recited at a high level of generality such that they could practically be performed in the human mind, Electric Power Group, LLC v. Alstom, S.A.;
claims to “comparing BRCA sequences and determining the existence of alterations,” where the claims cover any way of comparing BRCA sequences such that the comparison steps can practically be performed in the human mind, University of Utah Research Foundation v. Ambry Genetics Corp.
a claim to collecting and comparing known information (claim 1), which are steps that can be practically performed in the human mind, Classen Immunotherapies, Inc. v. Biogen IDEC.
See p. 7-8 of October 2019 Update: Subject Matter Eligibility.
With respect to the pending claims, for example, a physician can perform the claimed step of generating by mentally noting information received from a sensor including analyte concentrations. The physician can then further receive that information mentally and use that information to mentally identify a plurality of analyte features, determine a performance and robustness metric, select an analyte feature combination and then output a disease risk prediction mentally and/or with the aid of a pen/pencil and paper. Thus, the claims can be readily interpreted as being a mere application of a mental process on a computer.
Regarding the dependent claims, the dependent claims are directed to either 1) steps that are also abstract or 2) additional data output that is well-understood, routine and previously known to the industry. For example, dependent claims recite steps (e.g. receiving; transmitting; displaying; executing; and predicting) that can be performed in the mind. Although the dependent claims are further limiting, they do not recite significantly more than the abstract idea. A narrow abstract idea is still an abstract idea and an abstract idea with additional well-known equipment/functions is not significantly more than the abstract idea.
This judicial exception (abstract idea) in claims 1-20 is not integrated into a practical application because:
The abstract idea amounts to simply implementing the abstract idea on a computer. For example, the recitations regarding the generic computing components for generating; receiving; selecting; associating; extracting; evaluating; transmitting; displaying; executing; and predicting merely invoke a computer as a tool.
The data-gathering step (receiving) and the data-output step (transmitting and displaying) do not add a meaningful limitation to the method as they are insignificant extra-solution activity.
There is no improvement to a computer or other technology. “The McRO court indicated that it was the incorporation of the particular claimed rules in computer animation that "improved [the] existing technological process", unlike cases such as Alice where a computer was merely used as a tool to perform an existing process.” MPEP 2106.05(a) II. The claims recite a computer that is used as a tool for generating; receiving; selecting; associating; extracting; evaluating; transmitting; displaying; executing; and predicting.
The claims do not apply the abstract idea to effect a particular treatment or prophylaxis for a disease or medical condition. Rather, the abstract idea is utilized to determine a relationship among data to provide information about a disease risk value.
The claims do not apply the abstract idea to a particular machine. “Integral use of a machine to achieve performance of a method may provide significantly more, in contrast to where the machine is merely an object on which the method operates, which does not provide significantly more.” MPEP 2106.05(b). II. “Use of a machine that contributes only nominally or insignificantly to the execution of the claimed method (e.g., in a data gathering step or in a field-of-use limitation) would not provide significantly more.” MPEP 2106.05(b) III. The pending claims utilize a computer for generating; receiving; selecting; associating; extracting; evaluating; transmitting; displaying; executing; and predicting. The claims do not apply the obtained data to a particular machine. Rather, the data is merely output in an post-solution step.
The additional elements are identified as follows: continuous analyte monitoring system; a sensor electronics module; one or more computing devices; a graphical user interface; a model; and a network computing device.
Those in the relevant field of art would recognize the above-identified additional elements as being well-understood, routine, and conventional means for data-gathering and computing, as demonstrated by
the patent literature cited herewith:
Frank (US 20210401330 A1)
see [0034]-[0035]; [0039]; [0055]; and [0154]-[0157]
Thus, the claimed additional elements “are so well-known that they do not need to be described in detail in a patent application to satisfy 35 U.S.C. § 112(a).” Berkheimer Memorandum, III. A. 3.
Furthermore, the court decisions discussed in MPEP § 2106.05(d)(lI) note the well-understood, routine and conventional nature of such additional elements as those claimed. See option III. A. 2. in the Berkheimer memorandum.
When considered in combination, the additional elements (i.e. the generic computer functions and conventional equipment/steps) do not amount to significantly more than the abstract idea. Looking at the claim limitations as a whole adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation.
Examiner Comment on Prior Art
Koike Akino (US 20230162023 A1; previously cited) teaches high performance metric (see paragraph 0103: accuracy score) and high robustness (see paragraph 0040 and 0008). However, the closest prior art of record Frank (US 20210401330 A1; previously cited) and Koike Akino (US 20230162023 A1; previously cited) do not teach or suggest “select a combination of features calculated from the measured analyte data, wherein the combination of features is selected based on a performance and a robustness metrics”; and “select a model and a combination of features based on a performance metric and a robustness metric” in combination with the additional required claim elements and when considered as a whole.
Conclusion
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/N.N.P./Examiner, Art Unit 3791
/JENNIFER ROBERTSON/Supervisory Patent Examiner, Art Unit 3791
