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 2, 2026, claim 1-9, 11-17 and 19 are amended. Claims 10 and 20 are cancelled and new claims 21-22 are added. Claims 1-9, 11-19 and 21-22 are pending.
Response to Arguments
Applicant’s arguments, see Remarks, filed July 2, 2026, with respect to specification objection have been fully considered and are persuasive in view of the amendments. The objection of specification has been withdrawn.
Applicant's arguments filed July 2, 2026 have been fully considered but they are not persuasive with respect to the rejection of claims under 35 U.S.C 101.
In response to applicant’s arguments that the claims do not recite an abstract idea, Examiner respectfully disagrees. The abstract ideas are identified as the steps of generating; receiving; identifying; determining; and selecting. That is, as broadly and reasonably interpreted, the above recited steps of generating; receiving; identifying; determining; and selecting are steps that can practically be performed in the mind or with the aid of pen/paper. 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 quantitative disease risk value 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.
An improved abstract idea is still an abstract idea even if such an abstract idea results in more accurate results. Applicant refers to the tangible claim elements that are in addition to the abstract idea (i.e., the additional elements). Applicant argues that because the additional elements are tangible, the claims are not directed to an abstract idea. However, this is not the test for eligibility. “As the Supreme Court explained in Alice Corp., mere physical or tangible implementation of an exception does not guarantee eligibility.” MPEP 2106.04(d) I. citing Alice Corp. Pty. Ltd. v. CLS Bank Int’l, 573 U.S. 208, 224, 110 USOQ2d 1976, 1983-84 (2014). Thus, applicant’s identification of the additional elements in the claims as not being abstract does not influence the eligibility analysis. Applicant should not conflate the abstract idea with the elements of the claim that are in addition to the abstract idea (i.e. additional elements).
In response to Applicant’s argument that the claims integrate the abstract idea into practical application, Examiner respectfully disagrees. An improvement to the technology cannot be in the abstract idea. MPEP 2106.05a. “[L]imitations that amount to merely indicating a field of use or technological environment in which to apply a judicial exception do not amount to significantly more than the exception itself, and cannot integrate a judicial exception into a practical application.” MPEP 2106.05(h). “[T]he additional element in Flook ... was not sufficient to make the claim eligible, because it was merely an incidental or token addition to the claim that did not alter or affect how the process steps of calculating the alarm limit value were performed.” Further, the data-gathering step of “measuring and receiving” and the data-output steps of “transmitting and displaying” do not add a meaningful limitation to the claims as they are insignificant extra-solution activity. Furthermore, the abstract idea amounts to simply implementing the abstract idea on a computer. For example, the recitations regarding the generic computer components for generating; receiving; identifying; determining; selecting; transmitting; executing; and displaying. merely invoke a computer as a tool to perform an existing process. The additional elements are identified in the 101 section below as being the elements that comprise continuous analyte monitoring system; a sensor electronics module; a computing device; a memory; a processor, a graphical user interface; and machine learning model. 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.
Applicant’s arguments, see Remarks, filed July 2, 2026, with respect to rejection of claims under 35 U.S.C 102 have been fully considered and are persuasive in view of the amendments. The rejection of claims 1-8 and 11-18 has been withdrawn.
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 1-9, 11-19 and 21-22 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Claims 1-9, 11-19 and 21-22 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;
identify a plurality of analyte features able to be determined utilizing sensor data packages;
determine a performance metric and a robustness metric for each of the plurality of analyte features;
select an analyte feature combination from the plurality of analyte features based on the performance and robustness metrics for each combination of the plurality of analyte features; and
generate a quantitative risk value for the medical condition based on the analyte feature combination, the quantitative risk value having a range from a minimum risk value to a maximum risk value
The independent claim 11 recites:
generating sensor data packages including measured analyte concentration levels
receiving sensor data packages;
identifying a plurality of analyte features able to be determined utilizing sensor data packages;
determining a performance metric and a robustness metric for each of the plurality of analyte features;
selecting an analyte feature combination from the plurality of analyte features based on the performance and robustness metrics for each combination of the plurality of analyte features; and
generating a quantitative risk value for the medical condition based on the analyte feature combination, the quantitative risk value having a range from a minimum risk value to a maximum risk value
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; identifying; determining; and selecting 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 quantitative disease risk value 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. executing and receiving) 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; identifying; determining; selecting; transmitting; executing; and displaying merely invoke a computer as a tool.
The data-gathering step (measuring and 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; identifying; determining; selecting; transmitting; executing; and displaying.
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; identifying; determining; selecting; transmitting; executing; and displaying. 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; a computing device; a memory; a processor, a graphical user interface; and machine learning model.
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 “identify a plurality of analyte features able to be determined utilizing sensor data packages; based on the medical condition, determine a performance metric and a robustness metric for each of the plurality of analyte features; and select an analyte feature combination from the plurality of analyte features based on the performance and robustness metrics for each combination of the plurality of analyte features” in combination with the additional required claim elements and when considered as a whole.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
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/N.N.P./Examiner, Art Unit 3791
/JENNIFER ROBERTSON/Supervisory Patent Examiner, Art Unit 3791
