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 Arguments
Applicant's arguments, see Remarks pages 7-9, filed 07/07/2026, with respect to the 35 USC 101 rejection of claims 14-29 have been fully considered but they are not persuasive.
In response to the applicant’s argument that the claims should be found eligible at Step 2A Prong 1 of the Alice/Mayo test, the examiner respectfully disagrees. The examiner notes in the previous office action, dated 04/08/2026, pages 6-8 detail how the claims are drawn to the mental processes and/or mathematical concepts, which the courts have found to fall under the abstract idea grouping.
In response to the applicant’s argument that the claims should be found eligible at Step 2A Prong 2 as the claims allegedly integrate the abstract idea into a practical application as it provides an improvement to a technology, the examiner respectfully disagrees. The examiner notes that the judicial exception alone cannot provide the improvement. The improvement can be provided by one or more additional elements. See the discussion of Diamond v. Diehr, 450 U.S. 175, 187 and 191-92, 209 USPQ 1, 10 (1981)) in subsection II, below. In addition, the improvement can be provided by the additional element(s) in combination with the recited judicial exception. See MPEP § 2106.04(d) (discussing Finjan, Inc. v. Blue Coat Sys., Inc., 879 F.3d 1299, 1303-04, 125 USPQ2d 1282, 1285-87 (Fed. Cir. 2018)). Instead, the examiner finds the applicant’s claimed invention similar to example iii found in MPEP 2106.05(a)(II), which the courts have indicated may not be sufficient to show an improvement to technology, which states “Gathering and analyzing information using conventional techniques and displaying the result, TLI Communications, 823 F.3d at 612-13, 118 USPQ2d at 1747-48”.
In response to the applicant’s argument that the claims should be found eligible subject matter at Step 2B as, allegedly, the claims as a whole amount to significantly more than the judicial exception, the examiner respectfully disagrees. The examiner notes that the claims add insignificant extra solution activities to the judicial exception (the “receiving” data and “generating an indication” steps) and are further simply appending well-understood, routine, and conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception. See MPEP 2106.05.
Therefore, the 35 USC 101 rejection of claims 14-29 is maintained.
Applicant’s arguments, see Remarks pages 9-13, filed 07/07/2026, with respect to the 35 USC 103 rejection of claims 14-29 have been fully considered and are persuasive. The examiner notes that the applicant has amended subject matter into the independent claims that require an unreasonable combination of references that would not suffice for a realistic case of obviousness. In particular, the examiner finds the amended elements “determining, based on the heart-beat interval data and the probabilistic model, the most likely user glucose value at the second time”, “determining a difference between the particular user glucose value and the most likely user glucose value”, and “in response to determining that the probability exceeds the first threshold and that the difference exceeds the second threshold, determining the modification amount as the numeric correction amount equal to the difference” as elements that are not reasonably taught in the applicant’s field of endeavor. The 35 USC 103 rejection of claims 14-29 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 14-29 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Independent Claim 14 recites:
A method implemented by a computing device, the method comprising:
receiving glucose data describing user glucose values measured by a glucose sensor of a continuous glucose monitoring (CGM) system;
receiving non-glucose data that includes heart-beat interval data captured by a heart-rate sensor of the CGM system;
determining historic heart-rate variability values of a user of the CGM system based on the heart-beat interval data over a moving time window;
generating a probabilistic model configured to output a most likely user glucose value at a second time, a probability that the user will experience the most likely user glucose value at the second time, and a confidence level corresponding to the probability, wherein the probability and the confidence level are determined based on the glucose data and the historic heart-rate variability values;
determining a modification amount as a numeric correction amount, wherein determining the modification amount comprises:
determining, based on the heart-beat interval data and the probabilistic model, the most likely user glucose value at the second time;
identifying a particular user glucose value from the glucose data, the particular user glucose value having a timestamp corresponding to the second time;
determining that the probability exceeds a first threshold;
determining a difference between the particular user glucose value and the most likely user glucose value;
determining that the difference exceeds a second threshold; and
in response to determining that the probability exceeds the first threshold and that the difference exceeds the second threshold, determining the modification amount as the numeric correction amount equal to the difference;
generating modified glucose data by modifying the user glucose values based on the modification amount; and generating an indication of the modified glucose data to cause a user interface of a display device to display the modified glucose data.
Independent Claim 19 recites:
A method implemented by a computing device, the method comprising:
receiving session data describing historic user glucose values measured by a glucose sensor of a continuous glucose monitoring (CGM) system;
receiving non-glucose data that includes heart-beat interval data captured by a heart-rate sensor of the CGM system;
determining historic heart-rate variability values of a user of the CGM system based on the heart-beat interval data over a moving time window;
generating a probabilistic model configured to output a most likely user glucose value at a second time, a probability that the user will experience the most likely user glucose value at the second time, and a confidence level corresponding to the probability, wherein the probability and the confidence level are determined based on the session data and the historic heart-rate variability values;
generating modified session data, wherein generating the modified session data comprises:
modifying the historic user glucose values based on a modification amount, wherein modifying the historic user glucose values comprises:
determining, based on the heart-beat interval data and the probabilistic model, the most likely user glucose value at the second time;
identifying a particular user glucose value from the session data, the particular user glucose value having a timestamp corresponding to the second time;
determining that the probability exceeds a first threshold;
determining a difference between the particular user glucose value and the most likely user glucose value;
determining that the difference exceeds a second threshold; and
in response to determining that the probability exceeds the first threshold and that the difference exceeds the second threshold, modifying the historic user glucose values based on the modification amount, the modification amount comprising a numeric correction amount equal to the difference; and
removing historic user glucose values from the session data that were measured by the glucose sensor during a temporal window that begins at a time corresponding to a timestamp of an oldest historic user glucose value described by the session data;
generating a glucose value report based on the modified session data; and
generating an indication of the glucose value report to cause a user interface of a display device to display the glucose value report.
Step 1:
The examiner determines that independent claims 14 and 19 are drawn to methods.
Step 2A Prong 1:
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.
“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).
The claimed steps of receiving, accessing, predicting, determining, and generating recite mental processes and/or mathematical concepts (i.e., mathematical relationships, mathematical formulas or equations, and mathematical calculations).
The step of “determining” historic heart rate variability values in claims 14 and 19 are part of the mathematical concepts grouping which uses concepts from statistics, signal processing, and time-series analysis to calculate how much a series fluctuates within a moving window. The step of “generating” a probabilistic model in claims 14 and 19 is part of the mathematical concepts grouping. A probabilistic model is merely a formal mathematical representation of uncertainty, mathematically describing the likelihood of events or outcomes among random variables. The steps of “determining” a modification amount in claim 14 and “generating” modified data in claims 14 and 19 are part of the mathematical concepts grouping, particularly mathematical optimization. The modification amount is merely an adjustment or correction applied to a value to achieve a desired property, such as improved signal-to-noise ratio, amplitude scaling, or error minimization. The steps of “modifying” glucose values and “removing” glucose values in claim 19 is part of the mathematical concepts grouping wherein data in mathematically manipulated by various mathematical operations (i.e. addition, subtraction, etc.).
The claimed steps of determining, generating, modifying, and removing 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.
“[T]he ‘mental processes’ abstract idea grouping is defined as concepts performed in the human mind, and examples of mental processes include observations, evaluations, judgments, and opinions.” MPEP 2106.04(a)(2) III. The pending claims merely recite steps for estimation that include observations, evaluations, and judgments.
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, 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.
Regarding the dependent claims 15-18, 20-21, 23-25, and 27-29, 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. 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.
Step 2A Prong 2:
This judicial exception (abstract idea) in Claims 14-29 is not integrated into a practical application because:
• The abstract idea amounts to simply implementing the abstract idea on a computing device. For example, the recitations regarding the generic computing components for receiving, accessing, predicting, determining, and generating merely invoke a computer as a tool.
• The data-gathering step (“receiving” data) and the data-output (“generating” an indication) step 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 computing device that is used as a tool for determining, generating, modifying, and removing.
• 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 estimate bio-information.
• 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 computing device for determining, generating, modifying, and removing. The claims do not apply the obtained prediction to a particular machine. Rather, the data is merely output in a post-solution step.
Step 2B:
The additional elements are identified as follows: heart rate monitor/sensor.
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
• Applicant’s specification (e.g. paragraph [0069]) which discloses that the heart rate monitor comprise generic components that are configured to perform the generic functions that are well-understood, routine, and conventional activities previously known to the pertinent industry.
• Applicant’s Background in the specification; and
• The non-patent literature of record in the application.
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 generic computer components as those claimed. See option III. A. 2. in the Berkheimer memorandum.
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the units associated with the steps do not add meaningful limitation to the abstract idea. A computer, processor, memory, or equivalent hardware is merely used as a tool for executing the abstract idea(s). The process claimed does not reflect an improvement in the functioning of the computer.
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.
Conclusion
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JONATHAN M HANEY whose telephone number is (571)272-0985. The examiner can normally be reached Monday through Friday, 0730-1630 ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Alexander Valvis can be reached at (571)272-4233. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JONATHAN M HANEY/ Examiner, Art Unit 3791 /ALEX M VALVIS/Supervisory Patent Examiner, Art Unit 3791
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