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 .
Amendment Entered
This Office action is responsive to the Amendment filed on November 10th, 2025. The examiner acknowledges the amendments to claims 1 and 14, as well as the cancellation of claims 4 and 11. New claim 16 has been entered. Claims 1-3, 5-10, and 12-16 remain pending in the application.
Response to Arguments
Applicant’s arguments, filed November 10th, 2025, with respect to the claim objections have been fully considered. The claim objections are withdrawn.
Applicant’s arguments, filed November 10th, 2025, with respect to the rejections under 35 U.S.C. 112(b) have been fully considered. The rejections under 35 U.S.C. 112(b) are withdrawn.
Applicant’s arguments, filed November 10th, 2025, with respect to the rejections under 35 U.S.C. 101 have been fully considered but are not persuasive.
At pages 9-10, Applicant argues that claims have been amended to provide a first and second analyte sensor, that analyte detection cannot be carried out in the human mind, and as such the claims are no longer directed to an abstract idea. Examiner respectfully disagrees. The addition of “providing a first analyte sensor” and “providing a second analyte sensor” does not add a meaningful limitation to the method as it merely adds data-gathering to perform the abstract ideas. With or without the claimed abstract idea, the first analyte sensor and the second analyte sensor gathers data the same. Therefore, it is unclear how there can be an improvement to the technology. Furthermore, page 8 of the previous office action clearly identified the limitations that are considered abstract. “It is essential that the broadest reasonable interpretation (BRI) of the claim be established prior to examining a claim for eligibility.” MPEP 2106 II. In light of Applicant’s specification, the claim encompasses one or more consecutive glucose measurement values. See, for example, [0022-0026]. “The courts consider a mental process (thinking) that "can be performed in the human mind, or by a human using a pen and paper" to be an abstract idea.” MPEP 2106.04(a)(2) III. The claimed steps can be performed using one or more consecutive glucose measurements in the human mind or by using a pen and paper. Furthermore, the claim provides the first and second analyte sensors which are generic and well-known in the industry – as evidenced by the prior art of record. See Otto (US 20170112452 A1) in paragraph [0013] discloses conventional SMBG meters; Zhou (US 20200253513 A1) in para. [0063] discloses a conventional analyte monitor, such as a continuous glucose monitor; Mora, et al., Use of a Novel, Remotely Connected Diabetes Management System Is Associated with Increased Treatment Satisfaction, Reduced Diabetes Distress, and Improved Glycemic Control in Individuals with Insulin-Treated Diabetes: First Results from the Personal Diabetes Management Study, Diabetes Technology & Therapeutics, 2019, 19(12): 715-722, https://doi.org/10.1089/dia.2017.0206; El Youssef J, Castle J, Ward WK. A Review of Closed-Loop Algorithms for Glycemic Control in the Treatment of Type 1 Diabetes. Algorithms. 2009; 2(1):518-532. https://doi.org/10.3390/a2010518; Tokuda et al., Vital sign triage to rule out diabetic ketoacidosis and non-ketotic hyperosmolar syndrome in hyperglycemic patients, Diabetes Research and Clinical Practice, Volume 87, Issue 3, 2010, Pages 366-371, ISSN 0168-8227, https://doi.org/10.1016/j.diabres.2009.11.020.
At pages 10, Applicant argues that the claimed invention allows for comparison of measurements between multiple sensor device types, including spot monitoring device and continuous monitoring devices and the ability to integrate data from multiple glucose monitors represents an improvement to existing monitoring systems. Examiner respectfully disagrees. The improvement cannot be found in the abstract idea itself. “[I]t is important to keep in mind that an improvement in the abstract idea itself ... is not an improvement in technology.” MPEP 2106.05(a) Il. There is no improvement to a computer or other technology. Rather, the alleged improvement lies solely within the processing steps performed by the computer. The computer and analyte sensors appear to perform the same with or without the claimed abstract idea. Therefore, it is unclear how the abstract idea can improve the standard functions of the additional elements. Furthermore, merely adding generic computer components to perform the method is not sufficient. Thus, the claim must include more than mere instructions to perform the method on a generic component or machinery to qualify as an improvement to an existing technology." Id.
With respect to claim 14, it seems as if Applicant is arguing more than what is actually being claimed. Claim 14 recites a physiological data input device in line 3 and does not recite multiple sensor device types. Therefore, claim 14 does not encompass comparing measurements between multiple sensor device types since claim 14 recites determining measurements between a first set of readings and a second set of readings acquired from a single physiological data input device.
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 1-3, 5-10, and 12-16 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
The claims recite:
providing a first analyte sensor;
acquiring from the first analyte sensor a first set of glucose readings assigned to a first patient, the first set of glucose readings collected by conducting a first frequency of measurements;
providing a second analyte sensor;
acquiring from the second analyte sensor a second set of glucose readings assigned to a second patient, the second set of glucose readings collected by conducting a second frequency of measurements different from the first frequency of measurements;
providing a plurality of evaluation parameters in a data storage device, each of the evaluation parameters assigned to at least one of a first and a second group of similar patients;
pre-processing the first and second sets of glucose readings;
using the pre-processed first and second sets of glucose readings to determine a first frequency of measurements for the first set of glucose readings and a second frequency of measurements for the second set of glucose readings;
assigning the first patient to the first group of similar patients based on the first frequency of measurements and the second patient to the second group of similar patients based on the second frequency of measurements;
determining a first evaluation parameter from the plurality of evaluation parameters for the first patient based on the first group of similar patients;
determining a second evaluation parameter from the plurality of evaluation parameters for the second patient based on the second group of similar patients, the second evaluation parameter being different than the first evaluation parameter;
determining, from the first set of glucose readings, a plurality of first evaluation values assigned to the first patient for a plurality of first evaluation parameter parameters, wherein the plurality of first evaluation parameters comprises low blood glucose index (LBGI), high blood glucose index (HBGI), warning signs (WS), and median blood glucose (median);
determining, from the second set of glucose readings, a plurality of second evaluation values assigned to the second patient for a plurality of second evaluation parameter parameters, wherein the plurality of second evaluation parameters comprises low blood glucose index (LBGI), high blood glucose index (HBGI), stability index (SI), and total daily blood glucose variation determined by summing peak risks of hypoglycemia and hyperglycemia events per day (ADRR);
determining a first total risk score and a second total risk score by summing first and second risk scores for the plurality of first evaluation values and the plurality of second evaluation values, respectively, wherein the first and second risk scores for the plurality of first evaluation values and the plurality of second evaluation values, respectively, are determined as follows:
PNG
media_image1.png
337
729
media_image1.png
Greyscale
- a parameter value for warning signs is calculated as warning sign risk variable (WSRV)
PNG
media_image2.png
58
125
media_image2.png
Greyscale
wherein index i denotes events, weight for the event with index i is denoted with w;, and variable x; represents a Boolean value whether (Boolean value =1) or not (Boolean value = 0) the event has occurred; and
determining the relative risk for lack of glycemic control by comparing the first total risk score and the second total risk score, the relative risk indicating the risk for lack of glycemic control being higher for the first patient or the second patient.
The above claim limitations (using, assigning, determining) constitute an abstract idea that is part of the 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.
The claimed steps of using, assigning, determining 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 monitoring a relative risk for lack of glycemic control 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, the dependent claims are directed to either 1) steps that are also abstract or 2) additional data gathering/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.
Claims 2-3, 5-10, 12-13, and 15 are directed to more abstract ideas and further limitations on abstract ideas is already recite.
Claim 16 is directed to a continuous monitoring sensor/additional data gathering that is well-understood, routine and previously known to the industry.
This judicial exception (abstract idea) in Claims 1-3, 5-10, 12-16 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 using, assigning, determining merely invoke a computer as a tool.
The data-gathering step (providing, acquiring, pre-processing) and the data-output 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 computer that is used as a tool for using, assigning, determining.
The claims do not apply the abstract idea to affect a particular treatment or prophylaxis for a disease or medical condition. Rather, the abstract idea is utilized for determining a relative risk for lack of glycemic control.
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 providing, determining. The claims do not apply the obtained calculation to a particular machine. Rather, the data is merely output in a post-solution step.
The additional elements are identified as follows: analyte sensor; physiological data input device; continuous monitoring sensor; data storage device; data processor; algorithm; non-transitory computer readable medium.
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., paragraphs [0017, 0057]) which discloses that the data processor(s)/data storage device comprise generic computer components that are configured to perform the generic computer functions (e.g., using, assigning, determining) that are well-understood, routine, and conventional activities previously known to the pertinent industry.
Applicant’s Background in the specification;
The prior art of record: Sugimoto (US 5706423 A), in column 1 lines 24-33, discloses a conventional data processor.
The prior art of record: Chang (US 20050114570 A1), in paragraphs [0003-0004], discloses conventional data storage devices.
The prior art of record: Hasan (US 20160358439 A1) in paragraph [0028], discloses conventional non-transitory computer-readable media.
The prior art of record: Otto (US 20170112452 A1) in paragraph [0013] discloses conventional SMBG meters.
The prior art of record: ; Zhou (US 20200253513 A1) in para. [0063] discloses a conventional analyte monitor, such as a continuous glucose monitor.
The non-patent literature of record in the application;
Mora, et al., Use of a Novel, Remotely Connected Diabetes Management System Is Associated with Increased Treatment Satisfaction, Reduced Diabetes Distress, and Improved Glycemic Control in Individuals with Insulin-Treated Diabetes: First Results from the Personal Diabetes Management Study, Diabetes Technology & Therapeutics, 2019, 19(12): 715-722 , https://doi.org/10.1089/dia.2017.0206
El Youssef J, Castle J, Ward WK. A Review of Closed-Loop Algorithms for Glycemic Control in the Treatment of Type 1 Diabetes. Algorithms. 2009; 2(1):518-532. https://doi.org/10.3390/a2010518
Tokuda et al., Vital sign triage to rule out diabetic ketoacidosis and non-ketotic hyperosmolar syndrome in hyperglycemic patients, Diabetes Research and Clinical Practice, Volume 87, Issue 3, 2010, Pages 366-371, ISSN 0168-8227, https://doi.org/10.1016/j.diabres.2009.11.020.
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.
Claims 1-3, 5-10, 12-13, and 16 are rejected under 35 U.S.C. 101 because the claims refer to a “computer-implemented method” which can be transitory in nature. Examiner suggests rewording the claims to recite that the computer-implemented method is embodied on a non-transitory computer readable medium.
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 ANDREW ELI HOFFPAUIR whose telephone number is (571)272-4522. The examiner can normally be reached Monday-Friday 8:00-5:00.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at
http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Marmor II can be reached on (571) 272-4730. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/CHARLES A MARMOR II/Supervisory Patent Examiner, Art Unit 3791
/A.E.H./Examiner, Art Unit 3791