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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 01/26/2026 has been entered.
Response to Amendment
The amendment, filed 01/26/2026, has been entered. The examiner notes claims 1-20 are pending.
Response to Arguments
Applicant's arguments, see Remarks pages 9-16, filed 01/26/2026, regarding the 35 USC 101 rejection of claims 1-20 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. Regarding the ability for the human mind to perform steps, such as “outputting” data to a GUI, the examiner notes that these limitations are found to be insignificant extra-solution activities and not part of the judicial exception. For further clarity, the examiner in interpreting the “preventing” data from being output and “accessing” rules to be the abstract idea, both actions of which are capable of being performed in the human mind. As to the argument about the steps requiring the additional element of a glucose monitoring graphical user interface, the examiner notes that additional elements are analyzed in step 2A prong 2 and step 2B.
In response to the applicant’s argument that the claims should be found eligible at step 2A prong 2 of the Alice/Mayo test, the examiner respectfully disagrees. Firstly, the examiner notes that the examples from the 2019 Revised Patent Subject Matter Eligibility Guidance are non-precedential. Regarding the claims providing an improvement technology/technical field, 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)). Further, the examiner disagrees that the system allegedly provides an improvement to system usability by controlling how much/when the information to a user as the improvement is solely in the judgement of how much to display. This task is often done by physicians testing for certain diseases. The patient often receives a simple affirmation or rejection as to whether a disease is present in the patient’s system, while the more detailed results of the tests/examinations are withheld.
Regarding the applicant’s argument that the claims should be found eligible under step 2B, the examiner respectfully disagrees. The examiner further reiterates the rebuttal of the argument of claim eligibility when analyzing the claims at step 2A prong 2 above in that the improvement cannot be provided by the judicial exception alone. The examiner finds the additional elements to be well-understood, routine, and conventional and/or add insignificant extra-solution activity to the judicial exception.
Therefore, for the reasons provided above, the 35 USC 101 rejection of claims 1-20 is maintained.
Applicant’s arguments, see Remarks pages 16-17, filed 01/26/2026, with respect to the 35 USC 102 and 103 rejections of claims 19 and 20 have been fully considered and are persuasive. The examiner notes that the elements from claims 1-18 that were found to overcome the art rejections have been amended into claims 19-20. The 35 USC 102 and 103 rejections of claims 19 and 20 have 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 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Independent Claim 1 recites:
A computer-implemented method comprising:
initiating a multi-phase glucose monitoring program comprising at least a first phase and a second phase;
obtaining first glucose data of a user during the first phase of the multi-phase glucose monitoring program;
preventing output of the first glucose data in a glucose monitoring graphical user interface of a computing device during the first phase of the multi-phase glucose monitoring program;
accessing a first rule and a second rule based on a corresponding phase of the multi-phase glucose monitoring program, the first rule associated with a first information to be displayed during the second phase of the multi-phase glucose monitoring program and the second rule associated with a second information to be omitted during the second phase of the multi-phase glucose monitoring program;
obtaining second glucose data of the user during the second phase of the multi-phase glucose monitoring program; and
outputting, in real-time and based on the first rule, the second glucose data in the glucose monitoring graphical user interface of the computing device during the second phase of the multi-phase glucose monitoring program.
Independent claim 9 recites:
A computer-implemented method comprising:
obtaining first glucose data of a user using a first glucose sensor during a first phase of a multi-phase glucose monitoring program;
obtaining second glucose data of the user using a second glucose sensor during a second phase of the multi-phase glucose monitoring program;
obtaining third glucose data of the user using a third glucose sensor during a third phase of the multi-phase glucose monitoring program;
obtaining fourth glucose data of the user using a fourth glucose sensor during a fourth phase of the multi-phase glucose monitoring program; and
generating a glucose report based on the first glucose data, the second glucose data, the third glucose data, and the fourth glucose data, wherein:
the glucose report omits a portion of the first glucose data according to a first rule associated with the first phase of the multi-phase glucose monitoring program,
the glucose report includes a portion of the second glucose data according to a second rule associated with the second phase of the multi-phase glucose monitoring program,
the glucose report includes a portion of the third glucose data according to a third rule associated with the third phase of the multi-phase glucose monitoring program, and
the glucose report includes a portion of the fourth glucose data according to a fourth rule associated with the fourth phase of the multi-phase glucose monitoring program; and
outputting, in real-time, the glucose report in a glucose monitoring graphical user interface of a computing device.
Independent claim 15 recites:
A system comprising:
a sensor kit for a multi-phase glucose monitoring program, the sensor kit comprising at least a first glucose sensor for monitoring glucose during a first phase of the multi-phase glucose monitoring program and a second glucose sensor for monitoring glucose during a second phase of the multi-phase glucose monitoring program; and
a multi-phase engine configured to:
control a glucose monitoring graphical user interface of a computing device during the multi-phase glucose monitoring program;
obtain first glucose data of a user during the first phase of the multi-phase glucose monitoring program from the first glucose sensor of the sensor kit;
prevent output of the first glucose data in the glucose monitoring graphical user interface during the first phase of the multi-phase glucose monitoring program;
access a first rule and a second rule based on a corresponding phase of the multi- phase glucose monitoring program, the first rule associated with a first information to be displayed during the second phase of the multi-phase glucose monitoring program and the second rule associated with a second information to be omitted during the second phase of the multi-phase glucose monitoring program;
obtain second glucose data of the user during the second phase of the multi- phase glucose monitoring program; and
output, in real-time and based on the first rule, the second glucose data in the glucose monitoring graphical user interface during the second phase of the multi-phase glucose monitoring program.
Independent claim 19 recites:
A computer-readable storage device comprising instructions stored thereon that, responsive to execution by one or more processors, performs operations comprising:
initiating a multi-phase glucose monitoring program comprising at least a first phase and a second phase;
obtaining first glucose data of a user during the first phase of the multi-phase glucose monitoring program;
preventing output of the first glucose data in a glucose monitoring graphical user interface of a computing device during the first phase of the multi-phase glucose monitoring program;
accessing a first rule and a second rule based on a corresponding phase of the multi-phase glucose monitoring program, the first rule associated with a first information to be displayed during the corresponding phase of the multi-phase glucose monitoring program and the second rule associated with a second information to be omitted during the corresponding phase of the multi- phase glucose monitoring program;
obtaining second glucose data of the user during a second phase of the multi-phase glucose monitoring program; and
outputting, in real-time and based on the first rule, the second glucose data in the glucose monitoring graphical user interface during the second phase of the multi-phase glucose monitoring program.
Step 1:
The examiner finds claims 1 and 9 drawn to methods and claims 15 and 19 drawn to a machine.
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 initiating, controlling, obtaining, generating, preventing, outputting, and accessing recite mental processes.
The step of “initiating a multi-phase glucose monitoring program” in independent Claims 1 and 19 is a mental process capable of being performed by the human mind. For example, the human mind is capable of initiating a conversation by deciding to speak to someone and formulating the initial words or topic. The step of “controlling a glucose monitoring user interface” in independent claim 15 is a mental process capable of being performed by the human mind. For example, the human mind is capable of cognitive abilities, such as motor skills, to operate a television remote control. The steps of “obtaining first glucose data” in independent claims 1, 9, 15, and 19 and “generating a glucose report” are mere data gathering steps that utilizes a computational device and further is a mental process capable of being performed by the human mind. For example, the human mind can generate mental images of various restaurants when deciding on what to eat. The step of “preventing output of the first glucose data” in independent claims 1, 15, and 19 is a mental process capable of being performed in the human mind. For example, the human mind is capable of performing a preventive action, such as instructing the body to put on a seatbelt, as proactive measure to mitigate a potential negative outcome. The step of “outputting”, in real-time, the second glucose data” in independent claims 1, 15, and 19 is an insignificant extra-solution activity (post-solution) of providing a representation of information and also a mental process capable of being performed in the human mind. For example, the human mind is capable of outputting information in the form of speech or gestures. The step of “accessing” a first rule and second rule in independent claims 1, 15, and 19 recite a mental process capable of being performed in the human mind. For example, the human mind is capable of accessing memory to recall various information.
The claimed steps of initiating, controlling, obtaining, generating, preventing, outputting, and accessing 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 2-8, 10-14, 16-18, and 20, 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 1-20 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 initiating, controlling, obtaining, generating, preventing, outputting, and accessing merely invoke a computer as a tool.
• The data-gathering step (obtaining and generating) and the data-output step (outputting) 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 initiating, controlling, obtaining, generating, preventing, outputting, and accessing.
• 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 initiating, controlling, obtaining, generating, preventing, outputting, and accessing. 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: sensor, sensor kit, transmitter, and a multi-phase engine.
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 [0110]) which discloses that “…a computing device 1202 that is representative of one or more computing systems and/or devices that may implement the various techniques described herein. This is illustrated through inclusion of the multi-phase engine 108”, thus detailing how a “multi-phase engine” is part of a general “computing device”.
• Montero (US 20210275742 A1) which disclose the use of a sensor kit, sensor, and transmitter as a conventional means for performing their respective tasks (gathering data/sending data) in the applicant’s field of endeavor (see Montero para. 0003 “Conventional glucose sensor sets typically include three main components: a disposable sensor with its mounting base; a durable, rechargeable transmitting device that is coupled to cooperate with the sensor; and a sensor insertion tool”);
• 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
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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/JONATHAN M HANEY/Examiner, Art Unit 3791
/JUSTIN XU/Primary Examiner, Art Unit 3791
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