DETAILED ACTION
Notice to Applicant
This communication is in response to the Request for Continued Examination (RCE) submitted May 20, 2026. The present application is a CON of application 15/206,095 (now U.S. Patent Number 10,888,272). Claims 1 – 44 were previously cancelled. Claims 45, 52, and 58 are amended. Claims 45 – 78 are pending.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 May 20, 2026 has been entered.
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 45 – 78 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Step One
Claims 45 – 78 are drawn to a system and method, which is/are statutory categories of invention (Step 1: YES).
Step 2A Prong One
Independent claim 45 recites improving the health of an individual by detecting a plurality of meal events received by detecting the plurality of meal events based at least on a glucose rate of change; associate historical meal information with a plurality of ranges of glucose data related to the detected plurality of meal events, wherein the plurality of ranges of glucose data reflect a plurality of glucose responses of the individual to a plurality of meals; determine if each of the plurality of ranges of glucose data is less than or above a threshold of glucose response magnitude; and determine a grouping of the historical meal information, wherein the historical meal information comprises the detected plurality of meal events, wherein the grouping comprises the historical meal information associated with at least a portion of the plurality of ranges of glucose data that was determined either to be less than or above the threshold of glucose response magnitude; detect a new meal event; select meal information for the new detected meal event from the grouping of the historical meal information; receive the user selected meal information; determine if the user-selected meal information is associated with a range of glucose data that was above the threshold glucose response magnitude.
Independent claim 58 recite improving the health of an individual by detecting a plurality of meal events received by detecting the plurality of meal events based at least on a glucose rate of change; associating historical meal information with a plurality of ranges of glucose data related to the detected plurality of meal events, wherein the plurality of ranges of glucose data reflect a plurality of glucose responses of the individual to a plurality of meals; determining if each of the plurality of ranges of glucose data is less than or above a threshold of glucose response magnitude; outputting a grouping of the historical meal information, wherein the historical meal information comprises the detected plurality of meal events, wherein the grouping comprises the historical meal information associated with at least a portion of the plurality of ranges of glucose data that was determined either to be less than or above the threshold of glucose response magnitude; detect a new meal event; select meal information for the new detected meal event from the grouping of the historical meal information; receive the user selected meal information; determine if the user-selected meal information is associated with a range of glucose data that was above the threshold glucose response magnitude.
The recited limitations, as drafted, under their broadest reasonable interpretation, cover certain methods of organizing human activity, as reflected in the specification, which states that “The present subject matter broadly relates to systems, devices, and methods for the collection of information about analyte levels of certain individuals and information about meals that those individuals consume. The present subject matter further relates to processing, analyzing, and/or presenting this information for the purpose of correlating meal information to analyte levels, and identifying and implementing adjustments to the diet, lifestyle, and/or medical treatment regimens of those individuals.” (paragraph 2 of the published specification). If a claim limitation, under its broadest reasonable interpretation, covers managing personal behavior or relationships or interactions between people, then it falls within the “Certain Methods of Organizing Human Activity” grouping of abstract ideas. The present claims cover “Certain Methods of Organizing Human Activity” because they address a need in which “Resulting information can be presented to the individual to show which meals or aspects of the meals are causing the most impact on analyte levels. These results can be organized and categorized based on preselected criteria chosen directly by the individual or based upon consultation between the individual and a medical professional (paragraph 10 of the published specification). Accordingly, the claims recite an abstract idea(s) (Step 2A Prong One: YES).”
Step 2A Prong Two
This judicial exception is not integrated into a practical application. The claims are abstract but for the inclusion of the additional elements including:
Claim 45: “glucose monitoring system”, “sensor control device comprising an in vivo glucose sensor, the sensor control device configured to automatically transmit data…… to a reader device in a periodic fashion based on a predetermined time interval”, “reader device”, “wireless communication circuitry…… transmit historical data indicative of the glucose level to a server”, “graphical user interface circuitry”, “display”, “first processing circuitry communicatively coupled ….. communication circuitry”, “first memory and a server”, “second processing circuitry communicatively coupled with the second wireless communication circuitry”, “second memory”, “wherein instructions stored on either the first memory or the second memory, when executed by the first processing circuitry or the second processing circuitry”, “meal event detector software”, “output a real-time notification”
Claims 46, 48, 50 – 52, 56: “system”
Claims 47, 49, 53 – 55, 57: “system”, “instructions further cause the first processing circuitry to [perform]”, “display”
Claim 58: “sensor control device”, “in vivo glucose monitoring system comprising the sensor control device, a reader device, and a server”, “automatically transmitting, by the sensor control device”, “reader device”, “meal event detector software”, “display”, “server”
Claims 60, 62, 68: “displaying”
Claims 69, 70: “sensor control device”, “in vivo glucose sensor”
Claims 72 and 76: “Wi-Fi”, “Bluetooth”, “BLE connection”
These features are additional elements that are recited at a high level of generality such that they amount to no more than mere instruction to apply the exception using generic computer components. See: MPEP 2106.05(f).
The additional elements are merely incidental or token additions to the claim that do not alter or affect how the process steps or functions in the abstract idea are performed. Therefore, the claimed additional elements do not add meaningful limitations to the indicated claims beyond a general linking to a technological environment. See: MPEP 2106.05(h).
The combination of these additional elements is no more than mere instructions to apply the exception using generic computer components. Accordingly, even in combination, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea.
Hence, the additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. Accordingly, the claims are directed to an abstract idea (Step 2A Prong Two: NO).
Step 2B
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, using the additional elements to perform the abstract idea amounts to no more than mere instructions to apply the exception using generic components. Mere instructions to apply an exception using a generic components cannot provide an inventive concept. See MPEP 2106.05(f).
Further, the claimed additional elements, identified above, are not sufficient to amount to significantly more than the judicial exception because they are generic components that are not integrated into the claim because they are merely incidental or token additions to the claim that do not alter or affect how the process steps or functions in the abstract idea are performed. Therefore, the claimed additional elements do not add meaningful limitations to the indicated claims beyond a general linking to a technological environment. See: MPEP 2106.05(h).
Further, the claimed additional elements, identified above, are not sufficient to amount to significantly more than the judicial exception because they are generic components that are configured to perform well-understood, routine, and conventional activities previously known to the industry. See: MPEP 2106.05(d). Said additional elements are recited at a high level of generality and provide conventional functions that do not add meaningful limits to practicing the abstract idea. The published specification supports this conclusion as follows:
[0034] In vivo monitoring systems can also include a device that receives sensed analyte data from the sensor control device and processes and/or displays that sensed analyte data, in any number of forms, to the user. This device, and variations thereof, can be referred to as a "reader device" ( or simply a "reader"), "handheld electronics" ( or a handheld), a "portable data processing" device or unit, a "data receiver," a "receiver" device or unit (or simply a receiver), or a "remote" device or unit, to name a few. Other devices such as personal computers have also been utilized with or incorporated into in vivo and in vitro monitoring systems.
[0045] Computer system 170 may be a personal or laptop computer, a tablet, or other suitable data processing device. Computer 170 can be either local ( e.g., accessible via a direct wired connection such as USB) or remote to reader device 120 and can be (or include) software for data management and analysis and communication with the components in analyte monitoring system 100. Operation and use of computer 170 is further described in the '225 Publication incorporated herein by reference. Analyte monitoring system 100 can also be configured to operate with a data processing module (not shown), also as described in the incorporated '225 Publication.
Viewing the limitations as an ordered combination, the claims simply instruct the additional elements to implement the concept described above in the identification of abstract idea with routine, conventional activity specified at a high level of generality in a particular technological environment.
Hence, the claims as a whole, considering the additional elements individually and as an ordered combination, do not amount to significantly more than the abstract idea (Step 2B: NO).
Dependent claim(s) 46 – 57 and 59 – 78 when analyzed as a whole, considering the additional elements individually and/or as an ordered combination, are held to be patent ineligible under 35 U.S.C. 101 because the additional recited limitation(s) fail(s) to establish that the claim(s) is/are not directed to an abstract idea without significantly more. These claims fail to remedy the deficiencies of their parent claims above, and are therefore rejected for at least the same rationale as applied to their parent claims above, and incorporated herein.
Claim Rejections - 35 USC § 103
The rejection of Claim(s) 45 – 68 under 35 U.S.C. 103 were withdrawn in the Office Action mailed May 28, 2024.
Response to Arguments
Applicant's arguments filed May 5, 2026 have been fully considered but they are not persuasive. The Applicant’s arguments have been addressed in the order in which they were presented.
Rejections under Section 101
The Applicant argues the amended claims are integrated into a practical application, citing Example 42 of the 2019 Revised Guidelines. The Examiner respectfully disagrees. Example 42 recites “A method comprising: a) storing information in a standardized format about a patient's condition in a plurality of network-based non-transitory storage devices having a collection of medical records stored thereon; b) providing remote access to users over a network so any one of the users can update the information about the patient’s condition in the collection of medical records in real time through a graphical user interface, wherein the one of the users provides the updated information in a non-standardized format dependent on the hardware and software platform used by the one of the users; c) converting, by a content server, the non-standardized updated information into the standardized format; d) storing the standardized updated information about the patient’s condition in the collection of medical records in the standardized format; e) automatically generating a message containing the updated information about the patient’s condition by the content server whenever updated information has been stored; and f) transmitting the message to all of the users over the computer network in real time, so that each user has immediate access to up-to-date patient information.” The abstract idea is to provide remote access to users so any one of the users can update the information about the patient’s condition in the collection of medical records so that each user has immediate access to up-to-date patient information, and falls within the grouping of certain methods of organizing human activity. The combination of additional elements of the claim, integrate the abstract idea into a practical application by offering a specific improvement over prior art systems. The claims of example 42 are automatically generating a message and transmitting the message to a user. The present claims differ such that the additional elements are “glucose monitoring system”, “sensor control device comprising an in vivo glucose sensor, the sensor control device configured to automatically transmit data…… to a reader device in a periodic fashion based on a predetermined time interval”, “reader device”, “wireless communication circuitry…… transmit historical data indicative of the glucose level to a server”, “graphical user interface circuitry”, “display”, “first processing circuitry communicatively coupled ….. communication circuitry”, “first memory and a server”, “second processing circuitry communicatively coupled with the second wireless communication circuitry”, “second memory”, “wherein instructions stored on either the first memory or the second memory, when executed by the first processing circuitry or the second processing circuitry”, “meal event detector software”, “output a real-time notification”. The claim as a whole merely describes how to generally “apply” the concept of detecting a plurality of meal events, associating historic meal information with a plurality of ranges of glucose data related to the detected meal events, determining if the range of glucose data is above or below a threshold, displaying a grouping of historical meal information, and outputting a real-time notification in a computer environment. Unlike Example 42, which outputs a message to other users of the system, so they can adapt their own medical diagnostic and treatment strategy in accordance with other providers’ actions, the present application is outputting a real-time notification regarding a potential glycemic impact of the meal detection, but does not deliver a drug or treatment, since the notification is with regard to a potential impact. The present invention appears to be collecting meal information and comparing it to historical information to predict the impact of the meal on a patient’s glucose level where an alert is provided if the meal is determined to cause a potential glycemic impact. Thus, the Applicant’s argument is not persuasive and the rejection is maintained.
The Applicant argues the amended claims are integrated into a practical application by requiring that a real-time notification be outputted when certain conditions are met. The Examiner respectfully disagrees. The additional elements of the present claims fail to integrate the exception into a practical application of the exception. The 2019 PEG defines the phrase “integration into a practical application” to require an additional element or a combination of additional elements in the claim to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception, such that it is more than a drafting effort designed to monopolize the exception. For example, the 2019 PEG guidelines recite limitations that are indicative of integration into a practical application when recited in a claim with a judicial exception include:
Improvements to the functioning of a computer, or to any other technology or technical field, as discussed in MPEP 2106.05(a);
Applying or using a judicial exception to effect a particular treatment or prophylaxis for disease or medical condition – see Vanda Memo
Applying the judicial exception with, or by use of, a particular machine, as discussed in MPEP 2106.05(b);
Effecting a transformation or reduction of a particular article to a different state or thing, as discussed in MPEP 2106.05(c); and
Applying or using the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception, as discussed in MPEP 2106.05(e) and the Vanda Memo issued in June 2018.
The present claims fail to demonstrate an improvement to the functioning of a computer or to any other technology or technical field. Thus, Applicant’s argument is not persuasive, and the rejection is maintained.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KRISTINE K RAPILLO whose telephone number is (571)270-3325. The examiner can normally be reached Monday - Friday 7:30 - 4 pm.
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KRISTINE K. RAPILLO
Examiner
Art Unit 3626
/KRISTINE K RAPILLO/Examiner, Art Unit 3682
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