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 . In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Response to Amendment
This Office Action is responsive to the amendment filed 06/10/2026 (“Amendment”). Claims 1, 3-9, 11-16, and 18-23 are currently under consideration. The Office acknowledges the amendments to claims 1, 3, 4, 6, 8, 9, 11, 12, 15, 16, and 18-20, as well as the cancellation of claims 2, 10, and 17 and the addition of new claims 21-23.
The objection(s) to the drawings, specification, and/or claims, the interpretation(s) under 35 USC 112(f), and/or the rejection(s) under 35 USC 101 and/or 35 USC 112 not reproduced below has/have been withdrawn in view of the corresponding amendments.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “continuous analyte monitoring sensor device” or “sensor device” in claims 1, 9, and 16.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof (e.g. for “continuous analyte monitoring sensor device,” not just the sensor, but also e.g. a processor and transceiver).
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 21-23 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claim 21, there is no support for either element because the time-based examples in the specification are with respect to the time-in-range metric, not rapid analyte level rise (see e.g. ¶ 0145 of the specification as filed).
Regarding claim 22, there is no support because eating less is not the same as “meal content” (see e.g. ¶¶s 0134 and 0139 of the specification as filed), and because the time-based examples in the specification are with respect to the time-in-range metric, not rapid analyte level rise (see e.g. ¶ 0145 of the specification as filed).
Regarding claim 23, there is no support because the contextual message discussion is with respect to the time-in-range or analyte spike metrics, not rapid analyte level rise (see e.g. ¶¶s 0145 and 0150 of the specification as filed).
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, 3-9, 11-16, and 18-23 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1 of the subject matter eligibility test (see MPEP 2106.03).
Claims 9, 11-16, and 18-20 are directed to a “device” and a “system,” which describe one of the four statutory categories of patentable subject matter, i.e., a machine. Claims 1, 3-8, and 21-23 are directed to a “method,” which describes one of the four statutory categories of patentable subject matter, i.e., a process.
Step 2A of the subject matter eligibility test (see MPEP 2106.04).
Prong One: Claims 1, 9, and 16 recite (“set forth” or “describe”) the abstract idea of a mental process or mathematical concept, substantially as follows:
identifying an analyte rapidly rising insight event based on the measured analyte data within a predetermined time period, and generating an analyte rapidly rising insight notification based on the analyte rapidly rising insight event.
The identifying and generating steps can be practically performed in the human mind, with the aid of a pen and paper, but for performance on a generic computer, in a computer environment, or merely using the computer as a tool to perform the steps. If a person were to see e.g. a printout of the measured analyte data, they would be able to identify an insight event based on morphology, and generate a notification based on the event by e.g. making a decision. There is nothing to suggest an undue level of complexity in the identification or generation. Therefore, a person would be able to perform the steps mentally or with pen and paper.
The steps also involve the mathematical concepts of data analysis, criteria comparison, and result calculation. This step corresponds to “[w]ords used in a claim operating on data to solve a problem [that] can serve the same purpose as a formula.” See MPEP 2106.04(a)(2)(I).
Prong Two: Claims 1, 9, and 16 do not include additional elements that integrate the mental process or mathematical concept into a practical application. Therefore, the claims are “directed to” the mental process and mathematical concept. The additional elements merely:
recite the words “apply it” (or an equivalent) with the judicial exception, or include instructions to implement the abstract idea on a computer, or merely use the computer as a tool to perform the abstract idea (e.g. processors and memories with instructions), and
add insignificant extra-solution activity (the pre-solution activity of: measuring levels and generating analyte data, using generic data-gathering sensors (an analyte sensor of a sensor device); and the post-solution activity of: presenting an insight notification that includes a suggested activity, using generic data-outputting components (a display or GUI of a display device)).
As a whole, the additional elements merely serve to gather and feed information to the abstract idea, while generically implementing it on a computer. There is no practical application because the abstract idea is not applied, relied on, or used in a meaningful way. No improvement to the technology is evident, and the insight notification is not outputted in any way such that a diagnostic benefit is realized (at least because nobody needs to see, hear, or act on the notification). Therefore, the additional elements, alone or in combination, do not integrate the abstract idea into a practical application.
Step 2B of the subject matter eligibility test (see MPEP 2106.05).
Claims 1, 9, and 16 do not include additional elements, alone or in combination, that are sufficient to amount to significantly more than the judicial exception (i.e., an inventive concept) for the same reasons as described above.
Dependent Claims
The dependent claims merely further define the abstract idea and are, therefore, directed to an abstract idea for similar reasons: they merely
further describe the abstract idea (e.g. specifying a particular insight event (claims 3, 11, and 18), determining an occurrence of a related event (claims 4, 12, and 19), generating a related event notification (claims 6, 7, 14, and 19), the analyte data being glucose data, the notification comprising e.g. text or numbers, and the time period being particular minutes to days (claims 8, 15, and 20), etc.),
further describe the extra-solution activity (or the structure used for such activity) (e.g. the notification including a graph and text block (claims 3, 11, and 18), based on received data from a user (claims 5, 13, and 19), and presenting the related event notification (claims 6, 14, and 19), etc.).
Taken alone and in combination, the additional elements do not integrate the judicial exception into a practical application at least because the abstract idea is not applied, relied on, or used in a meaningful way (e.g. the notification need not be seen, hear, or acted on in any way). They also do not add anything significantly more than the abstract idea. Their collective functions merely provide computer/electronic implementation and processing, and no additional elements beyond those of the abstract idea. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements individually. There is no indication that the combination of elements improves the functioning of a computer, output device, improves another technology or technical field, etc. Therefore, the claims are rejected as being directed to non-statutory subject matter.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1, 3-9, 11-16, and 18-23 are rejected under 35 U.S.C. 103 as being unpatentable over various teachings of US Patent Application Publication 2022/0000399 (“Hayter”).
Regarding claim 1, Hayter teaches [a] method for providing insight notifications on a display device (Fig. 1, display 122 of reader device 120, ¶¶s 0061, 0107 (the user can be notified), 0133 (notification via display), 0274, etc.), the method comprising: receiving, from a continuous analyte monitoring sensor device, measured analyte data (¶¶s 0079, 0100, etc., Fig. 3A, step 304, via sensor control device 102); identifying an analyte rapidly rising insight event based on the measured analyte data within a predetermined time period (Fig. 4A and ¶¶s 0102, 0140, 0141, 0147, 0148, etc., describing identification of a rapid rise in the analyte level within e.g. an eight hour period or window); generating an analyte rapidly rising insight notification based on the analyte rapidly rising insight event (Figs. 4C or 4D, indicator 408); and presenting the analyte rapidly rising insight notification to a user in a graphical user interface (GUI) (as shown in Figs. 4C or 4D), wherein the analyte rapidly rising insight notification includes at least one suggested activity to address a rapidly rising analyte concentration level (¶¶s 0218 and 0219, the trusted computer can output a recommendation to adjust e.g. a meal time or an insulin dose to relieve the glucose trend. Although it is not explicit that this is specifically in response to detection of the analyte rapidly rising event, that is one of the trends that the system can identify, and ¶¶s 0169-0171 explain that e.g. insulin may be issued based on the occurrence of an excursion (i.e., the event). ¶¶s 0172 and 0173 also tie this insulin adjustment to the log/meal minder shown in Fig. 4C. Thus, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include a suggested activity such as an insulin adjustment with the analyte rapidly rising insight notification, for the purpose of helping the user relieve the trend (¶ 0219)).
Regarding claim 3, Hayter teaches all the features with respect to claim 1, as outlined above. Hayter further teaches wherein: the insight event is an analyte rapidly rising insight event (¶¶s 0141, 0147, 0148); and the insight notification is an analyte rapidly rising insight notification that includes a graph of analyte concentration level over time (Figs. 4C or 4D, analyte level indication 406), and an alphanumeric text block indicating that the analyte concentration level is rising (Fig. 4C shows an alphanumeric window 429 indicating the detection of a possible meal event. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make this window say that the possible meal event is due to e.g. a rise in the detected level of analyte, as already contemplated in ¶¶s 0148 (i.e., based on detection of an excursion) and 0169 (notification due to glucose excursion), for the purpose of explaining the notification to the user more fully, and encouraging them to act on it (¶ 0169)).
Regarding claim 4, Hayter teaches all the features with respect to claim 1, as outlined above. Hayter further teaches wherein the method further comprises: determining an occurrence of a related event within the predetermined time period, the related event comprising a meal, an activity, or a medicament dosing (¶ 0102, detecting e.g. meal events based on analyte data over 8 hours – also see ¶¶s 0103, 0141, 0147, and 0148, as well as Fig. 4A, showing identification of a rapid rise corresponding to e.g. a meal event).
Regarding claim 5, Hayter teaches all the features with respect to claim 4, as outlined above. Hayter further teaches wherein determining the occurrence of the related event is based on related event data received from the user, the related event data including an event type, a date, and a time (¶ 0102 notes that the algorithmic detection is supplemented as shown in Fig. 3A, steps 308-312, with user input of meal information, which includes event type, date, and time as described ¶¶s 0120, 0176-0178, 0184, etc. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to receive date data from the user in the case that they are annotating meals from a previous day, for the purpose of enabling meal annotation at a later time, as contemplated by ¶¶s 0148 and 0151).
Regarding claim 6, Hayter teaches all the features with respect to claim 5, as outlined above. Hayter further teaches generating a related event notification based on the related event, the related event notification including: a graph of analyte concentration levels over time (Figs. 4C and 4D, showing the indication of analyte levels 406), an icon displayed at a related event start time (¶ 0238, an icon identifying the start of the event – also see indicator 408 generally, or the icons shown in e.g. Fig. 12), and an alphanumeric text block describing the related event (Figs. 10A-1, 10A-2, etc., alphanumeric windows 824 or 842, describing the event); and presenting the related event notification to the user in the GUI (Figs. 4C, 4D, 10A-1, 10A-2, etc. as shown).
Regarding claim 7, Hayter teaches all the features with respect to claim 6, as outlined above. Hayter further teaches wherein: the related event is a meal, the icon is a meal icon, and the alphanumeric text block describes a content of the meal (Figs. 5B, 9A-2, 13B-5, etc.); the related event is an activity, the icon is an activity icon, and the alphanumeric text block describes the activity; or the related event is a medicament dosing, the icon is a medicament dosing icon, and the alphanumeric text block describes the medicament dosing.
Regarding claim 8, Hayter teaches all the features with respect to claim 1, as outlined above. Hayter further teaches wherein: the measured analyte data are measured glucose data (¶¶s 0049, 0050, 0088, etc.); the insight notification comprises one or more images, numbers, alphanumeric text, or graphical control elements (Figs. 4C or 4D, indicator 408); and the predetermined time period is between 5 minutes and 30 minutes, between 30 minutes and 3 hours, or between 3 hours and 3 days (¶¶s 0102 and 0140, 8 hours being between 3 hours and 3 days).
Regarding claim 9, Hayter teaches [a] display device (Fig. 1, display 122 of reader device 120, ¶¶s 0061, 0107 (the user can be notified), 0133 (notification via display), 0274, etc.), comprising: a memory comprising executable instructions (¶¶s 0063 and 0070); and a processor (¶¶s 0063 and 0070), coupled to a display (display 122), the processor in data communication with the memory and configured to execute the executable instructions (¶¶s 0063 and 0070) to: receive, from a continuous analyte monitoring sensor device, measured analyte data (¶¶s 0079, 0100, etc., Fig. 3A, step 304, via sensor control device 102); identify an analyte rapidly rising insight event based on the measured analyte data within a predetermined time period (Fig. 4A and ¶¶s 0102, 0140, 0141, 0147, 0148, etc., describing identification of a rapid rise in the analyte level within e.g. an eight hour period or window); generate an analyte rapidly rising insight notification based on the analyte rapidly rising insight event (Figs. 4C or 4D, indicator 408); and present, on the display, the analyte rapidly rising insight notification to a user in a graphical user interface (GUI) (as shown in Figs. 4C or 4D), wherein the analyte rapidly rising insight notification includes at least one suggested activity to address a rapidly rising analyte concentration level (¶¶s 0218 and 0219, the trusted computer can output a recommendation to adjust e.g. a meal time or an insulin dose to relieve the glucose trend. Although it is not explicit that this is specifically in response to detection of the analyte rapidly rising event, that is one of the trends that the system can identify, and ¶¶s 0169-0171 explain that e.g. insulin may be issued based on the occurrence of an excursion (i.e., the event). ¶¶s 0172 and 0173 also tie this insulin adjustment to the log/meal minder shown in Fig. 4C. Thus, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include a suggested activity such as an insulin adjustment with the analyte rapidly rising insight notification, for the purpose of helping the user relieve the trend (¶ 0219)).
Regarding claim 11, Hayter teaches all the features with respect to claim 9, as outlined above. Hayter further teaches wherein: the insight event is an analyte rapidly rising insight event (¶¶s 0141, 0147, 0148); and the insight notification is an analyte rapidly rising insight notification that includes a graph of analyte concentration level over time (Figs. 4C or 4D, analyte level indication 406), and an alphanumeric text block indicating that the analyte concentration level is rising (Fig. 4C shows an alphanumeric window 429 indicating the detection of a possible meal event. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make this window say that the possible meal event is due to e.g. a rise in the detected level of analyte, as already contemplated in ¶¶s 0148 (i.e., based on detection of an excursion) and 0169 (notification due to glucose excursion), for the purpose of explaining the notification to the user more fully, and encouraging them to act on it (¶ 0169)).
Regarding claim 12, Hayter teaches all the features with respect to claim 9, as outlined above. Hayter further teaches wherein the processor is further configured to determine an occurrence of a related event within the predetermined time period, the related event comprising a meal, an activity, or a medicament dosing (¶ 0102, detecting e.g. meal events based on analyte data over 8 hours – also see ¶¶s 0103, 0141, 0147, and 0148, as well as Fig. 4A, showing identification of a rapid rise corresponding to e.g. a meal event).
Regarding claim 13, Hayter teaches all the features with respect to claim 12, as outlined above. Hayter further teaches wherein the processor is further configured to determine the occurrence of the related event is based on related event data received from the user, the related event data including an event type, a date, and a time (¶ 0102 notes that the algorithmic detection is supplemented as shown in Fig. 3A, steps 308-312, with user input of meal information, which includes event type, date, and time as described ¶¶s 0120, 0176-0178, 0184, etc. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to receive date data from the user in the case that they are annotating meals from a previous day, for the purpose of enabling meal annotation at a later time, as contemplated by ¶¶s 0148 and 0151).
Regarding claim 14, Hayter teaches all the features with respect to claim 13, as outlined above. Hayter further teaches wherein the processor is further configured to: generate a related event notification based on the related event, the related event notification including: a graph of analyte concentration levels over time (Figs. 4C and 4D, showing the indication of analyte levels 406), an icon displayed at a related event start time (¶ 0238, an icon identifying the start of the event – also see indicator 408 generally, or the icons shown in e.g. Fig. 12), and an alphanumeric text block describing the related event (Figs. 10A-1, 10A-2, etc., alphanumeric windows 824 or 842, describing the event); and present the related event notification to the user in the GUI (Figs. 4C, 4D, 10A-1, 10A-2, etc. as shown), wherein: the related event is a meal, the icon is a meal icon, and the alphanumeric text block describes a content of the meal (Figs. 5B, 9A-2, 13B-5, etc.); the related event is an activity, the icon is an activity icon, and the alphanumeric text block describes the activity; or the related event is a medicament dosing, the icon is a medicament dosing icon, and the alphanumeric text block describes the medicament dosing.
Regarding claim 15, Hayter teaches all the features with respect to claim 9, as outlined above. Hayter further teaches wherein: the measured analyte data are measured glucose data (¶¶s 0049, 0050, 0088, etc.); the insight notification comprises one or more images, numbers, alphanumeric text, or graphical control elements (Figs. 4C or 4D, indicator 408); and the predetermined time period is between 5 minutes and 30 minutes, between 30 minutes and 3 hours, or between 3 hours and 3 days (¶¶s 0102 and 0140, 8 hours being between 3 hours and 3 days).
Regarding claim 16, Hayter teaches [a] continuous analyte monitoring (CAM) system (¶¶s 0079, 0100, etc., Fig. 3A, step 304, via sensor control device 102 of Fig. 1), comprising: a sensor device including: an analyte sensor configured to measure analyte concentration levels, and a processor configured to generate measured analyte data based on the measured analyte concentration levels (Fig. 1, sensor control device 102, ¶¶s 0059-0061, 0076-0078, etc. – also see Fig. 2B, analyte sensor 104 and processor 256); and a display device (Fig. 1, reader device 120) including: a processor, coupled to a display (¶¶s 0063 and 0070, Fig. 1, display 122 – also see Fig. 2A), configured to: receive measured analyte data from the sensor device (¶¶s 0079, 0100, etc., Fig. 3A, step 304, via sensor control device 102); identify an analyte rapidly rising insight event based on the measured analyte data within a predetermined time period (Fig. 4A and ¶¶s 0102, 0140, 0141, 0147, 0148, etc., describing identification of a rapid rise in the analyte level within e.g. an eight hour period or window); generate an analyte rapidly rising insight notification based on the analyte rapidly rising insight event (Figs. 4C or 4D, indicator 408); and present the analyte rapidly rising insight notification to a user in a graphical user interface (GUI) (as shown in Figs. 4C or 4D), wherein the analyte rapidly rising insight notification includes at least one suggested activity to address a rapidly rising analyte concentration level (¶¶s 0218 and 0219, the trusted computer can output a recommendation to adjust e.g. a meal time or an insulin dose to relieve the glucose trend. Although it is not explicit that this is specifically in response to detection of the analyte rapidly rising event, that is one of the trends that the system can identify, and ¶¶s 0169-0171 explain that e.g. insulin may be issued based on the occurrence of an excursion (i.e., the event). ¶¶s 0172 and 0173 also tie this insulin adjustment to the log/meal minder shown in Fig. 4C. Thus, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include a suggested activity such as an insulin adjustment with the analyte rapidly rising insight notification, for the purpose of helping the user relieve the trend (¶ 0219)).
Regarding claim 18, Hayter teaches all the features with respect to claim 16, as outlined above. Hayter further teaches wherein: the insight event is an analyte rapidly rising insight event (¶¶s 0141, 0147, 0148); and the insight notification is an analyte rapidly rising insight notification that includes a graph of analyte concentration level over time (Figs. 4C or 4D, analyte level indication 406), and an alphanumeric text block indicating that the analyte concentration level is rising (Fig. 4C shows an alphanumeric window 429 indicating the detection of a possible meal event. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to make this window say that the possible meal event is due to e.g. a rise in the detected level of analyte, as already contemplated in ¶¶s 0148 (i.e., based on detection of an excursion) and 0169 (notification due to glucose excursion), for the purpose of explaining the notification to the user more fully, and encouraging them to act on it (¶ 0169)).
Regarding claim 19, Hayter teaches all the features with respect to claim 16, as outlined above. Hayter further teaches wherein the processor of the display device is further configured to: determine an occurrence of a related event (¶ 0102, detecting e.g. meal events based on analyte data over 8 hours – also see ¶¶s 0103, 0141, 0147, and 0148, as well as Fig. 4A, showing identification of a rapid rise corresponding to e.g. a meal event) based on related event data received from the user, the related event data including an event type, a date, and a time (¶ 0102 notes that the algorithmic detection is supplemented as shown in Fig. 3A, steps 308-312, with user input of meal information, which includes event type, date, and time as described ¶¶s 0120, 0176-0178, 0184, etc. It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to receive date data from the user in the case that they are annotating meals from a previous day, for the purpose of enabling meal annotation at a later time, as contemplated by ¶¶s 0148 and 0151); generate a related event notification based on the related event, the related event notification including: a graph of analyte concentration levels over time (Figs. 4C and 4D, showing the indication of analyte levels 406), an icon displayed at a related event start time (¶ 0238, an icon identifying the start of the event – also see indicator 408 generally, or the icons shown in e.g. Fig. 12), and an alphanumeric text block describing the related event (Figs. 10A-1, 10A-2, etc., alphanumeric windows 824 or 842, describing the event); and present the related event notification to the user in the GUI (Figs. 4C, 4D, 10A-1, 10A-2, etc. as shown), wherein: the related event is a meal, the icon is a meal icon, and the alphanumeric text block describes a content of the meal (Figs. 5B, 9A-2, 13B-5, etc.), the related event is an activity, the icon is an activity icon, and the alphanumeric text block describes the activity, or the related event is a medicament dosing, the icon is a medicament dosing icon, and the alphanumeric text block describes the medicament dosing.
Regarding claim 20, Hayter teaches all the features with respect to claim 16, as outlined above. Hayter further teaches wherein: the measured analyte data are measured glucose data (¶¶s 0049, 0050, 0088, etc.); the insight notification comprises one or more images, numbers, alphanumeric text, or graphical control elements (Figs. 4C or 4D, indicator 408); and the predetermined time period is between 5 minutes and 30 minutes, between 30 minutes and 3 hours, or between 3 hours and 3 days (¶¶s 0102 and 0140, 8 hours being between 3 hours and 3 days).
Regarding claim 21, Hayter teaches all the features with respect to claim 1, as outlined above. Hayter further teaches wherein the suggested activity is determined based on: a current time of the analyte rapidly rising insight event (¶ 0219, the recommendation e.g. for adjusting the insulin dose or time of administration is meant to relieve the current rend); or a meal within a proximate time of a current time of the analyte rapidly rising insight event (¶ 0219, adjustments to meal times, introduction or elimination of snacks, etc.).
Regarding claim 22, Hayter teaches all the features with respect to claim 1, as outlined above. Hayter further teaches wherein the suggested activity is a suggested meal content within a proximate time of a current time of the analyte rapidly rising insight event (¶ 0219, adjustment of meal content (e.g. for a next/proximate meal) or introduction/elimination of a snack – also see e.g. ¶ 0217, describing adjusting meal contents to maintain analyte level stability, etc.).
Regarding claim 23, Hayter teaches all the features with respect to claim 1, as outlined above. Hayter further teaches wherein the suggested activity is provided in a contextual message (¶ 0218, provided in graphical form, a summary report, etc. – also see ¶¶s 0169, 0170, 0172, etc., notifying/prompting a user regarding a change to treatment profile, including based on a meal input).
Response to Arguments
Applicant’s arguments filed 06/10/2026 have been fully considered.
In response to the arguments regarding the “abstract idea” rejections under 35 USC 101, they are not persuasive. Regarding the “generating” step, Applicant has not explained why it cannot be performed in the human mind. And, while it is true that presenting a notification in a GUI cannot be performed in the human mind, the Office did not describe this element as part of the abstract idea. Instead, it is extra-solution activity.
Regarding a practical application, Applicant has not explained how presenting data is a practical application of the abstract idea. The user need not “identify[] the analyte rapidly rising insight within a predetermined time period” because the claims do not require this. Nothing requires the user to see and act on the information presented.
In response to the amendments and arguments regarding the rejections under 35 USC 102, they are persuasive to the extent that Hayter is not explicit in e.g. ¶ 0219 that the trend mentioned there is a rapidly rising analyte concentration level. However, the rejection is maintained under 35 USC 103 since Hayter teaches and suggests providing notifications that include suggested activities, including in response to a detected rapidly rising analyte concentration level.
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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/ANDREY SHOSTAK/Primary Examiner, Art Unit 3791
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