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.
Election/Restrictions
Applicant’s election with traverse of Group I (claims 1-8) in the reply filed on 02/26/2026 is acknowledged. Because no species election was made, Examiner called Adam Treiber (Reg. # 48,000) on 03/10/2026 to request a complete election. An election of specie b.i. (an analyte rapidly rising insight event) was made with traverse. Both traversals were for the reason that there would be no serious search burden. This is found persuasive with respect to the restriction between Groups, but not between species. In view of Applicant’s amendments, there would not be a burden to examine both groups together. Thus, that part of the restriction is withdrawn. However, the election of species requirement is maintained because the insight events are different, having their own calculation and display considerations. This requirement is still deemed proper and is therefore made FINAL.
No claims are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention or specie. Accordingly, claims 1-20 are currently under consideration.
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 Objections
Claims 6, 8, 15, 16, and 20 are objected to because of the following informalities:
Regarding claim 6, it should end with a period.
Regarding claims 8, 15, and 20, the recitations of “3 hours day” should instead read –3 hours--.
Regarding claim 16, the recitation of “to measure an analyte concentration levels” should instead read –to measure analyte concentration levels--.
Further regarding claim 16, the recitation of “worn by a user” in line 10 should instead read –worn by the user—since line 2 already includes the user.
Appropriate correction is required.
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” 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 16-20 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 16, there is no support for the sensor device including the display device as claimed. The display device is a separate element as shown in e.g. Fig. 2A.
Claims 17-20 are rejected because they depend on rejected claims.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 16-20 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Regarding claim 16, it is unclear whether the sensor device includes the display device or not, since based on grammar it does (e.g. no “and” after line 3), but based on the claiming of one receiving data from the other, it does not. For purposes of examination, the display device will be interpreted as a separate device.
Claims 17-20 are rejected because they depend on rejected claims.
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.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 16-20 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Regarding claim 16, it describes a sensor device worn by a user, which can be interpreted as including the user within the scope of the claim. This is impermissible.
Claims 17-20 are rejected because they depend on rejected claims.
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.
Step 1 of the subject matter eligibility test (see MPEP 2106.03).
Claims 9-20 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 1-8 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 insight event based on the measured analyte data within a predetermined time period, and generating an insight notification based on the 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, 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 2, 3, 10, 11, 17, 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 § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 2, 4, 8-10, 12, 15-17, and 20 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by US Patent Application Publication 2022/0000399 (“Hayter”).
Regarding claim 1, Hayter discloses [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 measured analyte data from a continuous analyte monitoring sensor device worn by a user (¶¶s 0079, 0100, etc., Fig. 3A, step 304, via sensor control device 102); identifying an insight event based on the measured analyte data within a predetermined time period (Fig. 4A and ¶¶s 0102, 0140, 0141, etc., describing identification of a rapid rise in the analyte level within e.g. an eight hour period or window); generating an insight notification based on the insight event (Figs. 4C or 4D, indicator 408); and presenting the insight notification to the user in a graphical user interface (GUI) (as shown in Figs. 4C or 4D).
Regarding claim 2, Hayter discloses all the features with respect to claim 1, as outlined above. Hayter further discloses wherein the insight event comprises: an analyte rapidly rising insight event (¶¶s 0141, 0147, 0148); an analyte spike insight event; an analyte falling insight event; an analyte back-in-range insight event; or an analyte time-in-range insight event.
Regarding claim 4, Hayter discloses all the features with respect to claim 2, as outlined above. Hayter further discloses 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 8, Hayter discloses all the features with respect to claim 1, as outlined above. Hayter further discloses 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 day and 3 days (¶¶s 0102 and 0140, 8 hours being between 3 hours and 3 days).
Regarding claim 9, Hayter discloses [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 measured analyte data from a continuous analyte monitoring sensor device worn by a user (¶¶s 0079, 0100, etc., Fig. 3A, step 304, via sensor control device 102); identify an insight event based on the measured analyte data within a predetermined time period (Fig. 4A and ¶¶s 0102, 0140, 0141, etc., describing identification of a rapid rise in the analyte level within e.g. an eight hour period or window); generate an insight notification based on the insight event (Figs. 4C or 4D, indicator 408); and present, on the display, the insight notification to the user in a graphical user interface (GUI) (as shown in Figs. 4C or 4D).
Regarding claim 10, Hayter discloses all the features with respect to claim 9, as outlined above. Hayter further discloses wherein the insight event comprises: an analyte rapidly rising insight event (¶¶s 0141, 0147, 0148); an analyte spike insight event; an analyte falling insight event; an analyte back-in-range insight event; or an analyte time-in-range insight event.
Regarding claim 12, Hayter discloses all the features with respect to claim 10, as outlined above. Hayter further discloses 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 15, Hayter discloses all the features with respect to claim 9, as outlined above. Hayter further discloses 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 day and 3 days (¶¶s 0102 and 0140, 8 hours being between 3 hours and 3 days).
Regarding claim 16, Hayter discloses [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 worn by a user, the sensor device including: an analyte sensor configured to measure an analyte concentration levels, 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 worn by a user (¶¶s 0079, 0100, etc., Fig. 3A, step 304, via sensor control device 102); identify an insight event based on the measured analyte data within a predetermined time period (Fig. 4A and ¶¶s 0102, 0140, 0141, etc., describing identification of a rapid rise in the analyte level within e.g. an eight hour period or window); generate an insight notification based on the insight event (Figs. 4C or 4D, indicator 408); and present the insight notification to the user in a graphical user interface (GUI) (as shown in Figs. 4C or 4D).
Regarding claim 17, Hayter discloses all the features with respect to claim 16, as outlined above. Hayter further discloses wherein the insight event comprises: an analyte rapidly rising insight event (¶¶s 0141, 0147, 0148); an analyte spike insight event; an analyte falling insight event; an analyte back-in-range insight event; or an analyte time-in-range insight event.
Regarding claim 20, Hayter discloses all the features with respect to claim 16, as outlined above. Hayter further discloses 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 day and 3 days (¶¶s 0102 and 0140, 8 hours being between 3 hours and 3 days).
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 3, 5-7, 11, 13, 14, 18, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over various teachings of US Patent Application Publication 2022/0000399 (“Hayter”).
Regarding claim 3, Hayter teaches all the features with respect to claim 2, 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 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 11, Hayter teaches all the features with respect to claim 10, 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 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 18, Hayter teaches all the features with respect to claim 17, 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 17, 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.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANDREY SHOSTAK whose telephone number is (408) 918-7617. The examiner can normally be reached Monday-Friday, 7am-3pm PT.
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/ANDREY SHOSTAK/Primary Examiner, Art Unit 3791