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 .
Election/Restrictions
Applicant’s election without traverse of Species A in the reply filed on 27 January 2026 is acknowledged.
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 Rejections - 35 USC § 112
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 1-21 and 23 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 defines both a time period and time increments; it is unclear how these relate to each other and whether these segments are overlapping or refer to the same durations of time, or if not which might comprise the other. Clarification is required.
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.
Claim(s) 1, 2, 5-7, 10-13, 20, 21, and 23 are is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Marcus (US 2008/0071580).
Regarding claim 1, Marcus discloses an analyte monitoring system, comprising:
a sensor control device comprising an analyte sensor coupled with sensor electronics, the sensor control device configured to be worn on a user's body and transmit data indicative of the user's analyte levels (paragraph [0083], a “glucose sensor”); and
a reader device (element 100) comprising:
a display (element 33);
wireless communication circuitry configured to receive the data indicative of the user's analyte levels (paragraph [0083], [0085]);
one or more processors coupled with a memory configured to store instructions (paragraph [0079]) that, when executed by the one or more processors, cause the one or more processors to output to the display a graphical user interface (GUI) comprising:
a graph portion comprising a trend portion indicative of the user's analyte levels over a predetermined time period, wherein the trend portion is based on the received data indicative of the user's analyte levels (elements 505, 510, 515); and
a plurality of summary metrics associated with the predetermined time period,
wherein the plurality of summary metrics comprises a minimum analyte level for the predetermined time period and a maximum analyte level for the predetermined time period (element 520, the “All Time Periods” column) , and
wherein the graph portion further comprises an x-axis comprising units of time (figure 5), and wherein a plurality of minimum analyte levels for a plurality of time increments and a plurality of maximum analyte levels for the plurality of time increments are aligned with the x-axis of the graph portion (element 520, the other columns).
Regarding claim 2, Marcus further discloses that the predetermined time period is one day (figure 5, 5a).
Regarding claim 5, Marcus further discloses that the graph portion further includes a y-axis comprising units indicative of analyte level concentrations (figure 5 or 5a, elements 505, 510, 515).
Regarding claim 6, Marcus further discloses that the graph portion further comprises a first label for a high analyte threshold value and a second label for a low analyte threshold value (paragraph [0159], elements 551 and 552).
Regarding claim 7, Marcus further discloses that the graph portion further defines a first line indicative of the high analyte threshold value and a second line indicative of the low analyte threshold value (paragraph [0159]).
Regarding claim 10, Marcus further discloses that the plurality of summary metrics further comprises a time in range metric (element 535).
Regarding claim 11, Marcus further discloses that the time in range metric is displayed as a percentage (element 535).
Regarding claim 12, Marcus further discloses that the plurality of summary metrics further comprises a total amount of carbohydrates consumed during the predetermined time period (figure 16).
Regarding claim 13, Marcus further discloses that the plurality of summary metrics further comprises a total amount of medication taken during the predetermined time period (figure 16).
Regarding claim 20, Marcus further discloses that the data indicative of the user's analyte levels comprises glucose data (paragraph [0159]).
Regarding claim 21, Marcus further discloses that the trend portion is a continuous trend line (figure 5A; paragraphs [0013], [0183]).
Regarding claim 23, Marcus further discloses that the GUI further comprises information relating to the user's ketone levels (paragraph [0141]).
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.
Claim(s) 3 and 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Marcus.
Regarding claims 3 and 4, Marcus further discloses the total duration of the increments being 24 hours (figures 5, 5A), but does not disclose that the plurality of time increments comprises twenty-four one-hour increments or that the x-axis comprises a plurality of labels arranged in two-hour increments. However, it would have been a mere matter of design choice for one of ordinary skill in the art at the time the invention was made to have used one-hour increments with the x-axis being labeled in two-hour increments, since Applicant has not disclosed use of these particular increments as providing a particular advantage, solving a stated problem, or serving a different purpose than that of the increments used by Marcus. Moreover, it appears that any duration of interval for display of data would perform equally well to allow observations of the user’s condition throughout a day. As such, it would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made to have made the system of Marcus with the GUI showing the plurality of time increments as twenty-four one-hour increments and with the x-axis comprising a plurality of labels arranged in two-hour increments, because such a modification would have been considered a mere design consideration that fails to patentably distinguish over Marcus.
Claim(s) 8 and 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Marcus in view of DeHennis (US 2015/0182115).
Regarding claims 8 and 9, Marcus does not disclose that the plurality of minimum analyte levels for the plurality of time increments and the plurality of maximum analyte levels for the plurality of time increments comprise:
one or more minimum analyte levels depicted in a first color if the one or more minimum analyte levels are above the high analyte level threshold value;
one or more maximum analyte levels depicted in the first color if the one or more maximum analyte levels are above the high analyte level threshold value,
one or more minimum analyte levels depicted in a second color if the one or more minimum analyte levels are below the low analyte level threshold value; and
one or more maximum analyte levels depicted in the second color if the one or more maximum analyte levels are below the low analyte level threshold value.
DeHennis teaches an analyte monitoring system configured to display a graphical user interface comprising a plurality of minimum and maximum analyte levels for a plurality of time intervals, where the maximum and minimum analyte levels for each interval are displayed in a color corresponding to whether that level is above a high threshold value, inside a given range, or below a low threshold value (figure 16, see the varying shades of each value in the “Highest” and “Lowest” rows). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to have made the system of Marcus and used different colors to identify the status analyte levels, as taught by DeHennis, in order to make more obvious when excursions take place.
Claim(s) 14 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Marcus in view of Kamath (US 2022/0273204).
Regarding claims 14 and 15, Marcus does not disclose that the trend portion comprises a first portion in a first color and a second portion in a second color, wherein the first portion is indicative of analyte levels above the high analyte threshold value, and wherein the second portion is indicative of analyte levels between the low analyte threshold value and the high analyte threshold value, and a third portion in a third color, wherein the third portion is indicative of analyte levels below the low analyte threshold value. Kamath teaches an analyte monitoring system configured to display a graphical user interface comprising a graph portion comprising a trend portion indicative of a user’s analyte levels over a predetermined time period, where the trend portion comprises first, second, and third portions in first, second, and third colors respectively, where the first portion is indicative of analyte levels above a high analyte threshold value, the second portion is indicative of analyte levels between a low analyte threshold value and the high analyte threshold value, and the third portion is indicative of analyte levels below the low analyte threshold value (figure 16, see 1602 and 1604). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to have made the system of Marcus and configured the trend portion to use different colors for analyte values to show their relationship to the threshold ranges, as taught by Kamath, in order to make obvious when excursions take place.
Claim(s) 16-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Marcus in view of Taub (US 2022/0110551).
Regarding claims 16 and 19, Marcus does not disclose the GUI further comprising an icon area configured to display a plurality of event icons, wherein the plurality of event icons includes at least one of: an alarm icon, a carbohydrate icon, and a medication icon, wherein the plurality of event icons is configured to be displayed in alignment with the x-axis of the graph portion. Taub teaches an analyte monitoring system configured to display a graphical user interface comprising a graph portion comprising a trend portion indicative of a user’s analyte levels over a predetermined time period (figure 61), the GUI further comprising an icon area configured to display a plurality of event icons including carbohydrate and medication icons, where the plurality of event icons are configured to be displayed in alignment with an x-axis of the graph portion (see elements 5502B, 5502C, 5502F, 5502i). See also figure 73A. It would have been obvious to one of ordinary skill in the art at the time the invention was filed to have made the system of Marcus and further included display of event icons representing carbohydrates and medication displayed in alignment with the graph, as taught by Taub, in order to readily observe the impacts of these events on the analyte levels.
Regarding claims 16-18, Marcus does not disclose the interface further comprising an icon area configured to display a plurality of event icons, wherein the plurality of event icons includes at least one of: an alarm icon, a carbohydrate icon, and a medication icon, wherein the alarm icon comprises an alarm label configured to textually describe an alarm condition associated with the alarm icon and wherein the alarm condition is selected from a group of a high analyte alarm condition, an urgent low analyte alarm condition, a projected high analyte alarm condition, a projected low analyte alarm condition, a falling fast analyte alarm condition, a rising fast analyte alarm condition, and a signal loss condition. Taub teaches an analyte monitoring system configured to display a graphical user interface (figures 10F, 10G) comprising a graph portion comprising a trend portion indicative of a user’s analyte levels over a predetermined time period (elements 412B, 416B) and a plurality of event icons (elements 412C, 416C, also the apple and syringe icons), where the alarm icon comprises an alarm label configured to textually describe an alarm condition associated with the alarm icon and wherein the alarm condition is selected from a group of a high analyte alarm condition and an “urgent” low analyte alarm condition (see elements 412C, 416C in figures 10F, 10g). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to have made the system of Marcus and configured the interface to include events including an alarm label configured to textually describe an alarm condition such as a high or low analyte level, as taught by Taub, in order to potentially prevent the user’s condition from worsening.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Mairs (US 2020/0135311).
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/KAREN E TOTH/Examiner, Art Unit 3791