DETAILED ACTION
Note: The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of Claims
Claims 1-29 are pending and currently under consideration for patentability under 37 CFR 1.104
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under U.S.C. 120, 121, or 365 is acknowledged. The prior-filed applications (63/416750 filed on 10/17/2022; and 63/535134 filed on 8/29/2023) are acknowledged.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 8 February 2024 and 5 April 2024 have been considered by the examiner.
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 1-29 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) as a whole, considering all claim elements both individually and in combination, do not amount to significantly more than an abstract idea. A streamlined analysis of claim 1 is follows.
Regarding claim 1, the claim recites a glucose monitoring system. Thus, the claim is directed to a machine/apparatus, which is one of the statutory categories of invention.
The claim is then analyzed to determine whether it is directed to any judicial exception. The following limitations set forth a judicial exception:
“…determine a score for each of one or more meal events, wherein the score corresponds to a glucose response based on the data indicative of the glucose level associated with each of the one or more meal events, at least one of: a glucose graph card comprising a glucose graph with a glucose trendline reflecting the data indicative of the glucose level; a logbook section with a list comprising the meal information… an average meal rating card configured to display an average meal rating, wherein the average meal rating is based on an average of the scores of a plurality of, optionally all of, the one or more meal events for a predetermined period of time.”
These limitations describe a mathematical calculation. Furthermore, the limitations also describe a mental process as the skilled artisan is capable of performing the recited limitations and making a mental assessment thereafter. Examiner also notes that nothing from the claims suggest that the limitations cannot be practically performed by a human, using simple pen/paper.
Next, the claim as a whole is analyzed to determine whether any element, or combination of elements, integrates the identified judicial exception into a practical application.
For this part of the 101 analysis, the following additional limitations are considered:
“A glucose monitoring system, comprising: a reader device, comprising: wireless communication circuitry configured to receive data indicative of a glucose level from a sensor control device; an input configured to receive meal information indicative of one or more meals consumed by a user; and one or more processors coupled with a memory, the memory storing meal monitoring application that, when executed by the one or more processors, causes the one or more processors to… output a home graphical user interface (GUI)…”
These additional limitations do not integrate the judicial exception into a practical application. Rather, the additional limitations are each recited at a high level of generality such that it amounts to insignificant extra-solution activity, e.g., mere data gathering steps necessary to perform the identified judicial exception and outputting. See MPEP 2106.05(g).
The additional limitations also do not add significantly more to the identified judicial exception because they pertain to widely-understood, conventional, and routine components in glucose monitoring systems.
Dependent claims 2-29 also fail to add something more to the abstract independent claims as they merely further limit the abstract idea, recite limitations that do not integrate the claims into a practical application for substantially similar reasons as set forth above, and/or do not recite significantly more than the identified abstract idea for substantially similar reasons as set forth above.
Therefore, claims 1-29 are not patent eligible under 35 USC 101.
Claim Rejections - 35 USC § 102(A)(1)
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 (i.e., changing from AIA to pre-AIA ) 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.
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.
Claims 1-29 are rejected under 35 U.S.C. 102(A)(1) as being anticipated by Hayter et al. (US PG Pub. No. 2022/0000399 A1) (hereinafter “Hayter1”).
With respect to claim 1, Hayter teaches a glucose monitoring system (analyte monitoring system 100 in Fig. 1), comprising:
a reader device (par.0019 “a reader device configured as a smartphone”), comprising:
wireless communication circuitry configured to receive data indicative of a glucose level from a sensor control device (par.0054 “reader device 120 that communicate…over a local communication path (or link) 140, which can be wired or wireless”; par.0061 “wirelessly communicate the collected data…. monitored analyte level”);
an input configured to receive meal information indicative of one or more meals consumed by a user (par.0262 “user may access a list of meals…the user can select a meal and a meal details screen 978 or log detail screen 840 can open to show all of the details of the meal, including a picture, description, maximum glucose level, time over 180, and a glucose concentration graph containing the relevant time period in which the meal was eaten”); and
one or more processors coupled with a memory (par.0070 “one or more processors… having an on-board non-transitory memory”), the memory storing meal monitoring application (par.0124 “meal monitor application can be programmed to store the information about any and all prior meals and associated meal information previously consumed by the user”) that, when executed by the one or more processors, causes the one or more processors to:
determine a score for each of one or more meal events, wherein the score corresponds to a glucose response based on the data indicative of the glucose level associated with each of the one or more meal events (par.0262 “user may access a list of meals ranked according to the corresponding glucose level recorded… the meals can be ordered from highest glucose level to lowest glucose level or alternatively, from lowest glucose level to highest glucose level, where the glucose levels may be the highest glucose concentration associated with that meal event.”),
output a home graphical user interface (GUI) (par.0280 “GUI”) comprising at least one of (NOTE: when taking into consideration broadest reasonable interpretation “at least one of”, only one of the subsequent limitations are required for purposes of applying prior art):
a glucose graph card comprising a glucose graph with a glucose trendline reflecting the data indicative of the glucose level;
a logbook section with a list comprising the meal information, wherein the list is configured to display the one or more meal events and the corresponding score associated with each of the one or more meal events;
an average meal rating card configured to display an average meal rating, wherein the average meal rating is based on an average of the scores of a plurality of, optionally all of, the one or more meal events for a predetermined period of time (par.0262 “meal rankings… ordered from highest glucose level to lowest glucose level… can open to show all of the details of the meal”; par.0280 “graph GUI of the logbook may include a glucose trace… a meal tile associated with the meal event marker… includes a graphical display of glucose levels for that day, in addition to a listing of the highest glucose level recorded that day with the recorded time, the lowest glucose level recorded that day with the recorded time, and the percentages of time spent in range”; par.0281 “may also be able to identify good and bad meals over time”).
With respect to claim 2, Hayter teaches wherein the sensor control device is configured to collect the data indicative of the glucose level in the user, the sensor control device comprising a glucose sensor, wherein at least a portion of the glucose sensor is configured to be in fluid contact with a bodily fluid of the user (par.0059-60).
With respect to claim 3, Hayter teaches wherein the score is a first assigned numerical value that corresponds to the glucose response based on the data indicative of the glucose level associated with each of the one or more meal events (par.0262, 0280-281).
With respect to claim 4, Hayter teaches wherein the data indicative of the glucose level is a change in a glucose level within a predefined time period after each of the one or more meals is consumed by the user (par.0087).
With respect to claim 5, Hayter teaches wherein a higher first assigned numerical value glucose to each of the one or more meals associated with a lower glucose response (par.0262, 0280-281).
With respect to claim 6, Hayter teaches wherein a lower first assigned numerical value corresponds to each of the one or more meals associated with a higher glucose response (par.0262, 0280-281).
With respect to claim 7, Hayter teaches wherein the first assigned numerical value can be any number between one and five (par.0262, 0280-281).
With respect to claim 8, Hayter teaches wherein the logbook section displays one or more star icons, wherein each of the one or more star icons comprises the score associated with each of the one or more meal events (par.0137, 0145, 0168, 0181, 0238, 0262).
With respect to claim 9, Hayter teaches wherein the average meal rating is a second assigned numerical value that corresponds to the average of the scores of a plurality of, optionally all of the one or more meal events for the predetermined period of time (par.0130).
With respect to clam 10, Hayter teaches wherein the second assigned numerical value can be any number between one and five (par.0262, 0280-281).
With respect to claim 11, Hayter teaches wherein the second assigned numerical value can comprise one or more decimal values (par.0108, 0262, 0280-281).
With respect to claim 12, Hayter teaches wherein a higher second assigned numerical value corresponds to a lower average glucose response (par.0262, 0280-281).
With respect to claim 13, Hayter teaches wherein a lower second assigned numerical value corresponds to a higher average glucose response (par.0262, 0280-281).
With respect to claim 14, Hayter teaches wherein the average meal rating card is further configured to display a graphical indication corresponding to the average meal rating (par.0137, 0145, 0168, 0181, 0238, 0262).
With respect to claim 15, Hayter teaches wherein the graphical indication comprises an average meal rating indicator, wherein the average meal rating indicator is configured to visually illustrate the average meal rating provided for the predetermined period of time (par.0137, 0145, 0168, 0181, 0238, 0262).
With respect to claim 16, Hayter teaches wherein the graphical indication is a plurality of stars comprising a colored portion, wherein a ratio of each of the plurality of stars that comprise a colored portion and a total plurality of stars is proportional to a ratio of the average meal rating to a maximum available meal rating (par.0137, 0145, 0168, 0181, 0232-233, 0238, 0256, 0258-259, 0262, 0279-280).
With respect to claim 17, Hayter teaches wherein the graphical indication is configured to display at least one star from the plurality of stars with a half-colored portion when the average meal rating is not a whole number (par.0137, 0145, 0168, 0181, 0232-233, 0238, 0256, 0258-259, 0262, 0279-280).
With respect to claim 18, Hayter teaches wherein the average meal rating is only provided after the user has received a first score associated with one of the one or more meal events (par.0262, 0280-281).
With respect to claim 19, Hayter teaches wherein the average meal rating is configured to continuously update to account for each of the one or more meal events that are being scored (par.0137, 0145, 0168, 0181, 0238, 0262).
With respect to claim 20, Hayter teaches wherein the home GUI further comprises an announcement card with a message indicating to the user that a first score is available upon a first of the one or more meal events being scored for the predetermined period of time (par.0096, 0227).
With respect to claim 21, Hayter teaches wherein the average meal rating is not displayed if none of the one or more meal events have been scored for the predetermined period of time (par.0137, 0145, 0168, 0181, 0238, 0262).
With respect to claim 22, Hayter teaches wherein a graphical indication comprising a plurality of stars is displayed on the average meal rating card when none of the one or more meal events have been scored, wherein none of the plurality of stars comprise a colored portion (par.0137, 0145, 0168, 0181, 0238, 0262).
With respect to claim 23, Hayter teaches wherein the average meal rating card is directly adjacent to and proximal relative to the glucose graph card (par.0137, 0145, 0168, 0181, 0238, 0262).
With respect to claim 24, Hayter teaches wherein the glucose graph card is configured to reflect a post-prandial glucose trace associated with each of the one or more meal events (par.0279, 0282-283).
With respect to claim 25, Hayter teaches wherein the glucose graph comprises an x-axis which includes a unit of time and a y-axis which includes a unit of measure associated with the data indicative of the glucose level (par.0140).
With respect to claim 26, Hayter teaches wherein the home GUI further comprises one or more selectable icons which are configured to allow the user to select a predefined amount of time over which the user's data indicative of the glucose level will be shown on the glucose graph card (par.0137, 0145, 0168, 0181, 0232-233, 0238, 0256, 0258-259, 0262, 0279-280).
With respect to claim 27, Hayter teaches wherein the one or more selectable icons are configured to allow the user to select the predefined amount of time of four hours, twelve hours, or twenty-four hours (par.0140, 0154, 0180).
With respect to claim 28, Hayter teaches wherein the home GUI further comprises an insights icon, wherein the insights icon is selectable, wherein the meal monitoring application, when executed by the one or more processors, further causes the one or more processors to: in response to a selection of the insights icon, output an insights GUI configured to provide the user information related to the user's progress with respect to a criterion (par.0137, 0145, 0168, 0181, 0232-233, 0238, 0256, 0258-259, 0262, 0279-280).
With respect to claim 29, Hayter teaches wherein the criterion is an average meal rating criterion (par.0137, 0145, 0168, 0175-181, 0238, 0262).
Prior Art of Record
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
US PG Pub. No. 2023/0154625
US PG Pub. No. 2022/0249779
US PG Pub. No. 2021/0200787
US PG Pub. No. 2021/0050085
US PG Pub. No. 2021/0030323
US PG Pub. No. 2018/0226150
US PG Pub. No. 2018/0217917
US PG Pub. No. 2017/0128007
US PG Pub. No. 2017/0053084
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PUYA AGAHI whose telephone number is (571)270-1906. The examiner can normally be reached M-F 8 AM - 5 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Alexander Valvis can be reached at 5712724233. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PUYA AGAHI/Primary Examiner, Art Unit 3791
1 The inventorship of the instant application is different from Hayter such that Hayter qualifies as valid prior art per MPEP 2151.
Moreover, and while the instant application claims priority to PRO 63/416750 filed on 10/17/2022, PRO ‘750 app does not appear to have support of the instant claims, in its entirety. Should applicant disagree, Examiner kindly requests applicant show where the limitations are supported in relation to the disclosure of the ‘750 app, including any future amendments in applicant’s reply to the current office action.