DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after 16 March 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 18 May 2026 has been entered.
Status of Claims
Claim(s) 1, 4, 11, 14 and 20 is/are currently amended. Claim(s) 2-3, 8, 12-13 and 18 has/have been canceled. New claim(s) 22-24 has/have been added. Claim(s) 1, 4-7, 9-11, 14-17 and 19-24 is/are pending.
Rejections Withdrawn
Rejections under 35 U.S.C. 101, under 35 U.S.C. 112(a) (or pre-AIA 35 U.S.C. 112, first paragraph) and/or under 35 U.S.C. 112(b) (or pre-AIA 35 U.S.C. 112, second paragraph) not reproduced below have been withdrawn in view of Applicant's amendments to the claims and/or submitted remarks.
Claim Objections
Claim(s) 1 is/are objected to because of the following informalities: "outputting a prompt on the display of the reader device…" should be amended/corrected to "output a prompt on the display of the reader device…" for consistency with surrounding limitations.
Appropriate correction is required.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
Determining the scope and contents of the prior art.
Ascertaining the differences between the prior art and the claims at issue.
Resolving the level of ordinary skill in the pertinent art.
Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1, 4-7, 9-11, 14-17 and 19-24 is/are rejected under 35 U.S.C. 103 as obvious over US 2017/0128007 A1 (Hayter '007) in view of US 2010/0075353 A1 (previously cited, Heaton '353) and US 6,663,564 B2 (Miller-Kovach).
Regarding claims 1, 4-7, 10-11, 14-17, 20 and 22-24, Hayter '007 discloses/suggests a glucose monitoring system, the system comprising:
a glucose sensor (analyte sensor 104; ¶ [0017]) comprising a portion configured to be positioned in a body of a user in fluid contact with a bodily fluid to sense glucose in the bodily fluid (¶ [0041]);
sensor electronics coupled to the glucose sensor (sensor electronics 250), the sensor electronics comprising: one or more processors (processor 256), memory coupled with the one or more processors (memory 253), and wireless communication circuitry configured to communicate data indicative of glucose levels based on the sensed glucose in the bodily fluid according to a Bluetooth communication protocol (communication circuitry 258; ¶ [0035]); and
a reader device (reader device 120) comprising: a display (display 122); one or more processors (i.e., computing device(s)) (processor(s) 222 and/or 224); a transceiver configured to receive the data indicative of the glucose levels (transceiver 228); and a non-transitory computer-readable medium or memory coupled to the one or more processors of the reader device and storing instructions (non-transitory memory 223 and/or 225) that when executed by the one or more processors of the reader device cause the one or more processors of the reader device to perform a method, the method comprising:
detecting a meal event based on the received data indicative of the glucose levels (Fig. 3A, step 306; ¶ [0082]; etc.), wherein the meal event is detected based on an excursion of the data indicative of the glucose levels outside of a target range (e.g., ¶ [0074]);
outputting a prompt on the display of the reader device for receiving user input about meal information if the meal event is detected (Fig. 3A, step 310);
determine a glucose curve associated with a glucose response to the meal event from a plurality of meal events (Fig. 3A, step 316, e.g., ¶ [0071] glucose response magnitude may be determined from a curve along (or approximating) the values of the collected glucose data from the start of the detected meal and ending upon or after a fixed time such as 6 hours, the start of the next detected meal, or an occurrence when the glucose trace falls below the value of the start of the meal);
calculate one or more glucose metrics for the meal event, wherein the glucose metrics comprise a first value representing an area under the glucose curve, a second value representing a duration of the glucose response to the meal event, and a third value representing a slope of the glucose curve (Fig. 3A, step 316, e.g., ¶ [0136] determined glycemic impact can be determined quantitatively in terms of, inter alia, duration of glucose response, rate of change of glucose level and/or area of the glucose response);
storing a food entry in a database, wherein the food entry comprises the detected meal event and the meal information input by the user (Fig. 3A, step 314; ¶ [0133]), wherein the meal information input by the user comprises a photograph captured by the reader device (e.g., ¶ [0117]; ¶ [0123]; etc.);
outputting on the display an interface comprising an indication of the glucose metrics (Fig. 3A, step 318).
Hayter '007 does not disclose calculating a numerical score, such as a single value, that is a function of the first value, the second value, and the third value, or the method comprises determine a cumulative score comprising a sum of the numerical scores associated with the plurality of meal events and outputting, on the display interface, the cumulative score, a target score, and a tip for meeting the target score.
Heaton '353 discloses/suggests a method for monitoring individual metabolic response and providing personalized and specific feedback supporting the user's diet management comprising calculating a numerical score for a meal event (Abstract, generating second data representing glycemic responses; ¶ [0060] generation of the second data comprises the calculation of an area-under-the-curve (AUC) value, e.g., Fig. 4A, calculated area is defined by the glucose curve and a duration of the response to each event/meal (i.e., ingestion of food) between glucose levels exceeding the baseline/fasting level and returning to said level; ¶ [0077] calculating AUC for a single food item or meal; etc.); determining a cumulative score comprising a sum of the numerical scores associated with the plurality of meal events in a day (¶ [0077] calculating AUC for a period of time, such as a day; ¶ [0121] calculating an accumulated iAUC value; i.e., sum of iAUC during a certain time period, e.g., present day, as described in ¶ [0109]; etc.); and outputting on a display an interface comprising each of the cumulative score, a target score, and a tip for meeting the target score (¶ [0051] providing real-time information about individual glycemic response, individual glycemic response budget and/or a comparison between the two quantities, e.g., Fig. 5, information provided on the display includes use of the glycemic response budget for the current day 24, a target value 25, and a suggestion 32 regarding how to achieve the personal metabolic goals of the user).
Miller-Kovach similarly discloses/suggests a method comprising determining a target score (col. 5, line 41-60); determining a plurality of metrics for a meal event (e.g., calories, fat content, fiber, etc.); calculating a single value, whole number score for the meal event (point value, p) as a function of the plurality of metrics (e.g., col. 3, lines 14-65), wherein is within a predetermined range of scores (e.g., col. 3, lines 38-40, where equation constants are chosen such that p is in the low tens); and determining a cumulative score comprising a sum of the numerical scores associated with the plurality of meal events in a day (col. 3, line 66 - col. 4, line 2).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Hayter '007 to comprise calculating a single value, whole number score as a function of the determined parameters of the glycemic response to the meal event (e.g., first value, second value, and third value), wherein the numerical score is within a predetermined range of scores; determining a cumulative score comprising a sum of the numerical scores associated with the plurality of meal events; and outputting on the display an interface comprising each of the cumulative score, a target score, and a tip for meeting the target score as taught/suggested by Heaton '353 and Miller-Kovach in order to integrate multiple complex factors of the user's meal response into single, easily understood value for providing personalized feedback supporting the user's diet management (Miller-Kovach, col. 1, line 52 - col. 2, line 43, col. 3, lines 38-40, etc.; Heaton '353, ¶ [0015]).
Regarding claims 9 and 19, Hayter '007 as modified discloses/suggests the limitations of claims 1 and 11, as discussed above, but does not expressly disclose the method further comprises determining a weekly score based on the numerical scores associated with the plurality of meal events. Heaton '353 discloses/suggests determining a weekly score based on the numerical scores associated with the plurality of events (e.g., ¶ [0077] calculating individual glycemic response for period of time, such as a week). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Hayter '007 to comprise determining a weekly score based on the numerical scores associated with the plurality of meal events as taught/suggested by Heaton '353 in order to evaluate the subject's performance with respect to dietary goals over an additional/alterative meaningful data interval (Heaton '353, ¶ [0077]).
Regarding claim 21, Hayter '007 as modified discloses/suggests the limitations of claim 1, as discussed above, but does not expressly disclose the interface does not display a glucose curve. Heaton '353 discloses different user interfaces and visualizations may be employed (¶ [0077]) and/or discloses other information, such as a prediction for approximate weight gain or weight loss based on the glycemic response budget, can be included on the interface instead of a curve (e.g., ¶ [0123]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Heaton '353 with the interface not displaying a glucose curve in order to facilitate presenting alternative information (¶ [0123]); to reduce visual clutter, particularly for non-diabetic users that do not require real-time glucose concentration information (¶ [0077]); etc.
Claim(s) 1, 4-7, 9-11, 14-17 and 19-24 is/are rejected under 35 U.S.C. 103 as obvious over Heaton '353 in view of US 2016/0328991 A1 (Simpson), US 2011/0053121 A1 (previously cited, Heaton '121), and Miller-Kovach.
Regarding claims 1, 4, 7, 10-11, 14, 17, 20 and 22-24, Heaton '353 discloses/suggests a glucose monitoring system, the system comprising:
a glucose sensor (Fig. 1, glucose sensor 110 of glucose measuring device 100) comprising a portion configured to be positioned in a body of a user in fluid contact with a bodily fluid to sense glucose in the bodily fluid (¶ [0093] glucose sensor 110 continuously measures glucose values in interstitial fluid, e.g., implanted in an arm);
sensor electronics coupled to the glucose sensor (Fig, 1, ¶ [0093] extra corporal part(s) of glucose measuring device 100), the sensor electronics comprising: one or more processors (CPU 120), memory coupled with the one or more processors (storage 130 connected to the CPU 120), and wireless communication circuitry configured to communicate data indicative of glucose levels based on the sensed glucose in the bodily fluid according to a Bluetooth communication protocol (interface unit 140 including a transceiver linked to an antenna 141; ¶ [0095] measured values are transmitted from the glucose measuring device 100 to computing and display equipment 200 via wireless RF connection 300; ¶ [0074] means of wireless communication may comprise Bluetooth); and
a reader device (Fig. 1, computing and display equipment 200) comprising: a display (display 270); one or more processors (computing devices) (CPU 220); a transceiver configured to receive the data indicative of the glucose levels (interface unit 240); and a non-transitory computer-readable medium or memory coupled to the one or more processors of the reader device (storage 230 connected to the CPU 220) and storing instructions (e.g., ¶ [0018] program code) that when executed by the one or more processors of the reader device cause the one or more processors of the reader device to perform a method, the method comprising:
determining a glucose curve based on the data indicative of the glucose levels, wherein the glucose curve is associated with a glucose response to a meal event from a plurality of meal events (Abstract, time-series of glucose level measurements represented by the first data, e.g., Fig. 2; ¶ [0102] the transmitted glucose level value is used to generate data representing the glycemic response of the user; etc.),
calculating one or more glucose metrics for the meal event, wherein the one or more glucose metrics comprises a numerical score for the meal event, wherein the numerical score is based on a first value representing an area under the glucose curve (Abstract, generating second data representing glycemic responses; ¶ [0060] generation of the second data comprises the calculation of an area-under-the-curve (AUC) value, e.g., Fig. 4A, calculated area is defined by the glucose curve and a duration of the response to each event/meal (i.e., ingestion of food) between glucose levels exceeding the baseline/fasting level and returning to said level; ¶ [0077] calculating AUC for a single food item or meal; etc.),
determining a cumulative score comprising a sum of the numerical scores associated with the plurality of meal events (¶ [0077] calculating AUC for a period of time, such as a day; ¶ [0121] calculating an accumulated iAUC value; i.e., sum of iAUC during a certain time period, e.g., present day, as described in ¶ [0109]; etc.), and
outputting on the display an interface comprising each of the cumulative score, a target score, and a tip for meeting the target score (¶ [0051] providing real-time information about individual glycemic response, individual glycemic response budget and/or a comparison between the two quantities, e.g., Fig. 5, information provided on the display includes use of the glycemic response budget for the current day 24, a target value 25, and a suggestion 32 regarding how to achieve the personal metabolic goals of the user).
Heaton '353 does not expressly disclose detecting a meal event based on the data indicative of the glucose levels, or outputting a prompt on the display of the reader device for receiving user input about meal information if the meal event is detected. However, Heaton '353 does disclose storing a food entry in a database, wherein the food entry comprises a meal event and meal information input by the user (e.g., ¶ [0077]).
Simpson discloses/suggests a system configured for detecting a meal event based on the data indicative of the glucose levels based on an excursion of the data indicative of the glucose levels outside of a target range; and outputting a prompt on a display of a reader device for receiving user input about meal information if the meal event is detected (e.g., ¶ [0329] following an unhealthy excursion, e.g., if a glucose concentration value exceeds 200 mg/dL, or a change in glucose concentration value over a predetermined period of time meets a certain criteria, e.g., exceeds a predetermined threshold, the user may be prompted for extra information, e.g., meal details), wherein the meal information input by the user comprises a photograph captured by the reader device (e.g., ¶ [0192]; ¶ [0318]; etc.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Heaton '353 with the method comprising detecting a meal event based on the data indicative of the glucose levels, wherein the meal event is detected based on an excursion of the data indicative of the glucose levels outside of a target range, and outputting a prompt on the display of the reader device for receiving user input about meal information if the meal event is detected, the meal information input by the user comprising a photograph captured by the reader device, as taught and/or suggested by Simpson, and storing a food entry in a database, wherein the food entry comprises the detected meal event and the meal information input by the user, in order to facilitate obtaining data similar to a logbook, but where the user only enters data if a significant event is detected (Simpson, ¶ [0329]), thereby simplifying meal logging for user and/or providing more rapid and accurate event logging (Simpson, ¶ [0274]).
Heaton '353 as modified does not disclose calculating a second value representing a duration of the glucose response to the event.
Heaton '121, in disclosing a comparable method, discloses area (e.g., AUC) of a glycemic response (e.g., to each meal, ¶ [0206]), is a measure of quantity of said glycemic response (e.g., ¶ [0100]), but does not provide a full picture (¶ [0011]). Heaton '121 therefore teaches/suggests further calculating a second value indicative of the quality of the glycemic response, or quality of the carbohydrates consumed (¶ [0011]). Heaton '121 discloses high glycemic variability in a measured response to a meal, characterized by a fast rise of blood glucose followed by a rapid decline, indicates the presence of high-glycemic index (fast absorbed) carbohydrates (¶ [0004]; ¶ [0096]; etc.), while a preferred (e.g., higher quality) response to a meal is characterized by a more gradual rise that is manageable by the body's tissues (¶ [0005]). Accordingly, Heaton '121 discloses/suggests duration of the glucose response to a meal can be used to assess the nutritional quality or value of the carbohydrates consumed. Heaton '121 further discloses providing an easy-to-understand parameter (e.g., numerical value) indicative of meal quality to a user enables a user to simply strive to achieve a target parameter value (e.g., ¶ [0165]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Heaton '353 with calculating a second value representing a duration of the glucose response to the event as taught/suggested by Heaton '121 in order to facilitate providing more comprehensive information about the quantity and quality of the user's glycemic response to a meal (or accumulated meals) to the user (Heaton '121, ¶ [0115]).
Heaton '353 as modified does not disclose calculating a numerical score for the meal event as a function of the first value representing area under the glucose curve and the second value representing duration of the glucose response to the meal event.
Miller-Kovach discloses/suggests a method comprising determining a target score (col. 5, line 41-60); determining a plurality of metrics for a meal event (e.g., calories, fat content, fiber, etc.); calculating a single value, whole number score for the meal event (point value, p) as a function of the plurality of metrics (e.g., col. 3, lines 14-65), wherein is within a predetermined range of scores (e.g., col. 3, lines 38-40, where equation constants are chosen such that p is in the low tens); and determining a cumulative score comprising a sum of the numerical scores associated with the plurality of meal events (col. 3, line 66 - col. 4, line 2).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Heaton '353 with the method comprising calculating a single value, whole number score as a function of the determined parameters of the glycemic response to the meal event (e.g., first value and second value), wherein the numerical score is within a predetermined range of scores, as taught/suggested by Miller-Kovach in order to integrate multiple complex factors of the user's meal response into single, easily understood value for providing personalized feedback supporting the user's diet management (Miller-Kovach, col. 1, line 52 - col. 2, line 43, col. 3, lines 38-40, etc.; Heaton '353, ¶ [0015]).
Regarding claims 5 and 15, Heaton '353 as modified discloses/suggests the cumulative score comprises the sum of the numerical scores for the plurality of events in a day (Heaton '353 ¶ [0109]; Miller-Kovach, col. 3, line 66 - col. 4, line 2).
Regarding claims 6 and 16, Heaton '353 as modified discloses/suggests the limitations of claims 1 and 11, as discussed above, but does not expressly disclose the numerical score is further calculated based on a slope of the glucose curve. However, as noted above, Heaton '121 discloses high glycemic variability in a measured response to a meal, characterized by a fast rise of blood glucose followed by a rapid decline, indicates the presence of high-glycemic index (fast absorbed) carbohydrates (¶ [0004]; ¶ [0096]; etc.), while a preferred (e.g., higher quality) response to a meal is characterized by a more gradual rise that is manageable by the body's tissues (¶ [0005]). Accordingly, Heaton '121 further teaches/suggests a slope (e.g., gradual rate of increase or fast rate of increase) of the glucose curve can be used to assess the quality of the carbohydrates consumed. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Heaton '353 with calculating the numerical score for the event as a function of a slope of the glucose curve (e.g., calculating an additional score and/or integrating a measured vs target slope into a combined score) as taught/suggested by Heaton '121 in order to provide more comprehensive information about the quantity and quality of carbs of a meal (or accumulated meals) to the user (Heaton '121, ¶ [0115]).
Regarding claims 9 and 19, Heaton '353 as modified discloses/suggests the method further comprises determining a weekly score based on the numerical scores associated with the plurality of events (e.g., ¶ [0077] calculating individual glycemic response for period of time, such as a week).
Regarding claim 21, Heaton '353 as modified teaches/suggests the limitations of claim 1, as discussed above. While Heaton '353 discloses/illustrates the interface may display a glucose curve (e.g., Fig. 5, curve 28), Heaton '353 further expressly discloses different user interfaces and visualizations may be employed in the context of the present invention (¶ [0077]) and/or discloses other information, such as a prediction for approximate weight gain or weight loss based on the glycemic response budget, can be included on the interface instead of a curve (e.g., ¶ [0123]). Accordingly, one of ordinary skill in the art would at once envisage Heaton '353, or Heaton '353 as modified, contemplates at least one interface/display that does not include a glucose curve. Alternatively/Additionally, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Heaton '353 with the interface not displaying a glucose curve in order to facilitate presenting alternative information (¶ [0123]); to reduce visual clutter, particularly for non-diabetic users that do not require real-time glucose concentration information (¶ [0077]); etc.
Response to Arguments
Applicant's arguments with respect to the limitations of detecting a meal and outputting a prompt have been considered but are moot because the new ground(s) of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
To the extent Applicant's remaining arguments are pertinent to the rejections of record (i.e., to the extent Applicant's remarks with respect to the combination with Neagle are applicable to the combination with the newly-cited reference to Miller-Kovach), said arguments have been fully considered but they are not persuasive.
Applicant contends, "[One] skilled in the art would have had no reason to look to Neagle when solving the problem of determining a metric to characterize a user's glucose response to a meal. […] Further, as Neagle does not relate to judging a user's glucose response to a meal, there is no motivation to modify Heaton to determine a score based on AUC and additionally a second measure of the glucose response to the meal, specifically a duration of a glucose response to the meal" (Remarks, pgs. 11-12).
The examiner respectfully disagrees. Heaton '353 is directed to providing personalized and specific feedback supporting the user's dietary management. Miller-Kovach is similarly directed to assisting persons in dietary management (e.g., for weight control or weight loss). Miller-Kovach discloses integrating complex diet parameters into a single numerical value, which can assist a user in easily implementing a plan of body weight management (e.g., col. 1, lines 24-61). Accordingly, one of ordinary skill in the art would be sufficiently motivated to look to existing dietary management methods, including those disclosed by Miller-Kovach, in order to similarly characterize a glycemic response (or complex parameters thereof) using a single, easy to interpret and implement numerical value/points-based system, particularly for users who are already familiar with using these existing methods (e.g., Weight Watchers).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Meredith Weare whose telephone number is 571-270-3957. The examiner can normally be reached Monday - Friday, 9 AM - 5 PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. Applicant is encouraged to use the USPTO Automated Interview Request at http://www.uspto.gov/interviewpractice to schedule an interview.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Tse Chen, can be reached on 571-272-3672. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Meredith Weare/Primary Examiner, Art Unit 3791
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