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 .
Response to Amendment
The amendment to the claims filed 18 August 2025 has been entered. Claim(s) 77, 88 and 111-112 is/are currently amended. Claim(s) 1-76, 78-82, 89-93, 100-101, 103-104, 106-107, 109-110 and 117-122 has/have been canceled. New claim(s) 123-124 has/have been added. Claim(s) 77, 83-88, 94-99, 102, 105, 108, 111-116 and 123-124 is/are pending.
Rejections Withdrawn
Rejections under 35 U.S.C. 112(a) (pre-AIA 35 U.S.C. 112, first paragraph) and/or under 35 U.S.C. 112(b) (pre-AIA 35 U.S.C. 112, second paragraph) not reproduced below has/have been withdrawn in view of Applicant's amendments to the claims and/or submitted remarks.
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) 77, 83, 86-87, 105, 111 and 115-116 is/are rejected under 35 U.S.C. 103 as obvious over US 2016/0328991 A1 (previously cited, Simpson) in view of US 2015/0173648 A1 (previously cited, Sano).
Regarding claims 77, 87 and 115-116, Simpson teaches and/or suggests a method comprising:
receiving, from a sensor control device configured to be worn on a subject's body (Fig. 2, sensor(s)/transmitter(s) 22, 22'; Figs. 54-58, sensor(s) and associated electronics, as described in ¶¶ [0531]-[0536]; ¶ [0483] the sensor system described in US 2009/0076360 A1 to Brister may be employed; etc.), a plurality of continuous measurements indicative of ketone levels, including a level of beta-hydroxybutyrate, in a bodily fluid (¶ [0186] receiving data from the sensor(s) and/or transmitter(s); ¶ [0532] one or more of the sensor devices 764 of the array 750 may be configured to detect and measure ketones; ¶ [0426], ¶ [0449] inputs include ketone levels; ¶ [0524] ketone bodies continuously measured by the sensor; etc.), wherein the sensor control device comprises an in vivo sensor having at least a first portion that is configured to be positioned under skin and in contact with the bodily fluid of the subject (Simpson, Figs. 54-57; Brister; sensor 32) and sensor electronics coupled to the in vivo sensor (Simpson, ¶ [0531] sensor electronics; Brister, sensor electronics 132), the sensor electronics comprising a processor (Brister, processor 138) and communication circuitry (Simpson, ¶ [0531] transmitter; Brister, RF module 148) for transmitting the measurements indicative of the ketone level (Simpson, ¶ [0531] wirelessly transmitting sensor data; Brister, ¶ [0336] wirelessly transmitting sensor data from the sensor to a receiver);
calculating at least one ketone metric related to the plurality of continuous ketone level measurements (¶ [0426] weight loss optimization method inputs, such as ketone levels, may be processed to determine if the input(s) meet requirements of a program or not; ¶ [0442] measuring rates of fat burning; ¶ [0446] cumulative fat burn over time, daily or weekly statistics; ¶ [0457] helpful metrics, such as averages over time, area under the curve, cumulative levels over time; etc.), the ketone metric(s) including an area under a curve of said measurements (¶ [0457]);
determining whether the subject is in a state of ketosis (i.e., fat metabolism, fat utilization, fat burning, etc.) based on the continuous ketone level measurements (e.g., ¶ [0446] determining if fat metabolism is occurring based on measured ketone levels); and
outputting at least one ketone metric to a graphical user interface (GUI) on a display of a reader device (¶ [0426] weight loss optimization method outputs; ¶¶ [0440]-[0450] outputs enabling a user to monitor byproducts of fat metabolism (i.e., ketone levels), an indication if fat metabolism is occurring, cumulative data, statistics, etc.; ¶ [0457] zone diagram, etc.), wherein the reader device comprises a smart phone (¶ [0184] the monitoring device is a smart phone);
outputting a nutrition recommendation for achieving the state of ketosis to a GUI on the display (¶ [0426] weight loss optimization method outputs may include actionable outputs informing a user of steps to take; ¶ [0447] feedback for a suggested lifestyle adjustment; ¶ [0450] program for exercise and meals can be modified to iteratively move the user closer to the desired goal; ¶ [0452] users may be instructed to optimize fat reduction by suggestion of meals, exercise, and other therapies that emphasize fat utilization; etc.).
As noted above, Simpson discloses a sufficiently "high" level of ketone is indicative of a fat utilization (e.g., ¶ [0452]), i.e., a state of ketosis, suggesting a desired ketone level indicating fat utilization/metabolism is occurring should be higher than some threshold level. Simpson further discloses outputs may include a graph or analyte level curve as a function of time, wherein said graph may include an indication of a desired analyte concentration value/range (¶ [0073], ¶ [0426] zone indicator, etc.), and teaches/suggests enabling a user to more easily and effectively learn how to lose weight based on, e.g., their unique physiology and lifestyle patterns (e.g., ¶ [0450]).
Similarly, Sano discloses, when a desired objective of a user is weight loss (i.e., state of fat burning, or slimming), an ideal ketone level curve is one in which ketone levels remain above a predetermined level, or threshold, for all periods of time (e.g., ¶ [0067]; Fig. 5), and teaches and/or suggests displaying on a first display of a device (display section 14 of health support device 10) a measured ketone level curve and the above-noted ideal curve (e.g., Fig. 16).
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 Simpson with determining whether the subject is in the state of ketosis (i.e., fat metabolism or burning is occurring) based on a comparison of the plurality of ketone level measurements to a ketosis threshold, and outputting an indication of times of day when the ketosis threshold has not been met to a GUI on the display of a reader device (e.g., concurrently displaying a measured ketone curve and an indication of the ketone threshold level) as taught/suggested by Sano in order to facilitate providing an indication to the user of the determination of whether his/her ketone levels are in the desired zone/range throughout the day (i.e., a state of ketosis, or fat utilization/burning), enabling the user to effectively learn how to lose weight by providing to the user an indication of when (e.g., times of a day) he/she does not achieve the goal ketosis/fat metabolism state, and allowing the user to identify when/at what time of day adjustments to his/her lifestyle (e.g., diet, exercise, etc.) should be made to optimize his/her weight loss.
Simpson as modified does not disclose the method comprises calculating a numerical score based on the ketone metric(s), such as the area of the curve, or outputting the numerical score on the GUI. However, Simpson teaches/suggests providing feedback to the user regarding the impact of different foods (e.g., ¶ [0447], ¶ [0462], etc.).
Sano discloses ketone levels typically fall from a peak to a trough in response to consuming food (¶ [0093]), teaching/suggesting comparing a calculated ketone metric, such as area under a measured ketone curve associated with a meal/eating, to a comparable area under an ideal ketone level curve (Fig. 17, ¶¶ [0098]-[0099]), and outputting a nutrition recommendation for achieving a slimming/fat burning state based on said ketone metric (¶ [0108] when the comparison indicates excessive food consumption, advice information is provided to promote fat burning, e.g., eating less carbohydrates). Sano further suggests a numerical score, such as achievement points, may be calculated and provided to a user in which higher overall points are associated with a higher degree of a target achievement of a selected health objective (e.g., ¶ [0086]). Sano discloses a score or points can be output on a display with measured and ideal ketone curves or an indication of a difference between measured and ideal ketone levels (e.g., Figs. 15-16).
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 Simpson with calculating a numerical score based on the area under a ketone level curve associated with a ketone response to a meal (e.g., assigning a number of achievement points based on the measured ketone response to a meal as compared to an ideal ketone meal response), outputting the numerical score, and the nutrition recommendation being based on said ketone metric as suggested by Sano in order to provide easy to understand feedback regarding the impact of a consumed meal or food and to further provide advice related to said feedback in view of the user's weight loss goals (Simpson, ¶ [0447], ¶ [0462], etc.; Sano, ¶ [0086]).
Simpson as modified does not expressly disclose outputting the nutrition recommendation on an additional GUI of the display. However, Simpson does disclose at least one embodiment in which an alert, such as nutrition advice, can be generated if relevant measured values are outside of set criteria, such as outside of a predefined range (e.g., ¶ [0555]), and further discloses advice can be provided on an additional GUI (e.g., ¶ [0267]; Fig. 26D; etc.). Accordingly, 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 Simpson with outputting the nutrition recommendation on an additional GUI as a simple substitution of one known means/method for presenting a nutrition recommendation(s) to a user for another to yield no more than predictable results. See MPEP 2143(I)(B). Alternatively/Additionally, at the time the invention was effectively filed, it would have been an obvious matter of design choice to a person of ordinary skill in the art to modify the method of Simpson with outputting the nutrient recommendation on an additional GUI because Applicant has not disclose that the claimed arrangement of output information provides an advantage, is used for a particular purpose, or solves a stated problem. As no evidence has been provided to the contrary, one of ordinary skill in the art would have expected Applicant's invention to perform equally well with outputting, in any manner or on any GUI, the nutrient recommendation as taught and/or suggested by Simpson as modified because either arrangement provides a recommendation(s) to the user for adjusting his/her lifestyle (e.g., diet) to achieve and/or move closer to his/her desired health objective.
Regarding claims 83 and 86, Simpson as modified teaches/suggests the method comprises outputting a ketone curve associated with a ketone excursion by displaying the ketone excursion on the GUI (see rejection of independent claims above, in which a measured ketone curve is displayed on the GUI along with an indication of the threshold level to enable the user to determine at what times a target predetermined/threshold level is not met).
Regarding claim 105, Simpson as modified teaches/suggests the nutrition recommendation comprises a macronutrient recommendation (Sano, ¶ [0108] advice may indicate too many carbohydrates are being eaten by suggesting eating less carbohydrates).
Regarding claim 111, Simpson as modified teaches/suggests the method further comprises receiving, from the sensor control device, measurements indicative of glucose levels, and calculating at least one glucose metric related to the plurality of ketone level measurements (e.g., ¶ [0444]; ¶ [0448]; ¶ [0458]), and the nutrition recommendation is determined based at least on the at least one ketone metric (see discussion of claims 77 or 88 above) or the at least one glucose metric (e.g., ¶ [0448]; ¶ [0458]).
Claim(s) 83-86 is/are rejected under 35 U.S.C. 103 as obvious over Simpson in view of Sano as applied to claim(s) 77 above, and further in view of US 2014/0188398 A1 (previously cited, Cohen).
Regarding claims 83-86, Simpson as modified teaches/suggests the limitations of claims 77, and further discloses outputting a ketone curve associated with a ketone excursion, as discussed above. Alternatively/Additionally, Simpson teaches identifying and alerting a user to predefined excursions in measured analyte data (¶ [0555]). Similarly, Cohen teaches/suggests identifying a ketone excursion or event comprising a violation of a high ketone level threshold and/or a ketone rate of change threshold (¶ [0059] wherein an event may comprise a measured analyte sensor value above or below a predetermined threshold, a rate of change of analyte measurements above a predetermined threshold, etc.; ¶ [0096] wherein the analyte may comprise ketone bodies), wherein the ketone curve associated with the ketone excursion is displayed in the graphical user interface on the reader device (¶ [0079] the remote monitor may be configured to automatically present, when an event message 196 is received, a page showing relevant event information, such as a trend graph covering a predetermined time period; Fig. 19). 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 Simpson with displaying a ketone curve associated with a ketone excursion on the GUI, the ketone excursion comprising a violation of a high ketone level threshold or a violation of a ketone rate of change threshold, as taught/suggested by Cohen in order to alert the user to a violation/excursion (Simpson, ¶ [0555]) and allow the user to visualize the violation/excursion, or problem zone thereof (Cohen, ¶ [0241]).
Claim(s) 108, 113 and 123 is/are rejected under 35 U.S.C. 103 as obvious over Simpson in view of Sano as applied to claim(s) 77 above, and further in view of US 2018/0052976 A1 (previously cited, Lee).
Regarding claims 108, 113 and 123, Simpson as modified teaches/suggests the limitations of claim 77, as discussed above, and discloses/suggests the method further comprises collecting activity level measurements by an accelerometer of the sensor control device (e.g., ¶ [0190]; ¶ [0444]; ¶ [0470]). Simpson as modified does not disclose the nutrition recommendation is further based on the physical activity level measurements, or age and gender of the subject. However, Simpson does disclose that initial and modified guidance based on measured analyte (e.g., ketone) levels may be provided to a user, such as nutrition choices and/or meals, in a weight loss program (¶ [0413]; ¶ [0447] and ¶ [0450] programs for meals; ¶ [0458] and ¶ [0462] programs for meals; etc.). Additionally, as discussed above with respect to the independent claims, Sano discloses the ketone metric (e.g., area under a curve associated with eating) can provide an indication of the amount of food (e.g., carbohydrates) consumed (¶¶ [0097]-[0098]).
Lee discloses a method comprising generating and outputting a nutrition recommendation (e.g., daily calorie intake, macronutrient recommendations, etc.) based on age, gender and general activity level of a subject in view of a health objective (e.g., weight loss goal) of said subject (¶¶ [0067]-[0068]). Lee discloses activity level may be assessed, or automatically logged, based on physical activity level measurements, and suggests consumption information may be similarly automatically logged (¶ [0034]). Lee discloses an initial recommendation can be dynamically updated based on user data, such as consumption data (e.g., ¶ [0032], ¶¶ [0090]-[0094], 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 method of Simpson with the nutrition recommendation being further based on age, gender and the activity level measurements of a subject as taught and/or suggested by Lee in order to establish initial guidance specific to the user and his/her weight loss goal(s) (Lee, ¶ [0067]); assist the user by providing modified advice (e.g., recommendation(s)) that will allow said user to meet, e.g., a daily goal, regardless of whether a previous meal goal(s) for the day were met (Lee, ¶¶ [0090]-[0094]); etc.
Claim(s) 88, 94, 97-99 and 112 is/are rejected under 35 U.S.C. 103 as obvious over Simpson in view of Sano and US 2006/0089840 A1 (previously cited, May).
Regarding claims 88 and 98, Simpson teaches/suggests an analyte monitoring system, the system comprising:
a sensor control device configured to be worn on a subject's body (e.g., Fig. 2, sensor(s) 22, 22'; Fig. 58, sensor array and associated electronics, ¶¶ [0531]-[0536]; ¶ [0483] where sensor system described in incorporated by reference US 2009/0076360 A1 to Brister may be employed; etc.), wherein the sensor control device comprises an in vivo sensor having at least a first portion that is configured to be positioned under skin and in contact with a bodily fluid of the subject (Simpson, Figs. 54-57; Brister; sensor 32) and sensor electronics coupled to the sensor (Simpson, ¶ [0531] sensor electronics; Brister, sensor electronics 132), the sensor electronics comprising a processor (Brister, processor 138) and communication circuitry (Simpson, ¶ [0531] transmitter; Brister, RF module 148) for transmitting a plurality of continuous measurements (Simpson, ¶ [0531] wirelessly transmitting sensor data; Brister, ¶ [0336] wirelessly transmitting sensor data from the sensor to a receiver via antenna 152) indicative of ketone levels (Simpson, ¶ [0532] one or more of the sensor devices 764 of the array 750 may be configured to detect and measure lactic acid, ketones, testosterone, cortisol, uric acid, or other analytes; ¶ [0426] inputs include ketone levels; ¶ [0524] ketone bodies continuously measured by the sensor; etc.);
one or more processors (Fig. 2, monitoring device 21, or inherent processing unit thereof);
a memory coupled with the one or more processors, the memory storing instructions which, when executed by the one or more processors (¶ [0186] the monitoring device 21 may include non-transitory computer readable memory running an application 27), cause the one or more processors to execute a method, the method comprising:
receiving, from the sensor control device, the plurality of continuous ketone level measurements (¶ [0186] receiving data from the sensor(s)/transmitter(s));
calculating at least one ketone metric related to the plurality of continuous ketone level measurements (¶ [0426] weight loss optimization method inputs, such as ketone levels, may be processed to determine if the input(s) meet requirements of a program or not, e.g., ¶ [0442] measuring rates of fat burning, ¶ [0446] cumulative fat burn over time, daily or weekly statistics; ¶ [0457] helpful metrics, such as averages over time, area under the curve, cumulative levels over time; etc.), the ketone metric(s) including an area under a curve of said measurements (¶ [0457]);
determining whether the subject is in a state of ketosis (i.e., fat metabolism, fat utilization, fat burning, etc.) based on the continuous ketone level measurements (e.g., ¶ [0446] determining if fat metabolism is occurring based on measured ketone levels);
outputting at least one ketone metric to a GUI on a display of a reader device comprising a smart phone (¶ [0426] weight loss optimization method outputs may include basic numerical value outputs, more significant/information outputs, etc.; e.g., ¶¶ [0440]-[0450] outputs enabling a user to monitor byproducts of fat metabolism (i.e., ketone levels), an indication if fat metabolism is occurring, cumulative data, statistics, etc.; ¶ [0457] zone diagram, etc.; ¶ [0184] the monitoring device is a smart phone), and
outputting a nutrition recommendation for achieving the state of ketosis to a GUI of the display, wherein the nutrition recommendation is based on the ketone metric(s) (¶ [0426] weight loss optimization method outputs may include actionable outputs informing a user of steps to take, e.g., ¶ [0447] feedback for a suggested lifestyle adjustment; ¶ [0450] program for exercise and meals can be modified to move the user closer to a desired goal; ¶ [0452] users may be instructed (e.g., ¶ [0410] textual indications on a display) to optimize fat reduction by suggestion of meals, exercise, and other therapies that emphasize fat utilization; etc.).
As noted above, Simpson discloses a sufficiently "high" level of ketone is indicative of a fat utilization (e.g., ¶ [0452]), i.e., a state of ketosis, suggesting a desired ketone level indicating fat utilization/metabolism is occurring should be higher than some threshold level. Simpson further discloses outputs may include a graph or analyte level curve as a function of time, wherein said graph may include an indication of a desired analyte concentration value/range (¶ [0073], ¶ [0426] zone indicator, etc.), and teaches/suggests enabling a user to more easily and effectively learn how to lose weight based on, e.g., their unique physiology and lifestyle patterns (e.g., ¶ [0450]).
Similarly, Sano discloses, when a desired objective of a user is weight loss (i.e., state of fat burning, or slimming), an ideal ketone level curve is one in which ketone levels remain above a predetermined level, or threshold, for all periods of time (e.g., ¶ [0067]; Fig. 5), and teaches and/or suggests displaying on a first display of a device (display section 14 of health support device 10) a measured ketone level curve and the above-noted ideal curve (e.g., Fig. 16).
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 Simpson with determining whether the subject is in the state of ketosis (i.e., fat metabolism or burning is occurring) based on a comparison of the plurality of ketone level measurements to a ketosis threshold, and outputting an indication of times of day when the ketosis threshold has not been met to a GUI on the display of a reader device (e.g., concurrently displaying a measured ketone curve and an indication of the ketone threshold level, for example, as is illustrated with an ideal curve) as taught/suggested by Sano in order to facilitate providing an indication to the user of the determination of whether his/her ketone levels are in the desired zone/range throughout the day (i.e., a state of ketosis, or fat utilization/burning), enabling the user to effectively learn how to lose weight by providing to the user an indication of when (e.g., times of a day) he/she does not achieve the goal ketosis/fat metabolism state, and allowing the user to identify when/at what time of day adjustments to his/her lifestyle (e.g., diet, exercise, etc.) should be made to optimize his/her weight loss.
Simpson as modified does not disclose the method comprises calculating a numerical score based on the ketone metric(s), such as the area of the curve, for each of a plurality of meals or outputting the numerical score for each of the plurality of meals on the GUI. However, Simpson does teach/suggest providing feedback to the user regarding the impact of different foods (e.g., ¶ [0447], ¶ [0462], etc.).
Sano discloses ketone levels typically fall from a peak to a trough in response to consuming food (¶ [0093]), teaching/suggesting comparing a calculated ketone metric for each of a plurality of meals, such as area under a measured ketone curve associated with a meal/eating, to a comparable area under an ideal ketone level curve (Fig. 17, ¶¶ [0095]-[0099] for each downward slope connecting peaks to troughs indicative of a meal/eating, a measured concentration integral value D is calculated and compared to a concentration integral value D for an ideal curve), and outputting a nutrition recommendation for achieving a slimming/fat burning state based on said ketone metric (¶ [0108] when the comparison indicates excessive food consumption, advice information is provided to promote fat burning, e.g., eating less carbohydrates). Sano further suggests a numerical score, such as achievement points, may be calculated and provided to a user in which higher overall points are associated with a higher degree of a target achievement of a selected health objective (e.g., ¶ [0086]; ¶ [0094]; etc.). Sano discloses the score or points can be output on a display with measured and ideal ketone curves or an indication of a difference between measured and ideal ketone levels (e.g., Figs. 15-16).
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 Simpson with calculating a numerical score based on the area under a ketone level curve associated with a ketone response to each of a plurality of meals (e.g., assigning a number of achievement points based on the measured ketone response to each meal as compared to an ideal ketone response for said meal), outputting the numerical score for each of the plurality of meals, and the nutrition recommendation being based on said ketone metric for each of said meals as suggested by Sano in order to provide easy to understand feedback regarding the impact of each consumed meal or food and to further provide advice related to said feedback in view of the user's weight loss goals (Simpson, ¶ [0447], ¶ [0462], etc.; Sano, ¶ [0086]).
Simpson as modified neither expressly discloses outputting the nutrition recommendation when the ketosis threshold is not met, nor the nutrition recommendation is output on an additional GUI of the display. However, Simpson does disclose at least one embodiment in which an alert, such as nutrition advice, can be generated if relevant measured values are outside of set criteria, such as outside of a predefined range (e.g., ¶ [0555]), and further discloses advice can be provided on an additional GUI (e.g., ¶ [0267]; Fig. 26D; 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 method of Simpson with outputting the nutrition recommendation on an additional GUI when the ketosis threshold is not met as a simple substitution of one known means/method for presenting a nutrition recommendation(s) to a user for another to yield no more than predictable results. See MPEP 2143(I)(B). Alternatively/Additionally, at the time the invention was effectively filed, it would have been an obvious matter of design choice to a person of ordinary skill in the art to modify the method of Simpson with outputting the nutrient recommendation when the ketosis threshold is not met and/or on an additional GUI because Applicant has not disclose that the claimed arrangement of output information provides an advantage, is used for a particular purpose, or solves a stated problem. As no evidence has been provided to the contrary, one of ordinary skill in the art would have expected Applicant's invention to perform equally well with outputting, in any manner or on any GUI, the nutrient recommendation when a ketosis metric threshold is not met as taught and/or suggested by Simpson as modified because either arrangement provides a recommendation(s) to the user for adjusting his/her lifestyle (e.g., diet) to achieve and/or move closer to his/her desired health objective.
Simpson as modified does not disclose outputting a target score to the GUI. However, Sano discloses the nearer to ideal the measured ketone levels are, the greater or higher the achievement points (e.g., ¶ [0086]), thereby suggesting that the highest possible amount of achievement points (or a highest possible score) is given/awarded when measured ketone levels and/or a ketone response to a meal (based on area under a curve associated with a meal, as discussed above) is equal to (e.g., the same as, substantially, the same as, etc.) the ideal curve/area. Accordingly, Sano (or Simpson as modified thereby) teaches/suggests a "target score" for a comparison between measured and ideal ketone levels is the number of available achievement points, or highest possible score, that may be awarded when measured and ideal ketone levels or metrics are equal.
May discloses a method comprising outputting a calculated numerical score (earned points) and a target score (possible/available points) on a GUI/display (e.g., Fig. 15).
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 Simpson with additionally outputting a target score, such as the highest possible amount of achievement points that the user could have earned, with the numerical score as taught/suggested by May in order to facilitate providing the user with a frame of reference by which to determine the quality of his/her numerical score; providing the user with an indication of his/her progress or compliance with his/her health objective (May, Fig. 15); etc.
Regarding claims 94 and 97, Simpson as modified teaches/suggests the method comprises outputting a ketone curve associated with a ketone excursion by displaying the ketone excursion on the GUI (see rejection of independent claims above, in which a measured ketone curve is displayed on the GUI along with an indication of the threshold level to enable the user to determine at what times a target predetermined/threshold level is not met).
Regarding claim 99, Simpson as modified teaches/suggests the nutrition recommendation comprises a macronutrient recommendation (Sano, ¶ [0108] advice may indicate too many carbohydrates are being eaten by suggesting eating less carbohydrates).
Regarding claim 112, Simpson as modified teaches/suggests the method further comprises receiving, from the sensor control device, measurements indicative of glucose levels, and calculating at least one glucose metric related to the plurality of ketone level measurements (e.g., ¶ [0444]; ¶ [0448]; ¶ [0458]), and the nutrition recommendation is determined based at least on the at least one ketone metric (see discussion of claims 77 or 88 above) or the at least one glucose metric (e.g., ¶ [0448]; ¶ [0458]).
Claim(s) 94-97 is/are rejected under 35 U.S.C. 103 as obvious over Simpson in view of Sano and May as applied to claim(s) 88 above, and further in view of Cohen.
Regarding claims 94-97, Simpson as modified teaches/suggests the limitations of claims 88, and further discloses outputting a ketone curve associated with a ketone excursion, as discussed above. Alternatively/Additionally, Simpson teaches identifying and alerting a user to predefined excursions in measured analyte data (¶ [0555]). Similarly, Cohen teaches/suggests identifying a ketone excursion or event comprising a violation of a high ketone level threshold and/or a ketone rate of change threshold (¶ [0059] wherein an event may comprise a measured analyte sensor value above or below a predetermined threshold, a rate of change of analyte measurements above a predetermined threshold, etc.; ¶ [0096] wherein the analyte may comprise ketone bodies), wherein the ketone curve associated with the ketone excursion is displayed in the graphical user interface on the reader device (¶ [0079] the remote monitor may be configured to automatically present, when an event message 196 is received, a page showing relevant event information, such as a trend graph covering a predetermined time period; Fig. 19). 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 Simpson with displaying a ketone curve associated with a ketone excursion on the GUI, the ketone excursion comprising a violation of a high ketone level threshold or a violation of a ketone rate of change threshold, as taught/suggested by Cohen in order to alert the user to a violation/excursion (Simpson, ¶ [0555]) and allow the user to visualize the violation/excursion, or problem zone thereof (Cohen, ¶ [0241]).
Claim(s) 102, 114 and 124 is/are rejected under 35 U.S.C. 103 as obvious over Simpson in view of Sano and May as applied to claim(s) 88 above, and further in view of Lee.
Regarding claims 102, 114 and 124, Simpson as modified teaches/suggests the limitations of claim 88, as discussed above, and discloses/suggests the method further comprises collecting activity level measurements by an accelerometer of the sensor control device (e.g., ¶ [0190]; ¶ [0444]; ¶ [0470]). Simpson as modified does not disclose the nutrition recommendation is further based on the physical activity level measurements, or age and gender of the subject. However, Simpson does disclose that initial and modified guidance based on measured analyte (e.g., ketone) levels may be provided to a user, such as nutrition choices and/or meals, in a weight loss program (¶ [0413]; ¶ [0447] and ¶ [0450] programs for meals; ¶ [0458] and ¶ [0462] programs for meals; etc.). Additionally, as discussed above with respect to the independent claims, Sano discloses the ketone metric (e.g., area under a curve associated with eating) can provide an indication of the amount of food (e.g., carbohydrates) consumed (¶¶ [0097]-[0098]).
Lee discloses a method comprising generating and outputting a nutrition recommendation (e.g., daily calorie intake, macronutrient recommendations, etc.) based on age, gender and general activity level of a subject in view of a health objective (e.g., weight loss goal) of said subject (¶¶ [0067]-[0068]). Lee discloses activity level may be assessed, or automatically logged, based on physical activity level measurements, and suggests consumption information may be similarly automatically logged (¶ [0034]). Lee discloses an initial recommendation can be dynamically updated based on user data, such as consumption data (e.g., ¶ [0032], ¶¶ [0090]-[0094], 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 method of Simpson with the nutrition recommendation being further based on age, gender and the activity level measurements of a subject as taught and/or suggested by Lee in order to establish initial guidance specific to the user and his/her weight loss goal(s) (Lee, ¶ [0067]); assist the user by providing modified advice (e.g., recommendation(s)) that will allow said user to meet, e.g., a daily goal, regardless of whether a previous meal goal(s) for the day were met (Lee, ¶¶ [0090]-[0094]); etc.
Response to Arguments
Applicant's arguments have been fully considered but they are not persuasive.
With respect to the prior art rejection of claim 77, Applicant contends, "Sano does not disclose or suggest that a score is calculated in the same manner as claimed" (Remarks, pg. 8); and "There is no disclosure or suggestion in the cited references of using an area under a ketone curve, the slope, or the length of the curve to calculate a numerical score, and the Office provides no reasoned explanation why doing so would be obvious" (Remarks, pg. 9).
The examiner respectfully disagrees. While Sano discloses a score (achievement points) may be calculated based on a difference between a measured ketone concentration level and a target ketone concentration level (Equation 1), Sano discloses/suggests achievement points may assigned using any equation expressing higher overall achievement points the higher the degree of achievement of the registered health objective, including equations employing differences and/or integrals (¶ [0091]). Further, Sano discloses various evaluation methods may be considered as a method for evaluating deviation of the actual measurement curve from the ideal curve, including the difference between a measured concentration integral value in response to a meal/eating, and a corresponding ideal concentration integral value (¶¶ [0094]-[0099]). Accordingly, Sano at least reasonably suggests a score or achievement points may be calculated/assigned based on the area under a curve of the ketone level measurements (i.e., difference between measured concentration integral value and ideal concentration integral in response to a meal/eating) that is indicative of the degree to which a meal or food consumed achieves the user's registered health objective.
Applicant further contends, "It is not clear from this passage [of paragraph [0446] of Simpson] that 'the signal' is even a signal indicative of a ketone level" (Remarks, pg. 9).
The examiner respectfully disagrees. Paragraph [0446] of Simpson is part of a description of a "Weight Less Optimization Example 2" (¶¶ [0440]-[0450]). In said example, "a user may be instructed how to optimize fat reduction through measurement of glycerol and/or ketones or similar analytes" (¶ [0441]), disclosing the inputs to this system including data from measurements of glycerol and/or ketones, e.g., from an array of sensors (¶¶ [0443]-[0444]). Accordingly, in the context of the disclosed example, it is clear that "the signal" of paragraph [0446] includes a signal indicative of ketone and/or glycerol levels, and may be utilized to determine if fat metabolism is occurring.
Lastly with respect to claim 77, Applicant contends, the system of Sano "does not make a determination if the subject is in a state of ketosis;" and "Sano does not disclose displaying any particular indication that the user is not in a state of ketosis" (Remarks, pgs. 9-10).
The examiner respectfully disagrees. Sano discloses an ideal ketone curve for "slimming" is one in which ketone concentration remains above a predetermined threshold throughout the day, thus indicating that fat is being burned (e.g., ¶ [0067]), i.e., the user is in a state of ketosis. Sano further discloses differences between a measured ketone concentration (e.g., area under a ketone curve) and an ideal ketone concentration may be compared to a predetermined threshold value to determine when, e.g., excessive food has been consumed, i.e., their health objective is not being achieved, and advice can be provided that will enable the user to achieve said health objective (¶ [0099]; ¶ [0108]; etc.). Accordingly, Sano discloses/suggests comparing measured ketone levels (concentration values, concentration integral values, etc.) to ideal ketone levels, and determining from said comparison if a user is achieving his/her desired health objective, which may be a state of ketosis when his/her objective is slimming.
Additionally, Sano alone is not relied on as a disclosure of displaying an indication that the user is not in a state of ketosis. Rather, as noted in the rejection(s) of record above, Simpson discloses a sufficiently "high" level of ketone is indicative of a fat utilization (e.g., ¶ [0452]), i.e., a state of ketosis, suggesting a desired ketone level indicating fat utilization/metabolism is occurring should be higher than some threshold level. Simpson further discloses outputs may include a graph or analyte level curve as a function of time, wherein said graph may include an indication of a desired analyte concentration value/range (¶ [0073], ¶ [0426] zone indicator, etc.), and teaches/suggests enabling a user to more easily and effectively learn how to lose weight based on, e.g., their unique physiology and lifestyle patterns (e.g., ¶ [0450]). Accordingly, Simpson discloses/suggests a ketone level curve as a function of time may be displayed and include an indication of a desired analyte concentration value/range. For weight loss, Simpson suggests ketone levels should be sufficiently high to indicate fat utilization. Sano similarly discloses for weight loss, or "slimming," an ideal ketone curve is one in which ketone levels remain above a predetermined level, or threshold, for all periods of time, indicating the user is in a state of fat burning/ketosis. Accordingly, Simpson discloses a desired ketone concentration can be indicated on a display of a ketone curve, and Sano discloses a desired ketone concentration is above a predetermined threshold for weight loss/slimming, such that it would have been obvious to modify Simpson with the desired ketone concentration level indication comprising an indication of the ketosis or fat burning threshold (e.g., concurrently displaying a measured ketone curve and an indication of the ketone threshold level) as taught/suggested by Sano for at least the reasons discussed in the rejection(s) of record above.
With respect to the rejection(s) of independent claim 88, Applicant contends, "Sano does not disclose or suggest that its achievement points are determined in connection with a meal" or "suggest displaying the achievement points for each of a plurality of meals on a GUI" (Remarks, pgs. 10-11).
The examiner respectfully disagrees. Sano discloses, in a first evaluation method, a ketone concentration integral value (D) is calculated based on the concentration difference between a peak and a trough of an actual measurement curve (e.g., ¶ [0095]). Sano discloses these regions of the curve are regions correspond to meals/eating (e.g., ¶ [0098]; ¶ [0105]). Further, as discussed with respect to the rejection of claim 77 above, Sano discloses/suggests achievement points may assigned using any equation expressing higher overall achievement points the higher the degree of achievement of the registered health objective, including equations employing differences and/or integrals (¶ [0091]). Further, Sano discloses various evaluation methods may be considered as a method for evaluating deviation of the actual measurement curve from the ideal curve, including the difference between a measured concentration integral value in response to a meal/eating, and a corresponding ideal concentration integral value (¶¶ [0094]-[0099]). Accordingly, Sano at least reasonably suggests a score or achievement points may be calculated/assigned based on the area under a curve of the ketone level measurements (i.e., difference between measured concentration integral value and ideal concentration integral in response to a meal/eating) that is indicative of the degree to which a meal or food consumed achieves the user's registered health objective. Sano further discloses calculated achievement points may be output to the user, and the display of said achievement points is not limited to the screen of, e.g., Fig. 15 (e.g., ¶ [0088]). Therefore, outputting the achievement points calculated based on the area under the curve in response to each meal would provide an indication of the degree to which a meal or food consumed achieves the user's registered health objective, thereby providing the user easy to understand feedback regarding the impact of each consumed meal/food (Simpson, ¶ [0447], ¶ [0462], etc.; Sano, ¶ [0086]).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/Meredith Weare/Primary Examiner, Art Unit 3791