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 07 August 2025 has been entered. Claim(s) 1, 3-5, 9, 11, 13-15 and 19-20 is/are currently amended. Claim(s) 2, 8, 12 and 18 has/have been canceled. Claim(s) 1, 3-7, 9-11, 13-17 and 19-21 is/are pending.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of pre-AIA 35 U.S.C. 112, first paragraph:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim(s) 1, 3-7, 9-11, 13-17 and 19-21 is/are rejected under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claim 1, claim 11, claim 20 and claims dependent thereon, the limitation(s) "output, based on the one or more glucose metrics, an indication of which of the plurality of meal events has the most nutritional value" of claim 1 and the comparable limitations of claims 11 and 20 lack sufficient support in the application as filed. In what appears to be the most relevant section of Applicant's specification to the above-noted limitation, Applicant discloses, "FIG. 7 is another example embodiment of a GUI for displaying analyte metrics on reader device 120. More specifically, GUI 400 can determine and display the physiological impact of a specific food or meal for a particular individual in comparison to a default standard food or meal. It is recognized that diet and nutrition must be customized for each individual. While it is true that there are common guidelines for all people, there is a wide variation in individual responses to foods based on individual physiology. Additionally, food choices may be restricted based on local availability, cultural acceptability, food allergies, and the like. GUI 400 can present information, specific to the individual, regarding which foods among those available provide the most nutritional benefit and the least negative impact on factors such as weight gain" (¶ [0051]). Applicant does not appear to disclose identifying which of a plurality of past meal events has the most nutritional value, but rather appears to disclose providing information to a user about which, of the foods available to him/her to consume, would provide the most "nutritional benefit." Further, apart from a generic indication that said information may be "specific to the individual," Applicant fails to disclose how foods having "the most nutritional benefit" of foods available are identified, and, more particularly, how, if at all, broadly any glucose metric(s), and particularly the numerical score as claimed, is utilized in such a determination. Accordingly, the above-noted limitation lacks sufficient support in the application as filed and is therefore directed to and/or encompasses new matter.
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 pre-AIA 35 U.S.C. 112, 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.
Claim(s) 1, 3-7, 9-11, 13-17 and 19-21 is/are rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Regarding claim 1, claim 11, claim 20 and claims dependent thereon, the limitation(s) "output, based on the one or more glucose metrics, an indication of which of the plurality of meal events has the most nutritional value" of claim 1 and the comparable limitations of claims 11 and 20 are indefinite. As discussed above with respect to rejections under 35 U.S.C. 112(a), Applicant fails to disclose the above-noted limitation. In view of this lack of disclosure, it is unclear how a glucose metric(s) is utilized to identified "nutritional value;" how, if at all, nutritional value relates to the numerical score calculated for each event; etc. Are two separate "parameters" calculated for each meal event, a numerical score and a nutritional value, and if so, how do these parameters differ and/or what different information do they provide to the user? Is the meal score also an indication of "nutritional value" of said meal? If so, does merely outputting individual meal scores sufficiently provide a user an indication of which of his/her past meal events had the "most nutritional value"?
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.
Claim(s) 1, 3-7, 9-11, 13-17 and 19-21 is/are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more.
The pending claims recite the step(s) of determining a glucose curve associated with a glucose response to each of a plurality of meal events and/or detecting excursions of data indicative of glucose levels outside of a target range; calculating a numerical score, such as assigning a whole number(s) out of a predetermined range of scores, for each event based on area under, duration of and slope of the glucose curve; determining a cumulative score by adding each score for each event within a day and/or week; determining which of the plurality of meal events has the most nutritional value; and generating advice to ensure and/or increase the likelihood that a subject's cumulative score meets a target score.
These limitations, as drafted, are a process that, under a broadest reasonable interpretation (BRI), covers performance of the limitations in the mind but for recitation, in some of the pending claims, of generic computer components (e.g., processor(s), computing device(s)). That is, other than reciting the limitations are performed by a processor(s) and/or computing device(s), nothing in the claim elements precludes these steps from practically being performed in the mind. Indeed, Applicant's claimed method(s), which does not recite any processor(s) or computing device(s) that perform the claimed steps, indicates/suggests no computer component is required, i.e., an essential element. For example, but for the processor(s) language (where present), determining a glucose curve associated with a glucose response to each of a plurality of events and/or detecting events based on an excursion of the data indicative of the glucose levels outside of a target range in the context of the pending claims encompasses a user manually and/or visually observing glucose levels in response to meals, or excursions in glucose levels relative to a fasting/baseline level, within data output by a glucose sensor (e.g., CGM), which are readily apparent in Fig. 4A of Heaton '353 (US 2010/0075353 A1). The step(s) of calculating a numerical score(s), such as by assigning a number(s) out of a predetermined range of scores, and/or assessing nutritional value, for each event based on, e.g., area under, duration of and/or slope of a glucose curve, encompasses a user merely considering the shape of a glucose curve associated with each meal and using features of said shape, in any manner he/she desires, to mentally form an opinion about the event to assign said event a score and/or a nutritional value. The step(s) of determining a cumulative score(s), such as daily or weekly scores, encompasses a user, mentally or with pen and paper, performing relatively simple mathematical operations, such as summing the assigned scores for each event in a particular time period. Lastly, the step(s) of generating advice to ensure and/or increase the likelihood that a subject's cumulative score meets a target score encompasses a user forming an opinion about how a subject should change his/her food consumption (e.g., amount of food, type of food, timing of ingestion, etc.) to best meet a predefined goal. If claim limitations, under their BRI, cover performance of the limitations in the mind but for the recitation of generic computer component(s), then it falls within the "mental processes" grouping of abstract ideas. See MPEP 2106.04(a)(2)(III). Accordingly, the pending claims recite an abstract idea.
This judicial exception is not integrated into a practical application. The claims recite the additional elements of using a processor(s)/computing device(s) to perform the steps of the abstract idea; a sensor/reader device arrangement used only for the purpose of data gathering necessary to perform the abstract idea (e.g., CGM data); generically outputting a result(s) of and/or data used in performing the steps of the abstract idea (e.g., calculated score(s) and/or value(s), formulated advice/opinions, target score(s)); and outputting a prompt for information associated with an event. The processor or computing device is recited at a high level of generality as a generic processor performing generic computer functions of comparing data to thresholds, assigning data to categories, adding numbers, etc., such that it amounts to no more than mere instructions to apply the exception using a generic computer component(s). The glucose sensor/reader device structure and/or steps are used only for gathering data necessary to perform the abstract idea, comparable to activities that have been found by the courts to be insignificant extra-solution activity, such as determining the level of a biomarker in blood. See MPEP 2106.05(g). The step of outputting the result(s) of and/or data used in performing the abstract idea is similarly comparable to activities that have been found by the courts to be an insignificant extra-solution activity and/or application, such as printing or downloading generated menus (i.e., data). See MPEP 2106.05(g). The step of outputting a prompt for information associated with the event is not meaningfully associated with the abstract idea, or steps thereof, in any manner (e.g., there is no required connection between this step and the step(s) of the abstract idea). Therefore, at best, this limitation appears to generally link the abstract idea to a particular technological environment (e.g., confines the use of the abstract idea to, e.g., reader devices that prompt users for information). See MPEP 2106.05(h). Accordingly, these additional elements either alone or in combination do not integrate the abstract idea into a practical application because they do not impose meaningful limits on practicing the abstract idea. The claims, therefore, are directed to an abstract idea.
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional element of using a processor to perform both the steps amounts to no more than mere instructions to apply the exception using a generic computer component. Additionally, the prior art of record, e.g., Heaton '353, indicates the claimed data gathering structure (glucose sensor in wireless communication via Bluetooth with a reader device) is well-understood, routine and/or conventional in the field. Specifically, Heaton '353 discloses CGMs and reader devices, e.g., consumer electronic devices, commensurate in scope with the present claims are commercially available (¶ [0065], ¶ [0067], ¶ [0074], etc.). Since mere instructions to apply an exception using a generic computer component; appending insignificant and/or well-understood, routine and conventional extra-solution activities; and/or generally linking a judicial exception to a particular technological environment cannot provide an inventive concept, claims 1, 3-7, 9-11, 13-17 and 19-21 are not patent eligible.
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, 3-6, 9, 11, 13-16 and 19-21 is/are rejected under 35 U.S.C. 103 as obvious over US 2010/0075353 A1 (previously cited, Heaton '353) in view of US 2011/0053121 A1 (previously cited, Heaton '121); or alternatively, over Heaton '353 in view of Heaton '121 and US 2015/0347689 A1 (previously cited, Neagle).
Regarding claims 1, 11 and 20, Heaton '353 teaches/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; ¶ [0099]; 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 discloses calculating the numerical score for the event is based in part on a second value representing a duration of the glucose response to the event, or outputting based on the one or more glucose metrics, an indication of which of the plurality of meal events has the most nutritional value.
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 teaches/suggests the 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 the numerical score for the event being based on a second value representing a duration of the glucose response to the event (e.g., calculating two numbers, a first number based on area and indicating quantity of carbohydrates consumed, and a second number based on duration and indicating quality of carbohydrates consumed), and outputting, on the display, said second value, as taught/suggested by Heaton '121 in order to provide more comprehensive information about the quantity and quality of a meal (or accumulated meals) to the user (Heaton '121, ¶ [0115]). Since Heaton '121 discloses the second value provides an indication of nutritional quality of the meal event, outputting said second value, or an indication thereof, would permit a user to determine which of his/her consumed meals has the most "nutritional value."
The step of calculating a numerical score based on the claimed first value and second value has been interpreted to encompass calculating two separate numbers as the score, which Heaton '353 as modified teaches/suggests, as discussed above. Alternatively/Additionally, if it is Applicant's intention that a single number or "score" is calculated based on the claimed first and second values, Neagle discloses calculating a food/meal merit score based on multiple parameters, including amount or quantity, type or quality, etc. (e.g., ¶ [0057] scores determined based on many properties, such as calories, amount of fiber, amount of protein, amount of sugar, quantity, type of food (meat, carbohydrate, fruit, vegetable, etc.), how it's prepared (e.g., raw, steamed, fried, sautéed, and broiled), that has been calculated by professionals after detailed analysis as to how good or beneficial particular food items are for human health and wellness, and specifically for this patient given his health condition and medical issues). 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 numerical score for a meal based in part on the first value representing an area under the glucose curve and the second value representing a duration of the glucose response to the event as taught/suggested by Neagle in order to integrate multiple factors into simple, easily understood number that a user can correlate with positive outcomes to further encourage compliance and engagement (Neagle, ¶ [0057]) and/or as a simple substitution of one suitable means/method for providing feedback indicative of both quantity and quality of a meal(s) to a user for another to yield no more than predictable results. See MPEP 2143(I)(B).
Regarding claims 3 and 13, Heaton '353 as modified teaches/suggests the method further comprises prompting the user to input information associated with the event and/or receiving user input of information associated with the event (e.g., ¶ [0142] user is prompted for information associated with the meal, e.g., ingredients, special circumstances, etc.).
Regarding claims 4 and 14, Heaton '353 as modified teaches/suggests the method further comprises automatically detecting the event based on an excursion of the data indicative of the glucose levels outside of a target range (e.g., ¶ [0108] intervals in which a measured glucose value is larger than a fasting glucose level are detected as events, wherein a "fasting glucose level" is comparable to the claimed "target range").
Regarding claims 5 and 15, Heaton '353 as modified teaches/suggests the cumulative score comprises the sum of the numerical scores for the plurality of events in a day (e.g., ¶ [0109]).
Regarding claims 6 and 16, Heaton '353 as modified teaches/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 being based on a slope of the glucose curve (e.g., calculating an additional score and/or integrating a measured slope into a combined score) as taught/suggested by Heaton '121 in order to provide more comprehensive information about the quantity and quality of carbohydrates of a meal (or accumulated meals) to the user (Heaton '121, ¶ [0115]).
Regarding claims 9 and 19, Heaton '353 as modified teaches/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.
Claim(s) 3-4 and 13-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Heaton '353 in view of Heaton '121 (or Heaton '353 in view of Heaton '121 and Neagle) as applied to claim(s) 1 and 11 above, and further in view of US 2016/0256087 A1 (previously cited, Doyle, III).
Regarding claims 3-4 and 13-14, Heaton '353 as modified teaches/suggests the limitations of claims 1 and 11, and further teaches and/or suggests the limitations of claims 3-4 and 13-14, as discussed above. Alternatively/Additionally, Heaton '353 teaches/suggests information about an event should be input relatively promptly, suggesting information supplied by the user quickly is more likely to be correct/accurate (e.g., ¶ [0139]). Doyle, III teaches/suggests a method comprising automatically detecting an event based on an excursion of the data indicative of the glucose levels outside of a target range (¶ [0039]-[0040] detecting increases in glucose associated with a meal based on a glucose value(s) exceeding a target range(s) (i.e., current value above Gmin, ROC values exceeding predetermined thresholds, etc.); and prompting a user to input information associated with the event (Fig. 1; ¶ [0044] detecting a glucose rate increase/meal triggers an alert that requests meal information). 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 further comprising automatically detecting the event based on an excursion of the data indicative of the glucose levels outside of a target range(s) and, in response to said detection, prompting the user to input information associated with the event and/or receiving user input of information associated with the event as taught/suggested by Doyle, III in order to ensure that the information supplied by the user relating to the corresponding event (e.g., food intake) is as accurate as possible (Heaton '353, ¶ [0139]).
Claim(s) 7, 10 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Heaton '353 in view of Heaton '121 (or Heaton '353 in view of Heaton '121 and Neagle) as applied to claim(s) 1 and 11 above; or alternatively, over Heaton '353 in view of Heaton '121 (or Heaton '353 in view of Heaton '121 and Neagle) as applied to claim(s) 1 and 11 above, and further in view of US 2009/0298021 A1 (previously cited, Black).
Regarding claims 7, 10 and 17, Heaton '353 as modified teaches/suggests the limitations of claims 1 and 11, as discussed above, but does not teach the numerical score comprises a whole number and/or the numerical score is within a predetermined range of scores. However, 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 system of Heaton with the numerical score comprising a whole number and/or being within a predetermined range of scores because Applicant has not disclosed that whole number scores or a numerical score within a predetermined range of scores provide an advantage, are used for a particular purpose, or solve a stated problem. Rather, Applicant discloses numerical scores may be expressed differently (e.g., as percentages), may comprise non-numerical representations, etc. (e.g., ¶ [0048]). Therefore, as no evidence has been provided to the contrary, one of ordinary skill in the art, furthermore, would have expected Applicant's invention to perform equally well with the numerical score(s) disclosed by Heaton '353 modified (e.g., two numerical scores or a single combined numerical score) because either method or arrangement sufficiently characterizes a glycemic response(s) for comparison with an allowable or target response, thereby enabling providing a user with feedback as to whether he/she is reaching his/her personal metabolic goals.
Alternatively/Additionally, Black discloses processing raw numerical scores to provide a whole number score within a predetermined range of scores (e.g., ¶ [0007], ¶ [0090], 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 numerical score(s) being a whole number score within a predetermined range of scores as taught/suggested by Black in order to facilitate providing a score(s) to a user that are easier to use/comprehend, track, etc. (Black, ¶ [0007]; ¶ [0024]; ¶ [0089]; etc.) and/or as a simple substitution of one suitable means and/or method for quantifying and/or scoring foods/meals for providing feedback to a user for another to yield no more than predictable results. See MPEP 2143(I)(B).
Response to Arguments
Applicant's arguments have been fully considered but they are not persuasive.
With respect to eligibility under 35 U.S.C. 101, Applicant contends the claims of the present application are not directed to an abstract idea as the claimed invention improves glucose monitoring systems by determining scores for meals based on the user's unique glucose response to each meal and that outputs an indication of which meal has the most nutritional value. In particular, Applicant contends, "The claimed invention provides a solution…by determining a numerical score based on the user's glucose response to meals actually consumed by the user, and by outputting the numerical scores for the meals along with an indication of which meals have the most nutritional value" (Remarks, pgs. 7-8).
The examiner respectfully disagrees. As noted in MPEP 2106.04(d)(1), "the specification should be evaluated to determine if the disclosure provides sufficient details such that one of ordinary skill in the art would recognize the claimed invention as providing an improvement. The specification need not explicitly set forth the improvement, but it must describe the invention such that the improvement would be apparent to one of ordinary skill in the art." Applicant's alleged improvement, and/or solution to the alleged problem, is inconsistent with the application as filed. As discussed with respect to rejections under 35 U.S.C. 112(a) and/or 35 U.S.C. 112(b) above, Applicant does not sufficiently disclose outputting an indication of which of the plurality of meal events has the most nutritional value based on the one or more glucose metrics. Applicant fails to disclose any means/method (e.g., algorithm) for assessing "nutritional value" generally, let alone specifically using "one or more glucose metrics," including a numerical score as claimed. Further, it is not readily apparent what outputting an indication "the most nutritional value" encompasses. Accordingly, the specification does not provide sufficient details that one of ordinary skill in the art would recognize the claimed invention as providing an improvement.
With respect to the prior art rejections, Applicant contends Heaton '353 and Heaton '121 fail to disclose providing an indication of which meal events have the most nutritional value for the user based on the glucose metrics for the meal events (Remarks, pgs. 8-9).
The examiner respectfully disagrees. As best understood by the examiner in view of the lack of description of this feature, outputting an indication of individual meal quality, as disclosed by Heaton '121, would provide such an indication to a user, and would have been an obvious modification for at least the reasons noted in the rejection of record above.
Applicant further contends the language of the independent claims does not encompasses calculating two separate numbers as the numerical score (Remarks, pgs. 8).
The examiner respectfully disagrees. The claims do not require that a single numerical value is calculated as a function of area under the curve and duration of the curve. All that is required is that a score is determined based on two values, and that said score is numerical. Heaton '121 discloses/suggests the area under the curve, a numerical value, is indicative of quantity of meal, and duration of the curve, another numerical value, is indicative of quality (e.g., nutritional value) of a meal. Providing each of these numerical values to a user provides an indication, or score, of the meal's quantity and quality, and therefore meets the limitations of the claim.
Applicant further contends, "the Office improperly fails to consider Heaton' 121 as a whole, as Heaton' 121 relates to providing nutritional feedback based on glucose measurements and a measure of variability of glucose levels, and comparing the measure of variability to reference data to generate a conclusion about nutritional quality of food. See Heaton' 121, [0019]. Heaton '121 discloses, for example, a measure for glycemic variability is preferably one of an M-value, Pi-index, coefficient of variation, J-index, MODD, CONGA, stability parameter, BG index, or ADRR. See Heaton' 121 at [0089]-[0092]. Thus, Heaton' 121 discloses relying in part on a measure of variability of glucose levels to assess nutrition and provides no disclosure of determining a numerical score based on a duration of a glucose response to a meal as alleged by the Office" (Remarks, pg. 10). Applicant further contends Neagle does not relate to a system that analyzes glucose, and "the Office provides no explanation why one skilled in the art not only could have, but would have, selected the two claimed glucose metrics to compute a numerical score" (pgs. 10-11).
The examiner respectfully disagrees. Heaton '121 discloses a plurality of metrics, which are calculated as numerical values, that are indicative of meal quality. Heaton '121 expressly discloses other kinds of metrics than those listed by Applicant may be used (e.g., ¶ [0186]), and, as noted in the rejection of record teaches/suggests duration of the curve (e.g., rapid spike and decline versus gradual rise and decline) is indicative of quality and/or nutritional value of the meal (quality of carbohydrates consumed, Heaton '121, ¶ [0011]). Accordingly, the numerical metric(s) of Heaton '121 reasonably encompass a score that is indicative of meal quality/value.
Alternatively/Additionally, if the claim can be presumed to be limited to calculating a single numerical value or score from each of the area under the curve and duration of the curve, which the examiner does not concede for the reasons noted above, Heaton '121 discloses these calculated metrics may be further compared with reference data, such as target values or ranges to draw conclusions about the meal (e.g., ¶ [0186]). Neagle discloses deriving a single food/meal score based on a plurality of metrics, including the quantity and type or quality of the food/meal (e.g., ¶ [0057]). Neagle further teaches/suggests the score is based on a detailed analysis as to how good/beneficial particular food items are for human health and wellness, and specifically for this patient given his health condition and medical issues, thereby suggesting there are ideal or target ranges for each of the metrics included in the score for a given user. Accordingly, Neagle discloses that properties of food or a meal can be combined into a single score individualized for a user that he/she can correlate with positive outcomes to further encourage compliance and engagement. Since Heaton '121 discloses area under the curve is indicative of meal quantity and duration and/or slope are indicative of meal quality, as discussed above, a combined score based on these parameters would provide the user with a simple, easily understood number or score indicative of both meal quantity and quality that a user can correlate with positive outcomes to further encourage compliance and engagement (Neagle, ¶ [0057]).
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 extension fee 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 date of this final action.
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/Meredith Weare/Primary Examiner, Art Unit 3791