DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 11/21/2024 was filed. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of US 12191024 B2 (“12191024”) in view of US 20190236465 A1 to Vleugels (“Vleugels”) as follows, where claim 1 of the instant application is represented in bold characters and where the reference patent 12191024 is represented in underlined characters:
A method comprising: determining an activity score based on a respective value of each of a plurality of activity indicators associated with a user, (determining ,… the mealtime score based on the respective value of each of the plurality of second mealtime detection indicators associated with the user, where the mealtime score is interpreted as the activity score and where the second mealtime detection indicators is interpreted as the activity indicators)
wherein the activity score is used to detect when the user is engaging in, has engaged in, or will engage in exercise or other elevated activity, and (determining a mealtime score for a user, wherein the first mealtime indicator is set at an estimated mealtime associated with the user; where the mealtime score is interpreted as a way to detect when the user is engaging in other elevated activity)
wherein the plurality of activity indicators comprise at least one of: a heartrate indicator that indicates an elevated blood flow, a heartbeat of the user, or an activity level of the user; a location indicator that indicates a location associated with the user; or a keyword indicator that indicates at least one keyword of a pre-scheduled event comprising at least one activity-related word; (wherein the plurality of second mealtime detection indicators comprise: … a location indicator that indicates a location of the device associated with the user; where the second mealtime indicator is interpreted as the activity indicator)
12191024 however does not teach:
determining that the activity score is above an activity threshold based on the respective value associated with each of the plurality of activity indicators; and
performing management of a diabetic condition based on the activity score being above the activity threshold.
Vleugels however teaches before the effective filing date of the current invention the following: [0172]- confidence level exceeds a pre-configured threshold to determine prediction if eating event occurred (interpreted as determining the activity score is above an activity threshold for the indicators). [0207]- an insulin microdosing apparatus being controlled to release insulin based on confidence level of eating event beginning (control of insulin release interpreted as performing management of diabetic condition based on activity score above threshold).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the current invention to have determined that the activity score is above an activity threshold based on the respective value associated with each of the plurality of activity indicators and performing management of a diabetic condition based on the activity score being above the activity threshold as in Vleugels in the method of 12191024 with the motivation of providing more activity indicators for better management of a diabetic condition as taught by Vleugels over that of 12191024.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-17 are rejected under 35 USC 101 because the claimed invention is directed to an abstract idea without significantly more.
It is appropriate for the Examiner to determine whether a claim satisfies the criteria for subject matter eligibility by evaluating the claim in accordance to the Subject Matter Eligibility Test as recited in the following Steps: 1, 2A, and 2B, see MPEP 2106(III.).
Patent Subject Matter Eligibility Test: Step 1:
First, the Examiner is to establish whether the claim falls within any statutory category including a process, a machine, manufacture, or composition of matter, see MPEP 2106.03(II.) and MPEP 2106.03(I).
Claims 1-17 are related to a method. Accordingly, these claims are all within at least one of the four statutory categories.
Patent Subject Matter Eligibility Test: Step 2A- Prong One:
Step 2A of the Subject Matter Eligibility Test demonstrates whether a clam is directed to a judicial exception, see MPEP 2106.04(I.). Step 2A is a two-prong inquiry, where Prong One establishes the judicial exception. Regarding Prong One of Step 2A, the claim limitations are to be analyzed to determine whether, under their broadest reasonable interpretation, they “recite” a judicial exception or in other words whether a judicial exception is “set forth” or “described” in the claims. An “abstract idea” judicial exception is subject matter that falls within at least one of the following groupings: a) mathematical concepts, b) certain methods of organizing human activity, and/or c) mental processes, see MPEP 2106.04(II.)(A.)(1.) and 2106.04(a)(2).
Representative independent claim 1 includes limitations that recite at least one abstract idea as underlined in the following limitations. Specifically, independent claim 1 recites:
A method comprising:
determining an activity score based on a respective value of each of a plurality of activity indicators associated with a user, wherein the activity score is used to detect when the user is engaging in, has engaged in, or will engage in exercise or other elevated activity, and wherein the plurality of activity indicators comprise at least one of:
a heartrate indicator that indicates an elevated blood flow, a heartbeat of the user, or an activity level of the user;
a location indicator that indicates a location associated with the user; or
a keyword indicator that indicates at least one keyword of a pre-scheduled event comprising at least one activity-related word;
determining that the activity score is above an activity threshold based on the respective value associated with each of the plurality of activity indicators; and
performing management of a diabetic condition based on the activity score being above the activity threshold.
The Examiner submits that the foregoing underlined limitations constitute “certain methods of organizing human activity”, more specifically managing interactions between people as the following abstract limitations recite steps for performing management of a diabetic condition based on the activity score being above a activity threshold for a user:
“determining” an activity score based on a respective value of each of a plurality of activity indicators associated with a user, wherein the activity score is used to detect when the user is engaging in, has engaged in, or will engage in exercise or other elevated activity, which are abstract limitations for the analysis of the activity of a user for the management of the diabetic condition for the user,
“determining” that the activity score is above an activity threshold based on the respective value associated with each of the plurality of activity indicators, which is an abstract limitation of analysis of activity to be used for the management of the diabetic condition for the user,
“performing” management of a diabetic condition based on the activity score being above the activity threshold, which is an abstract limitation for the management of the health of the user.
The claim limitations as a whole recite steps for performing management of a diabetic condition based on the activity score being above a activity threshold for a user, which recites social activity steps for the management of the health of the user and therefore recite managing interactions between people and is a certain method of organizing human activity.
Any limitations not identified above as part of the abstract idea are deemed “additional elements” and will be discussed in further detail below.
Accordingly, the claim as a whole recites at least one abstract idea.
Furthermore, dependent claims further define the at least one abstract idea, and thus fails to make the abstract idea any less abstract as noted below:
Claim 2 recites further detail of the abstract activity threshold as indicating that a threshold number of activity indicators have been detected, further describing the abstract idea. Claim 3 describes the activity threshold as being configured by the user, further describing the abstract idea. Claim 4 recites further abstract limitations of a form of the diabetic condition management is performed depending on the activity indicators or the score, further describing the abstract idea. Claim 5 recites further abstract limitations further describing the activity indicators as comprising a respective weight to determine the activity score, further describing the abstract idea. Claim 7 recites further detail of the management of the condition as instruction for a user to “control” a basal rate of the insulin pump, further describing the abstract idea. Claim 8 recites further abstract limitation of instruction for “delivering” a meal bolus of insulin to a user via the insulin pump, further describing the abstract idea. Claim 9 recites further abstract limitations describing the controlling of the basal rate of the insulin pump by considering different activity indicators and thresholds as described to generate different basal rates for a period of time, further describing the abstract idea.
Patent Subject Matter Eligibility Test: Step 2A- Prong Two:
Regarding Prong Two of Step 2A, it must be determined whether the claim as a whole integrates the abstract idea into a practical application. It must be determined whether any additional elements in the claim beyond the abstract idea integrates the exception into a practical application in a manner that imposes a meaningful limit on the judicial exception. The courts have indicated that additional elements merely using a computer to implement an abstract idea, adding insignificant extra solution activity, or generally linking use of a judicial exception to a particular technological environment or field of use do not integrate a judicial exceptions into a “practical application,” see MPEP 2106.04(II.)(A.)(2.) and 2106.04(d)(I.).
In the present case, the additional limitations beyond the above-noted at least one abstract idea are as follows (where the bolded portions are the “additional limitations” while the underlined portions continue to represent the at least one “abstract idea”):
A method comprising:
determining an activity score based on a respective value of each of a plurality of activity indicators associated with a user, wherein the activity score is used to detect when the user is engaging in, has engaged in, or will engage in exercise or other elevated activity, and wherein the plurality of activity indicators comprise at least one of:
a heartrate indicator that indicates an elevated blood flow, a heartbeat of the user, or an activity level of the user;
a location indicator that indicates a location associated with the user; or
a keyword indicator that indicates at least one keyword of a pre-scheduled event comprising at least one activity-related word (merely data gathering steps as noted below, see MPEP 2106.05(g) and Symantec);
determining that the activity score is above an activity threshold based on the respective value associated with each of the plurality of activity indicators; and
performing management of a diabetic condition based on the activity score being above the activity threshold.
For the following reasons, the Examiner submits that the above identified additional limitations do not integrate the above-noted at least one abstract idea into a practical application.
Regarding the additional limitations of the use of the plurality of activity indicators comprising at least one of, a heartrate indicator that indicates an elevated blood flow, a heartbeat of the user, or an activity level of the user; a location indicator that indicates a location associated with the user; or a keyword indicator that indicates at least one keyword of a pre-scheduled event comprising at least one activity-related word, these are merely pre-solution activity. The Examiner submits that this additional limitation merely adds insignificant extra-solution activity of collecting data to the at least one abstract idea in a manner that does not meaningfully limit the at least one abstract idea (see MPEP § 2106.05(g)). [0063] of the Applicant’s Specification recites interactions with the user’s device to acquire the activity indicators for location, or [0081] for the devices used to gather the heartrate indicator, for example. The use of the user devices to acquire the indicators are used to perform actions for the system including data gathering for the abstract idea, and thus recites insignificant pre-solution activities.
Taken alone, the additional elements do not integrate the at least one abstract idea into a practical application.
Looking at the additional limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. For instance, there is no indication that the additional elements, when considered as a whole, reflect an improvement in the functioning of a computer or an improvement to another technology or technical field, apply or use the above-noted judicial exception to perform management of a diabetic condition, implement/use the above-noted judicial exception with a particular machine or manufacture that is integral to the claim, effect a transformation or reduction of a particular article to a different state or thing, or apply or use the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is not more than a drafting effort designed to monopolize the exception, see MPEP 2106.04(d), 2106.05(a), 2106.05(b).
The remaining dependent claim limitations not addressed above fail to integrate the abstract idea into a practical application as set below:
Claim 6 recites additional elements of a user device that can autonomously perform the diabetic condition management, however because of this generic device generically automating part of the abstract idea, these limitations amount to nothing more than an instruction to apply the abstract idea using a generic computer and generic computing components (see MPEP § 2106.05(f)). Claim 7 recites the automatic nature of the abstract idea steps, however these limitations amount to nothing more than an instruction to apply the abstract idea using a generic computer and generic computing components. Claim 10 recites further detail of the keyword indicators that are gathered for the abstract idea; however, this still merely recites insignificant pre-solution activity. Claim 11 recites further detail of the blood flow data that are gathered using user devices and further detail of the heartrate indicators for the abstract idea, however this still merely recites insignificant pre-solution activity. Claim 12 similarly describes the heartrate indicator is detected based on change in acceleration of the user device, however this still merely recites insignificant pre-solution activity. Claim 13 similarly describes the heartrate indicator as being detecting using the user device based on deviation from heartrate from a previously stored threshold, however this still merely recites insignificant pre-solution activity. Claim 14 recites further detail of the keyword indicator as being detected and collected based on calendar planning accessed from a user device, however this still merely recites insignificant pre-solution activity. Claim 15 recites further detail of the location indicator as being detected based on pre scheduled events cross referenced with a list of locations, however this still merely recites insignificant pre-solution activity. Claim 16 recites further detail of the location indicator coming from GPS location and locations of a business with increased activity from the user, however this still merely recites insignificant pre-solution activity. Claim 17 recites the preserving battery power of the user device during operation by using the activity threshold to prevent the management of the diabetic condition based on the threshold, however these limitations amount to generally linking the use of a judicial exception to a particular technological environment or field of use (see MPEP § 2106.05(h)).
Thus, taken alone and in ordered combination, the additional elements do not integrate the at least one abstract idea into a practical application.
Patent Subject Matter Eligibility Test: Step 2B:
Regarding Step 2B of the Subject Matter Eligibility Test, the independent claim does not include additional elements (considered both individually and as an ordered combination) that are sufficient to amount to significantly more than the judicial exception for the same reasons to those discussed above with respect to determining that the claim does not integrate the abstract idea into a practical application, see MPEP 2106.05(II.). Further, it may need to be established, when determining whether a claim recites significantly more than a judicial exception, that the additional elements recite well understood, routine, and conventional activities, see MPEP 2106.05(d).
Regarding the additional limitations of the use of the plurality of activity indicators comprising at least one of, a heartrate indicator that indicates an elevated blood flow, a heartbeat of the user, or an activity level of the user; a location indicator that indicates a location associated with the user; or a keyword indicator that indicates at least one keyword of a pre-scheduled event comprising at least one activity-related word, these are merely pre-solution activity. The Examiner submits that this additional limitation merely adds insignificant extra-solution activity of collecting data to the at least one abstract idea in a manner that does not meaningfully limit the at least one abstract idea (see MPEP § 2106.05(g) and MPEP § 2106.05(d)(II), specifically “Symantec, 838 F.3d at 1321, 120 USPQ2d at 1362 (utilizing an intermediary computer to forward information)”). [0063] of the Applicant’s Specification recites interactions with the user’s device to acquire the activity indicators for location, or [0081] for the devices used to gather the heartrate indicator, for example. The use of the user devices to acquire the indicators are used to perform actions for the system including data gathering for the abstract idea, and thus recites insignificant pre-solution activities. The interconnected devices such as the GPS and other user devices to forward and send the indicator data for the method recites well understood, routine, and conventional activities.
The dependent claims do not include additional elements (considered both individually and as an ordered combination) that are sufficient to amount to significantly more than the judicial exceptions for the same reasons to those discussed above with respect to determining that the dependent claims do not integrate the at least one abstract idea into a practical application.
For the reasons stated, the claims fail the Subject Matter Eligibility Test and therefore claims 1-17 are rejected under 35 USC 101 as being directed to non-statutory subject matter.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-17 are rejected under 35 USC 102(a)(2) as being anticipated by US 20190236465 A1 to Vleugels (“Vleugels”):
Regarding claim 1:
Vleugels teaches a method comprising: determining an activity score based on a respective value of each of a plurality of activity indicators associated with a user, ([0172]- confidence level of eating event occurring (confidence level interpreted as activity score). [0173]- determination of eating event based on inputs (the inputs are interpreted as the respective value of each of a plurality of activity indicators associated with the user).)
wherein the activity score is used to detect when the user is engaging in, has engaged in, or will engage in exercise or other elevated activity, ([0172, 0173]- confidence score determines if eating event is occurring by using additional inputs and gestures (eating event interpreted as elevated activity).)
and wherein the plurality of activity indicators comprise at least one of: a heartrate indicator that indicates an elevated blood flow, a heartbeat of the user, or an activity level of the user; a location indicator that indicates a location associated with the user; or a keyword indicator that indicates at least one keyword of a pre-scheduled event comprising at least one activity-related word; ([0170]- heartrate is considered as a factor for the autonomous detection of food intake event)
determining that the activity score is above an activity threshold based on the respective value associated with each of the plurality of activity indicators; and ([0172]- confidence level exceeds a pre-configured threshold to determine prediction if eating event occurred)
performing management of a diabetic condition based on the activity score being above the activity threshold. ([0207]- an insulin microdosing apparatus being controlled to release insulin based on confidence level of eating event beginning (control of insulin release interpreted as performing management of diabetic condition based on activity score above threshold).)
Regarding claim 2:
Vleugels teaches all of the limitations of claim 1. Vleugels further teaches wherein the activity threshold indicates that a threshold number of activity indicators have been detected. ([0172]- use of threshold)
Regarding claim 3:
Vleugels teaches all of the limitations of claim 1. Vleugels further teaches wherein the activity threshold is configured by the user. ([0172]- thresholds are pre-configured)
Regarding claim 4:
Vleugels teaches all of the limitations of claim 1. Vleugels further teaches wherein a form of the management of the diabetic condition that is performed depends on the activity indicators or the activity score. ([0207]- an insulin microdosing apparatus being controlled to release insulin based on confidence level of eating event beginning)
Regarding claim 5:
Vleugels teaches all of the limitations of claim 1. Vleugels further teaches wherein each activity indicator of the plurality of activity indicators comprises a respective weight to determine the activity score. ([0172]- confidence level given to a detected gesture (indicates confidence or weight of eating event given to each activity indicator).)
Regarding claim 6:
Vleugels teaches all of the limitations of claim 1. Vleugels further teaches wherein the management of the diabetic condition is autonomously performed via at least one of a user device or an insulin pump. ([0151, 0152]- the event detection system can be connected to an insulin pump to control insulin levels based on if event has been detected (interpreted as autonomous diabetic condition management).)
Regarding claim 7:
Vleugels teaches all of the limitations of claim 6. Vleugels further teaches wherein the management of the diabetic condition comprises automatically controlling a basal rate of the insulin pump. ([0151, 0152]- the event detection system can be connected to an insulin pump to control insulin levels based on if event has been detected (interpreted as autonomous insulin pump control).)
Regarding claim 8:
Vleugels teaches all of the limitations of claim 7. Vleugels further teaches wherein the management of the diabetic condition comprises delivering a meal bolus of insulin to the user via the insulin pump. ([0207]- an insulin microdosing apparatus being controlled to release insulin based on confidence level of eating event beginning)
Regarding claim 9:
Vleugels teaches all of the limitations of claim 7. Vleugels further teaches wherein the basal rate of the insulin pump is controlled differently based on different activity indicators indicating different levels of activity or information associated with the user, wherein activity levels below a threshold being detected based on the activity indicators causes a first basal rate of the insulin pump, and wherein activity levels above the threshold being detected based on the activity indicators causes a second basal rate of the insulin pump for a period of time, wherein the second basal rate is higher than the first basal rate. ([0152, 0207]- microdosing system used to begin insulin regulation based on detection of eating event and prediction of when eating will occur (indicates multiple basal rates based on activity).)
Regarding claim 10:
Vleugels teaches all of the limitations of claim 1. Vleugels further teaches wherein each number of keyword indicators increase a weight associated with the activity score. ([0164]- use of the data retrieved from calendar. [0173-174]- more input data, increase confidence level (indicates with more keywords, increase confidence level of eating event occurring).)
Regarding claim 11:
Vleugels teaches all of the limitations of claim 1. Vleugels further teaches wherein the blood flow of the user or the heartrate of the user are detected via a user device, a wearable device, or a heartrate monitor, and wherein the heartrate indicator is detected when the heartrate or blood flow of the user is above a threshold. ([0169]- use of heart rate sensor. [0175]- use of triggers (indicates crossing a threshold to detect activity) which includes monitoring the heart rate)
Regarding claim 12:
Vleugels teaches all of the limitations of claim 1. Vleugels further teaches wherein the heartrate indicator is detected based on a change in acceleration or orientation of a user device. ([0052]- accelerometer used to detect food intake activity of the user (for detecting the activity level of the user).)
Regarding claim 13:
Vleugels teaches all of the limitations of claim 1. Vleugels further teaches wherein the heartrate indicator is detected at a user device based on a deviation from a heartrate, blood flow, or activity level previously stored at the user device. ([0176]- use of historical data such as recent heart rate for tracking previous eating events.)
Regarding claim 14:
Vleugels teaches all of the limitations of claim 1. Vleugels further teaches wherein the keyword indicator is detected based on a calendar or other event planning or scheduling medium configured to be accessed via a user device. ([0206]- use of calendar)
Regarding claim 15:
Vleugels teaches all of the limitations of claim 1. Vleugels further teaches wherein the location indicator is detected based on a pre-scheduled event being cross referenced with a list of locations. ([0206]- calendar has pre stored data related to location)
Regarding claim 16:
Vleugels teaches all of the limitations of claim 1. Vleugels further teaches wherein the location indicator is detected based on a GPS location, a short-range radio frequency (RF) communication, or an input of a user at a user device indicating that the user is currently located at a business or location where increased user activity will occur. ([0206]- use of GPS.)
Regarding claim 17:
Vleugels teaches all of the limitations of claim 1. Vleugels further teaches wherein the management of the diabetic condition is performed via a user device or an insulin pump that comprises a battery, an wherein the activity threshold is configured to prevent the management of the diabetic condition from being performed prior to the activity score being determined to be above the activity threshold to preserve power of the battery during operation. ([0234]- battery usage and saving battery power considered based on detection of meal activity)
The following references have been considered, however have not been used in the above rejections:
WO 2018031803 A1 to Cabrera et al. teaches of glucose monitoring and using insulin data along with data from calendar events and location to determine when eating is occurring.
NPL “Insulin pump therapy guidelines for successful outcomes” to Scheiner et al. teaches of consideration of meal time activity when using insulin pump.
Conclusion
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/CONSTANTINE SIOZOPOULOS/
Examiner
Art Unit 3686