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 .
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 1-20 are rejected under 35 U.S.C. §101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1:
Claims 1-10 are directed to a method (i.e., a process) and claims 11-20 are directed to a system (i.e., a machine). Accordingly, claims 1-20 are all within at least one of the four statutory categories.
Step 2A - Prong One:
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) certain methods of organizing human activity, b) mental processes, and/or c) mathematical concepts.
Representative independent claim 1 includes limitations that recite at least one abstract idea. Specifically, independent claim 1 recites:
1. A method for managing alerts communicated to a user of an insulin delivery pump, the method comprising:
determining a pattern indicative of a user experience based on a plurality of user data relating to use of plurality of insulin delivery pumps different from the insulin delivery pump;
determining an event corresponding to the pattern;
determining a user record corresponding to the user of the insulin delivery pump;
determining the user record comprises the event;
determining a user message associated with the event, the user message corresponding to the user experience;
causing, based on determining the user record comprises the event, a user device associated with the insulin delivery pump to present the user message; and
populating, automatically, the user record with a record of the user message.
The Examiner submits that the foregoing underlined limitations constitute “a mental process” because determining a pattern indicative of a user experience based on a plurality of user data; determining an event corresponding to the pattern; determining a user record corresponding to the user; determining the user record comprises the event; determining a user message associated with the event, the user message corresponding to the user experience; causing, based on determining the user record comprises the event, to present the user message; and populating the user record with a record of the user message amount to observations/evaluations/judgments/analyses that can, at the currently claimed high level of generality, be practically performed in the human mind or via pen and paper.
Accordingly, the claim recites at least one abstract idea.
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 integrate 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 exception into a “practical application.”
The limitations of claims 1 and 11, as drafted, is a process that, under its broadest reasonable interpretation, covers performance of the limitations in the mind but for the recitation of generic computer components. That is, other than reciting insulin delivery pumps, a user device, a memory, and at least one computer processor to perform the limitations, nothing in the claim elements precludes the steps from practically being performed in the mind. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components, then it falls within the “Mental Processes” grouping of abstract ideas. Accordingly, the claims recite an abstract idea.
This judicial exception is not integrated into a practical application. In particular, the insulin delivery pumps, user device, memory, and at least one computer processor are recited at a high-level of generality (i.e., as generic computer components performing generic computer functions of determining data, presenting data, and populating data) such that it amounts no more than mere instructions to apply the exception using generic computer components. Accordingly, these additional elements do not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. The claims are directed to an abstract idea.
Thus, taken alone, the additional elements do not amount to significantly more than the above-identified judicial exception (the abstract idea). Looking at the 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 effect a particular treatment or prophylaxis for a disease or medical 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 § 2106.05). Their collective functions merely provide conventional computer implementation.
Claims 2-10 and 12-20 are ultimately dependent from Claim(s) 1 and 11 and include all the limitations of Claim(s) 1 and 11. Therefore, claim(s) 2-10 and 12-20 recite the same abstract idea. Claims 2-10 and 12-20 describe further limitations regarding determining the user message based on the user experience; associating the user message with the event; determine the user message is associated with the event; a plurality of events associated with a plurality of user messages; wherein the user message comprises textual, video, haptic, and/or audio information; wherein the user message is a training video adapted to be displayed; wherein the user message is a reminder to change the insulin pump infusion site; determining sensor data, wherein the event is determined based on the sensor data; wherein the event is determined based on an amount of elapsed time and/or a set amount of event indicators; determining a second user message associated with the user record; and determining, before presenting the user message, that the user message does not conflict with the second user message. These are all just further describing the abstract idea recited in claims 1 and 11, without adding significantly more.
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 elements amount to no more than mere instructions to apply the exception using generic computer components. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept. The claims are not patent eligible.
Step 2B:
Regarding Step 2B, independent claims 1 and 11 do 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 reasons the same as those discussed above with respect to determining that the claim does not integrate the abstract idea into a practical application.
Regarding the additional limitation directed to causing a user device associated with the insulin delivery pump to present the user message, all of which the Examiner submits merely add insignificant extra-solution activity to the abstract idea or are claimed in a merely generic manner (e.g., at a high level of generality), the Examiner further submits that such steps are not unconventional as they merely consist of receiving and transmitting data over a network. See MPEP 2106.05(d)(II).
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 exception 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.
Therefore, claims 1-20 are ineligible under 35 USC §101.
Claim Objections
Claims 7 and 17 are objected to because of the following informalities: change “the insulin pump infusion site” to “the insulin pump’s infusion site.” Appropriate correction is required.
Claims 12, 18, and 20 are objected to because of the following informalities: change “access memory…” to “access the memory…” Appropriate correction is required.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Brewer et al. (US 2022/0130506 A1).
(A) Referring to claim 1, Brewer discloses A method for managing alerts communicated to a user of an insulin delivery pump, the method comprising (para. 13 & 35 of Brewer; inventory management system can automatically keep the PWD or a caregiver updated in real-time about their usage patterns and remaining supply and prompt the user to reorder needed supplies (or can automatically reorder such supplies when, for instance, the user has preauthorized such automatic reorders). For example, inventory management systems can provide alerts and notifications to a PWD and/or caregiver's computing device, such as push notifications, regarding status, reorder suggestions/confirmations, automatically placed reorders, and/or other relevant information. In some cases, a PWD or caregiver can enter information into an insulin pump or a handheld device configured to control an insulin pump to indicate to the inventory management system they have used or disposed of a diabetes supply. The controller can include a display that is programmed to output alerts in a graphical user interface presented on the display, the alerts being output to the person with diabetes about a personal diabetes supplies inventory condition.):
determining a pattern indicative of a user experience based on a plurality of user data relating to use of plurality of insulin delivery pumps different from the insulin delivery pump (para. 7, 31, & 35 of Brewer; methods and systems provided herein can estimate a personal inventory based on a recommended usage pattern, a usage pattern particular to the PWD, an average usage pattern for typical PWDs, or based on activities detected by the system. Additionally, upon the PWD seeking to fulfill the service prescription by providing the payment or copay, a determination of the initial supplies and quantities needed for the PWD will be automatically determined based upon the expected usage patterns, reorder delivery time period, and/or permitted usage and reorder parameters for the PWD, insurance provider, and/or prescription service. For example, the total daily insulin amount can determine an estimated rate of insulin use by the PWD. In some cases, inventory management system can automatically keep the PWD or a caregiver updated in real-time about their usage patterns and remaining supply and prompt the user to reorder needed supplies (or can automatically reorder such supplies when, for instance, the user has preauthorized such automatic reorders). For example, inventory management systems can provide alerts and notifications to a PWD and/or caregiver's computing device, such as push notifications, regarding status, reorder suggestions/confirmations, automatically placed reorders, and/or other relevant information.);
determining an event corresponding to the pattern (para. 35 of Brewer; In some cases, inventory management system can automatically keep the PWD or a caregiver updated in real-time about their usage patterns and remaining supply and prompt the user to reorder needed supplies (or can automatically reorder such supplies when, for instance, the user has preauthorized such automatic reorders). For example, inventory management systems can provide alerts and notifications to a PWD and/or caregiver's computing device, such as push notifications, regarding status, reorder suggestions/confirmations, automatically placed reorders, and/or other relevant information.);
determining a user record corresponding to the user of the insulin delivery pump (para. 35 of Brewer; In some cases, inventory management system can automatically keep the PWD or a caregiver updated in real-time about their usage patterns and remaining supply and prompt the user to reorder needed supplies (or can automatically reorder such supplies when, for instance, the user has preauthorized such automatic reorders). For example, inventory management systems can provide alerts and notifications to a PWD and/or caregiver's computing device, such as push notifications, regarding status, reorder suggestions/confirmations, automatically placed reorders, and/or other relevant information. In some cases, a PWD or caregiver can enter information into an insulin pump or a handheld device configured to control an insulin pump to indicate to the inventory management system they have used or disposed of a diabetes supply. In some cases, a PWD or caregiver can use their computing device to provide updates to the inventory management system with an updated count for each delivered diabetes supply. In some cases, devices and systems provided herein can automatically track usage and/or maintenance activities to automatically estimate a remaining count of the diabetes supplies.);
determining the user record comprises the event (para. 35 of Brewer; in regards to FIG. 4, customer care system 1070 can include a GUI including both a personal inventory features and a virtual inventory features that can be output concurrently and combined in the same GUI view. In some cases, inventory management system can automatically keep the PWD or a caregiver updated in real-time about their usage patterns and remaining supply and prompt the user to reorder needed supplies (or can automatically reorder such supplies when, for instance, the user has preauthorized such automatic reorders). For example, inventory management systems can provide alerts and notifications to a PWD and/or caregiver's computing device, such as push notifications, regarding status, reorder suggestions/confirmations, automatically placed reorders, and/or other relevant information. As discussed above, various techniques can be used to provide such notifications to a PWD and/or caregiver's computing device when the device is offline, such as through communication with a secondary/alternative computing device. In some cases, a PWD or caregiver can enter information into an insulin pump or a handheld device configured to control an insulin pump to indicate to the inventory management system they have used or disposed of a diabetes supply. In some cases, a PWD or caregiver can use their computing device to provide updates to the inventory management system with an updated count for each delivered diabetes supply. In some cases, devices and systems provided herein can automatically track usage and/or maintenance activities to automatically estimate a remaining count of the diabetes supplies.);
determining a user message associated with the event, the user message corresponding to the user experience (para. 35 of Brewer; in regards to FIG. 4, customer care system 1070 can include a GUI including both a personal inventory features and a virtual inventory features that can be output concurrently and combined in the same GUI view. In some cases, inventory management system can automatically keep the PWD or a caregiver updated in real-time about their usage patterns and remaining supply and prompt the user to reorder needed supplies (or can automatically reorder such supplies when, for instance, the user has preauthorized such automatic reorders). For example, inventory management systems can provide alerts and notifications to a PWD and/or caregiver's computing device, such as push notifications, regarding status, reorder suggestions/confirmations, automatically placed reorders, and/or other relevant information. As discussed above, various techniques can be used to provide such notifications to a PWD and/or caregiver's computing device when the device is offline, such as through communication with a secondary/alternative computing device. In some cases, a PWD or caregiver can enter information into an insulin pump or a handheld device configured to control an insulin pump to indicate to the inventory management system they have used or disposed of a diabetes supply. In some cases, a PWD or caregiver can use their computing device to provide updates to the inventory management system with an updated count for each delivered diabetes supply. In some cases, devices and systems provided herein can automatically track usage and/or maintenance activities to automatically estimate a remaining count of the diabetes supplies.);
causing, based on determining the user record comprises the event, a user device associated with the insulin delivery pump to present the user message (para. 35, 36, 64, and 13 of Brewer; in regards to FIG. 4, customer care system 1070 can include a GUI including both a personal inventory features and a virtual inventory features that can be output concurrently and combined in the same GUI view. In some cases, inventory management system can automatically keep the PWD or a caregiver updated in real-time about their usage patterns and remaining supply and prompt the user to reorder needed supplies (or can automatically reorder such supplies when, for instance, the user has preauthorized such automatic reorders). For example, inventory management systems can provide alerts and notifications to a PWD and/or caregiver's computing device, such as push notifications, regarding status, reorder suggestions/confirmations, automatically placed reorders, and/or other relevant information. As discussed above, various techniques can be used to provide such notifications to a PWD and/or caregiver's computing device when the device is offline, such as through communication with a secondary/alternative computing device. In some cases, a PWD or caregiver can enter information into an insulin pump or a handheld device configured to control an insulin pump to indicate to the inventory management system they have used or disposed of a diabetes supply. In some cases, a PWD or caregiver can use their computing device to provide updates to the inventory management system with an updated count for each delivered diabetes supply. In some cases, devices and systems provided herein can automatically track usage and/or maintenance activities to automatically estimate a remaining count of the diabetes supplies.); and
populating, automatically, the user record with a record of the user message (para. 46, 26, 29, 34, and 35 of Brewer; inventory management systems can provide alerts and notifications to a PWD and/or caregiver's computing device, such as push notifications, regarding status, reorder suggestions/confirmations, automatically placed reorders, and/or other relevant information. As discussed above, various techniques can be used to provide such notifications to a PWD and/or caregiver's computing device when the device is offline, such as through communication with a secondary/alternative computing device. In some cases, a PWD or caregiver can enter information into an insulin pump or a handheld device configured to control an insulin pump to indicate to the inventory management system they have used or disposed of a diabetes supply. In some cases, a PWD or caregiver can use their computing device to provide updates to the inventory management system with an updated count for each delivered diabetes supply. In some cases, devices and systems provided herein can automatically track usage and/or maintenance activities to automatically estimate a remaining count of the diabetes supplies. In some cases, the types of supplies to be delivered to the PWD or caregiver can be automatically populated based on a prescription that is processed for a PWD, such as through the form 2000 described above in FIG. 2. A PWD or caregiver may be prompted to confirm addition of one or more automatically identified supplies before they are formally added to the types of supplies to be delivered to the PWD or caregiver.).
(B) Referring to claim 2, Brewer discloses further comprising: determining the user message based on the user experience; and associating the user message with the event in a database (para. 7, 12-14 & 35 of Brewer).
(C) Referring to claim 3, Brewer discloses wherein determining the user message is associated with the event comprises using the database to determine the user message is associated with the event (para. 7, 12-14 & 35 of Brewer).
(D) Referring to claim 4, Brewer discloses wherein the database comprises a plurality of events associated with a plurality of user messages (para. 12-14 of Brewer).
(E) Referring to claim 5, Brewer discloses wherein the user message comprises textual, video, haptic, and/or audio information (para. 33-35 of Brewer).
(F) Referring to claim 6, Brewer discloses wherein the user message is a training video adapted to be displayed on the user device (para. 33 of Brewer).
(G) Referring to claim 7, Brewer discloses wherein the user message is a reminder to change the insulin pump infusion site (para. 8, 39, 40, 43, and 63 of Brewer).
(H) Referring to claim 8, Brewer discloses further comprising determining sensor data, wherein the event is determined based on the sensor data (para. 35 of Brewer).
(I) Referring to claim 9, Brewer discloses wherein the event is determined based on an amount of elapsed time and/or a set amount of event indicators (para. 14, 28, and 31 of Brewer).
(J) Referring to claim 10, Brewer discloses further comprising: determining a second user message associated with the user record; and determining, before causing the user device to present the user message, that the user message does not conflict with the second user message (para. 32, 39, 13, and 35 of Brewer).
(K) Claim 11 differs from claim 1 by reciting “A system for managing alerts communicated to a user of an insulin delivery pump, the system comprising: memory configured to store computer-executable instructions; and at least one computer processor configured to access memory and execute the computer-executable instructions to:” (see Figures 3A & 3B, para. 13, 35, 39, and 54 of Brewer).
The remainder of claim 11 repeats the same limitations as claim 1, and is therefore rejected for the same reasons given above.
(L) Claims 12-20 repeat substantially the same limitation as claims 2-10, and are therefore rejected for the same reasons given above.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The cited but not applied prior art teaches remote monitoring of analyte measurements (US 2014/0187890 A1); systems and methods for providing bolus dosage recommendations (US 2010/0161346 A1); pattern recognition and filtering in a therapy management system (US 2010/0161236 A1); and safety system for insulin delivery advisory algorithms (US 2010/0145262 A1).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LENA NAJARIAN whose telephone number is (571)272-7072. The examiner can normally be reached Monday - Friday 9:30 am-6 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Mamon Obeid can be reached at (571)270-1813. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LENA NAJARIAN/Primary Examiner, Art Unit 3687
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