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 .
The Amendment filed on 02/10/26 has been received and entered. Application No. 18/790,416 of which claims 2, 10, 17 and 18 are canceled. Claims 1, 3-9, 11-16, and 19-24 are pending in the application, all of which are ready for examination by the examiner.
Continued Examination under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 02/10/2026 has been entered.
Response to Amendment
Applicant’s amendment necessitated new grounds of rejection.
Applicant’s response, filed on 02/10/26, with respect to 101 rejections directed to an abstract idea of claims 1, 3-9, 11-16, and 19-24 have been fully considered but are not persuasive. The rejections are maintained.
Applicant’s response with respect to double patenting rejections of claims 1, 3-9, 11-16, and 19-24 have been fully considered but are not persuasive. The rejections are maintained.
Response to Arguments
Applicant's arguments with respect to 35 USC § 101 rejections of claims 1, 3-9, 11-16, and 19-24 have been fully considered but are not persuasive. Applicant made the following arguments:
Regarding claims 1, 9 and 16, Applicant argues “Applicant submits that the claims are not directed to a mental process, but rather, the claims are directed to a diabetes data management system that assists in preventing incorrect data entry due to user error by cross-checking user data against secondary data collected by a sensor assembly. Further, the claims recite steps of using sensors to measure relevant data (e.g., blood glucose level, blood pressure, heart rate, etc.) which is not possible to perform in the human mind. The claims further recite administering medication via an artificial pancreas, which is not possible to perform in the human mind”.
Examiner respectfully disagrees. The claimed limitations cross-checking the user-entered event data against the secondary data to determine whether the user-entered event data is consistent with the secondary data via the processor; assigning a state and a weight to the user-entered event data based on a result of cross-checking, wherein the state indicates a status of the user-entered event data, and wherein the weight indicates a confidence level of the user-entered event data; after cross-checking the user-entered event data against the secondary data, wherein the request is based on the state assigned to the user-entered event data; determining a diabetes management recommendation in response to the updated state and the updated weight assigned to the user-entered event data indicating a change in medication, testing, diet, or exercise. The limitations of cross-checking…, determine…, assigning…, as drafted, are processes that, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components. That is, other than reciting “method…,” nothing in the claim element precludes the step from practically being performed in the mind. For example, but for the “method…,” “of “cross-checking…, determine…, assigning…,” in the context of these claims encompass the user manually cross-checking user-entered data against secondary data, determine data consistency, assigning a state and weight to user-entered data, determining . 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 claim recites an abstract idea. This judicial exception is not integrated into a practical application. In particular, the claim only recites additional elements – request…, store…, obtaining…, displaying…, updating…, administering…. The “administering” limitations amount to mere instructions to apply an exception (see MPEP 2106.05f). The “request”, “store”, “obtaining”, “displaying”, and “updating” limitations are insignificant extra-solution activity (mere data gathering, outputting, please see MPEP 2106.05g). Accordingly, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. The claims 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. “Administering” amounts to mere instructions to apply an exception (see MPEP 2106.05f). The additional elements of “request”, “store”, “obtaining”, “displaying”, and “updating” is a well-understood, routine, and conventional activity (data gathering, outputting, see MPEP 2106.05d). The additional elements, individually and in combination, also do not amount to significantly more than the abstract idea. Examiner points that the improvement cannot be part of the abstract idea itself. Therefore, Applicant’s arguments are not persuasive. See 101 rejections below.
Regarding claims 1, 9 and 16, Applicant argues “The claims include limitations that integrate the alleged abstract idea into a practical application”.
Examiner respectfully disagrees. Examiner points to response to arguments II above. This judicial exception is not integrated into a practical application. In particular, the claim only recites additional elements – request…, store…, obtaining…, displaying…, updating…, administering…. The “administering” limitations amount to mere instructions to apply an exception (see MPEP 2106.05f). The “request”, “store”, “obtaining”, “displaying”, and “updating” limitations are insignificant extra-solution activity (mere data gathering, outputting, please see MPEP 2106.05g). Accordingly, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. The claims 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. “Administering” amounts to mere instructions to apply an exception (see MPEP 2106.05f). The additional elements of “request”, “store”, “obtaining”, “displaying”, and “updating” is a well-understood, routine, and conventional activity (data gathering, outputting, see MPEP 2106.05d). The additional elements, individually and in combination, also do not amount to significantly more than the abstract idea. Therefore, Applicant’s arguments are not persuasive. See 101 rejections below.
Regarding claims 1, 9 and 16, Applicant argues “that amended independent claims 1, 9, and 16 recite additional elements that integrate any alleged judicial exception into a practical application… the claims recite an improvement to the technical field by requesting the user to confirm or correct user-entered event data against secondary event data and determining a diabetes management recommendation for the user to reduce the impact of user-entered data errors in a data management system. Further, the claims administer medication according to the diabetes management recommendation”.
Examiner respectfully disagrees. Examiner points to response to arguments II & III above. This judicial exception is not integrated into a practical application. In particular, the claim only recites additional elements – request…, store…, obtaining…, displaying…, updating…, administering…. The “administering” limitations amount to mere instructions to apply an exception (see MPEP 2106.05f). The “request”, “store”, “obtaining”, “displaying”, and “updating” limitations are insignificant extra-solution activity (mere data gathering, outputting, please see MPEP 2106.05g). Accordingly, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. The claims 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. “Administering” amounts to mere instructions to apply an exception (see MPEP 2106.05f). The additional elements of “request”, “store”, “obtaining”, “displaying”, and “updating” is a well-understood, routine, and conventional activity (data gathering, outputting, see MPEP 2106.05d). The additional elements, individually and in combination, also do not amount to significantly more than the abstract idea. Examiner points that the improvement cannot be part of the abstract idea itself. Therefore, Applicant’s arguments are not persuasive. See 101 rejections below.
Regarding claims 1, 9 and 16, Applicant argues “The claims include "significantly more" than the alleged abstract idea and are not well-understood, routine, or conventional activity in the field”.
Examiner respectfully disagrees. Examiner points to response to arguments II, III, & IV above.
Applicant’s arguments with respect to 35 USC § 103 rejections of claims 1, 3-9, 11-16, and 19-24 have been fully considered but are moot because the arguments do not apply to any of the references being used in the current rejection.
Double Patenting
The non-statutory 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 non-statutory double patenting rejection is appropriate where the claims at issue 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); and 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 a non-statutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement.
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Claims 1, 3-9, 11-16, 19-24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No.12,079,199 in view of Weinert et al. (U.S. PGPub 2009/0006133).
Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1, 3-9, 11-16, 19-24 would have been an obvious variation of the invention defined in the patented claims to one of ordinary skill in the art. See the table below.
Instant Application
Claims 1 & 9 & 16 and claim 6. A method of reducing impact of user-entered data errors in a data management system (DMS), the DMS executing a DMS application on a processor to request user-entered event data from a user for an event via a DMS application interface
and store the user-entered event data received from the user into a primary DMS database, the method comprising: obtaining secondary data from one or more sensors;
cross-checking the user-entered event data against the secondary data to
determine whether the user-entered event data is consistent with the
secondary data via the processor; assigning a state and a weight to the user-entered event data based on a result of
cross-checking, wherein the state indicates a status of the user-entered
event data, and wherein the weight indicates a confidence level of the user-entered event data; displaying a request to the user to review and correct or confirm the user-entered event data after cross-checking the user-entered event data against the secondary data, wherein the request is based on the state assigned to the user-entered event data; updating the state and the weight of the user-entered event data in the primary DMS
database to an updated state and an updated weight based on a user's response to the request; and
determining a diabetes management recommendation in response to the updated state and the updated weight assigned to the user-entered event data; and administering medication via an artificial pancreas according to the diabetes management recommendation.
Claim 6. The method of claim 1, wherein at least one sensor of the one or more sensors detects non-glucose data.
Claims 4, 14 & 19. The method of claim 1 , wherein the state is at least one of "to be reviewed", "suspect", "unverified", "verified", "validated", and "invalidated", wherein the weight is a numerical value.
Claim 7. The method of claim 6, wherein the at least one sensor is an on-body sensor capable of detecting at least one of: analytes, blood pressure, heart rate, pulse, wakefulness, breathing rate, respiration, body temperature, ambient temperature, pulse oximetry, humidity, electrocardiogram, movement, acceleration, proximity, direction,
altitude, speed, applied force, pressure, perspiration, aging, sound, eating, drinking, snoring, bodyweight, height, and body composition.
Patent U.S. 12,079,199
Claims 1, 8 &14. A method of reducing impact of user-entered data errors in a data management system (DMS), the DMS executing a DMS application on a processor to request user-entered event data from a user for an event via a DMS application interface and store the user-entered event data received from the user into a primary DMS database, the method comprising: obtaining secondary data from at least two sensors, wherein a first sensor detects non-glucose data; storing the secondary data into a secondary tracking database; cross-checking the user-entered event data against the secondary data to determine whether the user-entered event data is consistent with the secondary data via the processor; assigning a state and a weight to the user-entered event data based on a result of cross-checking, wherein the state indicates a status of the user-entered event data, and wherein the weight indicates a confidence level in an accuracy of the user-entered event data; displaying a request to the user to review and correct or confirm the user-entered event data based on the state, wherein displaying the request includes prompting the user to indicate whether the user-entered event data are more accurate than the secondary data or whether the secondary data is more accurate than the user-entered event data; updating the state and the weight of the user-entered event data in the primary DMS database to an updated state and an updated weight based on a user's response to the request; and updating a diabetes management plan in response to the updated state and the updated weight assigned to the user-entered event data indicating a change in medication, testing, diet, or exercise.
Claims 5, 12 & 18. The method of claim 1, wherein the state is at least one of “to be reviewed”, “suspect”, “unverified”, “verified”, “validated”, and “invalidated”.
Claim 16. The method of claim 14, wherein the first sensor is an on-body sensor capable of detecting at least one of: analytes other than blood glucose, blood pressure, heart rate, pulse, wakefulness, breathing rate, respiration, body temperature, ambient temperature, pulse oximetry, humidity, electrocardiogram, movement, acceleration, proximity, direction, altitude, speed, applied force, pressure, perspiration, aging, sound, eating/drinking, snoring, bodyweight, height, and body composition.
Table 1
Although the conflicting claims are not identical, they are not patentably distinct from each other because claims 1, 3-9, 11-16, 19-24 of the instant application substantially recite the limitations of claims 1-19 of U.S. Patent No.12,079,199 which is the system and method to reduce the impact of user-entered data errors in diabetes management. Therefore, it would have been obvious to one of ordinary skill in the art of indicating whether the user-entered event data are more accurate than the secondary data or whether the secondary data is more accurate than the user-entered event data at the time the invention was made to incorporate the system and method for abstracting configuration data from blockchain from the independent claims 1-19 of U.S. Patent No.12,079,199. Regarding claims 1, 9, and 16, Claims 1, 8, and 14 of the patent does not explicitly disclose "administering medication via an artificial pancreas according to the diabetes management recommendation". One of ordinary skill in the art would have found these differences to be obvious because Weinert teaches drug administration information in form of recommended dosage [0004]-[0006] and diabetes control arrangement, administering medication process [0037]-[0038] and [0043]. One would have been motivated to administer medication via an administration device according to the diabetes management recommendation (Figures 4-5) [0009]-[0010], [0050].
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, 3-9, 11-16, and 19-24 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claims 1 and 9 recite cross-checking the user-entered event data against the secondary data to determine whether the user-entered event data is consistent with the secondary data via the processor; assigning a state and a weight to the user-entered event data based on a result of cross-checking, wherein the state indicates a status of the user-entered event data, and wherein the weight indicates a confidence level of the user-entered event data; after cross-checking the user-entered event data against the secondary data, wherein the request is based on the state assigned to the user-entered event data; determining a diabetes management recommendation in response to the updated state and the updated weight assigned to the user-entered event data indicating a change in medication, testing, diet, or exercise.
The limitations of cross-checking…, determine…, assigning…, as drafted, are processes that, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components. That is, other than reciting “method…,” nothing in the claim element precludes the step from practically being performed in the mind. For example, but for the “method…,” “of “cross-checking…, determine…, assigning…,” in the context of these claims encompass the user manually cross-checking user-entered data against secondary data, determine data consistency, assigning a state and weight to user-entered data, determining . 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 claim recites an abstract idea.
This judicial exception is not integrated into a practical application. In particular, the claim only recites additional elements – request…, store…, obtaining…, displaying…, updating…, administering…. The “administering” limitations amount to mere instructions to apply an exception (see MPEP 2106.05f). The “request”, “store”, “obtaining”, “displaying”, and “updating” limitations are insignificant extra-solution activity (mere data gathering, outputting, please see MPEP 2106.05g). Accordingly, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. The claims 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. “Administering” amounts to mere instructions to apply an exception (see MPEP 2106.05f). The additional elements of “request”, “store”, “obtaining”, “displaying”, and “updating” is a well-understood, routine, and conventional activity (data gathering, outputting, see MPEP 2106.05d). The additional elements, individually and in combination, also do not amount to significantly more than the abstract idea.
The claim 3 recites assessing an accuracy of the user-entered event data based on the updated state and the updated weight, wherein determining the diabetes management plan is based at least in part on the accuracy of the user-entered event data. The limitations only recite additional elements at a high level of generality. These limitations are recited at a high-level of generality (i.e., accessing, determining) such that it amounts no more than mere instructions to apply the exception using a generic computer component. Accordingly, this 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 claim is directed to an abstract idea. The additional elements, individually and in combination, also do not amount to significantly more than the abstract idea.
The claims 4, 14 and 19 recite wherein the state is at least one of "to be reviewed", "suspect", "unverified", "verified", "validated", and "invalidated", wherein the weight is a numerical value. The limitations only recite additional elements recited at a high level of generality. Accordingly, this 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. The additional elements, individually and in combination, also do not amount to significantly more than the abstract idea.
The claims 5 and 20 recite wherein the request is presented as a question to the user on a display of a DMS device executing the DMS application. The limitations only recite additional elements recited at a high level of generality. Accordingly, this 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. The additional elements, individually and in combination, also do not amount to significantly more than the abstract idea.
The claim 6 recites wherein at least one sensor of the one or more sensors detects non-glucose data. The limitations only recite additional elements recited at a high level of generality. Accordingly, this 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 claim is directed to an abstract idea. The additional elements, individually and in combination, also do not amount to significantly more than the abstract idea.
The claim 7 recites wherein the at least one sensor is an on-body sensor capable of detecting at least one of: analytes, blood pressure, heart rate, pulse, wakefulness, breathing rate, respiration, body temperature, ambient temperature, pulse oximetry, humidity, electrocardiogram, movement, acceleration, proximity, direction, altitude, speed, applied force, pressure, perspiration, aging, sound, eating, drinking, snoring, bodyweight, height, and body composition. The limitations only recite additional elements at a high level of generality. These limitations are recited at a high-level of generality (i.e., detecting) such that it amounts no more than mere instructions to apply the exception using a generic computer component. Accordingly, this 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 claim is directed to an abstract idea. The additional elements, individually and in combination, also do not amount to significantly more than the abstract idea.
The claim 8 recites associating the secondary data with one or more events described by user-entered data stored in the primary DMS database, wherein associating the secondary data with the one or more events includes storing pointers to the secondary data in records of the primary DMS database associated with the one or more events. The limitations only recite additional elements at a high level of generality. These limitations are recited at a high-level of generality (i.e., associating, storing) such that it amounts no more than mere instructions to apply the exception using a generic computer component. Accordingly, this 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 claim is directed to an abstract idea. The additional elements, individually and in combination, also do not amount to significantly more than the abstract idea.
The claim 11 recites wherein the secondary data comprises results of one or more rulesets stored in the memory applied to the user-entered event data stored in the primary DMS database related to the event. The limitations only recite additional elements recited at a high level of generality. Accordingly, this 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 claim is directed to an abstract idea. The additional elements, individually and in combination, also do not amount to significantly more than the abstract idea.
The claim 12 recites a secondary DMS database accessible by the DMS application, wherein the secondary data is stored in the secondary DMS database. The limitations only recite additional elements recited at a high level of generality. Accordingly, this 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 claim is directed to an abstract idea. The additional elements, individually and in combination, also do not amount to significantly more than the abstract idea.
The claim 13 recites wherein the primary DMS database includes: a time stamp field for storing a representation of a time and date that the event occurred; an event field for storing a representation of a description of the event; a state field for storing a representation of the state of the event; and a weight field for storing a representation of the weight of the event. The limitations only recite additional elements recited at a high level of generality. Accordingly, this 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 claim is directed to an abstract idea. The additional elements, individually and in combination, also do not amount to significantly more than the abstract idea.
The claim 15 recites wherein the secondary DMS database includes: a secondary time stamp field for storing a representation of a secondary time and date that an associated secondary event was recorded; a secondary event ID field for storing a representation of a unique identifier for the associated secondary event; and a secondary event field for storing a representation of a secondary description of the associated secondary event, wherein the primary DMS database further includes an associated secondary event ID field for storing a representation of one or more secondary event identifiers such that the DMS application records associations between primary DMS data stored in the primary DMS database and secondary DMS data stored in the secondary DMS database. The limitations only recite additional elements recited at a high level of generality. Accordingly, this 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 claim is directed to an abstract idea. The additional elements, individually and in combination, also do not amount to significantly more than the abstract idea.
The claim 16 recites cross-checking the user-entered event data against secondary data received from one or more sensors to determine whether the user-entered event data is consistent with the secondary data; assigning a status and a confidence level to the user-entered event data based on a result of cross-checking.
The limitations of cross-checking…, determine…, assigning…, as drafted, are processes that, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components. That is, other than reciting “method…,” nothing in the claim element precludes the step from practically being performed in the mind. For example, but for the “method…,” “of “cross-checking…, determine…, assigning…,” in the context of these claims encompass the user manually cross-checking user-entered data against secondary data, determine data consistency, assigning status and confidence level. 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 claim recites an abstract idea.
This judicial exception is not integrated into a practical application. In particular, the claim only recites additional elements – request…, displaying…, administering…. The “administering” limitations amount to mere instructions to apply an exception (see MPEP 2106.05f). The “request” and “displaying” limitations are insignificant extra-solution activity (mere data gathering, outputting, please see MPEP 2106.05g). Accordingly, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. The claim is directed to an abstract idea.
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. “Administering” amounts to mere instructions to apply an exception (see MPEP 2106.05f). The additional elements of “request” and “displaying” is a well-understood, routine, and conventional activity (data gathering, outputting, see MPEP 2106.05d). The additional elements, individually and in combination, also do not amount to significantly more than the abstract idea.
The claim 21 recites wherein requesting the user-entered event data includes prompting the user for information regarding at least one of a user's meal markers, a user's exercise, a user's medication, or a user's sleep. The limitations only recite additional elements at a high level of generality. These limitations are recited at a high-level of generality (i.e., requesting, prompting) such that it amounts no more than mere instructions to apply the exception using a generic computer component. Accordingly, this 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 claim is directed to an abstract idea. The additional elements, individually and in combination, also do not amount to significantly more than the abstract idea.
The claims 22 and 23 recite wherein at least one sensor assembly from the one or more sensor assemblies detects non-glucose data. The limitations only recite additional elements recited at a high level of generality. Accordingly, this 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 claim is directed to an abstract idea. The additional elements, individually and in combination, also do not amount to significantly more than the abstract idea.
The claim 24 recites wherein the diabetes management recommendation includes altering a medication dosage. The limitations only recite additional elements recited at a high level of generality. Accordingly, this 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 claim is directed to an abstract idea. The additional elements, individually and in combination, also do not amount to significantly more than the abstract idea.
Claim Rejections - 35 USC § 103
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 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 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 of this title, 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.
Claims 1, 3-9, 11-16, 19-24 are rejected under 35 U.S.C. 103 as being unpatentable over Weinert et al. (U.S. Pub 2012/0289803; hereinafter “Weinert”) in view of McKirdy et al. (U.S. PGPub 2017/0189755; hereinafter “McKirdy”) and further in view of Weinert et al. (U.S. PGPub 2009/0006133; hereinafter “Weinert2”).
As per claims 1 and 9, Weinert discloses a method of reducing impact of user-entered data errors in a data management system (DMS), the DMS executing a DMS application on a processor to request user-entered event data from a user for an event via a DMS application interface and store the user-entered event data received from the user into a primary DMS database, the method comprising: obtaining secondary data from one or more sensors; (See paras. 41, 107-109, 130, wherein structured collection procedure, secondary schedule of event, secondary adherence criterion are disclosed; as taught by Weinert.)
cross-checking the user-entered event data against the secondary data to determine whether the user-entered event data is consistent with the secondary data via the processor; (See Fig. 6D, paras. 43-44, 106-107, wherein adherence criterion, comparison/assessment of data, data collection process, structured collection procedure in which “adherence criterion can be applied to contextualized biomarker data so that a biomarker data is accepted depending on a comparison of the contextualized data about documenting and interrelating conditions that exists or occurs surrounding the collection of the specific biomarker”[0043] are disclosed, also See Fig. 6E, paras. 71, 167-168, wherein contextual information collected from user interface are disclosed, also See Fig. 9, paras. 176, wherein comparison of data process in which “contextualized data 170 is evaluated using adherence criterion (or criteria) 224 to generate accepted contextualized data 395 that meets the adherence criterion 224 in step 394. As the adherence criterion 224 can provide a basis for comparison of a data event value 256 with a standard, so the data event value can be either accepted and used or rejected and not used, the adherence criteria 224 can be used to filter data”[0176] (analogous to cross-checking user-entered data against secondary data) are disclosed; as taught by Weinert.)
assigning a state and a weight to the user-entered event data based on a result of cross-checking, wherein the state indicates a status of the user-entered event data, and wherein the weight indicates a confidence level of the user-entered event data. (See Fig. 5A, paras. 84, 99-100, 108-109, wherein status assessment, confidence interval are disclosed, also See paras. 130, 231, wherein status, recommendation to change adherence/criterion process, weighted adherence events are disclosed; as taught by Weinert.)
However, Weinert fails to disclose displaying a request to the user to review and correct or confirm the user-entered event data after cross-checking the user-entered event data against the secondary data, wherein the request is based on the state assigned to the user-entered event data; updating the state and the weight of the user-entered event data in the primary DMS database to an updated state and an updated weight based on a user's response to the request; determining a diabetes management recommendation in response to the updated state and the updated weight assigned to the user-entered event data.
On the other hand, McKirdy teaches displaying a request to the user to review and correct or confirm the user-entered event data after cross-checking the user-entered event data against the secondary data, wherein the request is based on the state assigned to the user-entered event data; (See paras. 37-39, wherein comparing data across devices in which “website may allow for the comparison of data across multiple different exercise devices 110 and may show registered users which exercise devices 110 provide them with the best results (analogous to cross-checking data against secondary data). Furthermore, the website may automatically email the registered user with updates on their weekly, monthly, quarterly, and/or yearly progress. This feedback may include results or status of race events that users have entered into as well as information on financial savings on health products and services to which they have asked to be kept aware. Additionally, the exercise data may be scanned to determine if the user has any health issues that the user may be unaware of and if so, may inform the user of such results” [0037] and “website may offer dietary advice and tools that allow users to input and track their daily, weekly and monthly diets and receive recommended diet plans to help them reach their personal fitness and health goals. Basic wellness information may also be provided by the website as well as an in depth wellness analysis of the users physical conditioning depending on the amount of dietary input the users contribute” [0039] are disclosed, also See paras. 45-47, wherein modifying settings of adjusting/tailoring exercise regime process in which “if after reviewing the exercise data and the resultant data the subject matter expert wanted the exercise device 110 to have specific settings that are tailored to the user, the modified settings may be downloaded from the website onto the USB flash drive 114 for transfer to the exercise device 110 prior to the user working out. Accordingly, an exercise regime may be tailored or adjusted by the subject matter expert by allowing the subject matter expert to modify the settings of the exercise device 110 responsive to the raw exercise data and/or resultant data” [0045] (analogous to correct or confirm the user-entered event data) and “The subject matter expert may then inform the user via the website that they are overstressing their heart muscle during this exercise. Additionally, the subject matter expert may also receive notification from the website of any irregularities or anomalies in the user's data that may indicate a health condition… subject matter expert may then advise the user to see their physician and/or download desired settings for the cardio device to the user's USB flash drive 114 to adjust the users exercise routine. The user would then be instructed to transfer these new device settings to the exercise device” [0046] (analogous to request to user) are disclosed; as taught by McKirdy.)
updating the state and the weight of the user-entered event data in the primary DMS database to an updated state and an updated weight based on a user's response to the request; (See Figs. 1F, 5B, paras. 35-37, 41-43, wherein website allowing user to input on exercise data, biological information (i.e. age/weight of user) and “If the user ( or other entity) wants to create or modify an exercise regime, the system would include software to allow this function to be implemented. It is also contemplated that the exercise device 610 may communicate directly with the computing device” [0041] are disclosed, also See paras. 45-47, wherein modifying settings of adjusting/tailoring exercise regime process in which “if after reviewing the exercise data and the resultant data the subject matter expert wanted the exercise device 110 to have specific settings that are tailored to the user, the modified settings may be downloaded from the website onto the USB flash drive 114 for transfer to the exercise device 110 prior to the user working out. Accordingly, an exercise regime may be tailored or adjusted by the subject matter expert by allowing the subject matter expert to modify the settings of the exercise device 110 responsive to the raw exercise data and/or resultant data” [0045] (analogous to correct or confirm the user-entered event data) and “The subject matter expert may then inform the user via the website that they are overstressing their heart muscle during this exercise. Additionally, the subject matter expert may also receive notification from the website of any irregularities or anomalies in the user's data that may indicate a health condition… subject matter expert may then advise the user to see their physician and/or download desired settings for the cardio device to the user's USB flash drive 114 to adjust the users exercise routine. The user would then be instructed to transfer these new device settings to the exercise device” [0046] (analogous to request to user) are disclosed; as taught by McKirdy.)
determining a diabetes management recommendation in response to the updated state and the updated weight assigned to the user-entered event data. (See paras. 37-39, 41-43, wherein offering recommended diet plans in which “website may offer dietary advice and tools that allow users to input and track their daily, weekly and monthly diets and receive recommended diet plans to help them reach their personal fitness and health goals. Basic wellness information may also be provided by the website as well as an in depth wellness analysis of the users physical conditioning depending on the amount of dietary input the users contribute”[0039] and “data may then be transferred and/or displayed over the duration (or limited desired period) of the workout, allowing the user to share this information with their primary care physician, cardiologist or other health professional. This information may be used to help treat the user, such as in the diagnosing of condition and/or prescribing of medications for diseases (for example, hypertension, diabetes, irregular heart beat, COPD, etc.). This information may also be used to help the user and/or user's personal trainer to better monitor their physical improvements” [0043] are disclosed; as taught by McKirdy.)
Therefore, it would have been obvious to a person of ordinary skill in the computer art before the effective filing date of the claimed invention to incorporate the McKirdy teachings in the Weinert system. Skilled artisan would have been motivated to incorporate the system for processing biological information from a monitoring device to generate resultant information in data communications between an exercise device and personal content device to taught by McKirdy in the Weinert system for efficient handling of structured collection protocols. In addition, both of the references (Weinert and McKirdy) teach features that are directed to analogous art and they are directed to the same field of endeavor, such as data partitioning. This close relation between both of the references highly suggests an expectation of success.
However, Weinert and McKirdy fails to disclose administering medication via an artificial pancreas according to the diabetes management recommendation.
On the other hand, Weinert2 teaches administering medication via an artificial pancreas according to the diabetes management recommendation. (See paras. 4-6, wherein drug administration information in form of recommended dosage in which “method may further comprise displaying the drug administration information in the form of a recommended dosage of the drug. Alternatively or additionally, the method may further comprise controlling a drug administration device to administer to the patient at least one amount of the drug based on the drug administration information” [0006] are disclosed, also See paras. 37-38, 43, wherein diabetes control arrangement, administering medication process in which “a diabetes control arrangement in which one or more recommended or automatically administered bolus(es) of a glucose-lowering drug is the illustrated and described mechanism for diabetes control, and relate more specifically to meal-related information as the illustrated and described patient input information from which the one or more recommended or automatically administered insulin bolus(es) is/are determined” [0037] are disclosed, also See Figs. 4-5, paras. 9-10, 50, wherein administration device, artificial endocrine pancreas are disclosed; as taught by Weinert2.)
Therefore, it would have been obvious to a person of ordinary skill in the computer art before the effective filing date of the claimed invention to incorporate the Weinert2 teachings in the Weinert system. Skilled artisan would have been motivated to incorporate the system for patient information input interface for a therapy to taught by Weinert2 in the combination of Weinert and McKirdy system for efficient handling of structured collection protocols. In addition, both of the references (Weinert, McKirdy, and Weinert2) teach features that are directed to analogous art and they are directed to the same field of endeavor, such as data partitioning. This close relation between both of the references highly suggests an expectation of success.
As per claim 3, the combination of Weinert, McKirdy, and Weinert2 discloses assessing an accuracy of the user-entered event data based on the updated state and the updated weight, wherein determining the diabetes management recommendation is based at least in part on the accuracy of the user-entered event data. (See paras. 133, 230, wherein determining accurate data/ratio, structured collection procedure are disclosed; as taught by Weinert.)
As per claims 4, 14 and 19, the combination of Weinert, McKirdy, and Weinert2 discloses wherein the state is at least one of "to be reviewed", "suspect", "unverified", "verified", "validated", and "invalidated", wherein the weight is a numerical value. (See paras. 109, 123, wherein predefined status are disclosed, also See paras. 130, 231, wherein status, recommendation to change adherence/criterion process, weighted adherence events are disclosed; as taught by Weinert.)
As per claims 5 and 20, the combination of Weinert, McKirdy, and Weinert2 discloses wherein the request is presented as a question to the user on a display of a DMS device executing the DMS application. (See Figs. 4, 5A, 5B, paras. 46, 71, 78, 84-85, wherein structured collection procedure, questions are disclosed; as taught by Weinert.)
As per claim 6, the combination of Weinert, McKirdy, and Weinert2 discloses wherein at least one sensor of the one or more sensors detects non-glucose data. (See Figs. 19A, paras. 66, 235, wherein various data, such as life style data, biomarker readings, medical indicators are disclosed; as taught by Weinert.)
As per claim 7, the combination of Weinert, McKirdy, and Weinert2 discloses wherein the at least one sensor is an on-body sensor capable of detecting at least one of: analytes, blood pressure, heart rate, pulse, wakefulness, breathing rate, respiration, body temperature, ambient temperature, pulse oximetry, humidity, electrocardiogram, movement, acceleration, proximity, direction, altitude, speed, applied force, pressure, perspiration, aging, sound, eating, drinking, snoring, bodyweight, height, and body composition. (See Fig. 4, paras. 64-65, 71, 86, 127, wherein biosensor, biomarker readings, heart rate measurement, etc. are disclosed; as taught by Weinert.)
As per claim 8, the combination of Weinert, McKirdy, and Weinert2 discloses associating the secondary data with one or more events described by user-entered data stored in the primary DMS database, wherein associating the secondary data with the one or more events includes storing pointers to the secondary data in records of the primary DMS database associated with the one or more events. (See paras. 38, 46, 50, wherein process of storing data together, collection device functions disclosed; as taught by Weinert.)
As per claim 11, the combination of Weinert, McKirdy, and Weinert2 discloses wherein the secondary data comprises results of one or more rulesets stored in the memory applied to the user-entered event data stored in the primary DMS database related to the event. (See paras. 39-40, wherein various criteria, rules, guidelines are disclosed; as taught by Weinert.)
As per claim 12, the combination of Weinert, McKirdy, and Weinert2 discloses a secondary DMS database accessible by the DMS application, wherein the secondary data is stored in the secondary DMS database. (See paras. 38, 46, 50, wherein process of storing data, collection device functions disclosed, also See para. 61, wherein storage units are disclosed; as taught by Weinert.)
As per claim 13, the combination of Weinert, McKirdy, and Weinert2 discloses wherein the primary DMS database includes: a time stamp field for storing a representation of a time and date that the event occurred; (See paras. 37, 40, wherein various factors, such as time, food, etc. with respect to collection of biomarker measurements are disclosed; as taught by Weinert.)
an event field for storing a representation of a description of the event; (See paras. 37, 40, 74, wherein various factors and descriptions, such as time, food, etc. with respect to collection of biomarker measurements are disclosed; as taught by Weinert.)
a state field for storing a representation of the state of the event; (See paras. 37, 40, 74, wherein various factors and descriptions, such as time, food, etc. with respect to collection, also See paras. 224, wherein various stages with respect to disease state and monitoring process, stages of collection procedure are disclosed; as taught by Weinert.)
and a weight field for storing a representation of the weight of the event. (See Fig. 5A, paras. 84, 99-100, 108-109, wherein status assessment, confidence interval are disclosed, also See paras. 130, 231, wherein status, recommendation to change adherence/criterion process, weighted adherence events are disclosed; as taught by Weinert.)
As per claim 15, the combination of Weinert, McKirdy, and Weinert2 discloses wherein the secondary DMS database includes: a secondary time stamp field for storing a representation of a secondary time and date that an associated secondary event was recorded; a secondary event ID field for storing a representation of a unique identifier for the associated secondary event; and a secondary event field for storing a representation of a secondary description of the associated secondary event, wherein the primary DMS database further includes an associated secondary event ID field for storing a representation of one or more secondary event identifiers such that the DMS application records associations between primary DMS data stored in the primary DMS database and secondary DMS data stored in the secondary DMS database. (See paras. 37, 40, wherein various factors, such as time, food, etc. with respect to collection of biomarker measurements are disclosed, also See paras. 90, 107, 184, wherein primary, secondary adherence criterion are disclosed; as taught by Weinert.)
As per claim 16, Weinert discloses a method of reducing impact of user-entered data errors in a data management system (DMS), the DMS executing a DMS application on a processor to request user-entered event data from a user via a DMS application interface, the method comprising: cross-checking the user-entered event data against secondary data received from one or more sensors to determine whether the user-entered event data is consistent with the secondary data; (See Fig. 6D, paras. 43-44, 106-107, wherein adherence criterion, comparison/assessment of data, data collection process, structured collection procedure are disclosed, also See Fig. 9, paras. 176, wherein comparison of data process are disclosed; as taught by Weinert.)
assigning a status and a confidence level to the user-entered event data based on a result of cross-checking. (See Fig. 5A, paras. 84, 99-100, 108-109, wherein status assessment, confidence interval are disclosed, also See paras. 130, 231, wherein status, recommendation to change adherence/criterion process, weighted adherence events are disclosed; as taught by Weinert.)
updating the status and the confidence level of the user-entered event data to an updated status and an updated confidence level based on a user's response to the request; (See Fig. 4, paras. 71, 96-98, 137, wherein updating, modifying data process are disclosed, also See paras. 130, 231, wherein status, recommendation to change adherence/criterion process, weighted adherence events are disclosed; as taught by Weinert.)
determining a diabetes management recommendation in response to the updated status and the updated confidence level assigned to the user-entered event data. (See Fig. 4, paras. 71, 96-98, 137, wherein updating, modifying data process are disclosed, also See Fig. 5A, paras. 52, 66, 75, 84-89, wherein patient data, blood pressure, exercise information are disclosed, also See Fig. 5A, paras. 84, 99-100, 108-109, wherein status assessment, confidence interval are disclosed, also See paras. 130, 231, wherein status, recommendation to change adherence/criterion process, weighted adherence events are disclosed; as taught by Weinert.)
However, Weinert fails to displaying a request to the user to correct or confirm the user-entered event data after crosschecking the user-entered event data against the secondary data, wherein the request is based on the status assigned to the user-entered event data.
On the other hand, McKirdy teaches displaying a request to the user to correct or confirm the user-entered event data after crosschecking the user-entered event data against the secondary data, wherein the request is based on the status assigned to the user-entered event data. (See paras. 37-39, wherein comparing data across devices in which “website may allow for the comparison of data across multiple different exercise devices 110 and may show registered users which exercise devices 110 provide them with the best results. Furthermore, the website may automatically email the registered user with updates on their weekly, monthly, quarterly, and/or yearly progress. This feedback may include results or status of race events that users have entered into as well as information on financial savings on health products and services to which they have asked to be kept aware. Additionally, the exercise data may be scanned to determine if the user has any health issues that the user may be unaware of and if so, may inform the user of such results” [0037] and “website may offer dietary advice and tools that allow users to input and track their daily, weekly and monthly diets and receive recommended diet plans to help them reach their personal fitness and health goals. Basic wellness information may also be provided by the website as well as an in depth wellness analysis of the users physical conditioning depending on the amount of dietary input the users contribute” [0039] are disclosed; as taught by McKirdy.)
Therefore, it would have been obvious to a person of ordinary skill in the computer art before the effective filing date of the claimed invention to incorporate the McKirdy teachings in the Weinert system. Skilled artisan would have been motivated to incorporate the system for processing biological information from a monitoring device to generate resultant information in data communications between an exercise device and personal content device to taught by McKirdy in the Weinert system for efficient handling of structured collection protocols. In addition, both of the references (Weinert and McKirdy) teach features that are directed to analogous art and they are directed to the same field of endeavor, such as data partitioning. This close relation between both of the references highly suggests an expectation of success.
However, Weinert and McKirdy fails to disclose administering medication via an artificial pancreas according to the diabetes management recommendation.
On the other hand, Weinert2 teaches administering medication via an artificial pancreas according to the diabetes management recommendation. (See paras. 4-6, wherein drug administration information in form of recommended dosage in which “method may further comprise displaying the drug administration information in the form of a recommended dosage of the drug. Alternatively or additionally, the method may further comprise controlling a drug administration device to administer to the patient at least one amount of the drug based on the drug administration information” [0006] are disclosed, also See paras. 37-38, 43, wherein diabetes control arrangement, administering medication process in which “a diabetes control arrangement in which one or more recommended or automatically administered bolus(es) of a glucose-lowering drug is the illustrated and described mechanism for diabetes control, and relate more specifically to meal-related information as the illustrated and described patient input information from which the one or more recommended or automatically administered insulin bolus(es) is/are determined” [0037] are disclosed, also See Figs. 4-5, paras. 9-10, 50, wherein administration device and artificial endocrine pancreas are disclosed; as taught by Weinert2.)
Therefore, it would have been obvious to a person of ordinary skill in the computer art before the effective filing date of the claimed invention to incorporate the Weinert2 teachings in the Weinert system. Skilled artisan would have been motivated to incorporate the system for patient information input interface for a therapy to taught by Weinert2 in the combination of Weinert and McKirdy system for efficient handling of structured collection protocols. In addition, both of the references (Weinert, McKirdy, and Weinert2) teach features that are directed to analogous art and they are directed to the same field of endeavor, such as data partitioning. This close relation between both of the references highly suggests an expectation of success.
As per claim 21, the combination of Weinert, McKirdy, and Weinert2 discloses wherein requesting the user-entered event data includes prompting the user for information regarding at least one of a user's meal markers, a user's exercise, a user's medication, or a user's sleep. (See para. 106, wherein prompt on display a question on meal/exercise are disclosed; as taught by Weinert.)
As per claims 22 and 23, the combination of Weinert and Weinert2 fails to disclose wherein at least one sensor assembly from the one or more sensor assemblies detects non-glucose data.
On the other hand, McKirdy teaches wherein at least one sensor assembly from the one or more sensor assemblies detects non-glucose data. (See paras. 26, 34-35, wherein data tracking process are disclosed, also See Fig. 2, para. 43, wherein sensors on exercise device on monitoring/detecting data are disclosed; as taught by McKirdy.)
See claims 9 and 16 for motivation above.
As per claim 24, the combination of Weinert and Weinert2 fails to disclose wherein the diabetes management recommendation includes altering a medication dosage.
On the other hand, McKirdy teaches wherein the diabetes management recommendation includes altering a medication dosage. (See paras. 37-39, 41-43, wherein offering recommended diet plans in which “website may offer dietary advice and tools that allow users to input and track their daily, weekly and monthly diets and receive recommended diet plans to help them reach their personal fitness and health goals”[0039] and “data may then be transferred and/or displayed over the duration (or limited desired period) of the workout, allowing the user to share this information with their primary care physician, cardiologist or other health professional. This information may be used to help treat the user, such as in the diagnosing of condition and/or prescribing of medications for diseases (for example, hypertension, diabetes, irregular heart beat, COPD, etc.). This information may also be used to help the user and/or user's personal trainer to better monitor their physical improvements” [0043] are disclosed; as taught by McKirdy.)
See claims 9 and 16 for motivation above.
Conclusion
1. The examiner requests, in response to this Office action, support be shown for language added to any original claims on amendment and any new claims. That is, indicate support for newly added claim language by specifically pointing to page(s) and line no(s) in the specification and/or drawing figure(s). This will assist the examiner in prosecuting the application.
2. When responding to this office action, Applicant is advised to clearly point out the patentable novelty which he or she thinks the claims present, in view of the state of the art disclosed by the references cited or the objections made. He or she must also show how the amendments avoid such references or objections See 37 CFR 1.111(c).
POINT OF CONTACT
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LIN LIN M HTAY whose telephone number is (571)272-7293. The examiner can normally be reached on M-F, 7am-3pm, PST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kavita Stanley can be reached on (571)272-8352. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/L. L. H./
Examiner, Art Unit 2153
/KAVITA STANLEY/ Supervisory Patent Examiner, Art Unit 2153
Prosecution Insights