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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 January 22, 2026 has been entered.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12/22/22 has been considered by the examiner.
Amendment Entered
In response to the amendment filed on December 22, 2025, amended claims 1, 21 and 25 have been entered.
Response to Arguments
Applicant's remarks and amendments with respect to the rejections under U.S.C. 101 have been fully considered, but were not persuasive. Examiner argues that nothing from the claims, accompanying specification, and/or drawings suggest that the method steps cannot be practically performed mentally, or using pen/paper. Applicant argues the invention is not an abstract idea. Examiner notes that although the claims include a glucose sensor, a processor and a display, no physical aspect of the device mentioned in the claims is novel. The claims merely recite data gathering/outputting steps. Applicant further argues the claims integrate into a practical application. Examiner notes that according to MPEP 2106.04(d)(2), the practical application consists of administering a specific medication in response to the collected data. Alternately, a practical application would consist of incorporating additional structure to the device. Lastly, Applicant argues the invention is significantly more based on the additional elements. Examiner notes the components of the invention are all well known in the art and conventional. Therefore, as currently claimed, the invention is not an improvement in technology. Accordingly, Examiner maintains that the identified judicial exception recites a mathematical equation and mental process that is not integrated into a practical application. As such, the 35 USC 101 rejections are maintained. Examiner notes that incorporating a particular treatment based on the results or more structure to the claims would help move prosecution forward. Please see corresponding rejection heading below for more detailed analysis.
Applicant’s arguments filed with respect to the prior art rejections raised in the previous office action were fully considered and are moot in view of the current combination of references that were necessitated by amendment. Please see prior art section below for more detail, updated citations (Agrawal reference), and updated rationale
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 1-6, 9-12, 14, 21 and 25 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) as a whole, considering all claim elements both individually and in combination, do not amount to significantly more than an abstract idea. A streamlined analysis of claim 1 follows.
Regarding claim 1, the claim recites a method comprising: receiving a first data stream of glucose measurements from a first glucose sensor worn by a user. Thus, the claim is directed to a process, which is one of the statutory categories of invention
The claim is then analyzed to determine whether it is directed to any judicial exception. The following limitations set forth a judicial exception:
“receiving a first data stream of glucose measurements from a first glucose sensor worn by a user; receiving a second data stream of glucose measurements from a second glucose sensor worn by the user; determining at least one predicted glucose value based on the first data stream of glucose measurements received prior to the termination event; determining an accuracy of at least one of the glucose measurements of the second data stream based on a comparison of at least one of the glucose measurements of the second data stream to the at least one predicted glucose value, wherein the determining the accuracy is performed without receiving additional reference data from a non-continuous reference source; determining an estimated glucose values for the user based on both the first data stream of glucose measurements received from the first glucose sensor prior to the termination event and the second data stream of glucose measurements received from the second glucose sensor;”
These limitations describe a mental process as the skilled artisan is capable of performing the judicial exception mentally, or using pen and paper. Furthermore, nothing from the claims or applicant’s accompanying specification shows that the skilled artisan would not be able to perform the judicial exception mentally, or using pen and paper.
Next, the claim as a whole is analyzed to determine whether any element, or combination of elements, integrates the identified judicial exception into a practical application.
For this part of the 101 analysis, the following additional limitations are considered:
“detecting a termination event for the first glucose sensor; a second glucose sensor worn by the user; ending the warmup period; and displaying, on a display, the estimated glucose value for the user.”
These additional limitations do not integrate the judicial exception into a practical application. Rather, the additional limitations are each recited at a high level of generality such that it amounts to insignificant pre-solution and post-solution activity, e.g., mere receiving data, generic sensor components and means for presenting said data.
Furthermore, the additional limitations do not add significantly more to the judicial exception as the recited limitations amount to well-known and conventional data gathering techniques in the art. Examiner takes official notice that the additional limitations are conventional components in prior analyte monitoring systems. Kamath teaches these additional elements, showing these additional elements are well known and conventional [par. 147, 362, 417, 426].
Claim 21 recites the additional limitations:
“one or more processors; memory storing computer-readable instructions”
These additional limitations do not integrate the judicial exception into a practical application. Rather, the additional limitations are each recited at a high level of generality such that it amounts to insignificant pre-solution and post-solution activity, e.g., mere generic computer components
Furthermore, the additional limitations do not add significantly more to the judicial exception as the recited limitations amount to well-known and conventional data gathering techniques in the art. Examiner takes official notice that the additional limitations are conventional components in prior analyte monitoring systems. Kamath teaches these additional elements, showing these additional elements are well known and conventional [par. 24, 376].
Dependent Claims 10, 11 and 14 recite the additional limitations:
“a timer; user interface; CGM”
These additional limitations do not integrate the judicial exception into a practical application. Rather, the additional limitations are each recited at a high level of generality such that it amounts to insignificant pre-solution and post-solution activity, e.g., mere generic sensor and computer components
Furthermore, the additional limitations do not add significantly more to the judicial exception as the recited limitations amount to well-known and conventional data gathering techniques in the art.
Independent claim 25 is also not patent eligible for substantially similar reasons
Dependent claims 2-6, 9-12 and 14 also fail to add something more to the abstract independent claims as they merely further limit the abstract idea.
Therefore, claims 1-6, 9-12, 14, 21 and 25 are not patent eligible under 35 USC 101.
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, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 2, 4-6, 12 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Kamath (U.S. Patent Application Publication 2012/0277566 A1) and in further view of Agrawal (U.S. Patent Application Publication 2021/0038163 A1).
Kamath was cited in Applicant’s IDS and the previous office action
Regarding claim 1, Kamath teaches a method comprising: receiving a first data stream of glucose measurements from a first glucose sensor worn by a user [fig. 21, element 261; par. 417]; detecting a termination event for the first glucose sensor [par. 147]; receiving a second data stream of glucose measurements from a second glucose sensor worn by the user [par. 147, 417]; determining at least one predicted glucose value based on the first data stream of glucose measurements received prior to the termination event [par. 452-454]; determining an accuracy of at least one of the glucose measurements of the second data stream [par. 419, 426, 427]; during a warmup period for the second glucose sensor, outputting estimated glucose values for the user based on both the first data stream of glucose measurements received from the first glucose sensor prior to the termination event and the second data stream of glucose measurements received from the second glucose sensor [fig. 21; par. 147, 452]; and displaying, on a display, the estimated glucose value for the user [par. 362]
Although Kamath does not explicitly teach determining an accuracy of at least one of the glucose measurements of the second data stream based on a comparison of at least one of the glucose measurements of the second data stream to the at least one predicted glucose value, this would be obvious to a person having ordinary skill in the art when the invention was filed since Kamath also suggests matching reference data with sensor data [par. 419] and that sensor stability can be determined from a correlation between sensor and reference values [par. 426]. Additionally, Examiner notes the reference data is received from the first sensor [par. 146]. Therefore, incorporating determining an accuracy of at least one of the glucose measurements of the second data stream based on a comparison of at least one of the glucose measurements of the second data stream to the at least one predicted glucose value would only involve routine skill in the art.
However, Kamath does not teach determining an accuracy of at least one of the glucose measurements of the second data stream based on a comparison of at least one of the glucose measurements of the second data stream to the at least one predicted glucose value, wherein the determining the accuracy is performed without receiving additional reference data from a non-continuous reference source; and ending the warmup period for the second glucose sensor when the accuracy of the glucose measurements of the second data stream satisfies an accuracy threshold
Agrawal teaches determining an accuracy of at least one of the glucose measurements of the second data stream based on a comparison of at least one of the glucose measurements of the second data stream to the at least one predicted glucose value, wherein the determining the accuracy is performed without receiving additional reference data from a non-continuous reference source [par. 129 “the computing system can determine if the sequence of the estimated glucose values are within an acceptable accuracy range by measuring difference between estimated glucose value and periodic measurements that were taken by a CGM device and then comparing that difference to an accuracy threshold”, 130]; and ending the warmup period for the second glucose sensor when the accuracy of the glucose measurements of the second data stream satisfies an accuracy threshold [par. 129, 130]
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Kamath, to incorporate determining an accuracy of at least one of the glucose measurements of the second data stream based on a comparison of at least one of the glucose measurements of the second data stream to the at least one predicted glucose value, wherein the determining the accuracy is performed without receiving additional reference data from a non-continuous reference source; and ending the warmup period for the second glucose sensor when the accuracy of the glucose measurements of the second data stream satisfies an accuracy threshold, for informing the user that they should not trust the estimated glucose values being generated by the estimation model if the values are not within an acceptable accuracy range, as evidence by Agrawal [par. 130].
Regarding claim 2, Kamath further teaches the estimated glucose value is based on both the at least one predicted glucose value and the second data stream of glucose measurements received from the second glucose sensor [par. 452-454].
Regarding claim 4, Kamath further teaches the outputting further comprises determining a weighted average between the predicted glucose values and the second data stream of glucose measurements received from the second glucose sensor [par. 419].
Regarding claim 5, Kamath further teaches after the warmup period is ended, outputting estimated glucose values based on the second data stream of glucose measurements received in real-time from the second glucose sensor worn by the user [par. 426, 450]. Regarding claim 6, Kamath further teaches the warmup period for the second glucose sensor comprises a predetermined amount of time [par. 426].
Regarding claim 12, Kamath further teaches the first glucose sensor is subcutaneously inserted into skin of the user, and wherein the termination event is detected in response to the first glucose sensor being removed from the skin of the user [par. 388, 389]
Regarding claim 14, Kamath further teaches the first glucose sensor and the second glucose sensor are disposable continuous glucose monitoring (CGM) sensors [fig. 1E; par. 147].
Regarding claim 21, Kamath teaches a system comprising: one or more processors; and memory storing computer-readable instructions that are executable by the one or more processors to perform operations [par. 24, 376] including: receiving a first data stream of glucose measurements from a first glucose sensor worn by a user [fig. 21, element 261; par. 417]; detecting a termination event for the first glucose sensor [par. 147]; receiving a second data stream of glucose measurements from a second glucose sensor worn by the user [par. 147, 417]; determining at least one predicted glucose value based on the first data stream of glucose measurements received prior to the termination event [par. 452-454]; determining an accuracy of at least one of the glucose measurements of the second data stream [par. 419, 426, 427]; and during a warmup period for the second glucose sensor, outputting estimated glucose values for the user based on both the first data stream of glucose measurements received from the first glucose sensor prior to the termination event and the second data stream of glucose measurements received from the second glucose sensor [fig. 21; par. 147, 452]; and displaying, on a display, the estimated glucose value for the user [par. 362]
However, Kamath does not teach determining an accuracy of at least one of the glucose measurements of the second data stream based on a comparison of at least one of the glucose measurements of the second data stream to the at least one predicted glucose value, wherein the determining the accuracy is performed without receiving additional reference data from a non-continuous reference source; and ending the warmup period for the second glucose sensor when the accuracy of the glucose measurements of the second data stream satisfies an accuracy threshold
Agrawal teaches determining an accuracy of at least one of the glucose measurements of the second data stream based on a comparison of at least one of the glucose measurements of the second data stream to the at least one predicted glucose value, wherein the determining the accuracy is performed without receiving additional reference data from a non-continuous reference source [par. 129 “the computing system can determine if the sequence of the estimated glucose values are within an acceptable accuracy range by measuring difference between estimated glucose value and periodic measurements that were taken by a CGM device and then comparing that difference to an accuracy threshold”, 130]; and ending the warmup period for the second glucose sensor when the accuracy of the glucose measurements of the second data stream satisfies an accuracy threshold [par. 129, 130]
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Kamath, to incorporate determining an accuracy of at least one of the glucose measurements of the second data stream based on a comparison of at least one of the glucose measurements of the second data stream to the at least one predicted glucose value, wherein the determining the accuracy is performed without receiving additional reference data from a non-continuous reference source; and ending the warmup period for the second glucose sensor when the accuracy of the glucose measurements of the second data stream satisfies an accuracy threshold, for informing the user that they should not trust the estimated glucose values being generated by the estimation model if the values are not within an acceptable accuracy range, as evidence by Agrawal [par. 130].
Regarding claim 25, Kamath teaches a non-transitory computer-readable medium storing instructions that are executable by one or more processors to perform operations [par. 24, 376] comprising: receiving a first data stream of glucose measurements from a first glucose sensor worn by a user [fig. 21, element 261; par. 417]; detecting a termination event for the first glucose sensor [par. 147]; receiving a second data stream of glucose measurements from a second glucose sensor worn by the user [par. 147, 417]; determining at least one predicted glucose value based on the first data stream of glucose measurements received prior to the termination event [par. 452-454]; determining an accuracy of at least one of the glucose measurements of the second data stream [par. 419, 426, 427]; and during a warmup period for the second glucose sensor, outputting estimated glucose values for the user based on both the first data stream of glucose measurements received from the first glucose sensor prior to the termination event and the second data stream of glucose measurements received from the second glucose sensor [fig. 21; par. 147, 452]; and displaying, on a display, the estimated glucose value for the user [par. 362].
However, Kamath does not teach determining an accuracy of at least one of the glucose measurements of the second data stream based on a comparison of at least one of the glucose measurements of the second data stream to the at least one predicted glucose value, wherein the determining the accuracy is performed without receiving additional reference data from a non-continuous reference source; and ending the warmup period for the second glucose sensor when the accuracy of the glucose measurements of the second data stream satisfies an accuracy threshold
Agrawal teaches determining an accuracy of at least one of the glucose measurements of the second data stream based on a comparison of at least one of the glucose measurements of the second data stream to the at least one predicted glucose value, wherein the determining the accuracy is performed without receiving additional reference data from a non-continuous reference source [par. 129 “the computing system can determine if the sequence of the estimated glucose values are within an acceptable accuracy range by measuring difference between estimated glucose value and periodic measurements that were taken by a CGM device and then comparing that difference to an accuracy threshold”, 130]; and ending the warmup period for the second glucose sensor when the accuracy of the glucose measurements of the second data stream satisfies an accuracy threshold [par. 129, 130]
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Kamath, to incorporate determining an accuracy of at least one of the glucose measurements of the second data stream based on a comparison of at least one of the glucose measurements of the second data stream to the at least one predicted glucose value, wherein the determining the accuracy is performed without receiving additional reference data from a non-continuous reference source; and ending the warmup period for the second glucose sensor when the accuracy of the glucose measurements of the second data stream satisfies an accuracy threshold, for informing the user that they should not trust the estimated glucose values being generated by the estimation model if the values are not within an acceptable accuracy range, as evidence by Agrawal [par. 130].
Claims 3 and 9-11 are rejected under 35 U.S.C. 103 as being unpatentable over Kamath and Agrawal and in further view of Belliveau (U.S. Patent Application Publication 2018/0182491 A1).
Belliveau was cited in Applicant’s IDS and the previous office action
Regarding claim 3, Kamath and Agrawal teach a medical detection device and method, as disclosed above.
However, Kamath and Agrawal do not teach the predicting is further based on at least one of food logging data or activity data.
Belliveau teaches the predicting is further based on at least one of food logging data or activity data [par. 412, 413].
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Kamath and Agrawal, to incorporate the predicting is further based on at least one of food logging data or activity data, for increasing accuracy and confidence of the data, as evidence by Belliveau [par. 413].
Regarding claim 9, Kamath further teaches predicting glucose values for the user based on the first data stream of glucose measurements received from the first glucose sensor prior to the termination event [par. 453, 454];
However, Kamath and Agrawal do not teach outputting the predicted glucose values for a time period that is after the termination event and before the second glucose sensor is worn by the user
Belliveau teaches outputting the predicted glucose values for a time period that is after the termination event [par. 169, Examiner notes the predicted glucose values are continuous and would have predicted glucose values at the time of termination]
Although Belliveau does not explicitly teach outputting the predicted glucose values for a time period that is after the termination event and before the second glucose sensor is worn by the user, this would be obvious to a person having ordinary skill in the art when the invention was filed since Belliveau also suggests predicting future glucose values with the first sensor [par. 266]. Examiner notes since the sensor measures glucose values continuously [par. 169], the first sensor predicts glucose values until the sensor is terminated and replaced. Thus, at the time of termination of the first sensor, future glucose values have already been predicted for the period after termination and before the new sensor session begins. Therefore, incorporating outputting the predicted glucose values for a time period that is after the termination event and before the second glucose sensor is worn by the user would only involve routine skill in the art.
Regarding claim 10, Belliveau further teaches the detecting the termination event for the first glucose sensor comprises detecting the termination event when a timer associated with the first glucose sensor expires [par. 220]
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Kamath and Agrawal, to incorporate the detecting the termination event for the first glucose sensor comprises detecting the termination event when a timer associated with the first glucose sensor expires, for allowing the transmitter to enter an inactive state, as evidence by Belliveau [par. 220].
Regarding claim 11, Belliveau further teaches the detecting the termination event for the first glucose sensor comprises detecting the termination event based on a loss of connectivity with the first glucose sensor or based on user interaction with a user interface [par. 360].
Therefore, it would have been prima facie obvious to a person having ordinary skill in the art when the invention was filed to modify the method as taught by Kamath and Agrawal, to incorporate the detecting the termination event for the first glucose sensor comprises detecting the termination event based on a loss of connectivity with the first glucose sensor or based on user interaction with a user interface, for transferring data based on user interaction, as evidence by Belliveau [par. 360].
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GRACE L ROZANSKI whose telephone number is (571)272-7067. The examiner can normally be reached M-F 8:30am-5pm, alt F 8:30am-5pm.
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/GRACE L ROZANSKI/Examiner, Art Unit 3791
/ALEX M VALVIS/Supervisory Patent Examiner, Art Unit 3791