DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claim Objections
The Claims are objected to because of the following informalities:
In Claim 12, the term “displaying, an upper boundary of the confidence band, an upper series of predicted blood glucose values of the user over the future period at” should be replaced with -- displaying, at an upper boundary of the confidence band, an upper series of predicted blood glucose values of the user over the future period [[at]] -- to address a grammatical error.
In Claim 20, the term “based at least partially on the determine series of predicted blood glucose values of the user,” should be replaced with -- based at least partially on the determined series of predicted blood glucose values of the user,” -- to address a typographical error.
Appropriate correction is required and applicant should carefully review the Claims for any other informalities.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 11 and claims dependent thereon rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Claim 11 recites the limitation " The method of claim 9. wherein the specific event comprises one or more of an administered bolus dose or consumption of a meal." There is insufficient antecedent basis for this limitation in the claim. Examiner suggests amending the claim to depend off of Claim 10 to address this issue and will be interpreting the claim as such.
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 a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Regarding Claim 1, the claim(s) recites “based at least partially on the received blood glucose data, determining a series of predicted blood glucose values of the user over a future period of time commencing at a current time;”
“based at least partially on the series of predicted blood glucose values, generating … at least one recommended action to improve the user’s blood glucose values during the future period of time” which amounts to an abstract idea (mental process).
This judicial exception is not integrated into a practical application because:
- The claims fail to outline an improvement to the technical field.
- The claims fail to apply the judicial exception to effect a particular treatment.
- The claims fail to apply the judicial exception with a particular machine.
- The claims fail to effect a transformation or reduction of a particular article to a different state or thing.
Next, the claim as a whole is analyzed to determine whether any element or a combination of elements, integrates judicial exception into a practical application.
For this part of the 101 analysis, the following additional limitations are considered:
“receiving, from a blood glucose monitoring device, blood glucose data representing measured blood glucose values of a user;”
“causing at least one curve representing the series of predicted blood glucose values to be displayed on a mobile device;”
“based at least partially on the series of predicted blood glucose values, … providing at least one recommended action to improve the user’s blood glucose values during the future period of time”
The additional elements are insufficient to amount to significantly more than the judicial exception because they seem to merely generally link the use of the judicial exception to a particular technological environment.
Moreover, the claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because they pertain merely to insignificant extrasolution data gathering activities and generic postsolution activity.
Furthermore, glucose monitoring devices and mobile devices are general field of use.
None of these limitations, considered as an ordered combination provide eligibility because the claim taken as a whole, does not amount to significantly more than the underlying abstract idea of predicting blood glucose value and providing recommendations from that basis and does not purport to improve the functioning of the signal processing, or to improve any other technology or technical field. Use of a generic signal processing does not amount to significantly more than the abstract idea itself. Dependent claims 2-13 also do not add significantly more to the exception as they merely add details to the mental steps, add details to the extrasolution data gathering steps, add general field of use components to facilitate the extrasolution data gathering, and add mental steps.
Regarding Claim 14, the claim(s) recites “for a future period of time and based at least partially on the received blood glucose data, predicting a risk of the user reaching a blood glucose level at or below a lower threshold blood glucose value; and
generating … at least one recommended action to reduce the risk of the user reaching the blood glucose level at or below the lower threshold blood glucose value” which amounts to an abstract idea (mental process).
This judicial exception is not integrated into a practical application because:
- The claims fail to outline an improvement to the technical field.
- The claims fail to apply the judicial exception to effect a particular treatment.
- The claims fail to apply the judicial exception with a particular machine.
- The claims fail to effect a transformation or reduction of a particular article to a different state or thing.
Next, the claim as a whole is analyzed to determine whether any element or a combination of elements, integrates judicial exception into a practical application.
For this part of the 101 analysis, the following additional limitations are considered:
“receiving, from a blood glucose monitoring device, blood glucose data representing measured blood glucose values of a user;”
“…providing at least one recommended action to reduce the risk of the user reaching the blood glucose level at or below the lower threshold blood glucose value”
The additional elements are insufficient to amount to significantly more than the judicial exception because they seem to merely generally link the use of the judicial exception to a particular technological environment.
Moreover, the claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because they pertain merely to insignificant extrasolution data gathering activities and generic postsolution activity.
Furthermore, glucose monitoring devices are general field of use.
None of these limitations, considered as an ordered combination provide eligibility because the claim taken as a whole, does not amount to significantly more than the underlying abstract idea of predicting blood glucose value and providing recommendations from that basis and does not purport to improve the functioning of the signal processing, or to improve any other technology or technical field. Use of a generic signal processing does not amount to significantly more than the abstract idea itself. Dependent claims 15-19 also do not add significantly more to the exception as they merely add details to the mental steps, add details to the extrasolution data gathering steps, add general field of use components to facilitate the extrasolution data gathering, and add mental steps.
Regarding Claim 20, the claim(s) recites “based at least partially on the received blood glucose data, determining a series of predicted blood glucose values of the user over a future period of time commencing at a current time;”
“based at least partially on the determined series of predicted blood glucose values of the user; determining a risk of the user reaching a blood glucose level at or below a lower threshold blood glucose value”
“generating … at least one recommended action to reduce the risk of the user reaching the blood glucose level at or below the lower threshold blood glucose value” which amounts to an abstract idea (mental process).
This judicial exception is not integrated into a practical application because:
- The claims fail to outline an improvement to the technical field.
- The claims fail to apply the judicial exception to effect a particular treatment.
- The claims fail to apply the judicial exception with a particular machine.
- The claims fail to effect a transformation or reduction of a particular article to a different state or thing.
Next, the claim as a whole is analyzed to determine whether any element or a combination of elements, integrates judicial exception into a practical application.
For this part of the 101 analysis, the following additional limitations are considered:
“receive, from a blood glucose monitoring device, blood glucose data representing measured blood glucose values of a user;”
“…and providing at least one recommended action to reduce the risk of the user reaching the blood glucose level at or below the lower threshold blood glucose value” which amounts to an abstract idea (mental process).
Moreover, the claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because they pertain merely to insignificant extrasolution data gathering activities and generic postsolution activity.
Furthermore, insulin delivery devices are general field of use and processors and non-transitory computer readable storage media are generic computer elements used to perform generic computer functions and don’t add significantly more and are well-understood, routine, and previously known to the industry.
None of these limitations, considered as an ordered combination provide eligibility because the claim taken as a whole, does not amount to significantly more than the underlying abstract idea of predicting blood glucose value and providing recommendations from that basis and does not purport to improve the functioning of the signal processing, or to improve any other technology or technical field. Use of a generic signal processing does not amount to significantly more than the abstract idea itself.
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 pre-AIA 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 –
(b) the invention was patented or described in a printed publication in this or a foreign country or in public use or on sale in this country, more than one year prior to the date of application for patent in the United States.
Claim(s) 1, 4-7, 10-16, and 19-20 is/are rejected under pre-AIA 35 U.S.C. 102(b) as being anticipated by Brauker et al (US 2005/0203360) (“Brauker”) as noted in Applicant IDS dated 1/29/2025.
Regarding Claim 1, Brauker teaches a method of insulin delivery (Abstract, [0250] the teachings of the invention may be incorporated into closed loop insulin delivery, [0251]-[0256] dynamic analyte value estimation steps), the method comprising:
receiving, from a blood glucose monitoring device, blood glucose data representing measured blood glucose values of a user (Fig. 3, [0253] analyte evaluation applied to glucose data, [0254] block 56 obtains sensor data of analyte, i.e. glucose, Fig. 1, [0222] continuous analyte sensor 10 provides glucose value measurements);
based at least partially on the received blood glucose data, determining a series of predicted blood glucose values of the user over a future period of time commencing at a current time (Fig. 3, [0255] block 58 dynamically and intelligently estimates future analyte values based on received data, Fig. 4, [0257] determining a series of predicted blood glucose values of the user over a future period of time of 15 minutes commencing at a current time t = 0);
causing at least one curve representing the series of predicted blood glucose values to be displayed on a mobile device (Fig. 3, [0256] block 60 provides output for an output module of user interface 20 and/or external device 34, “In some embodiments, output of estimated analyte values is combined with output of measured analyte values, such as described at the block 52, for example combined on an LCD screen, or by toggling between screens.” causing at least one curve representing the series of predicted blood glucose values to be displayed on an external device, [0331] where the external device can be a personal digital assistant, the personal digital assistant is recognized as a mobile device); and
based at least partially on the series of predicted blood glucose values, generating and providing at least one recommended action to improve the user’s blood glucose values during the future period of time (Fig. 3, [0256] “In some embodiments, an approaching clinical risk is output in the form of a visual, audible, or tactile prompt, such as described with reference to Figs. 20 to 22, for example. In some embodiments, therapy recommendations are output to aid the user in determining corrective action that can be performed in an effort to avoid or minimize clinical risk such as described with reference to Fig. 24, for example.” Therapy recommendations and corrective actions are recommended actions).
Regarding Claim 4, Brauker teaches the method of claim 1, further comprising:
for the future period of time, predicting a risk of the user (See Claim 1 Rejection) reaching a blood glucose level at or below a lower threshold blood glucose value ([0250]-[0251], [0257]-[0258] where the estimation steps can be applied to prevent hypoglycemic conditions, where thresholds are utilized to indicate an approaching of clinical risk, indicating that the predicted risk in step 60 will be reaching a blood glucose level at or below a lower threshold blood glucose value); and
generating and providing at least one recommended action to reduce the risk of the user reaching the blood glucose level at or below the lower threshold blood glucose value ([0256]-[0258] “In some embodiments, an approaching clinical risk is output in the form of a visual, audible, or tactile prompt, such as described with reference to Figs. 20 to 22, for example. In some embodiments, therapy recommendations are output to aid the user in determining corrective action that can be performed in an effort to avoid or minimize clinical risk such as described with reference to Fig. 24, for example.”).
Regarding Claim 5, Brauker teaches the method of claim 1, further comprising:
for the future period of time, predicting a risk of the user (See Claim 1 Rejection) reaching a blood glucose level at or above an upper threshold blood glucose value ([0250]-[0251], [0257]-[0258] where the estimation steps can be applied to prevent hyperglycemic conditions, where thresholds are utilized to indicate an approaching of clinical risk, indicating that the predicted risk in step 60 will be reaching a blood glucose level at or above an upper threshold blood glucose value); and
generating and providing at least one recommended action to reduce the risk of the user reaching the blood glucose level at or above the upper threshold blood glucose value ([0256]-[0258] “In some embodiments, an approaching clinical risk is output in the form of a visual, audible, or tactile prompt, such as described with reference to Figs. 20 to 22, for example. In some embodiments, therapy recommendations are output to aid the user in determining corrective action that can be performed in an effort to avoid or minimize clinical risk such as described with reference to Fig. 24, for example.”).
Regarding Claim 6, Brauker teaches the method of claim 1, further comprising:
responsive to the series of predicted blood glucose values indicating that the user’s blood glucose value will reach a value outside of a desired range, generating and outputting an alarm indicating the predicted blood glucose value outside of the desired range (See Claim 1 Rejection, [0256]-[0257] “The estimated glucose data 64 can be useful in providing alarms (e.g., hyper- and hypoglycemic alerts) and/or displaying on the user interface of the receiver, for example.”); and
generating and providing at least one recommended action to reduce a likelihood of the user reaching the predicted blood glucose value outside of the desired range (See Claim 1 Rejection, [0256]-[0257]).
Regarding Claim 7, Brauker teaches the method of claim 1, wherein providing the at least one recommended action to improve the user’s blood glucose values during the future period of time comprises causing the at least one recommended action to be displayed on the mobile device ([0359]-[0360] therapy recommendation / injection icon 228 shown on display).
Regarding Claim 10, Brauker teaches the method of claim 1, further comprising:
receiving an input of a specific event ([0230], [0360]); and
determining the series of predicted blood glucose values of the user over the future period of time based at least partially on the received input of the specific event ([0234]-[0235] prediction steps may be calibrated for specific events, [0230] where specific events can be recognized by user input).
Regarding Claim 11, Brauker teaches the method of claim 10, wherein the specific event comprises one or more of an administered bolus dose or consumption of a meal (See Claim 10 Rejection, [0230], [0360]).
Regarding Claim 12, Brauker teaches the method of claim 1, wherein causing at least one curve representing the series of predicted blood glucose values to be displayed on a mobile device provide a visual representation comprises:
displaying a middle series of predicted blood glucose values of the user over the future period of time, the middle series of predicted blood glucose values defining a center curve of a confidence band ([0318], Fig. 17, a middle series of estimated glucose values 172 for the future period of time of t =0 to t = 15 minutes, the middle series of predicted blood glucose values defining a center curve of a confidence band / 95% confidence interval);
displaying, an upper boundary of the confidence band, an upper series of predicted blood glucose values of the user over the future period at ([0318], Fig. 17, an upper series of estimated glucose values 174 for the future period of time of t =0 to t = 15 minutes, the upper series of predicted blood glucose values defining an upper boundary of a confidence band / 95% confidence interval); and
displaying, at a lower boundary of the confidence band, a lower series of predicted blood glucose values of the user over the future period ([0318], Fig. 17, a lower series of estimated glucose values 174 for the future period of time of t =0 to t = 15 minutes, the lower series of predicted blood glucose values defining an lower boundary of a confidence band / 95% confidence interval).
Regarding Claim 13, Brauker teaches the method of claim 12, wherein a width of the confidence band at any given point in time reflects a degree of confidence with which the series of predicted blood glucose values at the given point in time was determined (See Claim 12 Rejection, degree of confidence reflecting the 95% confidence interval).
Regarding Claim 14, Brauker teaches a method of insulin delivery, the method comprising:
receiving, from a blood glucose monitoring device, blood glucose data representing measured blood glucose values of a user (Fig. 3, [0253] analyte evaluation applied to glucose data, [0254] block 56 obtains sensor data of analyte, i.e. glucose, Fig. 1, [0222] continuous analyte sensor 10 provides glucose value measurements);
for a future period of time and based at least partially on the received blood glucose data, predicting a risk of the user reaching a blood glucose level at or below a lower threshold blood glucose value (Fig. 3, [0256] “In some embodiments, an approaching clinical risk is output in the form of a visual, audible, or tactile prompt, such as described with reference to Figs. 20 to 22, for example. In some embodiments, therapy recommendations are output to aid the user in determining corrective action that can be performed in an effort to avoid or minimize clinical risk such as described with reference to Fig. 24, for example.” Therapy recommendations and corrective actions are recommended actions, [0250]-[0251], [0257]-[0258] where the estimation steps can be applied to prevent hypoglycemic conditions, where thresholds are utilized to indicate an approaching of clinical risk, indicating that the predicted risk in step 60 will be reaching a blood glucose level at or below a lower threshold blood glucose value); and
generating and providing at least one recommended action to reduce the risk of the user reaching the blood glucose level at or below the lower threshold blood glucose value (Fig. 3, [0256] “In some embodiments, an approaching clinical risk is output in the form of a visual, audible, or tactile prompt, such as described with reference to Figs. 20 to 22, for example. In some embodiments, therapy recommendations are output to aid the user in determining corrective action that can be performed in an effort to avoid or minimize clinical risk such as described with reference to Fig. 24, for example.” Therapy recommendations and corrective actions are recommended actions).
Regarding Claim 15, Brauker teaches the method of claim 14, wherein predicting a risk of the user reaching a blood glucose level at or below a lower threshold blood glucose value comprises determining a series of predicted blood glucose values of the user over the future period of time commencing at a current time (See Claim 14 Rejection, [0250]-[0251], [0257]-[0258] where the estimation steps can be applied to prevent hypoglycemic conditions, where thresholds are utilized to indicate an approaching of clinical risk, indicating that the predicted risk in step 60 can be reaching a blood glucose level at or below a lower threshold blood glucose value).
Regarding Claim 16, Brauker teaches the method of claim 15, further comprising:
responsive to the series of predicted blood glucose values indicating that the user’s blood glucose value will reach a value outside of a desired range, generating and outputting an alarm indicating the predicted blood glucose value outside of the desired range (See Claim 15 Rejection, [0256]-[0257] “The estimated glucose data 64 can be useful in providing alarms (e.g., hyper- and hypoglycemic alerts) and/or displaying on the user interface of the receiver, for example.”); and
generating and providing at least one recommended action to reduce a likelihood of the user reaching the predicted blood glucose value outside of the desired range (See Claim 15 Rejection, [0256]-[0257]).
Regarding Claim 19, Brauker teaches the method of claim 14, wherein the lower threshold blood glucose value represents an increased risk of the user experiencing a hypoglycemic event (See Claim 14 Rejection).
Regarding Claim 20, Brauker teaches an insulin delivery monitoring system (Abstract, [0250] the teachings of the invention may be incorporated into closed loop insulin delivery, [0251]-[0256] dynamic analyte value estimation steps), comprising:
an insulin delivery device configured to deliver insulin to a user ([0250] closed loop glucose sensor and insulin pump); and
a controller comprising:
at least one processor ([0244]); and
at least one non-transitory computer-readable storage medium storing instructions thereon that, when executed by the at least one processor (the presence of at least one non-transitory computer-readable storage medium is necessary to provide instructions for the system’s processor), cause the controller to:
receive, from a blood glucose monitoring device, blood glucose data representing measured blood glucose values of the user (Fig. 3, [0253] analyte evaluation applied to glucose data, [0254] block 56 obtains sensor data of analyte, i.e. glucose, Fig. 1, [0222] continuous analyte sensor 10 provides glucose value measurements);
based at least partially on the series of predicted blood glucose values, generating and providing at least one recommended action to improve the user’s blood glucose values during the future period of time (Fig. 3, [0256] “In some embodiments, an approaching clinical risk is output in the form of a visual, audible, or tactile prompt, such as described with reference to Figs. 20 to 22, for example. In some embodiments, therapy recommendations are output to aid the user in determining corrective action that can be performed in an effort to avoid or minimize clinical risk such as described with reference to Fig. 24, for example.” Therapy recommendations and corrective actions are recommended actions).
based at least partially on the received blood glucose data, determining a series of predicted blood glucose values of the user over a future period of time commencing at a current time (Fig. 3, [0255] block 58 dynamically and intelligently estimates future analyte values based on received data, Fig. 4, [0257] determining a series of predicted blood glucose values of the user over a future period of time of 15 minutes commencing at a current time t = 0);
based at least partially on the determine series of predicted blood glucose values of the user, determining a risk of the user reaching a blood glucose level at or below a lower threshold blood glucose value (Fig. 3, [0256] “In some embodiments, an approaching clinical risk is output in the form of a visual, audible, or tactile prompt, such as described with reference to Figs. 20 to 22, for example. In some embodiments, therapy recommendations are output to aid the user in determining corrective action that can be performed in an effort to avoid or minimize clinical risk such as described with reference to Fig. 24, for example.” Therapy recommendations and corrective actions are recommended actions, [0250]-[0251], [0257]-[0258] where the estimation steps can be applied to prevent hypoglycemic conditions, where thresholds are utilized to indicate an approaching of clinical risk, indicating that the predicted risk in step 60 will be reaching a blood glucose level at or below a lower threshold blood glucose value); and
generating and providing at least one recommended action to reduce the risk of the user reaching the blood glucose level at or below the lower threshold blood glucose value (Fig. 3, [0256] “In some embodiments, an approaching clinical risk is output in the form of a visual, audible, or tactile prompt, such as described with reference to Figs. 20 to 22, for example. In some embodiments, ddtherapy recommendations are output to aid the user in determining corrective action that can be performed in an effort to avoid or minimize clinical risk such as described with reference to Fig. 24, for example.” Therapy recommendations and corrective actions are recommended actions).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
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.
Claim(s) 2-3 and 17-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Brauker in view of Kircher, Jr et al (US 2010/0292634) (“Kircher”) as noted in Applicant IDS dated 1/29/2025.
Regarding Claim 2, while Brauker teaches the method of claim 1, Brauker fails to teach wherein the future period of time comprises at least two hours.
However Kircher teaches an insulin delivery control method (Abstract) comprising a prediction of future values ([0227]), teaches that the prediction of future values can be arbitrarily set based on user preferences ([0236]-[0239]), and teaches future trajectories being analyzed four hours into the future (Fig. 18, [0338]).
It would have been obvious to one of ordinary skill in the art at the time of the invention to increase the length of prediction of Brauker to at least two hours as taught by Kircher as a way to increase the amount of planning a user can apply to their day. While it would be recognized by one of ordinary skill in the art that later predictions may be less accurate, Kircher teaches that a user may decide that these predictions remain sufficiently accurate at this length of time.
Regarding Claim 3, while Brauker teaches the method of claim 1, Brauker fails to teach wherein the future period of time comprises at least six hours.
However Kircher teaches an insulin delivery control method (Abstract) comprising a prediction of future values ([0227]), teaches that the prediction of future values can be arbitrarily set based on user preferences ([0236]-[0239]), and teaches future trajectories being analyzed four hours into the future (Fig. 18, [0338]).
It would have been obvious to one of ordinary skill in the art at the time of the invention to increase the length of prediction of Brauker to at least six hours Kircher teaches that prediction length can be set by a user, acting as a way to increase the amount of planning a user can apply to their day. While it would be recognized by one of ordinary skill in the art that later predictions may be less accurate, Kircher teaches that a user may decide that these predictions remain sufficiently accurate at this length of time. Thus, the chosen future period of time may be considered an optimization by routine experimentation of the balance between accuracy and future convenience [“[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In reAller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)].
Regarding Claim 17, while Brauker teaches the method of claim 14, Brauker fails to teach wherein the future period of time comprises at least two hours.
However Kircher teaches an insulin delivery control method (Abstract) comprising a prediction of future values ([0227]), teaches that the prediction of future values can be arbitrarily set based on user preferences ([0236]-[0239]), and teaches future trajectories being analyzed four hours into the future (Fig. 18, [0338]).
It would have been obvious to one of ordinary skill in the art at the time of the invention to increase the length of prediction of Brauker to at least two as taught by Kircher as a way to increase the amount of planning a user can apply to their day. While it would be recognized by one of ordinary skill in the art that later predictions may be less accurate, Kircher teaches that a user may decide that these predictions remain sufficiently accurate at this length of time.
Regarding Claim 18, while Brauker teaches the method of claim 14, Brauker fails to teach wherein the future period of time comprises at least six hours.
However Kircher teaches an insulin delivery control method (Abstract) comprising a prediction of future values ([0227]), teaches that the prediction of future values can be arbitrarily set based on user preferences ([0236]-[0239]), and teaches future trajectories being analyzed four hours into the future (Fig. 18, [0338]).
It would have been obvious to one of ordinary skill in the art at the time of the invention to increase the length of prediction of Brauker to at least two as taught by Kircher as a way to increase the amount of planning a user can apply to their day. While it would be recognized by one of ordinary skill in the art that later predictions may be less accurate, Kircher teaches that a user may decide that these predictions remain sufficiently accurate at this length of time. Thus, the chosen future period of time may be considered an optimization by routine experimentation of the balance between accuracy and future convenience [“[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” In reAller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)].
Claim(s) 8-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Brauker in view of Budiman et al (US 2011/0098548) (“Budiman”) as noted in Applicant IDS dated 1/29/2025.
Regarding Claim 8, while Brauker teaches the method of claim 1, Brauker fails to teach the method further comprising:
receiving an input of user-specific parameters; and
determining the series of predicted blood glucose values of the user over the future period of time based at least partially on the received user-specific parameters.
However Budiman teaches an insulin delivery control system (Abstract) comprising receiving an input of user-specific parameters ([0080]-[0082] analyte monitoring and known patient events enable analysis of user-specific parameters); and
Determining the series of predicted blood glucose values of the user over the future period of time based at least partially on the received user-specific parameters ([0082] updated user-specific parameters incorporated into glucose control evaluation).
It would have been obvious to one of ordinary skill in the art at the time of the invention to find and apply patient-specific parameters for the analysis of Brauker as Budiman teaches that calibrating patient-specific parameters produces “good patient-specific glucose control.”
Regarding Claim 9, while Brauker and Budiman teach the method of claim 8, wherein the user-specific parameters comprise one or more of insulin-to-carbohydrate ratio, insulin sensitivity factor, duration of insulin action, time for carbohydrate absorption, duration of exercise effect, or ratio of exercise per hour to carbohydrates (See Claim 8 Rejection, [0082] insulin-to-carbohydrate ratio and insulin sensitivity).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAIRO H PORTILLO whose telephone number is (571)272-1073. The examiner can normally be reached M-F 9:00 am - 5:15 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jacqueline Cheng can be reached at (571)272-5596. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JAIRO H. PORTILLO/
Examiner
Art Unit 3791
/PUYA AGAHI/Primary Examiner, Art Unit 3791
Prosecution Insights