Prosecution Insights
Last updated: April 19, 2026
Application No. 17/407,712

METHODS, SYSTEMS AND DEVICES FOR A MEDICAMENT DOSE CALCULATOR

Final Rejection §103
Filed
Aug 20, 2021
Examiner
GOLLAMUDI, NEERAJA
Art Unit
3783
Tech Center
3700 — Mechanical Engineering & Manufacturing
Assignee
Companion Medical Inc.
OA Round
6 (Final)
72%
Grant Probability
Favorable
7-8
OA Rounds
3y 3m
To Grant
99%
With Interview

Examiner Intelligence

Grants 72% — above average
72%
Career Allow Rate
110 granted / 153 resolved
+1.9% vs TC avg
Strong +42% interview lift
Without
With
+42.2%
Interview Lift
resolved cases with interview
Typical timeline
3y 3m
Avg Prosecution
51 currently pending
Career history
204
Total Applications
across all art units

Statute-Specific Performance

§101
1.0%
-39.0% vs TC avg
§103
48.8%
+8.8% vs TC avg
§102
25.8%
-14.2% vs TC avg
§112
21.5%
-18.5% vs TC avg
Black line = Tech Center average estimate • Based on career data from 153 resolved cases

Office Action

§103
DETAILED ACTION Notice of Pre-AIA or AIA Status The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA . Claim Rejections - 35 USC § 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. Claim(s) 1, 3, 6-8, 10, 12-13, 33 and 36 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sjolund et al. (US Patent Pub. 20190175841 hereinafter “Sjolund”) in view of Sloan et al. (US 20120232520 hereinafter “Sloan”), Saint et al. (US Patent Pub. 20160012205 hereinafter “Saint”) and Hayter et al. (US Patent Pub. 20090164239 hereinafter “Hayter”). Regarding Claim 1, Sjolund teaches a method for adjusting an insulin dose size by fixed-dose titration (see [0194-0195] teaching titration techniques), the method comprising: establishing a wireless connection between a mobile communication device (See [0033] and [0077]) of a patient user and a continuous glucose monitor (CGM) worn by the patient user (see [0058] teaching the glucose monitoring system includes a CGM and wirelessly transmits data); sensing with the CGM, a first glucose measurement of the patient user prior to consumption of a meal (See [0050] and [0061], since the data can be collected in timed increments it is interpreted that data could be collected prior to consumption of a meal); determining a first dose size of insulin to be recommended for administration to the patient user based on consumption of the meal (see [0180]); also see [0046] teaching that the device may have a physician preset dosages correlating to various meal sizes); transmitting, from the CGM to the mobile communication device the first glucose measurement (see [0060] teaching that the mobile device receives data from the glucose monitoring system) presenting to the patient user, via a display on at least one of the injection pen device or the mobile communication device, the recommended first dose size of insulin to be administered to the patient user (see [0156]); sensing, with the CGM, a second glucose measurement of the patient user within a predefined time period after consumption of the meal by the patient user (See [0171]); transmitting, from the CGM to the mobile communication device the second glucose measurement (see [0060] teaching that the mobile device receives data from the glucose monitoring system) determining a second dose size of insulin to be recommended for administration to the patient user for correcting the second glucose measurement to be within a target glucose level range (See [0176] and [0209]); and presenting to the patient user, via the display, the recommended second dose size of insulin to be administered to the patient user (See [0167], teaching that the system determines whether to adjust recommended doses based on past data; See [0180]). Sjolund does not specify the method wherein the determined first dose size of insulin is a predefined insulin amount matched to the patient user’s selection of (i) a meal type, or (ii) the meal type and a meal size of the meal type and wherein the determined second dose size is a calculated insulin amount calculated based on health data including the first glucose measurement and the second glucose measurement. Sloan teaches a method for adjusting an insulin dose size by fixed-dose titration (see [0125]) on an injection pen device (see [0092] and [0265]) in wireless communication with a mobile communication device (see [0064-0065] teaching wireless mobile device), the method comprising: receiving a first glucose measurement of a patient user of the injection pen device prior to consumption of a meal (see [0155] and [0167]); determining a first dose size of insulin to be recommended for administration to the patient user based on consumption of the meal, wherein the determined first dose size of insulin is a predefined insulin amount corresponding to (i) a meal type, or (ii) the meal type and a meal size of the meal type and is selected from a plurality of predefined insulin amounts each corresponding to (i) a different meal type, or (ii) a different combination of the meal type and a meal size (see [0156-0157]); presenting to the patient user, via a display on at least one of the injection pen device or the mobile communication device, the recommended first dose size of insulin to be administered to the patient user (see [0153] teaching that the recommended dosages may be displayed on a display unit); determining a second dose size of insulin to be recommended for administration to the patient user for correcting the second glucose measurement to be within a target glucose level range, wherein the determined second dose size is a calculated insulin amount calculated based on health data including the first glucose measurement and the second glucose measurement (See [0159-0163] teaching dose adjustments based on the blood glucose values after mealtime); and presenting to the patient user, via the display, the recommended second dose size of insulin to be administered to the patient user (see [0166] “the health monitor device 600 may recommend (e.g., display) a predetermined dose adjustment amount”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Sjolund such that includes the steps of wherein the determined first dose size of insulin is a predefined insulin amount corresponding to (i) a meal type, or (ii) the meal type and a meal size of the meal type and is selected from a plurality of predefined insulin amounts each corresponding to (i) a different meal type, or (ii) a different combination of the meal type and a meal size and wherein the determined second dose size is a calculated insulin amount calculated based on health data including the first glucose measurement and the second glucose measurement as taught by Sloan. One of ordinary skill in the art would have been motivated to do so as this is another method of calculating and recommending dosages for the user (Sloan [0153]). Sjolund does not specify the method receiving, at the mobile communications device for a meal to be consumed by the patient user, the patients user’s selection of a (i) meal type, or (ii) the meal type and a meal size of the meal type; and determining a success metric of the previous match between the predefined insulin amount and the (i) meal type, or (ii) the meal type and the meal size of the meal type. Saint teaches [0035] that the user could input the meal type or meal size into a mobile companion device (5). Saint also teaches that the data could contain metrics comparing the blood glucose values, the counted carbohydrates, the amount and sizes of doses given (See 0073-0074]. This is interpreted to be a metric that determines of the match between the insulin amount and the meal type (counting of carbohydrates) are matched. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Sjolund such that the method includes receiving, at the mobile communications device for a meal to be consumed by the patient user, the patients user’s selection of a (i) meal type, or (ii) the meal type and a meal size of the meal type; and determining a success metric of the previous match between the predefined insulin amount and the (i) meal type, or (ii) the meal type and the meal size of the meal type as taught by Saint. One of ordinary skill in the art would recognize this as a way to ensure the health care provider would get a visual indication of the doses to ensure correct guided therapy for the user (Saint [0074]). Sjolund does not specify the method determining a success metric for the first dose size based in part on the first and second glucose measurements; and, if the success metric is beyond a threshold, the predefined insulin amount matched to the patient user's selection of (i) the meal type, or (ii) the meal type and the meal size of the meal type. Hayter teaches [0122] a method including determining various metrics (average blood glucose) and comparing it to threshold values. Hayter also teaches making modifications if the metric exceeds the threshold (See [0122], [0136]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Sjolund such that it includes a step of determining a success metric for the first dose size based in part on the first and second glucose measurements and comparing it to a threshold as taught by Hayter. One of ordinary skill in the art would have been motivated to do so to provide another method of detecting adverse conditions from the measured blood glucose (Hayter [0122] and [0136]). Regarding Claim 3, the combination of Sjolund, Sloan, Saint and Hayter teaches all elements of claim 1 as described above. Sjolund further teaches the method wherein the meal size is selected from a group consisting of a small meal, a medium size meal, and a large size meal (See [0167] and [0171]). Regarding Claim 6, the combination of Sjolund, Sloan, Saint and Hayter teaches all elements of claim 1 as described above. Sjolund further teaches the method wherein the matched predefined insulin amount is estimated from an amount of carbohydrates estimated from the meal type and the meal size (See [0032], [0046-0047]). Regarding Claim 7, Sjolund teaches a system for administering a medicine using a fixed-dose titration protocol (see [0194-0195] teaching titration techniques), comprising: an injection pen device (110,120) including a dose setting mechanism to set a dose of a medicine contained in a medicine cartridge that is to be dispensed by the injection pen device (See [0093], a dispensing mechanism to dispense the medicine according to the set dose (see [0138] teaching a needle), and an electronics unit including a processor, a memory comprising instructions executable by the processor(see [0049] and [0062]), and a wireless transmitter, the processor of the injection pen device configured to generate dose data associated with a dispensing event of a dose of the medicine dispensed from the injection pen device and time data associated with the dispensing event, and to wirelessly transmit the dose data, wherein the medicine includes insulin (see [0063]), wherein the injection pen device is in wireless communication with a mobile communication device that includes a data processing unit including a processor and memory to receive and process the dose data (see [0065]), and wherein the mobile communication device includes a software application program product comprising a non-transitory computer-readable storage medium having instructions (see [0127-0128]), which when executed by the processor of the data processing unit, cause the mobile communication device to determine a first dose size of insulin to be recommended for administration to the patient user based on consumption of the meal (see [0180] and see [0046] teaching the user or healthcare professional may set a predefined dosage amount correlating to the meal type), present to the patient user, via a display on at least one of the injection pen device or the mobile communication device, the recommended first dose size of insulin to be administered to the patient user (See [0156]); determine a second dose size of insulin to be recommended for administration to the patient user based on health data, including a first glucose level of a patient user of the injection pen device that is measured prior to consumption of a meal and a second glucose level of the patient user that is measured within a predefined time period after consumption of the meal (see [0063-0064], [0127-128]); and present to the patient user, via the display, the recommended second dose size of insulin to be administered (See [0167], teaching that the system determines whether to adjust recommended doses based on past data; See [0180]). Sjolund does not specify the method wherein the determined first dose size of insulin is a predefined insulin amount matched to the patient user’s selection of (i) a meal type, or (ii) the meal type and a meal size of the meal type and is selected from a plurality of predefined insulin amounts each corresponding to (i) a different meal type, or (ii) a different combination of the meal type and a meal size and wherein the determined second dose size is a calculated insulin amount calculated based on health data including the first glucose measurement and the second glucose measurement. Sloan teaches a system which receives a first glucose measurement of a patient user of the injection pen device prior to consumption of a meal (see [0155] and [0167]); determines a first dose size of insulin to be recommended for administration to the patient user based on consumption of the meal, wherein the determined first dose size of insulin is a predefined insulin amount corresponding to (i) a meal type, or (ii) the meal type and a meal size of the meal type and is selected from a plurality of predefined insulin amounts each corresponding to (i) a different meal type, or (ii) a different combination of the meal type and a meal size (see [0156-0157]); presents to the patient user, via a display on at least one of the injection pen device or the mobile communication device, the recommended first dose size of insulin to be administered to the patient user (see [0153] teaching that the recommended dosages may be displayed on a display unit); determines a second dose size of insulin to be recommended for administration to the patient user for correcting the second glucose measurement to be within a target glucose level range, wherein the determined second dose size is a calculated insulin amount calculated based on health data including the first glucose measurement and the second glucose measurement (See [0159-0163] teaching dose adjustments based on the blood glucose values after mealtime); and presenting to the patient user, via the display, the recommended second dose size of insulin to be administered to the patient user (see [0166] “the health monitor device 600 may recommend (e.g., display) a predetermined dose adjustment amount”). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Sjolund such that the first dose size of insulin is a predefined insulin amount corresponding to (i) a meal type, or (ii) the meal type and a meal size of the meal type and is selected from a plurality of predefined insulin amounts each corresponding to (i) a different meal type, or (ii) a different combination of the meal type and a meal size and wherein the determined second dose size is a calculated insulin amount calculated based on health data including the first glucose measurement and the second glucose measurement as taught by Sloan. One of ordinary skill in the art would have been motivated to do so as this is another method of calculating and recommending dosages for the user (Sloan [0153]). Sjolund does not specify the method receiving, at the mobile communications device for a meal to be consumed by the patient user, the patients user’s selection of a (i) meal type, or (ii) the meal type and a meal size of the meal type; and determining a success metric of the previous match between the predefined insulin amount and the (i) meal type, or (ii) the meal type and the meal size of the meal type. Saint teaches [0035] that the user could input the meal type or meal size into a mobile companion device (5). Saint also teaches that the data could contain metrics comparing the blood glucose values, the counted carbohydrates, the amount and sizes of doses given (See 0073-0074]. This is interpreted to be a metric that determines of the match between the insulin amount and the meal type (counting of carbohydrates) are matched. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Sjolund such that the method includes receiving, at the mobile communications device for a meal to be consumed by the patient user, the patients user’s selection of a (i) meal type, or (ii) the meal type and a meal size of the meal type; and determining a success metric of the previous match between the predefined insulin amount and the (i) meal type, or (ii) the meal type and the meal size of the meal type as taught by Saint. One of ordinary skill in the art would recognize this as a way to ensure the health care provider would get a visual indication of the doses to ensure correct guided therapy for the user (Saint [0074]). Sjolund does not specify the method determining a success metric for the first dose size based in part on the first and second glucose measurements; and, if the success metric is beyond a threshold, the predefined insulin amount matched to the patient user's selection of (i) the meal type, or (ii) the meal type and the meal size of the meal type. Hayter teaches [0122] a method including determining various metrics (average blood glucose) and comparing it to threshold values. Hayter also teaches making modifications if the metric exceeds the threshold (See [0122], [0136]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Sjolund such that it includes a step of determining a success metric for the first dose size based in part on the first and second glucose measurements and comparing it to a threshold as taught by Hayter. One of ordinary skill in the art would have been motivated to do so to provide another method of detecting adverse conditions from the measured blood glucose (Hayter [0122] and [0136]). Regarding Claim 8, the combination of Sjolund, Sloan, Saint and Hayter teaches all elements of claim 7 as described above. Sjolund further teaches the system wherein the mobile communication device is further caused to: receive, from a glucose monitor in communication with the mobile communication device, the first glucose level of a patient user of the injection pen device prior to consumption of a meal (See [0050] and [0061], since the data can be collected in timed increments it is interpreted that data could be collected prior to consumption of a meal); and receive, from the glucose monitor, the second glucose level of the patient user within a predefined time period after consumption of the meal by the patient user (See [0171]). Regarding Claim 10, the combination of Sjolund, Sloan, Saint and Hayter teaches all elements of claim 7 as described above. Sjolund further teaches the system wherein the meal size is selected from a group consisting of a small meal, a medium size meal, and a large size meal (See [0167] and [0171]). Regarding Claim 12, the combination of Sjolund, Sloan, Saint and Hayter teaches all elements of claim 7 as described above. The combination further teaches the system wherein the matched predefined insulin amount is an estimated insulin amount based on an amount of carbohydrates estimated from the (i) meal type or (ii) the meal type and the meal size (See Sjolund [0032], [0046-0047] and Sloan [0156-0157]). Regarding Claim 13, the combination of Sjolund, Sloan, Saint and Hayter teaches all elements of claim 7 as described above. Sjolund further teaches the system wherein the software application program product includes (i) a data aggregator that obtains the health data and the meal data, (ii) a dose calculator that autonomously determines the recommended second dose size, and (iii) a user interface generator to produce a user interface on the display of the at least one of the injection pen device or the mobile communication device (See [0080] teaching the method includes calculating recommended dosage based on glucose measurements and meal types which are sent to a mobile device). Regarding Claim 33, the combination of Sjolund, Sloan, Saint and Hayter teaches the method of claim 1, wherein the determined second dose size is calculated based on health data and a model of the effects of carbs of the consumed meal on glucose measurements over time (See Sloan [0167-0170] teaching determining dosage on glucose measurements and carbohydrate measurements). Regarding Claim 36, the combination of Sjolund, Sloan, Saint and Hayter teaches the system of claim 7, wherein the determined second dose size is calculated based on health data and a model of the effects of carbs of the consumed meal on glucose measurements over time (See Sloan [0167-0170] teaching determining dosage on glucose measurements and carbohydrate measurements). Claim(s) 2, 5 and 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sjolund (US Patent Pub. 20190175841) in view of Sloan (US 20120232520), Saint (US Patent Pub. 20160012205) and Hayter (US Patent Pub. 20090164239) as applied to claims 1 and 7 above, and further in view of Sieh et al. (US Patent Pub. 20100016700 hereinafter “Sieh”). Regarding Claim 2, the combination of Sjolund, Sloan, Saint and Hayter teaches all elements of claim 1 as described above. Sjolund does not specify the method wherein the meal type is selected from a group consisting of breakfast, lunch, dinner, pre-breakfast snack, pre-lunch snack, pre-dinner snack, and post-dinner snack. Seih teaches [0050] an insulin device that allows the user to select a meal type from a group consisting of breakfast, lunch, dinner, pre-breakfast snack, pre-lunch snack, pre-dinner snack, and post-dinner snack. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Sjolund such that the meal type is selected from a group consisting of breakfast, lunch, dinner, pre-breakfast snack, pre-lunch snack, pre-dinner snack, and post-dinner snack as taught by Sieh. One of ordinary skill in the art would have been motivated to do so in order to ensure the dosage recommendation will not exceed a preset maximum daily value (See Sieh [0050]). Regarding Claim 5, the combination of Sjolund, Sloan, Saint and Hayter teaches all elements of claim 1 as described above. Sjolund does not specify the method comprising: prior to the determining the second dose size, prompting a confirmation input that the meal was consumed by the patient user. Sieh teaches ([0050] and [0060]) a method including timestamped meal recordings by the user and possible prompting to a user to confirm meal measurements. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Sjolund such that prior to the determining the second dose size, prompting a confirmation input that the meal was consumed by the patient user. One of ordinary skill in the art would have been motivated to do so in order to ensure the dosage recommendation will not exceed a preset maximum daily value (See Sieh [0050]). Regarding Claim 9, the combination of Sjolund, Sloan, Saint and Hayter teaches all elements of claim 7 as described above. Sjolund does not specify the method wherein the meal type is selected from a group consisting of breakfast, lunch, dinner, pre-breakfast snack, pre-lunch snack, pre-dinner snack, and post-dinner snack. Seih teaches [0050] an insulin device that allows the user to select a meal type from a group consisting of breakfast, lunch, dinner, pre-breakfast snack, pre-lunch snack, pre-dinner snack, and post-dinner snack. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Sjolund such that the meal type is selected from a group consisting of breakfast, lunch, dinner, pre-breakfast snack, pre-lunch snack, pre-dinner snack, and post-dinner snack as taught by Sieh. One of ordinary skill in the art would have been motivated to do so in order to ensure the dosage recommendation will not exceed a preset maximum daily value (See Sieh [0050]). Claim(s) 4 and 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sjolund (US Patent Pub. 20190175841) in view of Sloan (US 20120232520), Saint (US Patent Pub. 20160012205) and Hayter (US Patent Pub. 20090164239) as applied to claims 1 and 7 above, and further in view of Shadforth et al. (US Patent Pub. 20110077493 hereinafter “Shadforth”). Regarding Claim 4, the combination of Sjolund, Sloan, Saint and Hayter teaches all elements of claim 1 as described above. Sjolund does not specify the method wherein the meal type includes a food category. Shadforth teaches [0057] a device that allows the user to input a meal type through food categories. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Sjolund such that the meal type includes a food category as taught by Shadforth. One of ordinary skill in the art would have been motivated to do so in order to assist users who may have trouble determining the correct amount of carbohydrates to input (Shadforth [0057]). Regarding Claim 11, the combination of Sjolund, Sloan, Saint and Hayter teaches all elements of claim 7 as described above. Sjolund does not specify the system wherein the meal type includes a food category. Shadforth teaches [0057] a device that allows the user to input a meal type through food categories. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Sjolund such that the meal type includes a food category as taught by Shadforth. One of ordinary skill in the art would have been motivated to do so in order to assist users who may have trouble determining the correct amount of carbohydrates to input (Shadforth [0057]). Claim(s) 31 and 34 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sjolund (US Patent Pub. 20190175841) in view of Sloan (US 20120232520), Saint (US Patent Pub. 20160012205) and Hayter (US Patent Pub. 20090164239) as applied to claims 1 and 7 above, and further in view of Strachan et al. (US Patent Pub. 20110205065 hereinafter “Strachan”). Regarding Claim 31, the combination of Sjolund, Sloan, Saint and Hayter teaches all elements of claim 1 as described above. The combination does not specify the method wherein determining the second dose size is blocked for a predetermined time after consumption of a meal. Strachan teaches [0051] a few safety features that lock/deactivate the insulin calculator from determining a new dose size. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Sjolund such that it included a safety feature that locks/deactivates the insulin calculator as taught by Strachan. If the safety feature in the modified Sjolund was activated, it would result in the step of determining the second dose size being blocked for a predetermined time after consumption of a meal. One of ordinary skill in the art would have been motivated to do so in order to provide a safeguard in the insulin dosing for a user (Strachan [0006]). Regarding Claim 34, the combination of Sjolund, Sloan, Saint and Hayter teaches all elements of claim 7 as described above. The combination does not specify the system wherein determining the second dose size is blocked for a predetermined time after consumption of a meal. Strachan teaches [0051] a few safety features that lock/deactivate the insulin calculator from determining a new dose size. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Sjolund such that it included a safety feature that locks/deactivates the insulin calculator as taught by Strachan. If the safety feature in the modified Sjolund was activated, it would result in the step of determining the second dose size being blocked for a predetermined time after consumption of a meal. One of ordinary skill in the art would have been motivated to do so in order to provide a safeguard in the insulin dosing for a user (Strachan [0006]). Claim(s) 32 and 35 is/are rejected under 35 U.S.C. 103 as being unpatentable over Sjolund (US Patent Pub. 20190175841) in view of Sloan (US 20120232520), Saint (US Patent Pub. 20160012205) and Hayter (US Patent Pub. 20090164239) as applied to claims 1 and 7 above, and further in view of Soni et al. (US Patent Pub. 20110178820 hereinafter “Soni”). Regarding Claim 32, the combination of Sjolund, Sloan, Saint and Hayter teaches all elements of claim 1 as described above. Sjolund teaches in [0050] and [0061], that the data is collected in timed increments. However, the combination does not specify the method wherein the second glucose measurement is from a time that is at least a predetermined time period after consumption of the meal. Soni teaches [0121] measuring bG values after one or more meals over time would allow for therapy efficacy and determine the proper drug ang dose recommendations for patients. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of Sjolund such that one of the data collection times is from a time that is at least a predetermined time period after consumption of the meal as taught by Soni. One of ordinary skill in the art would have been motivated to do so in order to allow for therapy efficacy and determine the proper drug ang dose recommendations for patients (Soni [0121]). Regarding Claim 35, the combination of Sjolund, Sloan, Saint and Hayter teaches all elements of claim 7 as described above. Sjolund teaches in [0050] and [0061], that the data is collected in timed increments. However, the combination does not specify the system wherein the second glucose measurement is from a time that is at least a predetermined time period after consumption of the meal. Soni teaches [0121] measuring bG values after one or more meals over time would allow for therapy efficacy and determine the proper drug ang dose recommendations for patients. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of Sjolund such that one of the data collection times is from a time that is at least a predetermined time period after consumption of the meal as taught by Soni. One of ordinary skill in the art would have been motivated to do so in order to allow for therapy efficacy and determine the proper drug ang dose recommendations for patients (Soni [0121]). Response to Arguments Applicant’s arguments with respect to claim(s) 1 and 7 have been considered but are moot because the new ground of rejection takes into consideration the amendments relating to “determining a success metric of the previous match between the predefined insulin amount and the (i) the meal type or (ii) the meal type and the meal size of the meal type”. Conclusion Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a). A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action. Any inquiry concerning this communication or earlier communications from the examiner should be directed to NEERAJA GOLLAMUDI whose telephone number is (571)272-6449. The examiner can normally be reached Mon-Fri 8-5. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached on (571) 270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /NEERAJA GOLLAMUDI/Examiner, Art Unit 3783 /WESLEY G HARRIS/Examiner, Art Unit 3783
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Prosecution Timeline

Aug 20, 2021
Application Filed
Jun 10, 2024
Non-Final Rejection — §103
Sep 12, 2024
Response Filed
Oct 02, 2024
Final Rejection — §103
Nov 07, 2024
Interview Requested
Nov 14, 2024
Non-Final Rejection — §103
Nov 14, 2024
Applicant Interview (Telephonic)
Feb 12, 2025
Response Filed
May 09, 2025
Final Rejection — §103
Jul 16, 2025
Response after Non-Final Action
Jul 31, 2025
Request for Continued Examination
Aug 04, 2025
Response after Non-Final Action
Oct 09, 2025
Non-Final Rejection — §103
Jan 28, 2026
Response Filed
Mar 19, 2026
Final Rejection — §103 (current)

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SYSTEMS AND METHODS FOR ANCHORING MEDICAL DEVICES
2y 5m to grant Granted Mar 17, 2026
Patent 12508399
MANUFACTURE OF STEERABLE DELIVERY DEVICES
2y 5m to grant Granted Dec 30, 2025
Patent 12508423
Device For Tissue Electrotransfer Using A Microelectrode
2y 5m to grant Granted Dec 30, 2025
Patent 12485278
ELECTROPORATION DEVICE
2y 5m to grant Granted Dec 02, 2025
Study what changed to get past this examiner. Based on 5 most recent grants.

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Prosecution Projections

7-8
Expected OA Rounds
72%
Grant Probability
99%
With Interview (+42.2%)
3y 3m
Median Time to Grant
High
PTA Risk
Based on 153 resolved cases by this examiner. Grant probability derived from career allow rate.

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