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 .
Status of Claims
This office action is responsive to the application filed 23 July 2026.
Claims 1-2 are withdrawn.
Claims 3, 11, 13, 15, 19, and 20 are amended.
Claims 3-21 are presently pending in this application.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 3, 4, 6, 9, 10, 14-17, and 21 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Yodfat et al. (US Patent Publication No. 20100286601 A1), hereinafter Yodfat.
Regarding claim 3, Yodfat teaches a method (Yodfat: Fig. 9), in an automatic drug delivery system (Fig. 5a, device 1000), for directing a user to administer a self-guided insulin resistance test comprising: advising the user to fast for a predetermined fasting time (Fig. 9, in block 60, user is advised to fast for 5 hours; para. 0163); advising the user to ingest a predetermined quantity of fast-acting carbohydrates (Fig. 9, block 61, user can be asked to consume a specific amount of carbohydrates like glucose; para. 0095 and 0099); determining, for a predetermined post-prandial period after ingestion of the fast-acting carbohydrates whether an insulin administered (Fig. 9, block 61, correction bolus can be administered; para. 0143) during the post-prandial period is sufficient to lower blood glucose levels of the user to a baseline value (Fig. 9, block 60, user’s blood glucose level CBG is measured and verified if in the target range TBG; para. 0155); and when the insulin administered during the post-prandial period (61) is insufficient (Fig. 9, block 60a, if CBG is not in target zone; para. 0169), adjusting parameters of a medication delivery algorithm to correct for insulin resistance (Fig. 9, the correction bolus is adjusted based on insulin sensitivity; para 0144 and para. 0169) of the user. When the prior art device is the same as a device described in the specification for carrying out or being made by the claimed method, it can be assumed the device will inherently perform or be made by the claimed process. In re King, 801 F.2d 1324, 231 USPQ 136 (Fed. Cir. 1986). MPEP 2112.02
Regarding claim 4, Yodfat teaches the method above, wherein advising the user to fast for the predetermined fasting time (60) comprises providing an instruction to the user in a user interface (Fig. 7b, display device 3030) of the automatic drug delivery system (1000) advising of the length of the fasting time (60, para. 0163).
Regarding claim 6, Yodfat teaches the method above, wherein advising the user to ingest a predetermined quantity of fast-acting carbohydrates (61) comprises providing an instruction to the user in the user interface (3030) of the automatic drug delivery system (1000), the instruction including the desired quantity of fast-acting carbohydrates to be ingested (the amount of carbohydrates to consume is calculated and the user is advised; para. 0152 and 0155).
Regarding claim 9, Yodfat teaches the method above, further comprising: providing an instruction in a user interface (160) of the automatic drug delivery system (1000) instructing the user not to eat during the post-prandial period (Fig. 9, after ingesting carbohydrates at block 61, user is advised to fast for at least 5 hours; para. 0163).
Regarding claim 10, Yodfat teaches the method above, further comprising: determining, during the post-prandial period, an insulin response factor (Fig. 9, after ingesting carbohydrates at block 61, the insulin sensitivity, or IS, is determined; para. 0007 and 0163).
Regarding claim 14, Yodfat teaches the method above, wherein adjusting parameters of the medication delivery algorithm (recommended food adjustment is based on glucose concentration change; para. 0032 and claim 116) comprises: adjusting a recommended glucose target for the user (para. 0032 and claim 116).
Regarding claim 15, Yodfat teaches a system (1000) comprising: a drug delivery device (Fig. 5a, insulin infusion unit 1010); a blood glucose sensor (Fig. 20a, glucose measurement unit 90) in communication with the drug delivery device (Fig. 20a, unit 90 is part of remote control unit 1008 which communicates with the unit 1010; para. 0135); a user device (Fig. 20a, remote control unit 1008) in communication with the drug delivery device (para. 0135); and software executing on the user device or on the drug delivery device (Fig. 9, the algorithm of Fig. 9 can be carried out via software in the unit 1008 via processor 3010; para. 0138 and 0207) which causes the system to: advise the user to fast for a predetermined fasting time (Fig. 9, in block 60, user is advised to fast for 5 hours; para. 0163); advise the user to ingest a predetermined quantity of fast-acting carbohydrates (Fig. 9, block 61, user can be asked to consume a specific amount of carbohydrates like glucose; para. 0095 and 0099); determine, for a predetermined post-prandial period after ingestion of the fast-acting carbohydrates whether an insulin administered (Fig. 9, block 61, correction bolus can be administered; para. 0143) during the post-prandial period is sufficient to lower blood glucose levels of the user to a baseline value (Fig. 9, block 60, user’s blood glucose level CBG is measured and verified if in the target range TBG; para. 0155); and when the insulin administered during the post-prandial period (61) is insufficient (Fig. 9, block 60a, if CBG is not in target zone; para. 0169), adjust parameters of a medication delivery algorithm to correct for insulin resistance (Fig. 9, the correction bolus is adjusted based on insulin sensitivity; para 0144 and para. 0169) of the user.
Regarding claim 16, Yodfat teaches the device above, the software causing the system to: provide an instruction to the user in a user interface (Fig. 7b, display device 3030) of the user device (1008) advising of the length of the fasting time (60, para. 0163).
Regarding claim 17, Yodfat teaches the device above, the software further causing the system to: provide an instruction to the user in the user interface (3030) of the user device (1008), the instruction including the desired quantity of fast-acting carbohydrates to be ingested (the amount of carbohydrates to consume is calculated and the user is advised; para. 0152 and 0155).
Regarding claim 21, Yodfat teaches the device above, the software further causing the system to: adjust a recommended glucose target for the user (para. 0032 and claim 116).
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 5 is rejected under 35 U.S.C. 103 as being unpatentable over Yodfat.
Regarding claim 5, Yodfat teaches the method above.
Yodfat does not expressly disclose the predetermined fasting time is 10 hours. However, Yodfat discloses a fasting time of at least 5 hours (Yodfat: para. 0143), which includes a fasting time of 10 hours.
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the fasting time to be 10 hours as taught by Yodfat in order to eliminate the influence of residual insulin (para. 0163). Furthermore, applicant has not disclosed that this limitation solves any stated problem or is for any particular purpose and it appears that the device would perform equally well with other fasting times. Absent a teaching as to criticality of the fasting time of 10 hours, this particular arrangement is deemed to have been known by those skilled in the art since the instant specification and evidence of record fail to attribute any significance (novel or unexpected results) to a particular arrangement.
Claim 7, 8, 11-13, and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Yodfat in view of Sjolund et al. (US Patent No. 11197964 B2), hereinafter Sjolund.
Regarding claim 7, Yodfat teaches the method above,
Yodfat does not expressly disclose that the instruction further comprises providing suggestions of foods for the user to ingest comprising the desired quantity of fast- acting carbohydrates.
Sjolund teaches an instruction comprises providing suggestions of foods for the user to ingest comprising the desired quantity of fast-acting carbohydrates (Sjolund: Fig. 23, user interface can suggest fast-acting carb meals based on desired quantity; col 33, ln 12-27).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the method of Yodfat such that the instruction further comprises providing suggestions of foods for the user to ingest comprising the desired quantity of fast- acting carbohydrates as taught by Sjolund in order to inform the user on what carbohydrates to consume as well as the estimated amount of carbs that the meal comprises (Sjolund: col 33, ln 12-27).
Regarding claim 8, Yodfat teaches the method above.
Yodfat does not expressly disclose that the instruction further comprises a field allowing the user to enter the exact quantity of fast-acting carbohydrates that were ingested.
Sjolund teaches an instruction comprises a field allowing the user to enter the exact quantity of fast-acting carbohydrates that were ingested (user can select a meal ingested; col 20, ln 27-53).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the method of Yodfat such that the instruction further comprises a field allowing the user to enter the exact quantity of fast-acting carbohydrates that were ingested as taught by Sjolund in order to provide updated dosage recommendations (Sjolund: col 20, ln 27-53).
Regarding claim 11, Yodfat teaches the method above.
Yodfat does not expressly disclose determining a final insulin response factor comprises: aggregating an insulin response factor calculated during the post-prandial period of the current insulin response test with a final insulin response factor from a previous insulin response test.
Sjolund teaches determining a final insulin response factor (Sjolund: algorithms can update the insulin sensitivity factor based on detected patterns; col 34, ln 27-67 and col 57, ln 64-67) comprises: aggregating the insulin response factor (insulin sensitivity factor may be mathematically inferred between user’s daily dosage of insulin; col 33, ln 53-55) calculated during the post-prandial period (system 3420 can collect post-prandial data, such insulin sensitivity factor; col 4, ln 53 – col 5, ln 5 and col 33, ln 53-55) of an insulin response test (col 33, ln 53-55) with a final insulin response factor from a previous insulin response test (algorithms can update the insulin sensitivity factor based on detected patterns; col 34, ln 27-67 and col 57, ln 64-67).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the method of Yodfat such that determining a final insulin response factor comprises: aggregating the insulin response factor calculated during the post-prandial period of the current insulin response test with a final insulin response factor from a previous insulin response test as taught by Sjolund in order to determine recommended therapy setting changes and to improve glycemic outcomes (Sjolund: col 34, ln 27-67).
Regarding claim 12, Yodfat in view of Sjolund discloses the method above.
Yodfat does not expressly disclose that each cycle of the medication delivery algorithm is 5 minutes in duration.
Sjolund teaches each cycle of a medication delivery algorithm is 5 minutes in duration (blood glucose data is received every 5 minutes; col 12, ln 20-34).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the method of Yodfat such that each cycle of the medication delivery algorithm is 5 minutes in duration as taught by Sjolund in order to provide updates to therapy parameters if necessary (col 15, ln 13-30).
Regarding claim 13, Yodfat teaches the method above.
Yodfat does not expressly disclose that adjusting parameters of the medication delivery algorithm to correct for insulin resistance of the user comprises: adjusting a total daily insulin input parameter of the medication delivery algorithm by the final insulin response factor.
Sjolund teaches adjusting parameters of the medication delivery algorithm (Sjolund: adjust insulin delivery parameters; col 4, ln 53 – col 5, ln 5) to correct for insulin resistance (ISF) of the user comprises: adjusting a total daily insulin input parameter (total daily dose of basal insulin; col 4, ln 53 – col 5, ln 5) of the medication delivery algorithm (col 4, ln 53 – col 5, ln 5) by the final insulin response factor (algorithms can update the insulin sensitivity factor based on detected patterns; col 34, ln 27-67 and col 57, ln 64-67).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the method of Yodfat such that adjusting parameters of the medication delivery algorithm to correct for insulin resistance of the user comprises: adjusting a total daily insulin input parameter of the medication delivery algorithm by the final insulin response factor as taught by Sjolund in order to provide updates to therapy parameters if necessary (col 15, ln 13-30).
Regarding claim 18, Yodfat teaches the device above.
Yodfat does not expressly disclose the software causing the system to: provide suggestions of foods for the user to ingest comprising the desired quantity of fast-acting carbohydrates.
Sjolund teaches a software causing a system (Sjolund: col 11, ln 36-54) to: provide suggestions of foods for the user to ingest comprising the desired quantity of fast-acting carbohydrates (Sjolund: Fig. 23, user interface can suggest fast-acting carb meals based on desired quantity; col 33, ln 12-27).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the method of Yodfat such that the instruction further comprises providing suggestions of foods for the user to ingest comprising the desired quantity of fast- acting carbohydrates as taught by Sjolund in order to inform the user on what carbohydrates to consume as well as the estimated amount of carbs that the meal comprises (Sjolund: col 33, ln 12-27).
Regarding claim 19, Yodfat teaches the device above.
Yodfat does not expressly disclose the software further causing the system to: determine, during the post-prandial period, an insulin response factor; and aggregate the insulin response factor calculated during the post-prandial period of the current insulin response test with a final insulin response factor from a previous insulin response test.
Sjolund teaches a software causing a system (Sjolund: col 11, ln 36-54) to: determine, during a post-prandial period, an insulin response factor (insulin sensitivity factor may be mathematically inferred between user’s daily dosage of insulin; col 33, ln 53-55); and aggregate an insulin response factor (insulin sensitivity factor may be mathematically inferred between user’s daily dosage of insulin; col 33, ln 53-55) calculated during the post-prandial period (system 3420 can collect post-prandial data, such insulin sensitivity factor; col 4, ln 53 – col 5, ln 5 and col 33, ln 53-55) of an insulin response test (col 33, ln 53-55) with a final insulin response factor from a previous insulin response test (algorithms can update the insulin sensitivity factor based on detected patterns; col 34, ln 27-67 and col 57, ln 64-67).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the device of Yodfat such that the software further causing the system to: aggregate the insulin response factor calculated during the post-prandial period of the current insulin response test with a final insulin response factor from a previous insulin response test as taught by Sjolund in order to determine recommended therapy setting changes and to improve glycemic outcomes (Sjolund: col 34, ln 27-67).
Regarding claim 20, Yodfat teaches the device above.
Yodfat does not expressly disclose the software further causing the system to: determine, during the post-prandial period, an insulin response factor; and adjust a total daily insulin input parameter of the medication delivery algorithm by the final insulin response factor.
Sjolund teaches software causing a system (Sjolund: col 11, ln 36-54) to: determine, during a post-prandial period, an insulin response factor (insulin sensitivity factor may be mathematically inferred between user’s daily dosage of insulin; col 33, ln 53-55); and adjust a total daily insulin input parameter (total daily dose of basal insulin; col 4, ln 53 – col 5, ln 5) of the medication delivery algorithm (col 4, ln 53 – col 5, ln 5) by the final insulin response factor (algorithms can update the insulin sensitivity factor based on detected patterns; col 34, ln 27-67 and col 57, ln 64-67).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the device of Yodfat such that the software further causing the system to: adjust a total daily insulin input parameter of the medication delivery algorithm by the final insulin response factor as taught by Sjolund in order to provide updates to therapy parameters if necessary (col 15, ln 13-30).
Response to Arguments
Applicant’s arguments, see pages 10-11, filed 23 July 2026, with respect to the objection to the drawings have been fully considered and are persuasive. The objection to the drawings has been withdrawn.
Applicant’s arguments, see page 11, filed 23 July 2026, with respect to rejection of claims 3-21 under 35 USC 112(b), have been fully considered and are persuasive. The rejection of claims 3-21 has been withdrawn.
Applicant’s arguments, see page 11-14, filed 23 July 2026, with respect to rejections of claims 3-21 under 35 USC 102(a)(2) and 103 have been fully considered but they are not persuasive.
Applicant argues that Yodfat does not teach “directing a user to administer a self-guided insulin resistance test”, and, instead, is directed to insulin tailoring and glycemic control.
This argument is not persuasive, as Yodfat’s block 60 is disclosed to direct a user to administer a self-guided test for insulin sensitivity (para. 0144, 0155, and 0169).
Applicant argues that Yodfat does not teach "determining, for a predetermined post-prandial period after ingestion of the fast-acting carbohydrates whether the insulin administered during the post-prandial period is sufficient to lower blood glucose levels of the user to a baseline value". Specifically, Applicant argues that block 60 of Yodfat occurs before any carbohydrate ingestion or exercise and, thus, not during a post prandial monitoring window.
This argument is not persuasive, as block 60 of Yodfat can occur after block 61, in which the user can correct his/her blood glucose by administering a correction bolus or consuming carbohydrates (para. 0143). This can occur if the blood glucose determined in block 60 is not within the target range (para. 0143). Therefore, block 60 can occur after carbohydrate ingestion and, thus, in the post prandial monitoring window.
Applicant argues that Yodfat does not teach "when the insulin administered during the post- prandial period is insufficient, adjusting parameters of a medication delivery algorithm to correct for insulin resistance of the user". Specifically, Applicant argues that Yodfat does not measure insulin resistance, nor adjusts parameters based on insulin resistance derived from post-prandial carbohydrate challenge test.
This argument is not persuasive, as Yodfat tests for and adjusts parameters based on insulin sensitivity (Fig. 9, the correction bolus is adjusted based on insulin sensitivity; para 0144 and para. 0169). As described above, this can occur after consuming carbohydrates in block 61 (para. 0143), and, thus, in the post-prandial monitoring window.
Therefore, the rejections are maintained.
Conclusion
THIS ACTION IS MADE FINAL. 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.
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/LEI GONZALEZ/ Examiner, Art Unit 3783
/SCOTT J MEDWAY/ Primary Examiner, Art Unit 3783
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