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 § 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.
Claims 1-20 are 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites “wherein the valid glucose measurement value is determined to be accurate and/or reliable.” Firstly, this statement appears redundant since a “valid” glucose measurement would be understood to be accurate and reliable. Secondly, it is unclear if this is a conditional statement or if this is a definitive statement; if is the former it should be preceded by the term “if” or “when,” if it is a definitive statement, it seems to be indicating a situation where the glucose measurement value is always accurate and/or reliable, which may not always be true, given the nature of such devices, there are situations where values may be inaccurate.
Claim 2 recites “suspending insulin delivery at the insulin infusion dose.” If insulin delivery is being suspended, it is unclear how it can be suspended “at” a certain dose when there is no more insulin being delivered. In other words, suspended delivery cannot also have a dose amount.
Claims 4 and 11 recite “the threshold amount of IOB is determined based on a nominal basal infusion rate.” It is unclear how a threshold amount of IOB can be determined based on a nominal basal infusion rate. First, there is no indication that insulin was actually delivered at this nominal basal rate, if it is unclear if any insulin was actually delivered at this rate, it is unclear how a threshold amount of IOB can be determined based on the rate. Second, since no specifics are given about this nominal basal infusion rate, as claimed it appears to be a default infusion rate of the system. However, a default infusion rate of the system cannot be used to suit any and all patients and yield an accurate threshold amount of IOB. Third, since no circumstances are given about this nominal basal rate, it is unclear how a threshold IOB can actually be determined. For example, it is unclear how a threshold IOB can be determined if this nominal rate was applied simply applied after a meal or during hypoglycemia. Assuming the threshold amount of IOB to be an amount below which the effect of IOB on glucose is considered to be negligible, it is unclear how an arbitrary infusion rate alone, nominal or otherwise, can be used to determine it. For examination purposes and until the issue is resolved, the term “threshold” will not be considered.
Claim 15 recites “the valid glucose measurement value being less than a threshold glucose value such that a closed-loop operating mode generates an insulin delivery command of zero.” However, it is unclear why insulin delivery would be zero or stopped when the glucose value is too low, if the glucose is below the threshold the insulin delivery should be increased, not stopped. Additionally, it is unclear what is meant for a delivery command to be “zero,” does this refer to the rate or is it representative of some type of command. For purposes of examination since the current limitation appears to be operating a manner opposite to convention, such a limitation will not be considered.
Claim 16 recites the limitation “the predetermined threshold amount of IOB” in line 4. There is insufficient antecedent basis for this limitation in the claim.
Claim 19 recites “an insulin delivery rate that is a predetermined fraction of a minimum rate… while operating in the closed-loop operating mode.” It is unclear show a delivery rate can be a fraction of a minimal rate in a closed-loop operating mode where the insulin delivery command is zero. In other words, since claim 15, upon which claim 19 depends appears to define the closed-loop operating mode as having zero delivery, having a fraction of zero delivery is indefinite. In any case, this limitation is based on a limitation that is already indefinite. For examination purposes, such a limitation will not be considered until the limitation is clarified.
The remaining claims are rejected by virtue of being dependent on rejected base claim.
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 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.
Claims 1-3, 5-10, and 12-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent No. 8,257,300 to Budiman et al. (“Budiman”).
Regarding claim 1, Budiman teaches a system comprising one or more processors and one or more processor-readable media storing instructions which, when executed by the one or more processors (Fig. 1), cause performance of obtaining a glucose measurement value generated from a sensing arrangement (Fig. 2, CGM data), determining that the glucose measurement value is a valid glucose measurement value, wherein the valid glucose measurement value is determined to be accurate and/or reliable (column 7, lines 42-44, the glucose monitor is calibrated, also columns 23-24, negative calibration bias can be acceptable and even desirable, thereby making the values “reliable” in that they are still used to initiate closed-loop delivery since the processors compensate), determining a current insulin on board (IOB) (column 20, lines 64+), responsive to the valid glucose measurement value being less than a threshold glucose value (column 21, line 16) and responsive to the current IOB being less than a threshold amount of IOB (column 21, lines 29-30), determining an insulin infusion dose that bring the current IOB toward the threshold amount of IOB (column 21, lines 32-36), and delivering insulin via an insulin infusion device at the insulin infusion dose (column 21, 31-33).
Regarding claim 2, Budiman teaches the system of claim 1 as shown above, Budiman further teaching wherein the one or more processors further cause performance of suspending insulin delivery at the insulin delivery dose (column 24, lines 10-13, termination of basal rate).
Regarding claim 3, Budiman teaches the system of claim 2 as shown above, Budiman further teaching suspending the insulin delivery comprises determining that an updated current amount of IOB is greater than or equal to the threshold amount of IOB (column 24, lines 13-15, when IOB is high due to carbohydrate deficiency), and responsive to determining that the updated current amount of IOB is greater than or equal to the threshold amount of IOB, suspending the insulin delivery (column 24, lines 10-13, insulin is terminated).
Regarding claim 5, Budiman teaches the system of claim 1 as shown above, Budiman further teaching regulating the insulin delivered comprises regulating an insulin delivery rate to a minimum rate to bring the current IOB to the threshold amount of IOB (column 21, lines 31-36).
Regarding claim 6, Budiman teaches the system of claim 5 as shown above, Budiman further teaching the insulin delivery rate is a basal infusion rate (column 21, line 34).
Regarding claim 7, Budiman teaches the system of claim 1 as shown above, Budiman further teaching the threshold glucose value (column 24, lines 13-19, glucose level during carbohydrate deficiency) corresponds to a threshold value for insulin delivery suspension (delivery is terminated when there is carbohydrate deficiency as previously defined).
Regarding claim 8, Budiman teaches a processor-implemented method comprising obtaining a glucose measurement value generated from a sensing arrangement (Fig. 2, CGM data), determining that the glucose measurement value is a valid glucose measurement value, wherein the valid glucose measurement value is determined to be accurate and/or reliable (column 7, lines 42-44, the glucose monitor is calibrated, also columns 23-24, negative calibration bias can be acceptable and even desirable, thereby making the values “reliable” in that they are still used to initiate closed-loop delivery since the processors compensate), determining a current insulin on board (IOB) (column 20, lines 64+), responsive to the valid glucose measurement value being less than a threshold glucose value (column 21, line 16), and responsive to the current IOB being less than a threshold amount of IOB (column 21, lines 29-30), determining an insulin infusion dose that bring the current IOB toward the threshold amount of IOB (column 21, lines 32-36), and delivering insulin via an insulin infusion device at the insulin infusion dose (column 21, 31-33).
Regarding claim 9, Budiman teaches the method of claim 8 as shown above, Budiman further teaching suspending insulin delivery at the insulin delivery dose (column 24, lines 10-13, termination of basal rate).
Regarding claim 10, Budiman teaches the method of claim 9 as shown above, Budiman further teaching suspending the insulin delivery comprises determining that an updated current amount of IOB is greater or equal to than the threshold amount of IOB (column 24, lines 13-15, when IOB is high due to carbohydrate deficiency), and responsive to determining that the updated current amount of IOB is greater than or equal to the threshold amount of IOB, suspending the insulin delivery (column 24, lines 10-13, insulin is terminated).
Regarding claim 12, Budiman teaches the method of claim 8, Budiman further teaching regulating the insulin delivered comprising regulating an insulin delivery rate to a minimum rate to bring the current IOB to the threshold amount of IOB (column 21, lines 31-36).
Regarding claim 13, Budiman teaches the method of claim 12, Budiman further teaching the insulin delivery rate is a basal infusion rate (column 21, line 34).
Regarding claim 14, Budiman teaches the method of claim 8, wherein the threshold glucose value (column 24, lines 13-19, glucose level during carbohydrate deficiency) corresponds to a threshold value for insulin delivery suspension (delivery is terminated when there is carbohydrate deficiency as previously defined).
Regarding claim 15, Budiman teaches one or more non-transitory processor-readable media (Fig. 1) storing instructions which, when executed by one or more processors (Fig. 1), cause the performance of obtaining a glucose measurement value generated from a sensing arrangement (Fig. 2, CGM data), determining that the glucose measurement value is a valid glucose measurement value, wherein the valid glucose measurement value is determined to be accurate and/or reliable (column 7, lines 42-44, the glucose monitor is calibrated, also columns 23-24, negative calibration bias can be acceptable and even desirable, thereby making the values “reliable” in that they are still used to initiate closed-loop delivery since the processors compensate), determining a current insulin on board (IOB) (column 20, lines 64+), responsive to the valid glucose measurement value being less than a threshold glucose value (column 21, line 16)
Regarding claim 16, Budiman teaches the one or more non-transitory processor-readable media of claim 15 as shown above, Budiman further teaching determining the insulin infusion dose comprises utilizing proportional-integral-derivative (PID) control (column 15, lines 35-36) based on a difference between the current IOB and the
Regarding claim 17, Budiman teaches the one or more non-transitory processor-readable media of claim 15 as shown above, Budiman further teaching the instructions further causing performance of determining that an updated current amount of IOB is greater than or equal to the threshold amount of IOB (column 24, lines 13-15, when IOB is high due to carbohydrate deficiency), and responsive to determining that the current updated amount of IOB is greater than or equal to the threshold amount of IOB, suspending the insulin delivery (column 24, lines 10-13, insulin is terminated).
Regarding claim 18, Budiman teaches the one or more non-transitory processor-readable media of claim 15 as shown above, Budiman further teaching the threshold glucose value is a target glucose setpoint used by the insulin infusion device while operating in the closed-loop operating mode (claim 6).
Regarding claim 19, Budiman teaches the one or more non-transitory processor-readable media of claim 15 as shown above, Budiman further teaching determining the insulin infusion dose comprising determining an insulin delivery rate
Regarding claim 20, Budiman teaches the one or more non-transitory processor-readable media of claim 15 as shown above, Budiman further teaching the threshold amount of IOB is determined based on historical insulin requirements (column 4, lines 56-57, until the “historical insulin requirements” are further defined, the stored IOB threshold value is interpreted as “historical insulin requirements” given the broadest reasonable interpretation).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (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 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 4 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Budiman in view of U.S. Patent Publication No. 2010/0017141 to Campbell et al. (“Campbell”).
Regarding claims 4, Budiman teaches the system of claim 1 as shown above, but does not specify how the
Regarding claim 11, Budiman teaches the system of claim 9 as shown above, but does not specify how the
Response to Arguments
Applicant’s arguments and amendments with respect to claims 1, 8, and 15 over Budiman have been fully considered and are not persuasive. Applicant argues that Budiman does not mention a “valid” glucose measurement value. Examiner respectfully disagrees. As shown above, the sensor of Budiman is initially calibrated to ensure to ensure a correct or “valid” reading is being read. Additionally, as also shown above, values knowingly having calibration bias are still acceptable and even desirable, thereby making them “reliable” given the broadest reasonable interpretation. Applicant argues that Budiman does not mention determining an insulin dose “responsive” to the valid glucose measurement and that the portions relied upon assume a negative CGM calibration bias. Examiner respectfully disagrees. The process shown in column 21, lines 16-36 which changes the delivery amount is premised on a low glucose measurement and the negative CGM calibration bias is interpreted as a “reliable” value as shown above. Applicant argues that Budiman does not teach bringing the current IOB toward the threshold amount of IOB. Examiner respectfully disagrees, column 21, line 32-36 shows that increased insulin delivery occurs until IOB returns to a minimum safety limit. The rejection stands.
Applicant’s arguments and amendments with respect to art rejections over Mastrototaro have been fully considered and are persuasive. The rejections over Mastrototaro have been withdrawn.
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.
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/B.K./Examiner, Art Unit 3783 /THEODORE J STIGELL/Primary Examiner, Art Unit 3783
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