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 .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Specification
The amended claims recite in more detail, the disclosed control equations 3-4. Review of these equations in the Specification revealed a concern regarding Equation 4. Although Equation 3 appears to be capable of quantifying the mean quality of hyperglycemia control, Equation 4 does not appear to be capable of quantifying the mean quality of hypoglycemia control.
Equation 4 is disclosed as:
Q
n
,
h
y
p
o
=
1
7
∑
k
=
1
7
∑
i
=
t
n
,
1
t
n
,
f
m
i
n
0,70
-
G
k
i
2
t
n
,
f
-
t
n
,
1
During a hypoglycemic event, the blood glucose Gk would be less than 70mg/dL, thus yielding a positive term greater than 0. Selecting the minimum of zero versus the positive term will always return 0 for hypoglycemic events, in which case the value of
Q
n
,
h
y
p
o
will always be 0. This equation is fundamental to the invention and appears to render the invention inoperable in its current form.
It is requested that Applicant review Equation 4 for accuracy.
Claim Objections
Claims are objected to because of the following informalities:
cl.1: “a user” in l.16 is believed to be in error for --the user--
cl.19-20: “experiences” is believed to be in error for --experienced--
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Regarding claim 20, the recitation of setting the new rate of insulin delivery as “higher than a rate of insulin delivery for a preceding segment” does not appear to be supported by the original disclosure. No discussion of this function appears to be in the original disclosure.
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 20 is 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.
Regarding Claim 20, the recitation(s) “higher than a rate of insulin delivery for a preceding segment” is considered new matter and it is unclear whether Applicant intended to claim this subject matter or whether the recitation contains any typographical errors that need to be revised.
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) 16-20, 22-24, 26-35 is/are rejected under 35 U.S.C. 103 as being unpatentable over Toffanin1 in view of Rodbard2 and Fabris3.
1 Chiara Toffanin et al. Automatic adaptation of basal therapy for Type 1 diabetic patients: A Run-to-Run approach, 7 October 2016, Biomedical Signal Processing and Control, retrieved from Science Direct, Elsevier, https://www.sciencedirect.com/science/article/pii/S1746809416301288
2 David Rodbard, Quality of Glycemic Control: Assessment Using Relationships Between Metrics for Safety and Efficacy, 2021, Diabetes Technology and Therapeutics, Volume 23, DOI: 10.1089/dla.2021.0115
3 Chiara Fabris et al., Are Risk Indices Derived From CGM Interchangeable With SMBG-Based Indices?, 2016, Journal of Diabetes Science and Technology, Vol.10(1), p.50-59
Regarding Claim 16, Toffanin teaches an insulin delivery system (i.e. a pump-based therapy with continuous glucose monitoring, CGM; p.539 col.2 para.1) comprising:
an insulin storage for storing insulin (where the pump draws insulin from);
a drive mechanism (pump) for causing the insulin to flow out of the insulin storage for delivery to a user (patient);
a non-transitory media storing computer readable instructions (required for computer-based automation using algorithms; p.539 col.2 para.2);
a processor for executing the computer readable instructions to cause the processor to (required for computer-based automation using algorithms; p.539 col.2 para.2):
calculate a first unitless term (T-aj) representing a mean quality of glucose control for the user during a segment (j) of a basal profile (all of
b
j
(
k
)
f
o
r
j
=
1
,
…
,
n
for day k; p.540, col.2, section 2.1; Abstract, Title) for hyperglycemic incidence over a past predetermined period of time (p.540, col.2, section 2.1; Taj is the unitless percentage of time patient i spends at a blood glucose level above 180mg/dL in segment j of past period of time, day k; it is interpreted as representing the mean quality of glucose control for the user during the segment because a low value indicates average control of hyperglycemic incidence was relatively good and a high value indicates average control of hyperglycemic incidence was relatively poor);
calculate a second unitless term (Tbj) representing a mean quality of glucose control for the user during the segment of the basal profile for hypoglycemic incidence over the past predetermined period of time (p.540, col.2, section 2.1; Tbj is the unitless percentage of time patient i spends at a blood glucose level below 70mg/dL in segment j of past period of time, day k; it is interpreted as representing the mean quality of glucose control for the user during the segment because a low value indicates average control of hypoglycemic incidence was relatively good and a high value indicates average control of hypoglycemic incidence was relatively poor);
calculate a new rate of insulin delivery (bj(k+1) for day k+1) for the segment (j) based on the first and second unitless terms (equation 1 on p.540, col.2, section 2.1); and
cause the insulin delivery system to deliver the insulin to the user at the new rate of insulin delivery for the segment (by definition of automated Run-to-Run, pump-based insulin therapy per p.539 col.2 para.1-2).
Toffanin does not teach using first and second unitless terms that reflect the “mean amount” that a glucose level of the user exceeds (or falls below) a hyperglycemic (or hypoglycemic) glucose level threshold.
However, Rodbard teaches the substitutional equivalence of using percentage time above/below range (TAR/TBR)) and High/Low blood glucose index (HBGI/LBGI), and particularly the use of HBGI/LBGI in place of TAR/TBR in systems utilizing TAR/TBR (p.702, col.1 last paragraph).
And Fabris teaches the calculation of HBGI and LBGI (Eq.1-3) resulting in first and second unitless terms (p.51 col.2 section LBGI and HBGI, cont. to p.52 col.1) that reflect the mean amount (Eq.3 being, by definition, an average; and LBGI/HBGI calculating risk based on the amplitude of current BG excursion from the threshold; pp.51-52, section LBGI and HBGI) that a glucose level of the user exceeds (or falls below) a hyperglycemic (or hypoglycemic) glucose level threshold (e.g. both thresholds equal 112.5mg/dL).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Toffanin to use LBGI/HBGI as taught by Fabris in place of, or in addition to, percent time below/above range as taught by Rodbard, because Rodbard explicitly teaches their substitutional equivalence (p.702). Note, the use of both, rather than substitution, increases robustness and redundancy.
Regarding claims 17 and 19, Toffanin in view of Rodbard and Fabris teaches all the limitations of the claimed invention as discussed above. Toffanin further teaches the new rate of insulin delivery for the segment is lower than a preceding rate of insulin delivery for the segment if the user: (claim 17) experienced a hypoglycemic condition during the entire segment; and/or (claim 19) experiences any hypoglycemic incidence during the segment over the past predetermined period of time (per equation 1 on p.540, when
T
b
j
k
>
0
, i.e. user experienced a hypoglycemic condition of Gmj(k) < 70mg/dL for some amount of time greater than zero during the segment j of the previous day k, the rate of insulin delivery b-j- over segment j is updated to decrease insulin delivery by
b
j
-
k
1
j
T
b
j
(
k
)
).
Regarding claims 18 and 20, Toffanin in view of Rodbard and Fabris teaches all the limitations of the claimed invention as discussed above. Toffanin further teaches (claim 18) the new rate of insulin delivery for the segment is: (claim 18) higher than a preceding rate of insulin delivery for the segment if the user experienced a hyperglycemic condition during the entire segment; and/or (claim 20) higher than a rate of insulin delivery for a preceding segment (interpreted to be the same segment from a previous time period, e.g. from the previous day) if the user experiences any hyperglycemic incidence during the segment over the past predetermined period of time (per equation 1 on p.540, when
T
b
j
k
=
0
and
T
a
j
k
>
0
, i.e. user experienced a hyperglycemic condition for some amount of time greater than zero during the segment j of the previous day k and did not experience a hypoglycemic condition Gmj(k) > 180mg/dL during the segment, the rate of insulin delivery b-j- over segment j is updated to increase insulin delivery by
b
j
-
k
2
j
T
a
j
k
+
k
3
j
G
m
j
k
-
G
T
j
G
T
j
).
Regarding claim 22, Toffanin in view of Rodbard and Fabris teaches all the limitations of the claimed invention as discussed above. Toffanin in view of Rodbard and Fabris as discussed so far, does not teach the first unitless term is calculated based on squared deviations of glucose levels above the hyperglycemic glucose level threshold, and wherein the second unitless term is calculated based on squared deviations of glucose levels below the hypoglycemic glucose level threshold.
However, Fabris further teaches the first unitless term is calculated based on squared deviations of glucose levels above the hyperglycemic glucose level threshold, and wherein the second unitless term is calculated based on squared deviations of glucose levels below the hypoglycemic glucose level threshold (Eq 1-2 on pp.51-52 teach squaring the log deviations of glucose levels from 112mg/dL, which is both the hypo and hyper threshold).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Toffanin in view of Rodbard and Fabris to use LBGI/HBGI as taught by Fabris and Rodbard, for the same reason as above, i.e. because Rodbard explicitly teaches their substitutional equivalence (p.702).
Regarding claim 23, Toffanin in view of Rodbard and Fabris teaches all the limitations of the claimed invention as discussed above (including the calculation go the new rate of insulin delivery being dependent on the first and second unitless terms). Toffanin in view of Rodbard and Fabris as discussed so far, does not teach weighting the first unitless term and the second unitless term based on severity thresholds representing extreme hypoglycemic and hyperglycemic conditions.
However, Fabris further teaches the first unitless term and the second unitless term are weighted based on severity thresholds representing extreme hypoglycemic and hyperglycemic conditions (pp.51-52, section LBGI and HBGI teaches the two terms are weighted to balance the different numerical amplitudes between hypo condition and ideal condition versus hyper condition and ideal condition; e.g. 112-20 = 92 and 600-112 = 488 in mg/dL)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Toffanin in view of Rodbard and Fabris to use LBGI/HBGI as taught by Fabris and Rodbard, for the same reason as above, i.e. because Rodbard explicitly teaches their substitutional equivalence (p.702).
Regarding claim 24, Toffanin in view of Rodbard and Fabris teaches all the limitations of the claimed invention as discussed above. Toffanin further teaches the calculating of the new rate of insulin delivery comprises limiting the new rate of insulin delivery to within a predetermined percentage range of a current rate of insulin delivery for the segment (Eq.2-3 of Section 2.2 on p.540 teaches the new rate of insulin delivery is always positive and thus a percentage range of the current rate).
Regarding claim 26, Toffanin teaches a method for adjusting a basal profile (all of bj (k) for j = 1, …, n for day k; p.540, col.2 section 2.1; Abstract, Title) for a user (patient i; p.540, col.2 section 2.1) of an insulin delivery system (p.539, Abstract and col.2, combination of CGM and subcutaneous insulin infusion), wherein the basal profile includes multiple segments of time (j) and specifies rates of insulin delivery (b) for the segments (bj), the method comprising:
receiving glucose control outcomes (incl. average glucose concentration
G
m
j
, percentage time below range
T
b
j
, and percentage time above range
T
a
j
; where the range is 70-180mg/dL) for the user over a past predetermined period of time (k), the glucose control outcomes comprising glucose level measurements (required to determine average glucose measurement
G
m
j
);
for a selected one of the segments (bj(k)) of the basal profile, calculating a first unitless term (T-aj) representing a mean quality of glucose control for hyperglycemic incidence during the selected segment over the past predetermined period of time (p.540, col.2, section 2.1; Taj is the unitless percentage of time patient i spends at a blood glucose level above 180mg/dL in segment j of past period of time, day k; it is interpreted as representing the mean quality of glucose control for the user during the segment because a low value indicates average control of hyperglycemic incidence was relatively good and a high value indicates average control of hyperglycemic incidence was relatively poor);
for the selected segment of the basal profile (bj(k)), calculating a second unitless term (Tbj) representing a mean quality of glucose control for hypoglycemic incidence during the selected segment over the past predetermined period of time (p.540, col.2, section 2.1; Tbj is the unitless percentage of time patient i spends at a blood glucose level below 70mg/dL in segment j of past period of time, day k; it is interpreted as representing the mean quality of glucose control for the user during the segment because a low value indicates average control of hypoglycemic incidence was relatively good and a high value indicates average control of hypoglycemic incidence was relatively poor);
calculating a new rate of insulin delivery for the selected segment (bj(k+1)) based on the first unitless term and the second unitless term (equation 1 on p.540, col.2, section 2.1); and
causing the insulin delivery system to deliver insulin at the new rate of insulin delivery during the segment (by definition of automated Run-to-Run, pump-based insulin therapy per p.539 col.2 para.1-2).
Toffanin does not teach using first and second unitless terms that reflect the “mean amount” that a glucose level of the user exceeds (or falls below) a hyperglycemic (or hypoglycemic) glucose level threshold.
However, Rodbard teaches the substitutional equivalence of using percentage time above/below range (TAR/TBR)) and High/Low blood glucose index (HBGI/LBGI), and particularly the use of HBGI/LBGI in place of TAR/TBR in systems utilizing TAR/TBR (p.702, col.1 last paragraph).
And Fabris teaches the calculation of HBGI and LBGI (Eq.1-3) resulting in first and second unitless terms (p.51 col.2 section LBGI and HBGI, cont. to p.52 col.1) that reflect the mean amount (Eq.3 being, by definition, an average; and LBGI/HBGI calculating risk based on the amplitude of current BG excursion from the threshold; pp.51-52, section LBGI and HBGI) that a glucose level of the user exceeds (or falls below) a hyperglycemic (or hypoglycemic) glucose level threshold (e.g. both thresholds equal 112.5mg/dL).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Toffanin to use LBGI/HBGI as taught by Fabris in place of, or in addition to, percent time below/above range as taught by Rodbard, because Rodbard explicitly teaches their substitutional equivalence (p.702). Note, the use of both, rather than substitution, increases robustness and redundancy.
Regarding claim 27, Toffanin in view of Rodbard and Fabris teaches all the limitations of the claimed invention as discussed above (including the calculation go the new rate of insulin delivery being dependent on the first and second unitless terms). Toffanin in view of Rodbard and Fabris as discussed so far, does not teach weighting the first unitless term and the second unitless term asymmetrically.
However, Fabris further teaches the first unitless term and the second unitless term are weighted based asymmetrically (pp.51-52, section LBGI and HBGI teaches the two terms are weighted to balance the different numerical amplitudes between hypo condition and ideal condition versus hyper condition and ideal condition; e.g. 112-20 = 92 and 600-112 = 488 in mg/dL)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Toffanin in view of Rodbard and Fabris to use LBGI/HBGI as taught by Fabris and Rodbard, for the same reason as above, i.e. because Rodbard explicitly teaches their substitutional equivalence (p.702).
Regarding claim 28, Toffanin in view of Rodbard and Fabris teaches all the limitations of the claimed invention as discussed above (including the second unitless term comprising LBGI). Toffanin further teaches calculating the new rate of insulin delivery comprises: determining whether the second unitless term indicates any hypoglycemic incidence occurred during the segment; and if hypoglycemic incidence occurred, calculating the new rate of insulin delivery based on the second unitless term without consideration of the first unitless term (when
T
b
j
k
>
0
, calculate
b
j
(
k
+
1
)
based on
T
b
j
and without consideration of
T
a
j
; see Eq 1 on p.540).
Because HBGI and LBGI behave in the same/similar way to percentage time above and below range (by increasing from zero to 100 based on blood glucose, BG, level being a certain amount higher/lower than desired), the same logic/calculation of new insulin rate can be used for LBGI in place of
T
b
j
and HBGI in place of
T
a
j
.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Toffanin in view of Rodbard and Fabris to use LBGI/HBGI as taught by Fabris and Rodbard, for the same reason as above, i.e. because Rodbard explicitly teaches their substitutional equivalence (p.702).
Regarding claim 29, Toffanin in view of Rodbard and Fabris teaches all the limitations of the claimed invention as discussed above (including the second unitless term comprising LBGI, and the first unitless term comprising HBGI). Toffanin further teaches if no hypoglycemic incidence occurred, calculating the new rate of insulin delivery based on the first unitless term without consideration of the second unitless term (when
T
b
j
k
=
0
, calculate
b
j
(
k
+
1
)
based on
T
a
j
and without consideration of
T
b
j
; see Eq 1 on p.540).
Because HBGI and LBGI behave in the same/similar way to percentage time above and below range (by increasing from zero to 100 based on blood glucose, BG, level being a certain amount higher/lower than desired), the same logic/calculation of new insulin rate can be used for LBGI in place of
T
b
j
and HBGI in place of
T
a
j
.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Toffanin in view of Rodbard and Fabris to use LBGI/HBGI as taught by Fabris and Rodbard, for the same reason as above, i.e. because Rodbard explicitly teaches their substitutional equivalence (p.702).
Regarding claims 30-31, Toffanin in view of Rodbard and Fabris teaches all the limitations of the claimed invention as discussed above. Toffanin in view of Rodbard and Fabris as discussed so far, does not teach (claim 30) the first unitless term is calculated based on squared deviations of the glucose level measurements above the hyperglycemic glucose level threshold and (claim 31) the second unitless term is calculated based on squared deviations of glucose levels below the hypoglycemic glucose level threshold.
However, Fabris further teaches the first unitless term is calculated based on squared deviations of glucose levels above the hyperglycemic glucose level threshold, and wherein the second unitless term is calculated based on squared deviations of glucose levels below the hypoglycemic glucose level threshold (Eq 1-2 on pp.51-52 teach squaring the log deviations of glucose levels from 112mg/dL, which is both the hypo and hyper threshold).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Toffanin in view of Rodbard and Fabris to use LBGI/HBGI as taught by Fabris and Rodbard, for the same reason as above, i.e. because Rodbard explicitly teaches their substitutional equivalence (p.702).
Regarding claim 32, Toffanin in view of Rodbard and Fabris teaches all the limitations of the claimed invention as discussed above. Toffanin further teaches repeating the calculating steps for each segment of the basal profile to generate an updated basal profile (calculations of eq 1 are performed for each run and each interval; p.540, col.2 para.2).
Regarding claim 33, Toffanin teaches a non-transitory storage media storing programming instructions (required for computer-based automation using algorithms; p.539 col.2 para.2) that when executed by a processor (required for computer-based automation using algorithms; p.539 col.2 para.2) of a insulin delivery system (i.e. a pump-based therapy with continuous glucose monitoring, CGM; p.539 col.2 para.1) cause the processor to:
receive glucose control outcomes (incl. average glucose concentration
G
m
j
, percentage time below range
T
b
j
, and percentage time above range
T
a
j
; where the range is 70-180mg/dL) for the user over a past predetermined period of time (k), the glucose control outcomes comprising glucose level measurements (required to determine average glucose measurement
G
m
j
);
for a selected segment (bj(k)) of segments of a basal profile (all of bj (k) for j = 1, …, n for day k; p.540, col.2 section 2.1; Abstract, Title) in which the segments are periods and the basal profile specifies rates of insulin delivery for delivery during the segments (p.540 col.2 para.2-3),
calculate a first unitless term (
T
a
j
) representing a mean quality of glucose control for hyperglycemic incidence during the selected segment over the past predetermined period of time (p.540, col.2, section 2.1; Taj is the unitless percentage of time patient i spends at a blood glucose level above 180mg/dL in segment j of past period of time, day k; it is interpreted as representing the mean quality of glucose control for the user during the segment because a low value indicates average control of hyperglycemic incidence was relatively good and a high value indicates average control of hyperglycemic incidence was relatively poor),
for the selected segment of the basal profile, calculate a second unitless term (
T
b
j
) representing a mean quality of glucose control for hypoglycemic incidence during the selected segment over the past predetermined period of time (p.540, col.2, section 2.1; Tbj is the unitless percentage of time patient i spends at a blood glucose level below 70mg/dL in segment j of past period of time, day k; it is interpreted as representing the mean quality of glucose control for the user during the segment because a low value indicates average control of hypoglycemic incidence was relatively good and a high value indicates average control of hypoglycemic incidence was relatively poor),
calculate a new rate of insulin delivery for the selected segment (bj(k+1)) based on the first unitless term and the second unitless term (equation 1 on p.540, col.2, section 2.1); and
cause the insulin delivery system to deliver insulin at the new rate of insulin delivery during the segment (by definition of automated Run-to-Run, pump-based insulin therapy per p.539 col.2 para.1-2).
Toffanin does not teach using first and second unitless terms that reflect the “mean amount” that a glucose level of the user exceeds (or falls below) a hyperglycemic (or hypoglycemic) glucose level threshold.
However, Rodbard teaches the substitutional equivalence of using percentage time above/below range (TAR/TBR)) and High/Low blood glucose index (HBGI/LBGI), and particularly the use of HBGI/LBGI in place of TAR/TBR in systems utilizing TAR/TBR (p.702, col.1 last paragraph).
And Fabris teaches the calculation of HBGI and LBGI (Eq.1-3) resulting in first and second unitless terms (p.51 col.2 section LBGI and HBGI, cont. to p.52 col.1) that reflect the mean amount (Eq.3 being, by definition, an average; and LBGI/HBGI calculating risk based on the amplitude of current BG excursion from the threshold; pp.51-52, section LBGI and HBGI) that a glucose level of the user exceeds (or falls below) a hyperglycemic (or hypoglycemic) glucose level threshold (e.g. both thresholds equal 112.5mg/dL).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Toffanin to use LBGI/HBGI as taught by Fabris in place of, or in addition to, percent time below/above range as taught by Rodbard, because Rodbard explicitly teaches their substitutional equivalence (p.702). Note, the use of both, rather than substitution, increases robustness and redundancy.
Regarding claim 34, Toffanin in view of Rodbard and Fabris teaches all the limitations of the claimed invention as discussed above (including the calculation go the new rate of insulin delivery being dependent on the first and second unitless terms). Toffanin in view of Rodbard and Fabris as discussed so far, does not teach weighting the first unitless term and the second unitless term asymmetrically.
However, Fabris further teaches the first unitless term and the second unitless term are weighted based asymmetrically (pp.51-52, section LBGI and HBGI teaches the two terms are weighted to balance the different numerical amplitudes between hypo condition and ideal condition versus hyper condition and ideal condition; e.g. 112-20 = 92 and 600-112 = 488 in mg/dL)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Toffanin in view of Rodbard and Fabris to use LBGI/HBGI as taught by Fabris and Rodbard, for the same reason as above, i.e. because Rodbard explicitly teaches their substitutional equivalence (p.702).
Regarding claim 35, Toffanin in view of Rodbard and Fabris teaches all the limitations of the claimed invention as discussed above (including the second unitless term comprising LBGI). Toffanin further teaches calculating the new rate of insulin delivery comprises: determining whether the second unitless term indicates any hypoglycemic incidence occurred during the segment; and if hypoglycemic incidence occurred, calculating the new rate of insulin delivery based on the second unitless term without consideration of the first unitless term (when
T
b
j
k
>
0
, calculate
b
j
(
k
+
1
)
based on
T
b
j
and without consideration of
T
a
j
; see Eq 1 on p.540).
Because HBGI and LBGI behave in the same/similar way to percentage time above and below range (by increasing from zero to 100 based on blood glucose, BG, level being a certain amount higher/lower than desired), the same logic/calculation of new insulin rate can be used for LBGI in place of
T
b
j
and HBGI in place of
T
a
j
.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify Toffanin in view of Rodbard and Fabris to use LBGI/HBGI as taught by Fabris and Rodbard, for the same reason as above, i.e. because Rodbard explicitly teaches their substitutional equivalence (p.702).
Claim(s) 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Toffanin1 in view of Rodbard2 and Fabris3, and further in view of O’Connor US20190336684A1.
Regarding claim 21, Toffanin in view of Rodbard and Fabris teaches all the limitations of the claimed invention as discussed above. Toffanin in view of Rodbard and Fabris may not be clear as to whether an insulin delivery device includes the insulin storage and the drive mechanism.
However, O’Connor teaches implementing an insulin storage (125) and a drive mechanism (124) in a single insulin delivery device (102).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Toffanin in view of Rodbard and Fabris to be implemented on a single device as taught by O’Connor because it has been held that combining or simple substitution of prior art elements according to known methods to yield predictable results renders the limitation obvious (see MPEP 2141 (III)). In this case, using a single device (102 of O’Connor) to implement the drive mechanism and insulin storage required by Toffanin (in view of Rodbard and Fabris) would have yielded the predictable results of a physical device operating based on the method and computer-based automated controller of Toffanin in view of Rodbard and Fabris.
Claim(s) 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Toffanin1 in view of Rodbard2 and Fabris3, and further in view of Herrero4.
4 Pau Herrero et al., Automatic Adaptation of Basal Insulin Using Sensor-Augmented Pump Therapy, 2018, Journal of Diabetes Science and Technology, Vol.12(2), pp.282-294
Regarding claim 25, Toffanin in view of Rodbard and Fabris teaches all the limitations of the claimed invention as discussed above. Toffanin further teaches the past predetermined period of time being a single day (k).
Toffanin in view of Rodbard and Fabris does not teach the past predetermined period of time comprises multiple days, and wherein the first unitless term and the second unitless term are calculated by averaging glucose control outcomes across the multiple days for the segment.
However, Herrero teaches a run-to-run approach for tuning/updating an insulin basal profile, wherein the predetermined period of time may be adapted from a single day to three days by averaging calculations across the previous three days (which includes averaging the terms quantifying hypoglycemic and hyperglycemic incidents, and averaging the glucose control outcomes across the multiple days for the segment; p.285 col.1-2).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the predetermined period of time in Toffanin in view of Rodbard and Fabris to be three days as taught by Herrero, in order to increase the robustness of the algorithm in front of uncertainty and sensor errors (p.285, col.2 last paragraph).
Response to Arguments
Applicant’s arguments with respect to claim(s) 16-35 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to STEPHANIE SEBASCO CHENG whose telephone number is (469) 295-9153. The examiner can normally be reached on 1000-1600 Eastern.
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/STEPHANIE SEBASCO CHENG/Primary Examiner, Art Unit 3741
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