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 Objections
Claims 1-6, 10-15, and 17-20 are objected to because of the following informalities:
-Claim 1, line 1: please correct the semicolon to a colon
-Claim 1, line 2: please correct “the user” to “a user”
-Claim 1, line 3: please correct “a user” to “the user”
-Claim 1, line 4: please correct “glucose insulin” to “glucose-insulin”
-Claim 1, line 5: please correct “a drug delivery device” to “the drug delivery device”
-Claim 1, line 5: please correct “insulin” to “the insulin”
-Claim 1, line 9: please correct “the glucose history” to “the predicted glucose history”
-Claim 1, lines 9-10: please correct “glucose and insulin” to “glucose-insulin”
-Claim 1, line 12: please correct “glucose values” to “the actual glucose values”
-Claim 1, line 12: please correct “with” to “with the predicted glucose values at”
-Claim 1, line 14: please correct “groups of residual values” to “groups of the residual values”
-Claim 1, line 17: please correct “residual glucose values” to “the residual values”
-Claim 2, line 3: please correct “at least one calculated rate of change” to “at least one of the calculated rate of change”
-Claim 2, line 5: please correct “at least one calculated rate of change” to “at least one of the calculated rate of change”
-Claim 2, line 8: please correct “identifying” to “the identification”
-Claim 2, lines 8-9: please correct “delivery of insulin” to “delivery of the insulin”
-Claim 3, line 1: please correct “identifying” to “the identification”
-Claim 3, line 2: please correct “at least one calculated rate of change” to “the at least one of the calculated rate of change”
-Claim 3, line 3: please correct “a magnitude” to “the magnitude”
-Claim 3, line 4: please correct “a meal” to “the meal”
-Claim 4, line 2: please correct “dosage of a basal insulin” to “a basal dosage of the insulin”
-Claim 4, line 2: please correct “bolus of insulin” to “bolus of the insulin”
-Claim 5, line 1: please correct “the identifying” to “the identification”
-Claim 5, line 2: please correct “at least one calculated rate of change” to “the at least one of the calculated rate of change”
-Claim 5, line 3: please correct “a magnitude” to “the magnitude”
-Claim 5, line 5: please correct “an decrease” to “a decrease”
-Claim 6, line 2: please correct “dosage of a basal insulin” to “a basal dosage of the insulin”
-Claim 6, line 2: please correct “delivery of basal insulin” to “basal delivery of the insulin”
-Claim 10, line 2: please correct “calculate” to “calculating”
-Claim 10, line 4: please correct “calculate” to “calculating”
-Claim 10, lines 4-5: please correct “groups of residual values” to “groups of the residual values”
-Claim 10, line 7: please correct “the user” to “a user”
-Claim 11, line 2: please correct “at least one calculated rate of change” to “at least one of the calculated rate of change”
-Claim 11, line 4: please correct “at least one calculated rate of change” to “at least one of the calculated rate of change”
-Claim 12, line 2: please correct “at least one calculated rate of change” to “the at least one of the calculated rate of change”
-Claim 12, line 3: please correct “a magnitude” to “the magnitude”
-Claim 12, line 4: please correct “a meal” to “the meal”
-Claim 13, lines 1-2: please correct “dosage of a basal insulin” to “a basal dosage of the insulin”
-Claim 13, line 2: please correct “bolus of insulin” to “bolus of the insulin”
-Claim 14, line 2: please correct “at least one calculated rate of change” to “the at least one of the calculated rate of change”
-Claim 14, line 3: please correct “a magnitude” to “the magnitude”
-Claim 14, line 5: please correct “an decrease” to “a decrease”
-Claim 15, lines 1-2: please correct “dosage of a basal insulin” to “a basal dosage of the insulin”
-Claim 15, line 2: please correct “delivery of basal insulin” to “basal delivery of the insulin”
-Claim 17, line 4: please correct “the executing” to “the execution”
-Claim 17, line 6: please correct “determining” to “determine”
-Claim 17, line 7: please correct “users” to “user”
-Claim 17, line 8: please correct “determining” to “determine”
-Claim 17, line 8: please correct “deviations” to “the deviations”
-Claim 17, line 10: please correct “determining” to “determine”
-Claim 18, line 1: please correct “the executing” to “the execution”
-Claim 19, line 1: please correct “each” to “wherein each”
-Claim 20, line 1: please correct “the determining” to “the determination”
Appropriate correction is required.
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 9 and 12-15 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 9 recites “wherein the storage and the processor are part of a separate device that controls the drug delivery device”. It is unclear what is meant by “a separate device”. Does this mean that the storage and the processor are separate devices from each other? Or perhaps that the storage and the processor are located in a separate housing than a housing of the drug delivery device? For examination purposes, the Examiner interprets this limitation to mean that the storage and the processor are located in a separate housing than a housing of the drug delivery device.
Claim 12 recites the limitation "the model" in line 4. There is insufficient antecedent basis for this limitation in the claim. For examination purposes, the Examiner interprets “in the model” as deleted from the claim.
Claim 13 is rejected by virtue of its dependency on rejected claim 12.
Claim 14 recites the limitation "the model" in line 4. There is insufficient antecedent basis for this limitation in the claim. For examination purposes, the Examiner interprets “in the model” as deleted from the claim.
Claim 15 is rejected by virtue of its dependency on rejected claim 14.
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, 7-12, and 16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Steil et al. (US 2008/0183060 A1).
Regarding claim 1, Steil discloses a drug delivery system (see Figs. 1 and 14-15), comprising:
a drug delivery device (insulin delivery system 14) for delivering insulin to the user (see Fig. 1, par. [0054]);
a storage (memory, see par. [0044], [0061], [0137]) for storing an actual glucose history (sensor glucose profile 207) for a user, a predicted glucose history (predicted glucose profile 205) for the user, a model of glucose insulin interactions for the user (see par. [0136], [0138]) and a control application (software of controller 12 with commands 22) for controlling a drug delivery device for delivering insulin to the user (see par. [0054], [0056]);
wherein the actual glucose history (sensor glucose profile 207) contains actual glucose values (glucose sensor measurements) and indications of when the actual glucose values (glucose sensor measurements) were obtained (see block 230 in Fig. 14, see dashed line in Fig. 15b, par. [0138]) and the predicted glucose history (predicted glucose profile 205) contains predicted glucose values (model predicted glucose) and indications of when the predicted glucose values (model predicted glucose) were obtained and wherein the predicted glucose values in the glucose history are generated by the model of glucose and insulin interactions (see blocks 200 and 210 in Fig. 14, see solid line in Fig. 15b, par. [0137]-[0138]);
a processor (controller 12) for executing instructions causing the processor (controller 12) to:
calculate residual values between glucose values in the actual glucose history (sensor glucose profile 207) with like times in the predicted glucose history (predicted glucose profile 205) over a time window (see block 240 in Fig. 14, par. [0139], the processor measures the difference/discrepancy between the sensor and predicted glucose values);
calculate a rate of change of the residual values for groups of residual values for consecutive times in the time window (see par. [0140]-[0141], the processor measures a trend of increasing disparities between the sensor and predicted glucose values);
based on the calculated rate of change of the residual values for the groups of residual glucose values, determining that the user has either ingested a meal or exercised (see par. [0142], the identified discrepancies can be based on a meal ingested by the user).
Regarding claim 2, Steil discloses the drug delivery system of claim 1, wherein the processor (controller 12) further executes instructions that cause the processor (controller 12) to:
identify at least one calculated rate of change of the residual values for at least one of the groups that has a magnitude that exceeds a positive threshold and that is positive or identify at least one calculated rate of change of the residual values for at least one of the groups that has a magnitude that exceeds a negative threshold and that is negative (see par. [0140]-[0141], the processor identifies when the trend of increasing disparities between the sensor and predicted glucose values exceeds a predetermined threshold); and
responsive to the identifying, take a remedial measure that affects delivery of insulin delivered to the user (see par. [0141]-[0142]).
Regarding claim 3, Steil discloses the drug delivery system of claim 2, wherein further responsive to the identifying, where it is identified that at least one calculated rate of change of the residual values for at least one of the groups has a magnitude that exceeds the positive threshold and is positive (see par. [0140]-[0141], the processor identifies when the trend of increasing disparities between the sensor and predicted glucose values exceeds a predetermined threshold), the processor (controller 12) determines that the user has ingested a meal, designates a meal event by the user in the model, and performs the remedial measure to compensate for an increase in glucose level of the user due to the meal event (see par. [0142], the identified discrepancies and remedies can be based on a meal ingested by the user).
Regarding claim 7, Steil discloses the drug delivery system of claim 2, wherein at least one of the positive threshold or the negative threshold is customized to the user (see par. [0140]-[0141], the processor identifies when the trend of increasing disparities between the sensor and predicted glucose values exceeds a predetermined threshold).
Regarding claim 8, Steil discloses the drug delivery system of claim 1, wherein the drug delivery device (insulin delivery system 14) is an insulin pump device (see par. [0054], [0056]-[0057], [0139], [0141]).
Regarding claim 9, Steil discloses the drug delivery system of claim 1, wherein storage (memory, see par. [0044], [0061], [0137]) and the processor (controller 12) are part of a separate device that controls the drug delivery device (insulin delivery system 14) (see Fig. 1, par. [0054], [0056]-[0058]).
Regarding claim 10, Steil discloses a method performed by a processor (controller 12) in a drug delivery system (see Figs. 1 and 14-15), comprising:
with the processor (controller 12), calculating residual values between glucose values in an actual glucose history (sensor glucose profile 207) with like times in a predicted glucose history (predicted glucose profile 205) over a time window (see block 240 in Fig. 14, par. [0139], the processor measures the difference/discrepancy between the sensor and predicted glucose values);
with the processor (controller 12), calculating a rate of change of the residual values for groups of residual values for consecutive times in the time window (see par. [0140]-[0141], the processor measures a trend of increasing disparities between the sensor and predicted glucose values);
with the processor (controller 12), based on the calculated rate of change of the residual values for the groups of residual values, determining that the user has either ingested a meal or exercised (see par. [0142], the identified discrepancies can be based on a meal ingested by the user).
Regarding claim 11, Steil discloses the method of claim 10, further comprising:
with the processor (controller 12), identifying at least one calculated rate of change of the residual values for at least one of the groups that has a magnitude that exceeds a positive threshold and that is positive or identify at least one calculated rate of change of the residual values for at least one of the groups that has a magnitude that exceeds a negative threshold and that is negative (see par. [0140]-[0141], the processor identifies when the trend of increasing disparities between the sensor and predicted glucose values exceeds a predetermined threshold); and
with the processor (controller 12), responsive to the identifying, taking a remedial measure that affects delivery of insulin delivered to the user (see par. [0141]-[0142]).
Regarding claim 12, Steil discloses the method of claim 11, wherein further responsive to the identifying, where it is identified that at least one calculated rate of change of the residual values for at least one of the groups has a magnitude that exceeds the positive threshold and is positive (see par. [0140]-[0141], the processor identifies when the trend of increasing disparities between the sensor and predicted glucose values exceeds a predetermined threshold), determining that the user has ingested a meal, designating a meal event by the user in the model, and performing the remedial measure to compensate for an increase in glucose level of the user due to the meal event (see par. [0142], the identified discrepancies and remedies can be based on a meal ingested by the user).
Regarding claim 16, Steil discloses the method of claim 11, wherein at least one of the positive threshold or the negative threshold is customized to the user (see par. [0140]-[0141], the processor identifies when the trend of increasing disparities between the sensor and predicted glucose values exceeds a predetermined threshold).
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.
Claims 4 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Steil et al. (US 2008/0183060 A1), as applied to claims 3 and 12 above, in view of Blomquist et al. (US 2009/0177147 A1).
Regarding claim 4, Steil discloses the drug delivery system of claim 3. However, Steil fails to state wherein the remedial measure comprises increasing dosage of a basal insulin delivered to the user or delivering a bolus of insulin to the user.
Blomquist teaches a drug delivery system (see Figs. 1A-B) wherein the remedial measure comprises increasing dosage of a basal insulin delivered to the user or delivering a bolus of insulin to the user (see par. [0032], [0051]).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the drug delivery system of Steil to include wherein the remedial measure comprises increasing dosage of a basal insulin delivered to the user or delivering a bolus of insulin to the user, as taught by Blomquist, in order to automatically determine an appropriate amount and timing of insulin to be delivered to the user in response to a meal in order to achieve better glucose control (see Blomquist par. [0051]).
Regarding claim 13, Steil discloses the method of claim 12. However, Steil fails to state wherein the remedial measure comprises increasing dosage of a basal insulin delivered to the user or delivering a bolus of insulin to the user.
Blomquist teaches a method (see Figs. 1A-B) wherein the remedial measure comprises increasing dosage of a basal insulin delivered to the user or delivering a bolus of insulin to the user (see par. [0032], [0051]).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Steil to include wherein the remedial measure comprises increasing dosage of a basal insulin delivered to the user or delivering a bolus of insulin to the user, as taught by Blomquist, in order to automatically determine an appropriate amount and timing of insulin to be delivered to the user in response to a meal in order to achieve better glucose control (see Blomquist par. [0051]).
Claims 5-6 and 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Steil et al. (US 2008/0183060 A1), as applied to claims 2 and 11 above, in view of Chase (US 2021/0100951 A1).
Regarding claim 5, Steil discloses the drug delivery system of claim 2. However, Steil fails to state wherein further responsive to the identifying, where it is identified that at least one calculated rate of change of the residual values for at least one of the groups has a magnitude that exceeds the negative threshold and is negative, the processor determines that the user has exercised, designates an exercise event by the user in the model, and performs the remedial measure to compensate for an decrease in glucose level of the user due to the exercise event.
Chase teaches a drug delivery system (see Figs. 1, 3, and 5) wherein further responsive to the identifying, where it is identified that at least one calculated rate of change of the residual values for at least one of the groups has a magnitude that exceeds the negative threshold and is negative (see par. [0083], actual and predicted glucose values are compared to a threshold to detect exercise), the processor determines that the user has exercised, designates an exercise event by the user in the model, and performs the remedial measure to compensate for an decrease in glucose level of the user due to the exercise event (see par. [0083], insulin delivery is altered depending on detection of exercise and glucose values).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the drug delivery system of Steil to include wherein further responsive to the identifying, where it is identified that at least one calculated rate of change of the residual values for at least one of the groups has a magnitude that exceeds the negative threshold and is negative, the processor determines that the user has exercised, designates an exercise event by the user in the model, and performs the remedial measure to compensate for an decrease in glucose level of the user due to the exercise event, as taught by Chase, in order to automatically detect exercise and alter insulin delivery accordingly which allows for better compensation for changing physiological states of a diabetic individual (see Chase par. [0002], [0004], [0083]).
Regarding claim 6, modified Steil teaches the drug delivery system of claim 5 substantially as claimed. Modified Steil further teaches wherein the remedial measure comprises decreasing dosage of a basal insulin delivered to the user or suspending delivery of basal insulin to the user (see Steil par. [0083], see previous modifications in rejection of claim 5 above).
Regarding claim 14, Steil discloses the method of claim 11. However, Steil fails to state wherein further responsive to the identifying, where it is identified that at least one calculated rate of change of the residual values for at least one of the groups has a magnitude that exceeds the negative threshold and is negative, determining that the user has exercised, designating an exercise event by the user in the model, and performing the remedial measure to compensate for an decrease in glucose level of the user due to the exercise event.
Chase teaches a method (see Figs. 1, 3, and 5) wherein further responsive to the identifying, where it is identified that at least one calculated rate of change of the residual values for at least one of the groups has a magnitude that exceeds the negative threshold and is negative (see par. [0083], actual and predicted glucose values are compared to a threshold to detect exercise), determining that the user has exercised, designating an exercise event by the user in the model, and performing the remedial measure to compensate for an decrease in glucose level of the user due to the exercise event (see par. [0083], insulin delivery is altered depending on detection of exercise and glucose values).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Steil to include wherein further responsive to the identifying, where it is identified that at least one calculated rate of change of the residual values for at least one of the groups has a magnitude that exceeds the negative threshold and is negative, determining that the user has exercised, designating an exercise event by the user in the model, and performing the remedial measure to compensate for an decrease in glucose level of the user due to the exercise event, as taught by Chase, in order to automatically detect exercise and alter insulin delivery accordingly which allows for better compensation for changing physiological states of a diabetic individual (see Chase par. [0002], [0004], [0083]).
Regarding claim 15, modified Steil teaches the method of claim 14 substantially as claimed. Modified Steil further teaches wherein the remedial measure comprises decreasing dosage of a basal insulin delivered to the user or suspending delivery of basal insulin to the user (see Steil par. [0083], see previous modifications in rejection of claim 14 above).
Claims 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over Steil et al. (US 2008/0183060 A1) in view of Chase (US 2021/0100951 A1).
Regarding claim 17, Steil discloses a drug delivery system (see Figs. 1 and 14-15), comprising:
a drug delivery device (insulin delivery system 14) for delivering a drug to a user (see Fig. 1, par. [0054]);
a storage (memory, see par. [0044], [0061], [0137]) for storing computer programming instructions (see par. [0054], [0056], [0136], [0138]);
a processor (controller 12) configured to execute the computer programming instructions, the execution of the computer programming instructions causing the processor (controller 12) to:
determine deviations over a prediction interval between predictions of glucose levels of the user at times and actual glucose levels of the user at the times (see block 240 in Fig. 14, par. [0139], the processor measures the difference/discrepancy between the sensor and predicted glucose values);
determine a rate of change among deviations over successive times in the prediction interval (see par. [0140]-[0141], the processor measures a trend of increasing disparities between the sensor and predicted glucose values);
based on the rate of change, determine a warning condition (see par. [0140]-[0142]).
However, Steil fails to state determining that the user has exercised.
Chase teaches a drug delivery system (see Figs. 1, 3, and 5) comprising comparing discrepancies between actual and predicted glucose values to a threshold to determine that the user has exercised and modify insulin delivery accordingly (see par. [0083]).
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to modify the drug delivery system of Steil to include determining that the user has exercised and modifying insulin delivery accordingly, as taught by Chase, in order to automatically detect exercise and alter insulin delivery accordingly which allows for better compensation for changing physiological states of a diabetic individual (see Chase par. [0002], [0004], [0083]).
Regarding claim 18, modified Steil teaches the drug delivery system of claim 17 substantially as claimed. Modified Steil further teaches wherein the executing of the computer programming instructions further causes the processor (Steil, controller 12) to modify delivery of the drug to the user by the drug delivery device (Steil, insulin delivery system 14) (see Chase par. [0083], see previous modifications in rejection of claim 17 above).
Regarding claim 19, modified Steil teaches the drug delivery system of claim 17 substantially as claimed. Steil further teaches each of the times is associated with a cycle of the drug delivery system (see Steil Fig. 15b, the actual and predicted glucose values are evaluated at times related to the drug delivery system).
Regarding claim 20, modified Steil teaches the drug delivery system of claim 18 substantially as claimed. Modified Steil further teaches wherein the determining that the user has exercised (see Chase par. [0083], see previous modifications in rejection of claim 17 above) entails determining that the rate of change is negative and is more negative than a threshold value (see Steil par. [0140]-[0141], the processor identifies when the trend of increasing disparities between the sensor and predicted glucose values exceeds a predetermined threshold).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AVERY SMALE whose telephone number is (571)270-7172. The examiner can normally be reached Mon.-Fri. 8-4 ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Sirmons can be reached at (571) 272-4965. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/AVERY SMALE/Examiner, Art Unit 3783
/KAMI A BOSWORTH/Primary Examiner, Art Unit 3783
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