DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Response to Amendment
This office action is responsive to the amendment filed on 6/18/2026. As directed by the amendment: claim(s) 3 and 13 have been amended. Thus, claims 1-20 are presently pending in this application.
Response to Arguments
Applicant's arguments filed 6/18/2026 have been fully considered but they are not fully persuasive.
Regarding applicant’s argument regarding objections on page 6:
Applicant's present amendment resolves the preceding office actions stated objections.
Regarding applicant’s argument regarding 112(b) and 101 rejections on page 6-14:
Applicant's arguments referring to the 101 eligibility have been considered and are persuasive, accordingly the preceding office actions 112(b) and 101 rejections are withdrawn in light of the remarks.
Examiner notes that in reference to 101 analysis as organized in MPEP 2106, the 101 rejections are withdrawn at least in view of the analysis Step 2A, 2nd prong, 2nd consideration applying or using a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition, as discussed in MPEP § 2106.04(d)(2) - due to the claims being directed to an ambulatory infusion pump system that automatically delivers insulin to manage diabetes. See applicant’s remarks page 9-10.
Examiner further notes that in reference to 101 analysis as organized in MPEP 2106, the 101 rejections are withdrawn at least in view of the analysis Step 2A, 2nd prong, 3rd consideration - implementing a judicial exception with, or using a judicial exception in conjunction with, a particular machine or manufacture that is integral to the claim, as discussed in MPEP § 2106.05(b) - due to the claims being directed to an specific, integrated medical hardware components working together as a system: a pump mechanism configured to facilitate delivery of insulin to a user, a communications interface adapted to receive glucose levels from a continuous glucose monitor, and at least one processor configured to control insulin delivery based on the CGM data. See applicant’s remarks page 11-12.
Regarding applicant’s argument regarding the non-statutory double patenting rejection on page 16-17:
Applicant argues that because the reference claims of application 17732208 recites certain additional limitations not recited in the instant independent claims of the present application the preceding and present non-statutory double patenting rejection should be withdrawn.
However, where instant claims are generic (broader than, as the instant claims require the claimed singular mode is anticipated by the reference claims of the copending application reciting one mode, which anticipates the instant claims, selectable from multiple modes) to reference claims in a copending application, the generic instant claims are anticipated by the reference claims. See MPEP 804 (ii)(b)(1).
Regarding applicant’s argument regarding the independent claims on page 14-15:
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., the prevention of bolus in response to a user’s hyperglycemia) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Examiner notes that if such limitations specifying a relationship between the presently claimed high glucose threshold being indicative of a user in a hypoglycemic state, they may overcome the prior art rejection of record, however further search and consideration would be required to confirm or deny the allowability of such claimed subject matter. See applicant’s paragraph 38/ page 16 line 20-22 for this threshold being indicative of hyperglycemia.
Examiner notes that the preceding and present rejection are clear in that Lintereur’s system and method the automatic correction boluses may be scaled between 0 and 100% as warranted/prohibited by blood glucose measurements relative to level/threshold/range and in consideration of certain parameters such as meal consumption and active insulin on board to avoid hypoglycemia. Further, Blomquist is relied upon for the teaching of preventing bolus when a meal is consumed and monitoring blood glucose levels rising to a level for an amount of time until it is determined safe to deliver the bolus without risking inducing hyperglycemia. The claimed threshold is not necessarily representative of a user’s state of/risk for hyperglycemia, rather the threshold may be a blood glucose threshold which is high relative to a risk-of-hypoglycemia/hypoglycemic/severe-hypoglycemic threshold such that during Blomquist’s taught waiting for a BG to rise to normal levels for an amount of time, the bolus is prevented from delivery while blood glucose is rising from a level/threshold which is high relative to certain other levels of blood glucose, thus in the modified invention delivery of an insulin bolus may be prevented when glucose levels are over a high threshold and it is determined based on blood glucose levels that delivering this insulin bolus would induce hypoglycemia.
Claim Rejections - 35 USC § 103
Claims 1, 3, 6-11, 13, 16-20 are rejected under 35 U.S.C. 103 as being unpatentable over US 20200101222 A1, henceforth written as Lintereur, in view of US 20080172031 A1, henceforth written as Blomquist.
Regarding Claim 1,
Lintereur discloses:
An ambulatory infusion pump system, comprising:
(paragraph 34; portable fluid infusion device 200 in an infusion system 100; fig 1-2)
a pump mechanism configured to facilitate delivery of insulin to a user;
(paragraph 36; fluid medicament is dispensed from reservoir 205 by the action of drive system 208; fig 3-4)
a communications interface adapted to receive glucose levels from a continuous glucose monitor; and
(paragraph 35; user interface 230 presents glucose data from sensing arrangement 104; 1-4)
at least one processor configured to:
(paragraph 31+34; CCD 106 and computer 108 perform processing/storage to control device 200; fig 1)
operate in a closed loop mode in which basal insulin delivery with the pump mechanism is automatically adjusted based on the glucose levels of the user received from the continuous glucose monitor;
(paragraph 26+32-33+48-49+61-65+78-79; sensing arrangement 104 cooperates with infusion device 102 via its control system 520 cooperating with the claimed processor, CCD 106 computer 108, to implement closed-loop control system 700 to autonomously control the administration rate, therein basal insulin delivery, based on measured/predicted glucose levels forming a closed-loop operating mode; fig 5)
automatically calculate and cause correction boluses to be delivered with the pump mechanism in the closed loop mode when the glucose levels of the user received from the continuous glucose monitor are over a high glucose threshold;
(paragraph 25-26+48+78-88+91-94; automatic correction bolus are administered based on blood glucose measurement values reaching a level/threshold/range that warrants correction by administration of insulin)
determine that delivery of an automatic correction bolus to the user in the closed loop mode in which basal insulin delivery with the pump mechanism is automatically adjusted based on the glucose levels of the user with the user having a glucose level over the high glucose threshold would cause a risk of a low glucose level in the user; and
(paragraph 85-88; an automatically delivered initial correction bolus amount can be scaled to prevent a risk of hypoglycemia, therein determining that a correction bolus would could a risk of low blood glucose levels in the user; paragraph 78-79+91-92, noting this correction bolus calculation/determination is initiated and continues to occur during the automatically adjusted basal insulin delivery closed loop)
[scaling] delivery of automatic correction boluses in the closed loop mode in which basal insulin delivery with the pump mechanism is automatically adjusted based on the glucose levels of the user for a predetermined period of time if it is determined that delivery of an automatic correction bolus would cause a risk of a low glucose level in the user.
(Paragraph 84-96+100+105-117; the automatic correction bolus is adjusted/scaled between 0 and 100% to account for certain parameters such as meal consumption and active insulin on board, which the user had pre-adjusted a duration between two and eight hours in which the insulin is considered active, when it is determined that the original calculated automatic correction bolus would create a risk of low BG levels, or hypoglycemia, thus for the duration that a unit of insulin is considered active, the correction bolus will be continued to be scaled by that insulin unit for the predetermined duration that the insulin is considered active to avoid hypoglycemia; paragraph 78-79+91-92, noting this scaling of the correction bolus calculation/determination is initiated and continues to occur during the automatically adjusted basal insulin delivery closed loop)
Lintereur discloses the elements of the present claim, as described above. Yet, its present embodiment is silent on:
prevent delivery of automatic correction boluses in the closed loop mode for a predetermined period of time if it is determined that delivery of an automatic correction bolus would cause a risk of a low glucose level in the user.
However Blomquist teaches an invention for managing insulin therapy and correction bolus wherein:
a control system processor configured to prevent delivery of automatic correction boluses for a predetermined period of time if it is determined that delivery of an automatic correction bolus would cause a risk of a low glucose level in the user
(paragraph 157; if a user is intending to consume carbohydrates to avoid hypoglycemia, and communicates to the system an intention to consume an amount of carbohydrates in excess of an amount required to avoid hypoglycemia then an insulin bolus may be calculated & administered to counteract an excess influx of carbohydrates and maintain a desirable blood glucose level. The user can delay this counteracting corrective insulin bolus delivery by an amount of time, for instance 15 minutes, to allow for the consumption of the carbohydrate and recovery of blood glucose levels resulting from said consumption, therein preventing the delivery of corrective insulin bolus for a predetermined period of time in order to avoid inducing acute hypoglycemia from the influx of insulin before the carbohydrates have an opportunity to be consumed and metabolized to raise BG levels.)
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 apply Blomquist’s teachings of delaying an insulin bolus delivery by some amount of time in response to a user consuming carbohydrates to avoid hypoglycemia to the invention of Lintereur, such that Lintereur’s corrective insulin boluses are suspended for a user-set amount of time when a user indicates carbohydrates are being consumed as a form of negative meal bolus to raise blood glucose levels, in order to advantageously arrive at an invention which reduces risk associated with hypoglycemia by allowing for consumed carbohydrates to be metabolized the body and raise blood glucose levels prior to counteracting excessive glucose with a corrective insulin bolus, see paragraph 176 of Blomquist.
Regarding Claim 3,
The ambulatory infusion pump system of claim 1, wherein the at least one processor is configured to determine the rate of change over a predetermined period of time.
Lintereur: (paragraph 90+106; rate of change, slope, of a blood glucose levels are determined over the course of a sampling period of the sensor, therein a predetermined period of time; fig 9 demonstrates detecting a rate of change of a blood glucose value)
Regarding Claim 6,
The ambulatory infusion pump system of claim 1, wherein the glucose level of the user is a current glucose level.
Lintereur: (paragraph 106)
Regarding Claim 7,
The ambulatory infusion pump system of claim 1, wherein the glucose level of the user is a predicted future glucose level based on the glucose levels from the continuous glucose monitor.
Lintereur: (paragraph 112)
Regarding Claim 8,
The ambulatory infusion pump system of claim 1, wherein the predetermined period is a predetermined amount of time.
Blomquist: (paragraph 157; bolus is prevented for 15 minutes)
Regarding Claim 9,
The modified invention of Lintereur in view of Blomquist discloses all of the elements of the current invention which the present claim is dependent upon, as described above, including the following limitations of the present claim:
The ambulatory infusion pump system of claim 1, wherein the predetermined period of time ends upon receipt of a subsequent glucose level of the user from the continuous glucose monitor.
Blomquist: (paragraph 157; bolus is delayed by 15 minutes until carbohydrates have been consumed and blood glucose levels rise)
However, Lintereur in view of Blomquist is silent regarding:
The ambulatory infusion pump system of claim 1, wherein the predetermined period of time ends upon receipt of a subsequent glucose level of the user from the continuous glucose monitor.
However, Blomquist teaches that the bolus is prevented from being delivered until blood glucose levels have risen in response to the consumption of carbohydrates, see paragraph 157. Further in paragraph 157, a subsequent blood glucose test may be performed to determine if the bolus is needed.
Therefore, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention, to incorporate Blomquist’s further teachings that an insulin bolus is delayed for an amount time related to blood glucose levels rising to a certain degree to the modified invention of Lintereur in view of Blomquist, such that the period of time when a bolus is prevented ends upon a blood glucose level being measured at a level which warrants an insulin bolus, in order to advantageously arrive at an invention which avoids inducing hypoglycemia by administering insulin before carbohydrates have had a chance to metabolize and naturally raise blood glucose levels, see paragraph 157 of Blomquist.
Regarding Claim 10,
The ambulatory infusion pump system of claim 1, wherein the at least one processor is further configured to prevent delivery of automatic correction boluses for the predetermined period of time if it is determined that delivery of an automatic correction bolus would cause a risk of a low glucose level in the user and the glucose level is within a predetermined amount of the high glucose threshold.
Examiner notes that in light of the modification of Lintereur in view of Blomquist above, the modified invention calculates a delivery of automatic correction bolus based on a sensed glucose level being within a range (Lintereur paragraph 48), therein within a predetermined amount of a high level of that range, and the modified invention prevents delivery of that consequently calculated correction bolus if the delivery of that bolus would induce hypoglycemia before food can be consumed (Blomquist paragraph 157), thus arriving at the claimed invention wherein a hypoglycemia inducing bolus is prevented from delivery at a point when a glucose level is within an amount of a high threshold value.
Regarding Claim 11,
Lintereur discloses:
A method of diabetes therapy, comprising: operating an infusion pump in a closed loop mode in which basal insulin delivery is automatically adjusted based on glucose levels of a user;
(paragraph 26+32-33+48-49+61-65+78-79; sensing arrangement 104 cooperates with infusion device 102 via its control system 520 cooperating with the claimed processor, CCD 106 computer 108, to implement closed-loop control system 700 to autonomously control the administration rate, therein basal insulin delivery, based on measured/predicted glucose levels forming a closed-loop operating mode; fig 5)
automatically calculating and causing correction boluses to be delivered in the closed loop mode when the glucose levels of a user are over a high glucose threshold;
(paragraph 25-26+48+78-88+91-94; automatic correction bolus are administered based on blood glucose measurement values reaching a level/threshold/range that warrants correction by administration of insulin)
determining that delivery of an automatic correction bolus to the user with the user having a glucose level over the high glucose threshold would cause a risk of a low glucose level in the user; and
(paragraph 85-88; an automatically delivered initial correction bolus amount can be scaled to prevent a risk of hypoglycemia, therein determining that a correction bolus would could a risk of low blood glucose levels in the user; paragraph 78-79+91-92, noting this correction bolus calculation/determination is initiated and continues to occur during the automatically adjusted basal insulin delivery closed loop)
[scaling] delivery of automatic correction boluses in the closed loop mode in which basal insulin delivery with the pump mechanism is automatically adjusted based on the glucose levels of the user for a predetermined period of time if it is determined that delivery of an automatic correction bolus would cause a risk of a low glucose level in the user.
(Paragraph 84-96+100+105-117; the automatic correction bolus is adjusted/scaled between 0 and 100% to account for certain parameters such as meal consumption and active insulin on board, which the user had pre-adjusted a duration between two and eight hours in which the insulin is considered active, when it is determined that the original calculated automatic correction bolus would create a risk of low BG levels, or hypoglycemia, thus for the duration that a unit of insulin is considered active, the correction bolus will be continued to be scaled by that insulin unit for the predetermined duration that the insulin is considered active to avoid hypoglycemia; paragraph 78-79+91-92, noting this scaling of the correction bolus calculation/determination is initiated and continues to occur during the automatically adjusted basal insulin delivery closed loop)
Lintereur discloses the elements of the present claim, as described above. Yet, its present embodiment is silent on:
preventing delivery of automatic correction boluses in the closed loop mode in which basal insulin delivery with the pump mechanism is automatically adjusted based on the glucose levels of the user for a predetermined period of time if it is determined that delivery of an automatic correction bolus would cause a risk of a low glucose level in the user.
However Blomquist teaches an invention for managing insulin therapy and correction bolus wherein:
a control system configured to prevent delivery of automatic correction boluses for a predetermined period of time if it is determined that delivery of an automatic correction bolus would cause a risk of a low glucose level in the user
(paragraph 157; if a user is intending to consume carbohydrates to avoid hypoglycemia, and communicates to the system an intention to consume an amount of carbohydrates in excess of an amount required to avoid hypoglycemia then an insulin bolus may be calculated & administered to counteract an excess influx of carbohydrates and maintain a desirable blood glucose level. The user can delay this counteracting corrective insulin bolus delivery by an amount of time, for instance 15 minutes, to allow for the consumption of the carbohydrate and recovery of blood glucose levels resulting from said consumption, therein preventing the delivery of corrective insulin bolus for a predetermined period of time in order to avoid inducing acute hypoglycemia from the influx of insulin before the carbohydrates have an opportunity to be consumed and metabolized to raise BG levels.)
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 apply Blomquist’s teachings of delaying an insulin bolus delivery by some amount of time in response to a user consuming carbohydrates to avoid hypoglycemia to the invention of Lintereur, such that Lintereur’s corrective insulin boluses are suspended for a user-set amount of time when a user indicates carbohydrates are being consumed as a form of negative meal bolus to raise blood glucose levels, in order to advantageously arrive at an invention which reduces risk associated with hypoglycemia by allowing for consumed carbohydrates to be metabolized the body and raise blood glucose levels prior to counteracting excessive glucose with a corrective insulin bolus, see paragraph 176 of Blomquist.
Regarding Claim 13,
The method of claim 11, wherein the rate of change is determined over a predetermined period of time.
Lintereur: (paragraph 90+106; rate of change, slope, of a blood glucose levels are determined over the course of a sampling period of the sensor, therein a predetermined period of time; fig 9 demonstrates detecting a rate of change of a blood glucose value)
Regarding Claim 16,
The method of claim 11, wherein the glucose level of the user is a current glucose level.
Lintereur: (paragraph 106)
Regarding Claim 17,
The method of claim 11, wherein the glucose level of the user is a predicted future glucose level based on the glucose levels from the continuous glucose monitor.
Lintereur: (paragraph 112)
Regarding Claim 18,
The method of claim 11, wherein the predetermined period is a predetermined amount of time.
Blomquist: (paragraph 157; bolus is prevented for 15 minutes)
Regarding Claim 19,
The modified invention of Lintereur in view of Blomquist discloses all of the elements of the current invention which the present claim is dependent upon, as described above, including the following limitations of the present claim:
The method of claim 11, wherein the predetermined period of time ends upon receipt of a subsequent glucose level of the user from the continuous glucose monitor.
Blomquist: (paragraph 157; bolus is delayed by 15 minutes until carbohydrates have been consumed and blood glucose levels rise)
However, Lintereur in view of Blomquist is silent regarding:
The ambulatory infusion pump system of claim 1, wherein the predetermined period of time ends upon receipt of a subsequent glucose level of the user from the continuous glucose monitor.
However, Blomquist teaches that the bolus is prevented from being delivered until blood glucose levels have risen in response to the consumption of carbohydrates, see paragraph 157. Further in paragraph 157, a subsequent blood glucose test may be performed to determine if the bolus is needed.
Therefore, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention, to incorporate Blomquist’s further teachings that an insulin bolus is delayed for an amount time related to blood glucose levels rising to a certain degree to the modified invention of Lintereur in view of Blomquist, such that the period of time when a bolus is prevented ends upon a blood glucose level being measured at a level which warrants an insulin bolus, in order to advantageously arrive at an invention which avoids inducing hypoglycemia by administering insulin before carbohydrates have had a chance to metabolize and naturally raise blood glucose levels, see paragraph 157 of Blomquist.
Regarding Claim 20,
The method of claim 11, wherein the at least one processor is further configured to prevent delivery of automatic correction boluses for the predetermined period of time if it is determined that delivery of an automatic correction bolus would cause a risk of a low glucose level in the user and the glucose level is within a predetermined amount of the high glucose threshold.
Examiner notes that in light of the modification of Lintereur in view of Blomquist above, the modified invention calculates a delivery of automatic correction bolus based on a sensed glucose level being within a range (Lintereur paragraph 48), therein within a predetermined amount of a high level of that range, and the modified invention prevents delivery of that consequently calculated correction bolus if the delivery of that bolus would induce hypoglycemia before food can be consumed (Blomquist paragraph 157), thus arriving at the claimed invention wherein a hypoglycemia inducing bolus is prevented from delivery at a point when a glucose level is within an amount of a high threshold value.
Claims 2, 5, 12, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Lintereur in view of Blomquist and further in view of “Close-Loop Insulin Delivery in Adults with Type 1 Diabetes”, henceforth written as Kumareswaran.
Regarding Claim 2,
The modified invention of Lintereur in view of Blomquist discloses all of the elements of the current invention which the present claim is dependent upon, as described above, including the following limitations of the present claim:
The ambulatory infusion pump system of claim 1, wherein the at least one processor is configured to determine that delivery of an automatic correction bolus would cause a risk of a low glucose level in the user and to prevent delivery of automatic correction boluses in the closed loop mode
See modification of Lintereur in view of Blomquist arriving at an invention which determines and prevents the delivery of correction bolus while in a closed loop mode to avoid hypoglycemia induced by the corrective insulin bolus.
However, Lintereur in view of Blomquist is silent regarding:
wherein the at least one processor is configured to determine that delivery of an automatic correction bolus would cause a risk of a low glucose level in the user and to prevent delivery of automatic correction boluses in the closed loop mode if a rate of change of the user's glucose levels is falling at more than a predetermined rate.
However, Kumareswaran teaches a closed loop diabetes therapy management system comprising a model predictive control algorithm which suspend insulin delivery to avoid hypoglycemia when blood glucose levels are below 4.4mmol/L or rapidly declining, see page 51 paragraph 2.
Therefore, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention, to apply Kumareswaran’s teachings of suspending insulin delivery to avoid hypoglycemia when detecting a rapidly falling blood glucose levels to the invention of Lintereur in view of Blomquist in order to advantageously arrive at an invention which can reduce the likelihood that a user experiences hypoglycemia, see page 51 paragraph 2 of Kumareswaran.
Regarding Claim 5,
The modified invention of Lintereur in view of Blomquist discloses all of the elements of the current invention which the present claim is dependent upon, as described above, including the following limitations of the present claim:
The ambulatory infusion pump system of claim 1, wherein the at least one processor is configured to determine that delivery of an automatic correction bolus would cause a risk of a low glucose level in the user and to prevent delivery of automatic correction boluses in the closed loop mode
See modification of Lintereur in view of Blomquist arriving at an invention which determines and prevents the delivery of correction bolus while in a closed loop mode to avoid hypoglycemia induced by the corrective insulin bolus.
However, Lintereur in view of Blomquist is silent regarding:
wherein the at least one processor is configured to determine that delivery of an automatic correction bolus would cause a risk of a low glucose level in the user and to prevent delivery of automatic correction boluses in the closed loop mode if a low glucose alert indicating that a glucose level of a user is below a low threshold had been issued within a predetermined period of time.
However, Kumareswaran teaches a closed loop diabetes therapy management system wherein insulin delivery is suspended for up to two hours when a hypoglycemia alarm, indicating a user’s blood glucose level is below a predefined threshold, has not been responded to, see page 21 paragraph 2.
Therefore, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention, to apply Kumareswaran’s teachings of suspending insulin delivery for a set amount of time to avoid hypoglycemia when a hypoglycemi alarm has been sent to auser to the invention of Lintereur in view of Blomquist in order to advantageously arrive at an invention which can reduce the likelihood that a user experiences hypoglycemia induced by the delivery of an insulin bolus, see page 21 paragraph 2 of Kumareswaran.
Regarding Claim 12,
The modified invention of Lintereur in view of Blomquist discloses all of the elements of the current invention which the present claim is dependent upon, as described above, including the following limitations of the present claim:
The method of claim 11, wherein it is determined that delivery of an automatic correction bolus would cause a risk of a low glucose level in the user and delivery of automatic correction boluses in the closed loop mode is prevented
See modification of Lintereur in view of Blomquist arriving at an invention which determines and prevents the delivery of correction bolus while in a closed loop mode to avoid hypoglycemia induced by the corrective insulin bolus.
However, Lintereur in view of Blomquist is silent regarding:
wherein it is determined that delivery of an automatic correction bolus would cause a risk of a low glucose level in the user and delivery of automatic correction boluses in the closed loop mode is prevented if a rate of change of the user's glucose levels is falling at more than a predetermined rate.
However, Kumareswaran teaches a closed loop diabetes therapy management system comprising a model predictive control algorithm which suspend insulin delivery to avoid hypoglycemia when blood glucose levels are below 4.4mmol/L or rapidly declining, see page 51 paragraph 2.
Therefore, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention, to apply Kumareswaran’s teachings of suspending insulin delivery to avoid hypoglycemia when detecting a rapidly falling blood glucose levels to the invention of Lintereur in view of Blomquist in order to advantageously arrive at an invention which can reduce the likelihood that a user experiences hypoglycemia, see page 51 paragraph 2 of Kumareswaran.
Regarding Claim 15,
The modified invention of Lintereur in view of Blomquist discloses all of the elements of the current invention which the present claim is dependent upon, as described above, including the following limitations of the present claim:
The method of claim 11, wherein it is determined that delivery of an automatic correction bolus would cause a risk of a low glucose level in the user and delivery of automatic correction boluses in the closed loop mode is prevented
See modification of Lintereur in view of Blomquist arriving at an invention which determines and prevents the delivery of correction bolus while in a closed loop mode to avoid hypoglycemia induced by the corrective insulin bolus.
However, Lintereur in view of Blomquist is silent regarding:
wherein it is determined that delivery of an automatic correction bolus would cause a risk of a low glucose level in the user and delivery of automatic correction boluses in the closed loop mode is prevented if a low glucose alert indicating that a glucose level of a user is below a low threshold had been issued within a predetermined period of time.
However, Kumareswaran teaches a closed loop diabetes therapy management system wherein insulin delivery is suspended for up to two hours when a hypoglycemia alarm, indicating a user’s blood glucose level is below a predefined threshold, has not been responded to, see page 21 paragraph 2.
Therefore, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention, to apply Kumareswaran’s teachings of suspending insulin delivery for a set amount of time to avoid hypoglycemia when a hypoglycemi alarm has been sent to auser to the invention of Lintereur in view of Blomquist in order to advantageously arrive at an invention which can reduce the likelihood that a user experiences hypoglycemia induced by the delivery of an insulin bolus, see page 21 paragraph 2 of Kumareswaran.
Claims 4 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Lintereur in view of Blomquist and further in view of “Close-Loop Insulin Delivery in Adults with Type 1 Diabetes”, henceforth written as Kumareswaran, and “Combining continuous glucose monitoring and insulin pumps to automatically tune the basal insulin infusion in diabetes therapy: a review”, henceforth written as Vettoretti.
Regarding Claim 4,
The modified invention of Lintereur in view of Blomquist discloses all of the elements of the current invention which the present claim is dependent upon, as described above, including the following limitations of the present claim:
The method of claim 11, wherein it is determined that delivery of an automatic correction bolus would cause a risk of a low glucose level in the user and delivery of automatic correction boluses in the closed loop mode is prevented
See modification of Lintereur in view of Blomquist arriving at an invention which determines and prevents the delivery of correction bolus while in a closed loop mode to avoid hypoglycemia induced by the corrective insulin bolus.
However, Lintereur in view of Blomquist is silent regarding:
wherein the at least one processor is configured to determine that delivery of an automatic correction bolus would cause a risk of a low glucose level in the user and to prevent delivery of automatic correction boluses in the closed loop mode if a current glucose level of the user is greater than a predicted future glucose level of the user.
However, Kumareswaran teaches a closed loop diabetes therapy management system wherein hypoglycemia may be induced by the administration of correction doses of insulin responsive to an initial rise in glucose levels from the consumption of alcohol, see page 57 paragraph 1.
However, Vettoretti teaches an automatically tuned diabetes therapy management system wherein insulin delivery is attenuated/suspended based on forecasted future blood glucose levels, derived from current glucose measurements from a CGM, simulated doses, and predicted glucose measurements, falling below a threshold that would indicate that hypoglycemia is imminent, see page 3 paragraph 4.
Therefore, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention, to incorporate Kumareswaran’s teachings of hypoglycemia being induced by an insulin dose responding to a rapid rise in blood glucose levels to modified invention of Lintereur in view of Blomquist by applying Vettoretti’s teachings that a consideration of a current glucose level, simulated insulin delivery, and predicted future glucose level can be leveraged to attenuate/suspend insulin delivery, such that the modified invention may determine when a current glucose level exceeds a predicted glucose level in a manner that delivery of an insulin dose would induce hypoglycemia and preventing the delivery of said dose, in order to advantageously arrive at an invention which reduces the likelihood of inducing hypoglycemia in a user by administering an insulin bolus.
Regarding Claim 14,
The modified invention of Lintereur in view of Blomquist discloses all of the elements of the current invention which the present claim is dependent upon, as described above, including the following limitations of the present claim:
The method of claim 11, wherein it is determined that delivery of an automatic correction bolus would cause a risk of a low glucose level in the user and delivery of automatic correction boluses in the closed loop mode is prevented
See modification of Lintereur in view of Blomquist arriving at an invention which determines and prevents the delivery of correction bolus while in a closed loop mode to avoid hypoglycemia induced by the corrective insulin bolus.
However, Lintereur in view of Blomquist is silent regarding:
wherein it is determined that delivery of an automatic correction bolus would cause a risk of a low glucose level in the user and delivery of automatic correction boluses in the closed loop mode is prevented if a current glucose level of the user is greater than a predicted future glucose level of the user.
However, Kumareswaran teaches a closed loop diabetes therapy management system wherein hypoglycemia may be induced by the administration of correction doses of insulin responsive to an initial rise in glucose levels from the consumption of alcohol, see page 57 paragraph 1.
However, Vettoretti teaches an automatically tuned diabetes therapy management system wherein insulin delivery is attenuated/suspended based on forecasted future blood glucose levels, derived from current glucose measurements from a CGM, simulated doses, and predicted glucose measurements, falling below a threshold that would indicate that hypoglycemia is imminent, see page 3 paragraph 4.
Therefore, it would be obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention, to incorporate Kumareswaran’s teachings of hypoglycemia being induced by an insulin dose responding to a rapid rise in blood glucose levels to modified invention of Lintereur in view of Blomquist by applying Vettoretti’s teachings that a consideration of a current glucose level, simulated insulin delivery, and predicted future glucose level can be leveraged to attenuate/suspend insulin delivery, such that the modified invention may determine when a current glucose level exceeds a predicted glucose level in a manner that delivery of an insulin dose would induce hypoglycemia and preventing the delivery of said dose, in order to advantageously arrive at an invention which reduces the likelihood of inducing hypoglycemia in a user by administering an insulin bolus.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the "right to exclude" granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Instant claims 1-2, 4-5, 11-12, and 14-15 are rejected on the grounds of non-statutory double patenting as unpatentable over reference claims 1, 4, 7-16, 18, and 21 of reference US Patent Application 17/732,208. Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims are anticipated by the claims of the reference patent, as set forth in the following table.
Reference application
Instant application
Claim
Limitation
Claim
Limitation
1 and 11
a pump mechanism configured to facilitate delivery of insulin to a user; a user interface; a communications interface adapted to receive glucose levels from a continuous glucose monitor
1 and 11
a pump mechanism configured to facilitate delivery of
insulin to a user ; a communications interface adapted to receive glucose levels from a continuous glucose monitor ;
1 and 11
automatically calculate insulin doses with a closed loop delivery algorithm based on glucose levels received from the continuous glucose monitor according to the selected option
1 and 11
automatically calculate and cause correction boluses to
be delivered with the pump mechanism when glucose levels of the user received from the continuous
glucose monitor are over a high glucose threshold ;
1 and 11
automatically deliver the insulin doses calculated by the closed loop delivery algorithm to the user with the pump mechanism
1 and 11
automatically calculate and cause correction boluses to
be delivered with the pump mechanism when glucose levels of the user received from the continuous
glucose monitor are over a high glucose threshold ;
4 and 18
wherein the at least one processor is further configured to automatically suspend insulin delivery if the user's glucose level is below a low glucose threshold
1 and 11
prevent delivery of automatic correction boluses for a
predetermined period of time if it is determined that
delivery of an automatic correction bolus would
cause a risk of a low glucose level in the user
7
wherein in the alternate normal activity mode the at least one processor is configured prevent delivery of automatic correction boluses that would otherwise be delivered due to the user's predicted glucose level being over a high threshold with the bolus lockout feature when delivery of an automatic correction bolus would cause a risk of a low glucose level in the user
1 and 11
determine that delivery of an automatic correction
bolus to the user with the user having a glucose level
over the high glucose threshold would cause a risk of
a low glucose level in the user ; and
prevent delivery of automatic correction boluses for a
predetermined period of time if it is determined that
delivery of an automatic correction bolus would
cause a risk of a low glucose level in the user
8 and 14
wherein the at least one processor is configured to determine that delivery of an automatic correction bolus would cause a risk of a low glucose level if a rate of change of the user's glucose levels is falling at more than a predetermined rate
2 and 12
wherein the at least one processor is configured to determine that delivery of an automatic correction bolus would cause a risk of a low glucose level in the user if a rate of change of the user's glucose levels is falling at more than a predetermined rate
9 and 15
wherein the at least one processor is configured to determine that delivery of an automatic correction bolus would cause a risk of a low glucose level in the user if a current glucose level of the user is greater than a predicted future glucose level of the user
4 and 14
wherein the at least one processor is configured to determine that delivery of an automatic correction bolus would cause a risk of a low glucose level in the user if a current glucose level of the user is greater than a predicted future glucose level of the user
10 and 16
wherein the at least one processor is configured to determine that delivery of an automatic correction bolus would cause a risk of a low glucose level in the user if a low glucose alert indicating that a glucose level of a user is below a low threshold had been issued within a predetermined period of time
5 and 15
wherein the at least one processor is configured to determine that delivery of an automatic correction bolus would cause a risk of a low glucose level in the user if a low glucose alert indicating that a glucose level of a user is below a low threshold had been issued within a predetermined period of time
12
wherein the at least one processor is configured to selectively prevent delivery of automatic correction boluses that would otherwise be delivered due to the user's predicted glucose level being over a high threshold when the second glucose range has been selected with a bolus lockout feature.
1 and 11
determine that delivery of an automatic correction
bolus to the user with the user having a glucose level
over the high glucose threshold would cause a risk of
a low glucose level in the user ; and
prevent delivery of automatic correction boluses for a
predetermined period of time if it is determined that
delivery of an automatic correction bolus would
cause a risk of a low glucose level in the user
13
wherein the at least one processor is configured with the bolus lockout feature to prevent delivery of automatic correction boluses that would otherwise be delivered due to the user's predicted glucose level being over a high threshold when delivery of an automatic correction bolus would cause a risk of a low glucose level in the user
1 and 11
determine that delivery of an automatic correction
bolus to the user with the user having a glucose level
over the high glucose threshold would cause a risk of
a low glucose level in the user ; and
prevent delivery of automatic correction boluses for a
predetermined period of time if it is determined that
delivery of an automatic correction bolus would
cause a risk of a low glucose level in the user
1
wherein the at least one processor is configured to selectively prevent delivery of automatic correction boluses that would otherwise be delivered due to a user's predicted glucose level being over a high threshold in the alternate normal activity mode with a bolus lockout feature
1 and 11
determine that delivery of an automatic correction
bolus to the user with the user having a glucose level
over the high glucose threshold would cause a risk of
a low glucose level in the user ; and
prevent delivery of automatic correction boluses for a
predetermined period of time if it is determined that
delivery of an automatic correction bolus would
cause a risk of a low glucose level in the user
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to FORREST DIPERT whose telephone number is (703)756-1704. The examiner can normally be reached M-F 8:30am-5pm eastern.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Tsai can be reached on (571) 270-5246. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/FORREST B DIPERT/ Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783
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