DETAILED ACTION
Notice of 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.
Withdrawal of Objections and Rejections
Applicant's response, filed 03/23/2026, has been fully considered.
In view of the amendment and remarks from 03/23/2026, the objection to the claims and the rejection of the following claims are withdrawn:
claims 1-21 under 35 USC § 112(b);
claims 1-21 under U.S.C. § 101
reasons for patent eligibility: Referring to the 101 analysis as organized in MPEP 2106, the 101 rejections are withdrawn at least in view of the analysis Step 2A, 2nd prong, 2nd consideration applying or using a judicial exception to effect a particular treatment or prophylaxis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. Applicant's 03/23/26 remarks at pg. 10 para. 6 support withdrawal of the rejection. In the alternative, the 101 analysis as organized in MPEP 2106, the 101 rejections are withdrawn at least in view of the analysis Step 2A, 2nd prong, 3rd consideration - implementing a judicial exception with, or using a judicial exception in conjunction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. Applicant's 03/23/26 remarks at pg. 13 para. 4 support withdrawal of the rejection.
claims 12 and 21 under U.S.C. § 103 due to claims 12 and 21 being cancelled and
claims 12 and 21 under Double Patenting due to claims 12 and 21 being cancelled.
The following rejections and/or objections are either maintained or newly applied for claims 1-11 and 13-20. They constitute the complete set applied to the instant application. Herein, "the previous Office action" refers to the Non-Final Rejection of 12/31/2025.
Status of the Claims
Claims 12 and 21 are canceled.
Claims 1-11 and 13-20 are pending.
Claims 1-11 and 13-20 are rejected.
Priority
This US Application 17/732,208 (04/28/2022) claims priority from US Application No. 623/228,884 (08/03/2021) as reflected in the filing receipt mailed on 05/05/2022. The claims to the benefit of priority are acknowledged; and the effective filing date of claims 1-11 and 13-20 is 08/03/2021.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under pre-AIA 35 U.S.C. 103(a) are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
A. Claims 1-8, 10-11, 13-14 and 16-20 are rejected under 35 U.S.C. 103(a) as being unpatentable over Kumareswaran ("Closed-loop insulin delivery in adults with type 1 diabetes." Dissertation. University of Cambridge (2012)) in view of Bode ("Diabetes management in the new millennium using insulin pump therapy." Diabetes/metabolism research and reviews 18.S1:S14-S20 (2002)) in view of Ekhlaspour ("A review of continuous glucose monitoring data interpretation in the age of automated insulin delivery." Journal of Diabetes Science and Technology 13.4:645-663 (2019)), as cited on the 12/31/2025 Form PTO-892. Any newly recited portions are necessitated by claim amendment.
Claim 1 recites:
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; and
at least one processor configured to: … receive input through the user interface
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; and
automatically deliver the insulin doses calculated by the closed loop delivery algorithm to the user with the pump mechanism.
• Kumareswaran teaches an ambulatory closed-loop insulin delivery system composed of a continuous glucose monitor/sensor, a subcutaneous insulin pump connected to abdomen of the user and a control algorithm which computes the amount of insulin to be delivered by the pump based on real-time continuous glucose monitoring measurements (i.e. automatically deliver the insulin doses calculated by the closed loop delivery algorithm to the user with the pump mechanism) wherein a hand-held user device contains the control algorithm (i.e. user interface and a communications interface) (pg. 17 para. 1 and Fig. 1.3); wherein the control algorithm enables the construction of insulin infusion rates leading to a predefined ‘target’ glucose range (pg. 18 para. 1); wherein approaches to closed-loop insulin delivery differ by degree of user input, timing of application, or types of hormones infused (pg. 21 para. 1); wherein initiation of the algorithm is straightforward for the user, requiring entry of three parameters: weight, total daily insulin dose, and basal infusion rates (i.e. input received from the user) (pg. 154 col. 2).
present on the user interface at least two options for calculating and delivering insulin doses according to a closed loop delivery algorithm during normal activity of the user, including a normal activity mode having a first glucose range between which the closed loop delivery algorithm attempts to maintain the user's glucose levels and an alternate normal activity mode having a second glucose range … selecting the alternative normal activity mode
• Kumareswaran does not teach the recitation above. However, Bode teaches the described recitation as a review of aspects of insulin pump therapy for use in closed-loop artificial pancreas (pg. S19 col. 2 para. 2); wherein users should be provided with options for with an individualized target blood glucose range (pg. S15 col. 1 para. 1) depending of the patient status for pre-meal (i.e. normal activity) mode – healthy 4-8 mmol/L, prone to hypoglycemia 5-9 mmol/L, and pregnant 3.5-5 mmol/L (pg. S15 Table 1) (i.e. reading on first and second glucose ranges and normal vs alternate modes).
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
• Kumareswaran does not teach the recitations above. However, Kumareswaran teaches that one of the features of the model predictive control algorithm is the ability to suspend insulin delivery when sensor glucose levels are below 4.4 mmol/l or rapidly declining, lowering the risk of hypoglycemia (i.e. reading on the function of the bolus lockout feature) (pg. 51 para. 2). Furthermore, Ekhlaspour teaches correction doses given by automated insulin delivery (pg. 646 col. 2 para. 3); wherein the Auto Mode of the continuous closed loop continuous monitoring system MiniMed 670G allows for correction for hyperglycemia (i.e. correction for user's predicted glucose level being over a high threshold) without manual entry (pg. 650 col. 2 para. 3). Here, the feature of suspending insulin delivery based on a threshold applies to all types of delivery comprising eventual correction deliveries which reads on "prevent delivery of automatic correction boluses."
Claim 2 recites:
wherein the second glucose range is lower and narrower than the first glucose range
• Kumareswaran does not teach the recitations above. However, Bode teaches it as the range for pregnant patients (3.5-5 mmol/L) being lower and narrower than the range for healthy patients (4-8 mmol/L) (pg. S15 Table 1).
Claims 3 and 17 recite:
wherein both a low glucose level and a high glucose level of the second glucose range are lower than a corresponding low glucose level and high glucose level of the first glucose range
• Kumareswaran does not teach the recitations above. However, Bode teaches it as the low and high glucose levels of the range for pregnant patients (3.5-5 mmol/L) being lower than the low and high glucose levels of the range for healthy patients (4-8 mmol/L) (pg. S15 Table 1).
Claims 4 and 18 recite:
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
• Kumareswaran teaches the automated insulin delivery being suspended for up to two hours if the hypoglycemia alarm is not responded to when sensor glucose falls below a predefined threshold (pg. 21 para. 2).
Claims 5 and 19 recite:
wherein the low glucose threshold is below both the first glucose range and the second glucose range
Claims 6 and 20 recite:
wherein the low glucose threshold is equal to a low glucose level of the second glucose range
• Kumareswaran does not teach the recitations above. However, Kumareswaran teaches the threshold chosen for treatment of hypoglycemia (i.e. low glucose threshold) being 3.0 mmol/l (pg. 154 para. 5) or ≤ 3.5 mmol/l (pg. 121 para. 2). Furthermore, Bode teaches the normal glucose range for pregnant patients (3.5-5 mmol/L) and the normal glucose range for healthy patients (4-8 mmol/L) (pg. S15 Table 1); (i.e. low glucose threshold of 3.0 mmol/l being below both ranges described as in claims 5 and 19 – and - low glucose threshold being equal to a low glucose level of the second glucose range of 3.5-5 mmol/L as in claims 6 and 20; considering both possible low glucose threshold values taught by Kumareswaran of 3.0 mmol/l (pg. 154 para. 5) or ≤ 3.5 mmol/l.
• Regarding claims 5-6 and 19-20, "the low glucose threshold" taught by Kumareswaran can be lower or equal to a low glucose level of the second glucose range taught by Bode, depending on the parameter value chosen. One of ordinary skill in the art would be motivated to try a different threshold value for "low glucose" for routine optimization reasons for determination of the optimum or workable ranges. MPEP 2144.05 II states - The Supreme Court has clarified that an "obvious to try" line of reasoning may properly support an obviousness rejection. In In re Antonie, 559 F.2d 618, 195 USPQ 6 (CCPA 1977), the CCPA held that a particular parameter must first be recognized as a result-effective variable, i.e., a variable which achieves a recognized result, before the determination of the optimum or workable ranges of said variable might be characterized as routine experimentation, because "obvious to try" is not a valid rationale for an obviousness finding. However, in KSR International Co. v. Teleflex Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007), the Supreme Court held that "obvious to try" was a valid rationale for an obviousness finding, for example, when there is a "design need" or "market demand" and there are a "finite number" of solutions. 550 U.S. at 421, 82 USPQ2d at 1397 ("The same constricted analysis led the Court of Appeals to conclude, in error, that a patent claim cannot be proved obvious merely by showing that the combination of elements was ‘obvious to try.’ ... When there is a design need or market pressure to solve a problem and there are a finite number of identified, predictable solutions, a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely the product not of innovation but of ordinary skill and common sense.
Claim 7 recites:
wherein, in the alternate normal activity mode, the at least one processor is configured 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 with the bolus lockout feature when delivery of an automatic correction bolus would cause a risk of a low glucose level in the user
Claim 13 recites:
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
• Kumareswaran does not teach the recitations above. However, Kumareswaran teaches that one of the features of the model predictive control algorithm is the ability to suspend insulin delivery when sensor glucose levels are below 4.4 mmol/l or rapidly declining, lowering the risk of hypoglycemia (i.e. reading on the function of the bolus lockout feature) (pg. 51 para. 2). Furthermore, Ekhlaspour teaches correction doses given by automated insulin delivery (pg. 646 col. 2 para. 3); wherein the Auto Mode of the continuous closed loop continuous monitoring system MiniMed 670G allows for correction for hyperglycemia (i.e. correction for user's predicted glucose level being over a high threshold) without manual entry (pg. 650 col. 2 para. 3). Here, the feature of suspending insulin delivery based on a threshold applies to all types of delivery comprising eventual correction deliveries which reads on "prevent delivery of automatic correction boluses" as in claims 7 and 13.
Claims 8 and 14 recite:
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
• Kumareswaran teaches one of the features of the model predictive control algorithm being its ability to suspend insulin delivery when sensor glucose levels are below 4.4 mmol/l or rapidly declining, lowering the risk of hypoglycemia (pg. 51 para. 2).
Claims 10 and 16 recite:
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
• Kumareswaran teaches the automated insulin delivery being suspended for up to two hours if the hypoglycemia alarm (i.e. alert indication of hypoglycemia risk) is not responded to when sensor glucose falls below a predefined threshold (pg. 21 para. 2).
Claim 11 recites:
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; and
at least one processor configured to: … receive input through the user interface
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; and
automatically deliver the insulin doses calculated by the closed loop delivery algorithm to the user with the pump mechanism.
• Kumareswaran teaches an ambulatory closed-loop insulin delivery system composed of a continuous glucose monitor/sensor, a subcutaneous insulin pump connected to abdomen of the user and a control algorithm which computes the amount of insulin to be delivered by the pump based on real-time continuous glucose monitoring measurements (i.e. automatically deliver the insulin doses calculated by the closed loop delivery algorithm to the user with the pump mechanism) wherein a hand-held user device contains the control algorithm (i.e. user interface and a communications interface) (pg. 17 para. 1 and Fig. 1.3); wherein the control algorithm enables the construction of insulin infusion rates leading to a predefined ‘target’ glucose range (pg. 18 para. 1); wherein approaches to closed-loop insulin delivery differ by degree of user input, timing of application, or types of hormones infused (pg. 21 para. 1); wherein initiation of the algorithm is straightforward for the user, requiring entry of three parameters: weight, total daily insulin dose, and basal infusion rates (i.e. input received from the user) (pg. 154 col. 2).
present on the user interface at least two options for calculating and delivering insulin doses according to a closed loop delivery algorithm during normal activity of the user, including a first glucose range between which the closed loop delivery algorithm attempts to maintain the user's glucose levels and a second glucose range that is lower and narrower than the first glucose range… selecting one of the at least two options
• Kumareswaran does not teach the recitation above. However, Bode teaches the described recitation as a review of aspects of insulin pump therapy for use in closed-loop artificial pancreas (pg. S19 col. 2 para. 2); wherein users should be provided with options for with an individualized target blood glucose range (pg. S15 col. 1 para. 1) depending of the patient status for pre-meal (i.e. normal activity) mode – healthy 4-8 mmol/L, prone to hypoglycemia 5-9 mmol/L, and pregnant 3.5-5 mmol/L (pg. S15 Table 1) (i.e. reading on at least two options) (i.e. reading on first and second glucose ranges – with a second glucose range lower and narrower than the first glucose range)
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
• Kumareswaran does not teach the recitations above. However, Kumareswaran teaches that one of the features of the model predictive control algorithm is the ability to suspend insulin delivery when sensor glucose levels are below 4.4 mmol/l or rapidly declining, lowering the risk of hypoglycemia (i.e. reading on the function of the bolus lockout feature) (pg. 51 para. 2). Furthermore, Ekhlaspour teaches correction doses given by automated insulin delivery (pg. 646 col. 2 para. 3); wherein the Auto Mode of the continuous closed loop continuous monitoring system MiniMed 670G allows for correction for hyperglycemia (i.e. correction for user's predicted glucose level being over a high threshold) without manual entry (pg. 650 col. 2 para. 3). Here, the feature of suspending insulin delivery based on a threshold as taught by Kumareswaran applies to all types of delivery comprising eventual correction deliveries which reads on "prevent delivery of automatic correction boluses."
Rationale for combining (MPEP §2142-2143)
Regarding claims 1-8, 10-11, 13-14 and 16-20, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine, in the course of routine experimentation and with a reasonable expectation of success, the methods of Kumareswaran in view of Bode and Ekhlaspour because all references disclose methods for diabetes management. The motivation would have been to:
• incorporate glucose ranges for the user to choose from (pg. S15 Table 1 Bode and to review hyperglycemia troubleshooting for hypoglycemia treatment and prevention (pg. S19 col. 1 para. 3 Bode) and
• investigate patterns of automated correction doses (pg. 660 col. 2 para. 1 Ekhlaspour).
Therefore it would have been obvious to one of ordinary skill in the art to substitute diabetes management method of Kumareswaran to the methods by Bode and Ekhlaspour because such a substitution is no more than the simple substitution of one known element for another. One of ordinary skill in the art would be able to motivated to combine the teachings in these references with a reasonable expectation of success since the described teachings pertain to methods for diabetes management.
B. Claims 9 and 15 are rejected under 35 U.S.C. 103(a) as being unpatentable over Kumareswaran, Bode and Ekhlaspour as applied to claims 1-8, 10-11, 13-14 and 16-20 above further in view of Vettoretti "Combining continuous glucose monitoring and insulin pumps to automatically tune the basal insulin infusion in diabetes therapy: a review." Biomedical engineering online 18(1):37 (2019)), as cited on the 12/31/2025 Form PTO-892. Any newly recited portions are necessitated by claim amendment.
Claims 9 and 15 recite:
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
• Kumareswaran does not teach the recitations above. However, Kumareswaran teaches a reason for hypoglycemia being the administration of correction doses of insulin being to counter the initial rise in glucose levels that occurs when drinking alcohol (pg. 57 para. 1). Furthermore, Vettoretti teaches automatic attenuation/suspension of basal insulin based on prediction-based methods and continuous glucose monitoring measurements (i.e. current glucose measurements) used to forecast future glucose concentration; where if a hypoglycemia is predicted to occur in the near future, i.e. predicted glucose concentration falls below a threshold) then a basal insulin attenuation factor is calculated to reduce basal insulin delivery, thus possibly avoiding the predicted hypoglycemic event (pg. 3 para. 4).
Rationale for combining (MPEP §2142-2143)
Regarding claims 9 and 15, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine, in the course of routine experimentation and with a reasonable expectation of success, the methods of Kumareswaran, Bode and Ekhlaspour in view of Vettoretti because all references disclose methods for diabetes management. The motivation would have been to allow improving the detection of critical hypo- and hyper-glycemic episodes (pg. 1 para. 1 Vettoretti).
Therefore it would have been obvious to one of ordinary skill in the art to substitute diabetes management method of Kumareswaran, Bode and Ekhlaspour to the methods by Vettoretti because such a substitution is no more than the simple substitution of one known element for another. One of ordinary skill in the art would be able to motivated to combine the teachings in these references with a reasonable expectation of success since the described teachings pertain to methods for diabetes management.
Response to applicant's remarks in regard to Claim Rejection 35 U.S.C. ~ 103
The Remarks of 03/23/2026 have been fully considered but are not persuasive for the reasons below:
Applicant asserts starting in pg. 17 para. 2
The Office Action at p. 22 cites Kumareswaran as disclosing this feature based on suspending insulin in response to low glucose levels. However, correction boluses are only delivered in response to high glucose levels. The claimed feature is not a suspension of insulin delivery - in fact, it is quite the opposite as basal insulin will continue to be delivered based on the user's glucose levels to maintain the lower range in the Alternate Normal Mode. Rather, only correction boluses that would normally be delivered to a user's high glucose levels are prevented as a safety feature responsive to use of the lower target range in the Alternate Normal Mode. For example, the present application discloses that the bolus lockout can be activated, for example, when "the user's predicted glucose level in 30 minutes, i.e., gPred30, is less than the user's current estimated glucose level and the user's glucose level is below a certain, higher threshold, such as, e.g., 250 mg/dL." (Para. [0036].) A standard suspension of insulin delivery due to low glucose levels as disclosed in Kumareswaran is not sufficient to teach or suggest these limitations of the claims … Moreover, even if the references collectively disclosed all claim limitations (which they do not), one of ordinary skill in the art would not have been motivated to combine Kumareswaran's teaching of suspending basal insulin during low glucose with Ekhlaspour's teaching of delivering automatic correction boluses during hyperglycemia to arrive at the claimed invention of preventing automatic correction boluses during hyperglycemia based on predicted hypoglycemia risk … The claimed bolus lockout feature represents a non-obvious insight: that during periods of rapid glucose decline, automatic correction boluses delivered in response to current hyperglycemia can cause subsequent hypoglycemia despite being appropriate based on current glucose levels alone. This requires predictive assessment of glucose trajectory, not merely reactive suspension during detected hypoglycemia as taught by Kumareswaran
It is respectfully submitted that this is not persuasive because the argued "basal insulin will continue to be delivered based on the user's glucose levels to maintain the lower range in the Alternate Normal Mode" is not claimed in the instant invention. Under BRI, the lockout feature associated with this instant claims is being correctly interpreted in light of this instant specification which discloses a "bolus lockout feature can further be activated that selectively prevents delivery of automatic correction boluses" which support the current interpretation associated with the suspension (i.e. stopping insulin delivery). Therefore, the prior art to Kumareswaran and Ekhlaspour (i.e. as described in the Claim Rejections above) teach the recited " 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." The motivation to combine the teachings would have been to investigate patterns of automated correction doses (pg. 660 col. 2 para. 1 Ekhlaspour) and to incorporate the efficacy of a 'suspend feature' (pg. 21 para. 3 Kumareswaran).
The prima facie case of obviousness has been established. MPEP 2141.III for "RATIONALES TO SUPPORT REJECTIONS UNDER 35 U.S.C. 103"; wherein "(G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention."
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, 4, 7-11, 13-16 and 18 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 4-5, 11-12, and 14-15 of co-pending US Patent Application 17/587,468 in view of Kumareswaran in view of Bode in view of Ekhlaspour.
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.
Instant application
Reference 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 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 in the alternate normal activity mode 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
13
wherein 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
Regarding the recited user-selected normal and alternate modes as selectable modes for normal activity and the alternate normal activity mode being distinct from a standard normal activity mode with different glucose target ranges for different modes in claims 1 and 11, Bode teaches the described recitation as a review of aspects of insulin pump therapy for use in closed-loop artificial pancreas (pg. S19 col. 2 para. 2); wherein users should be provided with options for with an individualized target blood glucose range (pg. S15 col. 1 para. 1) depending of the patient status for pre-meal (i.e. normal activity) mode – healthy 4-8 mmol/L, prone to hypoglycemia 5-9 mmol/L, and pregnant 3.5-5 mmol/L (pg. S15 Table 1) (i.e. reading on first and second glucose ranges and normal vs alternative modes).
Regarding the recited "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" in claims 1 and 11, Kumareswaran teaches that one of the features of the model predictive control algorithm is the ability to suspend insulin delivery when sensor glucose levels are below 4.4 mmol/l or rapidly declining, lowering the risk of hypoglycemia (i.e. reading on the function of the bolus lockout feature) (pg. 51 para. 2). Furthermore, Ekhlaspour teaches correction doses given by automated insulin delivery (pg. 646 col. 2 para. 3); wherein the Auto Mode of the continuous closed loop continuous monitoring system MiniMed 670G allows for correction for hyperglycemia (i.e. correction for user's predicted glucose level being over a high threshold) without manual entry (pg. 650 col. 2 para. 3). Here, the feature of suspending insulin delivery based on a threshold as taught by Kumareswaran applies to all types of delivery comprising eventual correction deliveries which reads on "prevent delivery of automatic correction boluses."
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine, in the course of routine experimentation and with a reasonable expectation of success, the methods of Kumareswaran in view of Bode and Ekhlaspour because all references disclose methods for diabetes management. The motivation would have been to:
• incorporate glucose ranges for the user to choose from (pg. S15 Table 1 Bode and to review hyperglycemia troubleshooting for hypoglycemia treatment and prevention (pg. S19 col. 1 para. 3 Bode) and
• investigate patterns of automated correction doses (pg. 660 col. 2 para. 1 Ekhlaspour).
Therefore it would have been obvious to one of ordinary skill in the art to substitute diabetes management method of Kumareswaran to the methods by Bode and Ekhlaspour because such a substitution is no more than the simple substitution of one known element for another. One of ordinary skill in the art would be able to motivated to combine the teachings in these references with a reasonable expectation of success since the described teachings pertain to methods for diabetes management.
Response to applicant's remarks in regard to Double Patenting
The Remarks of 03/23/2026 have been fully considered but are not persuasive for the reasons below:
Applicant asserts in pg. 19 para. 5
In contrast, reference claims 1 and 11 recite operation "in a closed loop mode" (singular) where the system automatically calculates correction boluses when glucose levels exceed a high threshold and prevents delivery when hypoglycemia risk is detected. The reference claims do not disclose, suggest, or require: • Multiple selectable modes for normal activity • User selection between different operational modes • Different glucose target ranges for different modes • An "alternate normal activity mode" distinct from a standard "normal activity mode"
It is respectfully submitted that this is not persuasive because the argued aspects not taught by the reference claims in Application 17/587,468 have been addressed in the Double Patenting rejection above via an Obviousness-type Double Patenting.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/F.F.L./Examiner, Art Unit 1685
/OLIVIA M. WISE/Supervisory Patent Examiner, Art Unit 1685
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