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 9/10/2025. As directed by the amendment: claim(s) 1-2, 4-5, 11-12, 14-15, and 20 have been amended. Thus, claims 1-20 are presently pending in this application.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-2, 4-5, 11-12, and 14-15 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Objections
Claims 3 and 13 are objected to because of the following informalities: The claims state “determine the rate of change” and should instead recite “determine a rate of change”. Appropriate correction is required.
Claim interpretations
112(f) interpretation of particular recitations
Recited instances of "pump mechanism configured to facilitate delivery of insulin to a user" (claims 1 and 11)
The above recitation includes means (or an equivalent, nonce term, here " pump mechanism") and function and/or result (here "delivery of insulin"), but the recitation does not invoke 112/f because it is interpreted as well-known. MPEP 2181.I.A,3rd para. pertains with analogy to structures having "sufficiently definite meaning," such as "filters" and "brakes."
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-10 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.
Regarding claims 1-5 and 10 and the claims which depend on them
The claims recite are rejected as not clearly reciting the structure required for a claim to a 101 machine. Claim 1 is to a 101 machine or manufacture, i.e. a "system" in this instance, limited according to its claimed physical structure, but it is not clear what is the structure associated with the recited "processor is configured to..." The recited " system" and "processor" are not interpreted as requiring structure clearly linking the recited "system" to the recited "configured to" in a structural sense appropriate to a claim to a machine or manufacture. This rejection might be overcome by, for example, reciting a data storage device, comprised by the "system" or "processor" and instructions stored therein, the instructions "configured" as recited. Claims 2-4 and 10 also recites a "system..., comprising a processor..., wherein the processor is configured to" perform the steps.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-20 are rejected under 35 USC § 101 because the claimed inventions are directed to an abstract idea without significantly more. "Claims directed to nothing more than abstract ideas (such as a mathematical formula or equation), natural phenomena, and laws of nature are not eligible for patent protection" (MPEP 2106.04 § I). Abstract ideas include mathematical concepts, and procedures for evaluating, analyzing or organizing information, which are a type of mental process (MPEP 2106.04(a)(2)).
101 background
MPEP 2106 organizes JE analysis into Steps 1, 2A (Prong One & Prong Two), and 2B as analyzed below.
Step 1: Are the claims directed to a process, machine, manufacture, or composition of matter (MPEP 2106.03)?
Step 2A, Prong One: Do the claims recite a judicially recognized exception, i.e., a law of nature, a natural phenomenon, or an abstract idea (MPEP 2106.04(a-c))?
Step 2A, Prong Two: If the claims recite a judicial exception under Prong One, then is the judicial exception integrated into a practical application by an additional element (MPEP 2106.04(d))?
Step 2B: Do the claims recite a non-conventional arrangement of elements in addition to any identified judicial exception(s) (MPEP 2106.05)?
Analysis of instant claims
Step 1: Are the claims directed to a 101 process, machine, manufacture, or composition of matter (MPEP 2106.03)?
The instant claims are directed to a system (claims 1-10) or method (claims 11-20), each of which falls within one of the categories of statutory subject matter. [Step 1: claims 1-20 – Yes].
Claim 1 is directed to a 101 machine or manufacture, here a "system," with non-transitory elements such as "processors." Claims 2-10, depending from claims 1, are analyzed similarly.
Step 2A, Prong One: Do the claims recite a judicially recognized exception, i.e., a law of nature, a natural phenomenon, or an abstract idea (MPEP 2106.04(a-c))?
Background
With respect to Step 2A, Prong One, the claims recite judicial exceptions in the form of abstract ideas. MPEP § 2106.04(a)(2) further explains that abstract ideas are defined as:
• mathematical concepts (mathematical formulas or equations, mathematical relationships
and mathematical calculations) (MPEP 2106.04(a)(2)(I));
• certain methods of organizing human activity (fundamental economic principles or practices, managing personal behavior or relationships or interactions between people) (MPEP 2106.04(a)(2)(II)); and/or
• mental processes (concepts practically performed in the human mind, including observations, evaluations, judgments, and opinions) (MPEP 2106.04(a)(2)(III)).
Analysis of instant claims
Mathematical concepts recited in instant claims 1, 7-16 and 21, include the terms:
• "calculating/calculate " (claims 1 and 11);
• "closed loop mode" (claims 1 and 11);
• "automatic correction " (claims 1-2, 4-5, 10-12, 14-15, and 20);
Said terms are being identified as mathematical concepts. The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one having ordinary skill in the art. In this instant disclosure, [pg. 11 lines 1-18] describes the claimed closed loop mode performing calculations for insulin doses and correction steps; which indicates the use of math. Thus, the recited terms corresponds to verbal equivalents of mathematical concepts because they constitute actions executed by a group of mathematical steps in a form of a mathematical algorithm; thus mathematical concepts (MPEP 2106.04(a)(2)). A mathematical concept need not be expressed in mathematical symbols, because "words used in a claim operating on data to solve a problem can serve the same purpose as a formula." In re Grams, 888 F.2d 835, 837 and n.1, 12 USPQ2d 1824, 1826 and n.1 (Fed. Cir. 1989).
Mental processes, defined as concepts or steps practically performed in the human mind such as steps of observations, evaluations, judgments, analysis, opinions or organizing information include:
• " determine that delivery of an automatic correction bolus would cause a risk of a low glucose level" (claims 1-2, 4-5, 10-12, 14-15, and 20);
Under the BRI, the recited limitations are mental processes because a human mind is sufficiently capable of determine if an insulin dose would cause a risk of low glucose level based on available data about the user current levels.
Dependent claims 3, 6-9, 13, 16-19 recite further details about the "glucose level of the user" and “predetermined period” used by the closed loop mode; not reciting any additional non-abstract elements; all reciting further aspects of the information being analyzed, the manner in which that analysis is performed. Hence, the claims explicitly recite numerous elements that, individually and in combination, constitute abstract ideas. The instant claims must therefore be examined further to determine whether they integrate that abstract idea into a practical application (MPEP 2106.04(d)). [Step 2A Prong One: claims 1-20 – Yes].
Step 2A, Prong Two: If the claims recite a judicial exception under Prong One, then is the judicial exception integrated into a practical application by an additional element (MPEP 2106.04(d))?
Background
MPEP 2106.04(d).I lists the following example considerations for evaluating whether a judicial exception is integrated into a practical application:
An improvement in the functioning of a computer or an improvement to other technology or another technical field, as discussed in MPEP §§ 2106.04(d)(1) and 2106.05(a);
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);
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);
Effecting a transformation or reduction of a particular article to a different state or thing, as discussed in MPEP § 2106.05(c); and
Applying or using the judicial exception in some other meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception, as discussed in MPEP § 2106.05(e).
Analysis of instant claims
Instant claims 1, 11-14, 16, and 23-26 recite additional elements that are not abstract ideas:
• "a pump mechanism configured to facilitate delivery of insulin to a user" (claims 1 and 11);
• "a communications interface adapted to receive glucose levels from a continuous glucose monitor" (claims 1 and 11);
• "processor configured to …cause correction boluses to be delivered with the pump mechanism… and preventing delivery of automatic correction boluses " (claims 1 and 11);
The recited limitations in these claims are interpreted to require the use of a computer. Hence, the claims explicitly recite steps executed by computers and therefore can be described as computer functions or instructions to implement on a generic computer.
Claims 1-20 relate to computers or further aspects of the information being analyzed by computers, and do not describe any specific computational steps by which the computer performs or carries out the abstract idea, nor do they provide any details of how specific structures of the computer are used to implement these functions.
Dependent claims 6-9 and 16-19 recite further details about the glucose level of the user and the predetermined period; and dependent claims 2, 4-5, 10, 12, 14-15, and 20 recite further details about bolus delivery/prevention steps.
The recited claims related to receive input via an user-interface read on data gathering activities or the type of data being gathered; not amounting to a practical application. The type of data doesn’t change that it is mere data gathering or conventional computer receiving means.
The recited claims related to receive input and present data via an user interface read on receiving or transmitting data over a network, e.g., using the Internet to gather data, Symantec, 838 F.3d at 1321 MPEP 2106.05(a); which constitutes just necessary data gathering and outputting and therefore correspond to insignificant extra-solution activity.
The recited steps related to pump delivery mechanism and automatic insulin delivery steps read on apply it because said steps amount to nothing more than an instruction to apply the abstract idea (i.e. doses obtained via mathematical calculations). There are no additional limitations to indicate that the claimed computer, processor, or computer readable medium require anything other than generic computer components in order to carry out the recited abstract idea in the claims. Claims that amount to nothing more than an instruction to apply the abstract idea using a generic computer do not render an abstract idea eligible. MPEP 2106.05(b).
Hence, these are mere instructions to apply the abstract idea using a computer and insignificant extra-solution activity and therefore the claims do not integrate that abstract idea into a practical application (see MPEP 2106.04(d) § I; 2106.05(f); and 2106.05(g)). None of the dependent claims recite any additional non-abstract elements; they are all directed to further aspects of the information being analyzed, the manner in which that analysis is performed, or the mathematical operations performed on the information.
In Step 2A, Prong One above, claim steps and/or elements were identified as part of one or more judicial exceptions (JEs).
In this Step 2A, Prong Two immediately above claim steps and/or elements were identified as part of one or more additional elements. Additional elements are further discussed in Step 2B below.
Here in Step 2A, Prong Two, no additional step or element clearly demonstrates integration of the JE(s) into a practical application.
At this point in examination it is not yet the case that any of the Step 2A, Prong Two considerations enumerated above clearly demonstrates integration of the identified JE(s) into a practical application. Referring to the considerations above, none of 1. an improvement, 2. treatment, 3. a particular machine or 4. a transformation is clear in the record.
For example, regarding the first consideration at MPEP 2106.04(d)(1), the record, including for example the specification, does not yet clearly disclose an explanation of improvement over the previous state of the technology field. The claims do not yet clearly result in such an improvement.
[Step 2A Prong Two: claims 1-20 - No]
Step 2B: Do the claims recite a non-conventional arrangement of elements in addition to any identified judicial exception(s) (MPEP 2106.05)?
Claims found to be directed to a judicial exception are then further evaluated to determine if the claims recite an inventive concept that provides significantly more than the judicial exception itself. Step 2B of the 35 USC § 101 analysis determines whether the claims contain additional elements that amount to an inventive concept, and an inventive concept cannot be furnished by an abstract idea itself (MPEP 2106.05).
Claims 1-20 recite a computer or computer functions, interpreted as instructions to apply the abstract idea using a computer, where the computer does not impose meaningful limitations on the judicial exceptions; which can be performed without the use of a computer (MPEP 2106.04(d) § I; and MPEP 2106.05(f)).
Claims directed to "receiving" data read on performing a standard computer task, which the courts have identified as a conventional computer function in Symantec, 838 F.3d at 1321, 120 USPQ2d at 1362; OIP Techs., Inc., v. Amazon.com, Inc., 788 F.3d 1359, 1363, 115 USPQ2d 1090, 1093 (Fed. Cir. 2015); and buySAFE, Inc. v. Google, Inc., 765 F.3d 1350, 1355, 112 USPQ2d 1093, 1096 (Fed. Cir. 2014). MPEP 2106.05(d) pertains.
Claims directed to "present" data read on electronically outputting data on a computer which is a conventional computer function (Alice Corp. Pty. Ltd. v. CLS Bank Int'l, 573 U.S. 208, 225, 110 USPQ2d 1984 (2014) MPEP 2106.05(d)).
It is known in the art that the use of closed loop insulin delivery systems composed by automatic control algorithms is well-understood, routine and conventional (Kumareswaran t. al. "Closed-loop insulin delivery: towards improved diabetes care." Discovery medicine 13(69):159-170 (2012)).
When the claims are considered as a whole, they do not integrate the abstract idea into a practical application; they do not confine the use of the abstract idea to a particular technology; they do not solve a problem rooted in or arising from the use of a particular technology; they do not improve a technology by allowing the technology to perform a function that it previously was not capable of performing; and they do not provide any limitations beyond generally linking the use of the abstract idea to a broad technological environment. See MPEP 2106.05(a) and 2106.05(h). [Step 2B: claims 1-20 - No]
Conclusion: Instant claims are directed to non-statutory subject matter
For these reasons, the claims in this instant application, when the limitations are considered individually and as a whole, are directed to an abstract idea and lack an inventive concept. Hence, the claimed invention does not constitute significantly more than the abstract idea, so instant claims 1-20 are rejected under 35 USC § 101 as being directed to non-statutory subject matter.
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.
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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 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
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 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
21
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
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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/FORREST B DIPERT/ Examiner, Art Unit 3783
/MICHAEL J TSAI/Supervisory Patent Examiner, Art Unit 3783