DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of Claims
This action is in reply to Applicant’s communication filed on March 2, 2026.
Claims 1 and 20 have been amended and are hereby entered.
Claims 21 and 22 are new and are hereby entered.
Claims 1, 3-5, 7-8, 10-11 and 20-22 are currently pending and have been examined.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on March 2, 2026 has been entered.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 21 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 21 recites “the coefficient is equal to one minus the adaptivity rate.” Applicant points to paragraph 48 for support of this new claim. However, paragraph 48 states that the coefficient being described is (1-R) where “R is a parameter that affects the rate of adaptivity”. The specification does not state that R is the adaptivity rate itself, as recited in the claim.
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, 3-5, 7-8, 10-11 and 20-22 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1 analysis:
Claims 1 and 20 are directed to a method and a manufacture respectively and therefore all fall into one of the four statutory categories. (Step 1: Yes, the claims fall into one of the four statutory categories).
Step 2A analysis - Prong one:
The substantially similar independent method and computer readable media claims, taking claim 1 as exemplary, recite the following limitations: A method performed by a remote manager computing system for managing a selected medicament delivery device of a selected user, comprising: with the remote manager computing system, calculating adaptivity characteristics of other users of a same type of medicament delivery device as the selected medicament delivery device from data regarding the other users that includes historic glucose levels and historic insulin deliveries; with the remote manager computing system, categorizing the adaptivity characteristics of the other users into categories; with the remote manager computing system, calculating adaptivity characteristics of the selected user of the selected medicament delivery device; with the remote manager computing system, based at least in part on the calculated adaptivity characteristics of the selected user of the selected medicament delivery device, selecting a category for the user of the selected medicament delivery device; with the remote manager computing system, selecting an adaptivity rate from one or more adaptivity rates associated with the selected category for one or more parameters of the selected medicament delivery device for the selected user based on analyzing data related to adaptivity rates for the other users, wherein the one or more parameters play a role in regulating automatic medicament delivery by the selected medicament delivery device, and wherein the selected adaptivity rate is a device control parameter that governs how a control method of the selected medicament delivery device attempts to adapt a current value or current values of the one or more parameters to a desired value or desired values; sending a communication or command from the remote manager computing system to the selected medicament delivery device or to a management device of the selected medicament delivery device to set the adaptivity rate as the selected adaptivity rate for the selected medicament delivery device; determining new value(s) for each of the one or more parameters as a sum of a first product and a second product, wherein the first product is a product of a value proposed for the parameter and the selected adaptivity rate and wherein the second product is a product of a previous value of the parameter and a coefficient; and using the new value(s) of the one or more parameters to determine a next basal medicament delivery dose for the selected medicament delivery device and causing the selected medicament delivery device to deliver the determined next basal medicament delivery dose to the selected user.
The examiner interprets the above bolded limitations as additional elements as further discussed below. The remaining un-bolded limitations above, as drafted, is a process that, under the broadest reasonable interpretation, covers performance of the limitation in the mind but for recitation of generic computer components. That is, other than reciting the remote manager computing system, nothing in the claim precludes the step from practically being performed in the mind. For example, but for the identified additional elements, this claim encompasses a person reading historic data of other users of the same device as the patient, categorizing the users, placing the patient into an appropriate category and selecting the corresponding adaptivity rate for that category, calculating new device parameter values, determining a next basal does and administering the dose to the patient in the manner described in the identified abstract idea, supra. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components, then it falls within the “Mental Processes” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
Further, the un-bolded limitations above, as drafted, is a process that, under the broadest reasonable interpretation, covers certain methods of organizing human activity (i.e., managing personal behavior including following rules or instructions) but for recitation of generic computer components. That is, other than reciting a processor/remote manager computing system (computer) executing stored instructions, the claimed invention amounts to managing personal behavior or interaction between people. For example, but for the remote manager computing system, this claim encompasses a person collecting historic data, determining the adaptivity of a device(s), categorizing multiple users of the same type of device, determining parameters for a user of the device based on their category, sending a notification to set the device parameters accordingly, determine and reset the device with new parameters, and administer an appropriate basal dose to the user in the manner described in the identified abstract idea, supra. The Examiner notes that certain “method[s] of organizing human activity” includes a person’s interaction with a computer (see MPEP 2106.04(a)(2)(II)). If a claim limitation, under its broadest reasonable interpretation, covers managing personal behavior or interactions between people but for the recitation of generic computer components, then it falls within the “certain methods of organizing human activity” grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
The types of identified abstract ideas are considered together as a single abstract idea for analysis purposes. (Step 2A – Prong 1: Yes, the claims are abstract).
Step 2A analysis - Prong two:
This judicial exception is not integrated into a practical application. In particular, the claims recite a remote manager computing system, causing the selected medicament delivery device to deliver the determined next basal medicament delivery dose to the selected user, a processor, non-transitory computer-readable storage medium and instructions (interpreted as software) which are recited at a high-level of generality (i.e., as a generic processor performing generic computer functions) such that it amounts to no more than mere instructions to apply the exceptions using a generic computer component. For example, Applicant’s specification explains that the processor reads instructions, receives data inputs, analyzes data, executes control functions, etc. (see Applicant’s specification paras 10, 46). The identified additional elements equate to saying “apply it.” MPEP 2106.04(d)(I) indicates that merely saying “apply it” or equivalent to the abstract idea cannot provide a practical application. Further regarding the limitation of “causing the selected medicament delivery device to deliver the determined next basal medicament delivery dose to the selected user”: This limitation is merely reciting an outcome and fails to recite details of how the outcome to a problem is being accomplished. MPEP 2106.05(f)(1) states that the recitation of claim limitations that attempt to cover any solution to an identified problem with no restriction on how the result is accomplished and no description of the mechanism for accomplishing the result, does not integrate a judicial exception into a practical application or provide significantly more because this type of recitation is equivalent to the words "apply it".
Further, the additional element of (1) “sending a communication or command from the remote manager computing system to the selected medicament delivery device or to a management device of the selected medicament delivery device to set the adaptivity rate as the selected adaptivity rate for the selected medicament delivery device” is interpreted as insignificant extra-solution activity. The communication step (1) is recited at a high level of generality (i.e., as a general means of transmitting data) and amounts to the mere transmission of data, which is a form of extra-solution activity. MPEP 2106.04(d)(I) indicates that extra-solution data gathering activity cannot provide a practical application. Accordingly, even in combination, these additional elements do not integrate the abstract idea into a practical application.
Accordingly, these additional elements, when considered separately and as an ordered combination, do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. Therefore, Claims 1 and 20 are directed to an abstract idea without practical application. (Step 2A – Prong 2: No, the additional claimed elements are not integrated into a practical application).
Step 2B analysis:
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional elements of using a remote manager computing system, causing the selected medicament delivery device to deliver the determined next basal medicament delivery dose to the selected user, a processor, non-transitory computer-readable storage medium and instructions to perform the noted steps amounts to no more than mere instructions to apply the exception using a generic computer component. Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. The collective functions appear to be implemented using conventional computer systemization. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept (“significantly more”).
Also, as discussed above with respect to integration of the abstract idea into a practical application, the additional elements of (1) “sending a communication or command from the remote manager computing system to the selected medicament delivery device or to a management device of the selected medicament delivery device to set the adaptivity rate as the selected adaptivity rate for the selected medicament delivery device” was considered extra-solution activity. This has been re-evaluated under the “significantly more” analysis and determined to be well-understood, routine, conventional activity in the field.
The courts have recognized the following computer functions as well‐understood, routine, and conventional functions when they are claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity: i) receiving or transmitting data over a network, e.g., using the Internet to gather data, Symantec, 838 F.3d at 1321, 120 USPQ2d at 1362 (utilizing an intermediary computer to forward information); TLI Communications LLC v. AV Auto. LLC, 823 F.3d 607, 610, 118 USPQ2d 1744, 1745 (Fed. Cir. 2016) (using a telephone for image transmission); OIP Techs., Inc., v. Amazon.com, Inc., 788 F.3d 1359, 1363, 115 USPQ2d 1090, 1093 (Fed. Cir. 2015) (sending messages over a network); buySAFE, Inc. v. Google, Inc., 765 F.3d 1350, 1355, 112 USPQ2d 1093, 1096 (Fed. Cir. 2014) (computer receives and sends information over a network); but see DDR Holdings, LLC v. Hotels.com, L.P., 773 F.3d 1245, 1258, 113 USPQ2d 1097, 1106 (Fed. Cir. 2014) ("Unlike the claims in Ultramercial, the claims at issue here specify how interactions with the Internet are manipulated to yield a desired result‐‐a result that overrides the routine and conventional sequence of events ordinarily triggered by the click of a hyperlink." (emphasis added)). See MPEP §2106.05(d)(II).
This listing is not meant to imply that all computer functions are well‐understood, routine, conventional activities, or that a claim reciting a generic computer component performing a generic computer function is necessarily ineligible. Courts have held computer‐implemented processes not to be significantly more than an abstract idea (and thus ineligible) where the claim as a whole amounts to nothing more than generic computer functions merely used to implement an abstract idea, such as an idea that could be done by a human analog (i.e., by hand or by merely thinking). On the other hand, courts have held computer-implemented processes to be significantly more than an abstract idea (and thus eligible), where generic computer components are able in combination to perform functions that are not merely generic. See MPEP §2106.05(d)(II) – emphasis added.
The claims are directed to an abstract idea with additional generic computer elements that do not add meaningful limitations to the abstract idea because they require no more than a generic computer to perform generic computer functions that are well-understood, routine, and conventional activities previously known in the industry.
For the next step of the analysis, it must be determined whether the limitations present in the claims represent a patent-eligible application of the abstract idea. A claim directed to a judicial exception must be analyzed to determine whether the elements of the claim, considered both individually and as an ordered combination are sufficient to ensure that the claim as a whole amounts to significantly more than the exception itself.
For the role of a computer in a computer implemented invention to be deemed meaningful in the context of this analysis, it must involve more than performance of well-understood, routine, and conventional activities previously known to the industry. Further, the mere recitation of a generic computer cannot transform a patent ineligible abstract idea into a patent-eligible invention. See MPEP 2106.05(d).
Applicant’s specification discloses the following:
Applicant describes embodiments of the disclosure at a very high level to include the use of a wide variety of processors, biological sensors, memories, databases, input/output devices, networks, servers, computing devices, etc. (see Applicant’s spec. paras 37-38, 43-45). The invention, may use any computer via any transmission medium (a communication network or broadcast waves) capable of transmitting the program.
Generic computer components recited as performing generic computer functions that are well-understood, routine and conventional activities amount to no more than implementing the abstract idea with a computerized system.
In summary, these additional elements, when considered separately and as an ordered combination, do not integrate the abstract idea into a practical application because 1) mere instructions to apply an exception using a generic computer component cannot provide an inventive concept (“significantly more”) and 2) well-understood, routine, conventional activity cannot provide an inventive concept (“significantly more”). The claims do not provide an inventive concept significantly more than the abstract idea. Accordingly, these additional elements, when considered separately and as an ordered combination, do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. (Step 2B: No, the claims do not provide significantly more).
Dependent Claims 3-5, 7-8, 10-11 and 21-22 further define the abstract idea that is presented in independent Claim 1 and are further grouped as certain methods of organizing human activity and are abstract for the same reasons and basis as presented above. No further hardware components other than those found in the independent claims are recited, thus it is presumed that the claims are further utilizing the same generic systemization as presented in the independent claims. The claims do not recite additional elements that integrate the judicial exception into a practical application when considered both individually and as an ordered combination. Therefore, the dependent claims are also directed to an abstract idea.
Thus, claims 1, 3-5, 7-8, 10-11 and 20-22 are rejected under 35 U.S.C. 101 as being directed to abstract ideas without significantly more.
Claim Rejections - 35 USC § 103
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1, 3-4, 7-8, 11 and 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over Guerrini (US 20160089494) in view of Tao et al. (CN 106682432 A).
Regarding Claim 1, Guerrini discloses the following limitations:
A method, performed by a remote manager computing system for managing a selected medicament delivery device of a selected user, comprising: with the remote manager computing system, calculating adaptivity characteristics of other users of a same type of medicament delivery device as the selected medicament delivery device from data regarding the other users that includes historic glucose levels and historic insulin deliveries; (Guerrini discloses a method for controlling the administration of insulin to a patient such as controlling an infusion pump (managing a selected medicament delivery device of a selected user) wherein a target glucose level is set and a controller (a remote manager computing system) computes a recommended infusion rate based on a set of controller gains associated with a particular insulin class. Prior to actually administering insulin to a patient, a number of different insulin sensitivity classes (e.g., classes associated with insulin sensitivities regularly occurring in patients (other users of a same type of medicament delivery device as the selected medicament delivery device) or patients with rare insulin sensitivities (from data regarding the other users that includes historic glucose levels and historic insulin deliveries)) are determined. In order to determine the different classes, insulin sensitives values of other patients (adaptivity characteristics of other users) may be calculated (calculating adaptivity characteristics of other users - para 7). – abstract; paras 7, 22-23, 28-29, 40, 45, 62-63,125; FIG. 3-4)
with the remote manager computing system, categorizing the adaptivity characteristics of the other users into categories; (Guerrini discloses determining a number of different insulin sensitivity classes (categorizing the adaptivity characteristics) based on insulin sensitivities regularly occurring in patients or patients with rare insulin sensitivities (categorizing the adaptivity characteristics of the other users into categories). – para 63)
with the remote manager computing system, calculating the adaptivity characteristics of the selected user of the selected medicament delivery device; (Guerrini discloses that an insulin sensitivity of the patient (the adaptivity characteristics of the selected user of the selected medicament delivery device) is determined by means of a mathematical model taking into account the measured glucose level and an actual infusion rate of insulin administered to the patient (calculating the adaptivity characteristics of the selected user). – para 13)
with the remote manager computing system, based at least in part on the calculated adaptivity characteristics of the selected user of the selected medicament delivery device, selecting a category for the user of the selected medicament delivery device; (Guerrini discloses determining an insulin sensitivity value of the patient (based at least in part on the calculated adaptivity characteristics of the selected user of the selected medicament delivery device) and then determining which insulin sensitivity class the patient falls into (selecting a category for the user of the selected medicament delivery device). – paras 17, 21, 32-33)
with the remote manager computing system, selecting an adaptivity rate from one or more adaptivity rates associated with the selected category for one or more parameters of the selected medicament delivery device for the selected user based on analyzing data related to adaptivity rates for the other users, (Guerrini discloses that each predetermined insulin sensitivity class (based on analyzing data related to adaptivity rates for the other users) has an associated set of controller gains (selecting an adaptivity rate from one or more adaptivity rates associated with the selected category). The insulin sensitivity value (and thus the class the patient falls into) is used to set the controller gain and the controller gain determines a recommended infusion rate of insulin administered to the patient (for one or more parameters of the selected medicament delivery device for the selected user). – paras 16, 21-22, 46, 62; FIG. 4)
wherein the one or more parameters play a role in regulating automatic medicament delivery by the selected medicament delivery device, (Guerrini discloses determining a recommended infusion rate (the one or more parameters) for administering insulin to a patient (play a role in regulating automatic medicament delivery by the selected medicament delivery device). – para 18)
and wherein the selected adaptivity rate is a device control parameter that governs how a control method of the selected medicament delivery device attempts to adapt a current value or current values of the one or more parameters to a desired value or desired values; (Guerrini discloses that the adaption unit determines the controller gain (the selected adaptivity rate is a device control parameter that governs how a control method of the selected medicament delivery device attempts to adapt a current value or current values of the one or more parameters to a desired value or desired values) of the controller which determines a recommended infusion rate (the one or more parameters to a desired value or desired values). – paras 35-37, 40, 48, 50; FIG. 2) (Examiner notes that it is well known in the art that the controller gain of a controller is defined as determining how quickly or how slowly the controller responds/adapts to a deviation from the desired setpoint value. This position is further evidenced by Collins Dictionary (Controller gain definition in American English | collins english dictionary. Collins Dictionary. (n.d.). https://www.collinsdictionary.com/us/dictionary/english/controller-gain))
and sending a communication or command from the remote manager computing system to the selected medicament delivery device or to a management device of the selected medicament delivery device to set the adaptivity rate as the selected adaptivity rate for the selected medicament delivery device; (Guerrini discloses that the controller gain is determined and sent to the controller (sending a communication to set the adaptivity rate as the selected adaptivity rate) in order to then determine and output the recommended infusion rate to the infusion pump (sending a communication to the selected medicament delivery device). – paras 29-30, 78)
determining new value(s) for each of the one or more parameters…; (Guerrini discloses that an updated infusion rate (determining new value(s) for each of the one or more parameters) may be determined. The controller, by means of optimizing its PID controller equation, attempts to minimize the error by adjusting the process control inputs. The PID controller equation in addition may comprise a so-called compliance term for taking into account, when determining an updated recommended infusion rate (determining new value(s) for each of the one or more parameters), a deviation of the actual infusion rate from a previously determined recommended infusion rate. Within the method the controller gain is determined for use in the computation of the recommended infusion rate. – paras 31-33)
and using the new value(s) of the one or more parameters to determine a next basal medicament delivery dose for the selected medicament delivery device (Guerrini discloses that based on each newly determined insulin sensitivity value, then, the controller gain is modified, and the controller computes an updated recommended infusion rate (using the new value(s) of the one or more parameters) based on the currently measured glucose level and the target glucose level using the modified controller gain. The updated recommended infusion rate is used for administering insulin to a patient (determine a next basal medicament delivery dose for the selected medicament delivery device). – paras 16-17, 31-33)
and causing the selected medicament delivery device to deliver the determined next basal medicament delivery dose to the selected user. (Guerrini discloses a control device for controlling the administration of insulin to a patient. The recommended infusion rate () is calculated and communicated to the infusion pump which administers insulin to the patient using the recommended infusion rate (causing the selected medicament delivery device to deliver the determined next basal medicament delivery dose to the selected user). – paras 35-37, 48-49)
Guerrini does not disclose the following limitations met by Tao:
determining new value(s) for each of the one or more parameters as a sum of a first product and a second product, wherein the first product is a product of a value proposed for the parameter and the selected adaptivity rate and wherein the second product is a product of a previous value of the parameter and a coefficient; (Tao teaches determining operating parameters which incorporates a real-time operation sub-module which calculates a moving weight index mean value (i.e., an exponential weight moving average (EWMA)) (determining new value(s) for each of the one or more parameters). The equation is as follows:
EWMA(i) = a(i)*x + EWMA(i-1)*(1-x) (a sum of a first product and a second product). Where EWMA(i) is the weighting index corresponding to the i-th real-time detection data in the same batch, a(i) is the i-th real-time detected data (a value proposed for the parameter), x is the set smoothing index (the selected adaptivity rate), EWMA(i-1) is the i-1 weighted index (a previous value of the parameter ), and (1-x) is the weighted index (a coefficient). – page 4; page 9, Example 6)
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified calculating updated infusion rates as disclosed by Guerrini to incorporate calculating an exponential weighted moving average as taught by Tao in order to enhance the real-time performance of system monitoring (see Tao page 2).
Regarding Claim 3, Guerrini and Tao disclose all the limitations above and further disclose the following limitations:
The method of claim 1, wherein the selected adaptivity rate is for a single one of the one or more parameters. (Guerrini discloses that the controller gain (the selected adaptivity rate) is used for computing the infusion rate (is for a single one of the one or more parameters) for the infusion pump. – para 3)
Regarding Claim 4, Guerrini and Tao disclose all the limitations above and further disclose the following limitations:
The method of claim 1, wherein the medicament delivered by the medicament delivery device is insulin. (Guerrini discloses controlling the administration of insulin (wherein the medicament delivered by the medicament delivery device is insulin) to a patient and maintaining a patient's blood glucose level at or around a desired target glucose level. – abstract)
Regarding Claim 7, Guerrini and Tao disclose all the limitations above and further disclose the following limitations:
The method of claim 1, further comprising projecting an expected final value for the one or more parameters and selecting the adaptivity rate based on how great of a difference there is between expected final value(s) and an initial value(s) of the one or more parameters. (Guerrini discloses that, based on a newly determined insulin sensitivity value, the controller gain is modified (selecting the adaptivity rate), and the controller computes an updated recommended infusion rate based on the currently measured glucose level (based on how great of a difference there is between an initial value) and the target glucose level (the expected final value) using the modified controller gain. – abstract; paras 17, 30, 84; FIG. 2)
Regarding Claim 8, Guerrini and Tao disclose all the limitations above and further disclose the following limitations:
The method of claim 1, wherein the selecting of the adaptivity rate is based at least in part on glucose control outcomes. (Guerrini discloses that the patient is classified into a class associated with a set of controller gains (selecting of the adaptivity rate) based on their insulin sensitivity (glucose control outcomes). – paras 21-23, 71; FIGs. 3-4)
Regarding Claim 11, Guerrini and Tao disclose all the limitations above and further disclose the following limitations:
The method of claim 1, further comprising updating the data regarding the other users before the selecting. (Guerrini discloses that there may be more or less than four classes C1-C4, for example six classes. New classes may be created (updating the data regarding the other users) defined by a new insulin sensitivity (S.sub.Ic) value. – paras 63, 157, 163-164)
Regarding Claim 21, Guerrini and Tao disclose all the limitations above and further disclose the following limitations:
The method of claim 1, wherein the coefficient is equal to one minus the adaptivity rate. (Tao teaches determining operating parameters which incorporates a real-time operation sub-module which calculates a moving weight index mean value (i.e., an exponential weight moving average (EWMA)). The equation is as follows: EWMA(i) = a(i)*x + EWMA(i-1)*(1-x). Where EWMA(i) is the weighting index corresponding to the i-th real-time detection data in the same batch, a(i) is the i-th real-time detected data, x is the set smoothing index (the adaptivity rate), EWMA(i-1) is the i-1 weighted index, and (1-x) is the weighted index (the coefficient is equal to one minus the adaptivity rate). – page 4; page 9, Example 6)
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified calculating updated infusion rates as disclosed by Guerrini to incorporate calculating an exponential weighted moving average as taught by Tao in order to enhance the real-time performance of system monitoring (see Tao page 2).
Regarding Claim 22, Guerrini and Tao disclose all the limitations above and further disclose the following limitations:
The method of claim 1, wherein the categories are derived from data for users other than the selected user. (Guerrini discloses determining a number of different insulin sensitivity classes (the categories) based on insulin sensitivities regularly occurring in patients or patients with rare insulin sensitivities. The classes are determined in advance such that they are predefined when carrying out an actual insulin administration procedure (derived from data for users other than the selected user). – paras 63, 68)
Claims 5 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Guerrini, in view of Tao, further in view of Malave et al. (US 20020193679).
Regarding Claim 5, Guerrini and Tao disclose all the limitations above, however, do not disclose the following limitations met by Malave:
The method of claim 1, wherein the adaptivity characteristics are one or more of the following metrics: discrepancy between amount of insulin delivered automatically by the selected medicament delivery device for a day versus total daily insulin, a ratio of amount of insulin requested as boluses for a period versus an amount of automatically delivered insulin for the period or a ratio of a percentage of time where glucose is below a hypoglycemic threshold versus a percentage of time where automatic delivery of insulin was suspended. (Malave teaches a basal/bolus ratio graph showing the percent ratio of bolus delivery (amount of insulin requested as boluses) vs. basal rate delivery (versus an amount of automatically delivered insulin) for three time periods (for a period). – paras 92, 96, 105, 114; FIGS. 24, 18(b), 20(b))
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have further modified administration of insulin to a patient using adaptive infusion rates as disclosed by Guerrini to incorporate determining and displaying a ratio indicating the percent of bolus delivery vs. percent of basal delivery as taught by Malave in order to provide presentation of the data in a useful format (see Malave para 6).
Regarding Claim 20, Guerrini discloses the following limitations:
A non-transitory computer-readable storage medium storing instructions that when executed by a processor of a remote manager computing system for managing a selected medicament delivery device of a selected user cause the processor to perform the following: (Guerrini discloses a controller (a processor) performing the method of controlling the administration of insulin to a patient. This is indicative of the controller executing instructions in order to perform the disclosed method. – abstract)
with the remote manager computing system, calculating adaptivity characteristics of other users of a same type of medicament delivery device as the selected medicament delivery device from data regarding the other users that includes historic glucose levels and historic insulin deliveries; (Guerrini discloses a method for controlling the administration of insulin to a patient such as controlling an infusion pump wherein a target glucose level is set and a controller (the remote manager computing system) computes a recommended infusion rate based on a set of controller gains associated with a particular insulin class. Prior to actually administering insulin to a patient, a number of different insulin sensitivity classes (e.g., classes associated with insulin sensitivities regularly occurring in patients (other users of a same type of medicament delivery device as the selected medicament delivery device) or patients with rare insulin sensitivities (from data regarding the other users that includes historic glucose levels and historic insulin deliveries)) are determined. In order to determine the different classes, insulin sensitives values of other patients (adaptivity characteristics of other users) may be calculated (calculating adaptivity characteristics of other users - para 7). – abstract; paras 7, 22-23, 28-29, 40, 45, 62-63,125; FIG. 3-4)
with the remote manager computing system, categorizing the adaptivity characteristics of the other users into categories, wherein at least one of the adaptivity characteristics of the other users is a metric of historic glucose outcomes for the other users; (Guerrini discloses that prior to actually administering insulin to a patient, determining a number of different, discrete insulin sensitivity classes (categorizing the adaptivity characteristics of the other users into categories,) based on, for example, insulin sensitivities (the adaptivity characteristics) regularly occurring in patients (wherein at least one of the adaptivity characteristics of the other users is a metric of historic glucose outcomes for the other users); indicating that past data of insulin sensitivities regularly occurring in patients is being used (a metric of historic glucose outcomes). – paras 22, 63)
with the remote manager computing system, calculating adaptivity characteristics of the selected user of the selected medicament delivery device, (Guerrini discloses that an insulin sensitivity of the patient (the adaptivity characteristics of the selected user of the selected medicament delivery device,) is determined by means of a mathematical model taking into account the measured glucose level and an actual infusion rate of insulin administered to the patient (calculating the adaptivity characteristics of the selected user). – para 13)
with the remote manager computing system, based at least in part on the calculated adaptivity characteristics of the selected user of the selected medicament delivery device, selecting a category for the user of the selected medicament delivery device; (Guerrini discloses determining an insulin sensitivity value of the patient (based at least in part on the calculated adaptivity characteristics of the selected user of the selected medicament delivery device) and then determining which insulin sensitivity class the patient falls into (selecting a category for the user of the selected medicament delivery device). – paras 17, 21, 32-33)
with the remote manager computing system, select an adaptivity rate from one or more adaptivity rates associated with the selected category for one or more parameters of the selected medicament delivery device for the selected user based on analyzing data related to adaptivity rates for the other users, (Guerrini discloses that each predetermined insulin sensitivity class (based on analyzing data related to adaptivity rates for the other users) has an associated set of controller gains (select an adaptivity rate from one or more adaptivity rates associated with the selected category). The insulin sensitivity value (and thus the class the patient falls into) is used to set the controller gain and the controller gain determines a recommended infusion rate of insulin administered to the patient (for one or more parameters of the selected medicament delivery device for the selected user). – paras 16, 21-22, 46, 62; FIG. 4)
wherein the one or more parameters play a role in regulating automatic medicament delivery by the selected medicament delivery device, (Guerrini discloses determining a recommended infusion rate (the one or more parameters) for administering insulin to a patient (play a role in regulating automatic medicament delivery by the selected medicament delivery device). – para 18)
and wherein the adaptivity rate determines how quickly a control method of the selected medicament delivery device attempts to achieve a desired outcome; (Guerrini discloses that the adaption unit determines the controller gain (the adaptivity rate determines how quickly a control method of the selected medicament delivery device attempts to achieve a desired outcome) of the controller which determines a recommended infusion rate. – paras 35-37, 40, 48, 50; FIG. 2) (Examiner notes that it is well known in the art that the controller gain of a controller is defined as determining how quickly or how slowly the controller responds/adapts to a deviation from the desired setpoint value. This position is further evidence by Collins Dictionary (Controller gain definition in American English | collins english dictionary. Collins Dictionary. (n.d.). https://www.collinsdictionary.com/us/dictionary/english/controller-gain))
and send a communication or command from the remote manager computing system to the selected medicament delivery device or to a management device of the selected medicament delivery device to set the adaptivity rate as the selected adaptivity rate for the selected medicament delivery device; (Guerrini discloses that the controller gain is determined and sent to the controller (sending a communication to set the adaptivity rate as the selected adaptivity rate) in order to then determine and output the recommended infusion rate to the infusion pump (sending a communication to the selected medicament delivery device). – paras 29-30, 78)
determine new value(s) for each of the one or more parameters…; (Guerrini discloses that an updated infusion rate (determining new value(s) for each of the one or more parameters) may be determined. The controller, by means of optimizing its PID controller equation, attempts to minimize the error by adjusting the process control inputs. The PID controller equation in addition may comprise a so-called compliance term for taking into account, when determining an updated recommended infusion rate (determining new value(s) for each of the one or more parameters), a deviation of the actual infusion rate from a previously determined recommended infusion rate. Within the method the controller gain is determined for use in the computation of the recommended infusion rate. – paras 31-33)
and use the new value(s) of the one or more parameters to determine a next basal medicament delivery dose for the selected medicament delivery device (Guerrini discloses that based on each newly determined insulin sensitivity value, then, the controller gain is modified, and the controller computes an updated recommended infusion rate (using the new value(s) of the one or more parameters) based on the currently measured glucose level and the target glucose level using the modified controller gain. The updated recommended infusion rate is used for administering insulin to a patient (determine a next basal medicament delivery dose for the selected medicament delivery device). – paras 16-17, 31-33)
and cause the selected medicament delivery device to deliver the determined next basal medicament delivery dose to the selected user. (Guerrini discloses a control device for controlling the administration of insulin to a patient. The recommended infusion rate () is calculated and communicated to the infusion pump which administers insulin to the patient using the recommended infusion rate (causing the selected medicament delivery device to deliver the determined next basal medicament delivery dose to the selected user). – paras 35-37, 48-49)
Guerrini does not disclose the following limitations met by Tao:
determine new value(s) for each of the one or more parameters as a sum of a first product and a second product, wherein the first product is a product of a value proposed for the parameter and the selected adaptivity rate and wherein the second product is a product of a previous value of the parameter and a coefficient; (Tao teaches determining operating parameters which incorporates a real-time operation sub-module which calculates a moving weight index mean value (i.e., an exponential weight moving average (EWMA)) (determine new value(s) for each of the one or more parameters). The equation is as follows:
EWMA(i) = a(i)*x + EWMA(i-1)*(1-x) (a sum of a first product and a second product). Where EWMA(i) is the weighting index corresponding to the i-th real-time detection data in the same batch, a(i) is the i-th real-time detected data (a value proposed for the parameter), x is the set smoothing index (the selected adaptivity rate), EWMA(i-1) is the i-1 weighted index (a previous value of the parameter ), and (1-x) is the weighted index (a coefficient). – page 4; page 9, Example 6)
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified calculating updated infusion rates as disclosed by Guerrini to incorporate calculating an exponential weighted moving average as taught by Tao in order to enhance the real-time performance of system monitoring (see Tao page 2).
Guerrini does not disclose the following limitations met by Malave:
wherein at least one of the adaptivity characteristics of the selected user is a metric of historic glucose outcomes for the selected user; (Malave teaches utilizing data transferred from a diabetes related medical device to generate at least one report. Such data includes glucose meter history and glucose monitor history (a metric of historic glucose outcomes for the selected user). The at least one report can include tabular and graphical data, as well as statistical analysis, exception reporting, and clinical recommendations based on expert system analysis. FIG. 16 shows a table displaying bolus history, daily total insulin history, etc. in chronological order and highlights when a glucose measurement was out of range (para 90). Fig 18(a) shows a graphical display using a time axis and a plot of histories for basal rates, bolus, glucose readings, etc. (para 93). – paras 10, 90, 93; FIG. 16)
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have further modified administration of insulin to a patient using adaptive infusion rates as disclosed by Guerrini to incorporate historic data such as infusion pump and glucose measurements as taught by Malave in order to provide useful presentation of the data (see Malave para 6).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Guerrini, in view of Tao, further in view of Lintereur et al. (US 20200101223).
Regarding Claim 10, Guerrini and Tao disclose all the limitations above and further disclose the following limitations:
The method of claim 1, wherein the selecting of the an adaptivity rate for one or more parameters of the selected medicament delivery device for the selected user is also based on at least one of date, time, day of week or whether a day is a holiday or part of a holiday season. (Lintereur teaches that the patient's historical measurement data for postprandial periods following historical meal events may be analyzed to model or otherwise characterize the patient's glycemic response to the predicted size and type of meal for the current context (e.g., time of day, day of week, geolocation, etc.) (time, day of week). One or more aspects of the infusion device 102, 200, 502 that control or regulate insulin delivery may then be modified or adjusted to proactively account for the patient's likely meal activity and glycemic response (the selecting of the an adaptivity rate for one or more parameters of the selected medicament delivery device). – para 83)
It would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to have modified administration of insulin to a patient using adaptive infusion rates as disclosed by Guerrini to incorporate modifying insulin delivery based on the time of day or day of week as taught by Lintereur in order to suit the needs of individuals (see Lintereur para 6).
Response to Arguments
Regarding rejections under 35 USC § 112(b) to Claim 4, Applicant’s arguments have been fully considered and are persuasive regarding the amendments made to claim 4. The Examiner has withdrawn the previous 112(b) rejection.
Regarding rejections under 35 USC § 101 to Claims 1, 3-5, 7-8, 10-11 and 20-22, Applicant’s arguments have been fully considered and are not persuasive. The rejection has been updated in light of latest amendments. Applicant argues:
(a) The Examiner notes at page 7 of the Office Action, "The claims may be interpreted to recite a practical application of the abstract idea and overcome the 101 rejection if the independent claims are amended to recite limitations that administer a specific treatment." Applicant adopts this suggestion of the Examiner and amends claim 1 to recite "causing the selected medicament delivery device to deliver the determined next basal medicament delivery dose to the selected user." Applicant amends claim 20 to recite similar claim limitations. In view of these amendments, Applicant submits that the amended claims 1 and 20, as well as dependent claims 3-5, 7, 8, 10, and 11 that depend from claim 1, recite subject matter that is integrated into a practical application in delivering a more optimal basal dose of medicament to a user. Hence, Applicant respectfully submits that the claims are directed to patent eligible subject matter. (p. 8).
Regarding (a), Examiner respectfully disagrees. MPEP 2106.04(d)(2) indicates that a practical application may be present where the abstract idea effects a particular treatment or provides particular prophylaxis for a disease or medical condition. A particular treatment/prophylaxis is present where (a) there is a particular (i.e., named/described) treatment/prophylaxis that occurs when the claim is implemented; (b) the treatment/prophylaxis has more than a nominal connection/correlation to the abstract idea; and (c) the administration is more than extra-solution activity or a field of use.
Applicant’s claimed invention does not provide for a particular treatment/prophylaxis because there is no particularity to the recited treatment; the claim does not recite, for example, what the medication itself is, what type of medicament device is being used for delivery, what the basal dosage is (i.e., the amount), the length of treatment, the timing of treatment, etc. Amended claim 1 recites: “and using the new value(s) of the one or more parameters to determine a next basal medicament delivery dose for the selected medicament delivery device and causing the selected medicament delivery device to deliver the determined next basal medicament delivery dose to the selected user.” While the determined basal dose is delivered to the user, there is no indication in the claim that a particular type of treatment is being administered to a patient/user. Because a particular treatment/prophylaxis is not present in the claims, a practical application is not present.
For purposes of compact prosecution, the Examiner notes that the additional element of causing the selected medicament delivery device to deliver the determined next basal medicament delivery dose to the selected user is interpreted as merely reciting a solution or result without reciting details as to how the solution/result is being accomplished. For example, the claim does not recite the type of medicament device, and therefore it’s unknown how the device is being controlled in order to deliver the medication. MPEP 2106.05(f)(1) states that the recitation of claim limitations that attempt to cover any solution to an identified problem with no restriction on how the result is accomplished and no description of the mechanism for accomplishing the result, does not integrate a judicial exception into a practical application or provide significantly more because this type of recitation is equivalent to the words "apply it". See updated rejection above.
Regarding rejections under 35 USC § 103 to Claims 1, 3-5, 7-8, 10-11 and 20-22, Applicant’s arguments have been fully considered and are not persuasive. The rejection has been updated in light of latest amendments. Applicant argues:
(b) Guerrini does not disclose "selecting an adaptivity rate" wherein "the selected adaptivity rate is a device control parameter that governs how a control method of the selected medicament delivery device attempts to adapt a current value or current values of the one or more parameters to a desired value or desired values," as recited in amended claim 1. Guerrini selects a controller gain and generates a recommended infusion rate. The gain is not "a device control parameter that governs how a control method attempts to adapt a current value or current values of one or more parameters to a desired value or desired values, as claimed. (p. 9).
Regarding (b), Examiner respectfully disagrees. As noted in the rejection above, the controller gain is known in the art to be a parameter that defines how the controller responds to or adapts a current value to a desired value when the current value deviates from the desired value. The Examiners position is further evidenced by the Collins Dictionary (Controller gain definition in American English | collins english dictionary. Collins Dictionary. (n.d.). https://www.collinsdictionary.com/us/dictionary/english/controller-gain). Guerrini discloses that the adaption unit determines the controller gain of the controller which determines a recommended infusion rate.
(c) Further Guerrini does not disclose "determining new value(s) for each of the one or more parameters as a sum of a first product and a second product, wherein the first product is a product of a value proposed for the parameter and the selected adaptivity rate and wherein the second product is a product of a previous value of the parameter and a coefficient," as recited in claim 1. The Examiner points to the compliance term of the PID equation in Guerrini. The compliance term is an accounting for a deviation between a recommended infusion rate and an actual infusion rate and differs from the claimed sum of products. The PID equation of Guerrini does not sum a first product with a second product that is a product of a previous value of the parameter and a coefficient, as claimed. (p. 9-10).
Regarding (c), The Examiner no longer relies upon Guerrini to disclose the argued limitations. Thus, Applicants argument is moot. See updated rejection above.
(d) Claim 5 depends from amended claim 1 and thus includes all of the limitations of amended claim 1. Hence, Applicant respectfully requests reconsideration and withdrawal of the rejection of claim 5. Claim 20 is amended in a fashion like claim 1 and is novel and unobvious over both Guerrini and Malave as they do not disclose, teach, or suggest the distinguishing features identified above relative to claim 1. Claim 10 depends from amended claim 1 and thus includes all of the limitations of amended claim 1. Hence, Applicant respectfully requests reconsideration and withdrawal of the rejection of claim 10. (p. 10).
Regarding (d), Examiner respectfully disagrees. Based on response to arguments above, claim 1 is unpatentable and therefore similarly amended independent claim 20, as well as all claims depending therefrom, are unpatentable according to the same rationale.
Conclusion
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/K.E.V./Examiner, Art Unit 3681
/PETER H CHOI/Supervisory Patent Examiner, Art Unit 3681
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