DETAILED ACTION
Claims 1-17 (filed 04/22/2024) have been considered in this action. Claims 1-17 have been amended.
Drawings
The drawings are not of sufficient quality to permit examination. Accordingly, replacement drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to this Office action. The replacement sheet(s) should be labeled “Replacement Sheet” in the page header (as per 37 CFR 1.84(c)) so as not to obstruct any portion of the drawing figures. If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action.
Applicant is given a shortened statutory period of TWO (2) MONTHS to submit new drawings in compliance with 37 CFR 1.81. Extensions of time may be obtained under the provisions of 37 CFR 1.136(a) but in no case can any extension carry the date for reply to this letter beyond the maximum period of SIX MONTHS set by statute (35 U.S.C. 133). Failure to timely submit replacement drawing sheets will result in ABANDONMENT of the application.
New corrected drawings in compliance with 37 CFR 1.121(d) are required in this application because the submitted drawings are of poor general quality and present difficulties in legibility. Applicant is advised to employ the services of a competent patent draftsperson outside the Office, as the U.S. Patent and Trademark Office no longer prepares new drawings. The corrected drawings are required in reply to the Office action to avoid abandonment of the application. The requirement for corrected drawings will not be held in abeyance.
Claim Objections
Claim 1 is objected to because of the following informalities:
A typographical error exists in the program module limitation, whereby “the and to calculate an infusion amount” does not make grammatical sense as the word “the” appears to be mistakenly left in the claim during amendment, when it was intended to be deleted
Claim 5 is objected to because of the following informalities:
A typographical error in that “for the detecting delay” in the limitation with the symbol ③ improperly uses antecedent basis. For the sake of compact prosecution its definition is clear as “a detecting delay”.
Applicant is advised that should claim 6 be found allowable, claim 7 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Appropriate correction is required.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
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 of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “detection module”, “program module” and “infusion module” in claims 1-17.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof. Based upon the provided specification, the detection module is a continuous glucose monitor for detecting real-time blood glucose ([0105]), and the infusion module is “[0107] essential mechanical assemblies used to infuse insulin”. No particular structure is referred to as being a program module.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 1-17 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim limitation “program module” and “infusion module” invokes 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. However, the written description fails to disclose the corresponding structure, material, or acts for performing the entire claimed function and to clearly link the structure, material, or acts to the function. The specification is devoid of any structure that is capable of performing the functions of the program module. When looking to the specification, paragraph [0106] of published US patent application US 20250235614 teaches only what a program module is “used for” but fails to describe any particular structure performing these intended uses. Paragraph [0107] describes the infusion module as including “the essential mechanical assemblies used to infuse insulin”, however this fails to clearly define what exactly is encompassed by this claimed element, such that when considered the meets and bounds of the “infusion module” a person of ordinary skill in the art would not be apprised of its meaning. Therefore, the claim is indefinite and is rejected under 35 U.S.C. 112(b) or pre-AIA 35 U.S.C. 112, second paragraph.
Applicant may:
(a) Amend the claim so that the claim limitation will no longer be interpreted as a limitation under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph;
(b) Amend the written description of the specification such that it expressly recites what structure, material, or acts perform the entire claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(c) Amend the written description of the specification such that it clearly links the structure, material, or acts disclosed therein to the function recited in the claim, without introducing any new matter (35 U.S.C. 132(a)).
If applicant is of the opinion that the written description of the specification already implicitly or inherently discloses the corresponding structure, material, or acts and clearly links them to the function so that one of ordinary skill in the art would recognize what structure, material, or acts perform the claimed function, applicant should clarify the record by either:
(a) Amending the written description of the specification such that it expressly recites the corresponding structure, material, or acts for performing the claimed function and clearly links or associates the structure, material, or acts to the claimed function, without introducing any new matter (35 U.S.C. 132(a)); or
(b) Stating on the record what the corresponding structure, material, or acts, which are implicitly or inherently set forth in the written description of the specification, perform the claimed function. For more information, see 37 CFR 1.75(d) and MPEP §§ 608.01(o) and 2181.
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 3-5 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 3 recites the formula:
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The claim then goes on to define the variables/symbols of the formula, however, no explanation is given to the meaning of the symbol r that comes before cPID(t). While it would generally be understood as a form of multiplication factor, its underlying meaning remains indefinite. Without a proper definition of what this symbol means, its definition remains unclear and thus the scope of claim 3 is indefinite.
Claims 4-5 are dependent upon claim 3, and thus inherit the rejection of claim 3 under 35 U.S.C. 112(b).
Claim 7 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 7 recites the limitation "the rPID " in the first limitation of claim 7. There is insufficient antecedent basis for this limitation in the claim. It is unclear what “the rPID” is in reference to, and thus is rejected under 35 U.S.C. 112(b).
Claims 9-11 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 9 recites the formula:
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274
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The claim then goes on to define the variables/symbols of the formula, however, no explanation is given to the meaning of the symbol JrMPC that comes at the start of the formula. Without a proper definition of what this symbol means, its definition remains unclear and thus the scope of claim 9 is indefinite.
Claims 10-11 are dependent upon claim 9, and thus inherit the rejection of claim 9 under 35 U.S.C. 112(b).
Claim 16 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 16 recites the limitation "the third module" at the end of its only limitation. There is insufficient antecedent basis for this limitation in the claim. It is unclear what “the third module” is in reference to. For the sake of compact prosecution, the examiner shall consider “the third module” to refer to the other of the two connected “detection module”, “program module” and “infusion module”. In other words, if the detection module and program module are the two connected, the infusion module is attached at a different position, and vice versa for the other combinations.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Palerm et al. (US 20190015590, hereinafter Palerm) in view of Rollins et al. (US 20200016337, hereinafter Rollins).
In regards to Claim 1, Palerm teaches “A closed-loop artificial pancreas insulin infusion control system, comprising:” ([0044] In the illustrated embodiment of FIG. 1, the infusion device 102 is designed as a portable medical device suitable for infusing a fluid, a liquid, a gel, or other agent into the body of a user. In exemplary embodiments, the infused fluid is insulin, [0049] In some embodiments, the sensing arrangement 104 and/or the infusion device 102 are cooperatively configured to utilize a closed-loop system for delivering fluid to the user) “a detection module, configured to detect a current blood glucose level G continuously;” ([0045] The sensing arrangement 104 generally represents the components of the infusion system 100 configured to sense, detect, measure or otherwise quantify a condition of the user, and may include a sensor, a monitor, or the like, for providing data indicative of the condition that is sensed, detected, measured or otherwise monitored by the sensing arrangement. In this regard, the sensing arrangement 104 may include electronics and enzymes reactive to a biological condition, such as a blood glucose level, or the like, of the user, and provide data indicative of the blood glucose level to the infusion device 102, the CCD 106 and/or the computer 108. [0049] the sensing arrangement 104 continues to sense or otherwise quantify a current condition of the user, thereby allowing the infusion device 102 to deliver fluid continuously in response to the condition currently (or most recently) sensed by the sensing arrangement 104 indefinitely) “program module, connected to the detection module, and configured to preset with a hybrid artificial pancreas algorithm, the and to calculate an insulin infusion amount required by an user” ([0043] Turning now to FIG. 1, one exemplary embodiment of an infusion system 100 includes, without limitation, a fluid infusion device (or infusion pump) 102, a sensing arrangement 104, a command control device (CCD) 106, and a computer 108; [0047] the CCD 106 and/or the computer 108 may include electronics and other components configured to perform processing, delivery routine storage, and to control the infusion device 102 in a manner that is influenced by sensor data measured by and/or received from the sensing arrangement 104. [0063] [0063] In the illustrated embodiment, the infusion device 502 includes a motor control module 512 coupled to a motor 507 (e.g., motor assembly 207) that is operable to displace a plunger 517 (e.g., plunger 217) in a reservoir (e.g., reservoir 205) and provide a desired amount of fluid to the body 501 of a user...The motor control module 512 is coupled to the motor driver module 514, and the motor control module 512 generates or otherwise provides command signals that operate the motor driver module 514 to provide current (or power) from the energy source 503 to the motor 507 to displace the plunger 517 in response to receiving, from a pump control system 520, a dosage command indicative of the desired amount of fluid to be delivered. In this regard, the pump control system 520 generally represents the electronics and other components that control operation of the fluid infusion device 502 according to a desired infusion delivery program in a manner that is influenced by sensor data pertaining to a condition of a user (e.g., the user's current glucose level) received from the sensing arrangement 504 and/or in a manner that is dictated by the user. To support closed-loop control, the pump control system 520 receives or otherwise obtains a desired value (e.g., a target or command blood glucose value) for the condition in the body 501 of the user. For example, the infusion device 502 may store or otherwise maintain the target value in a data storage element accessible to the pump control system 520. Alternatively, the target value may be received from an external component (e.g., CCD 106 and/or computer 108)) “the hybrid artificial pancreas algorithm comprises a cPID algorithm and/or a cMPC algorithm…” ([0123] if the current delivery mode is a PID closed-loop delivery mode, the command generation application 1114 continues generating delivery commands using the current glucose measurement value and/or the predicted blood glucose value. For example, if the current glucose measurement value is valid and usable, the command generation application 1114 may calculate or otherwise determine a difference between the current glucose measurement value and a target blood glucose reference value (or glucose setpoint) and apply proportional-integral-derivative (PID) control parameters to the difference to arrive at a delivery command configured to regulate the current glucose measurement value to the target blood glucose reference value, as described in greater detail below in the context of FIG. 22) “and an infusion module, connected to the program module, and configured to infuse insulin, controlled by the program module, according to the insulin infusion amount calculated by the hybrid artificial pancreas algorithm” ([0061] FIG. 5 depicts an exemplary embodiment of a control system 500 suitable for use with an infusion device 502, such as the infusion device 102 in FIG. 1 or the infusion device 200 of FIG. 2. The control system 500 is configured to control or otherwise regulate a condition in the body 501 of a user to a desired (or target) value or otherwise maintain the condition within a range of acceptable values. In one or more exemplary embodiments, the condition being regulated is sensed, detected, measured or otherwise quantified by a sensing arrangement 504 (e.g., sensing arrangement 104) communicatively coupled to the infusion device 502. [0063] In the illustrated embodiment, the infusion device 502 includes a motor control module 512 coupled to a motor 507 (e.g., motor assembly 207) that is operable to displace a plunger 517 (e.g., plunger 217) in a reservoir (e.g., reservoir 205) and provide a desired amount of fluid to the body 501 of a user).
Palerm fails to explicitly teach “the hybrid artificial pancreas algorithm comprises a cPID algorithm and/or a cMPC algorithm, where an input of the cPID algorithm is a intermediate value of a MPC algorithm, and an input of the cMPC algorithm is an output value of a PID algorithm”.
Rollins teaches “the hybrid artificial pancreas algorithm comprises a cPID algorithm and/or a cMPC algorithm, where an input of the cPID algorithm is a intermediate value of a MPC algorithm, and an input of the cMPC algorithm is an output value of a PID algorithm” (Fig. 1A shows output of model 2 (MPC output) going into difference block that is fed into controller Gc (PID) [0052] The FBPC system preferably comprises a two-stage method that first applies the Wiener/Semi-Coupled method and obtains the input-only Model 1. It then uses the pre-whitening method to model the serial correlation structure of the Model 1 residuals to address unmeasured disturbances and model bias. This is Model 2 and is the predictive model for future BGC using current and past BGC measurements. According to this system, BGC is predicted a distance into the future equal to the given value of dead time for exogenous insulin flow rate. The future feedback error is determined using this value and a conventional PID controller is used to manipulate insulin flowrate in the present. Preferably, FBPC control uses a PID control algorithm, with the minimum prediction horizon, no specified control horizon, and an inherent cause-and-effect relationship between MV and CV that is “built-in” to the PID structure. [0056] An exemplary block diagram for FBPC is shown in FIG. 1A. The controller G.sub.c is preferably a PID controller. FIG. 1B provides an exemplary block diagram mimicking FIG. 1A, but employing a model predictive controller. In both FIGS. 1A and 1B, the output from G.sub.v represents adjustments of the MV. In an automatic insulin delivery system, the output from G.sub.v would represent varying the insulin flow rate or quantity of insulin administered to a patient. [0089] As shown in FIG. 1, for FBPC the controller is a common PID controller, and thus can have a three-dimensional tuning space. The FBE requires the predicted value of the controlled variable k.sub.1Δt time into the future, the time when current change in the manipulated variable affects the output).
It would have been obvious to a person having ordinary skill in the art before the effective file date of the claimed invention to have modified the system for closed-loop insulin infusion which uses a PID loop for controlling the amount of insulin delivered by an infusion device, and improving it with the use of a PID loop that accepts a predicted value of glucose from a predictive control module (intermediate value) as an input as taught by Rollins because it can be considered the simple substitution a portion of a control algorithm with another. This is further supported because Palerm even suggests “[0123] if the current delivery mode is a PID closed-loop delivery mode, the command generation application 1114 continues generating delivery commands using the current glucose measurement value and/or the predicted blood glucose value” suggesting that the use of predicted blood glucose values in a classic PID loop, such as that utilized by Rollins. Furthermore, the claim recites “the hybrid artificial pancreas algorithm comprises a cPID and/or cMPC algorithm” thus requiring only one of the cPID or cMPC algorithms, as both are not required. By combining these elements, it can be considered taking the known use of a closed-loop control system that uses a PID loop, and improve it by modifying the control loop with the use of a PID loop that takes as input a predictive value of glucose from a model predictive controller to determine a control command for insulin infusion in a known way that achieves predictable results.
In regards to Claim 16, the combination of Palerm and Rollins teaches the insulin infusion system as incorporated by claim 1 above. Palerm further teaches “According to the closed-loop artificial pancreas insulin infusion control system of claim 1, wherein, any two of the detection module, the program module and the infusion module are connected to each other, and are configured to form a single part whose attached position on a skin is different from the third module” ([0046] Still referring to FIG. 1, in various embodiments, the sensing arrangement 104 may be secured to the body of the user or embedded in the body of the user at a location that is remote from the location at which the infusion device 102 is secured to the body of the user. In various other embodiments, the sensing arrangement 104 may be incorporated within the infusion device 102. In other embodiments, the sensing arrangement 104 may be separate and apart from the infusion device 102, and may be, for example, part of the CCD 106. In such embodiments, the sensing arrangement 104 may be configured to receive a biological sample, analyte, or the like, to measure a condition of the user).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Palerm and Rollins as applied to claim 1 above, and further in view of Stafford (US 20080119707, hereinafter Stafford).
In regards to Claim 17, the combination of Palerm and Rollins teaches the insulin infusion control system as incorporated by claim 1 above.
Palerm further teaches “According to the closed-loop artificial pancreas insulin infusion control system of claim 1, wherein, the detection module, the program module and the infusion module are connected together…” ([0045] the infusion device 102, the CCD 106 and/or the computer 108 may include a display for presenting information or data to the user based on the sensor data received from the sensing arrangement 104, such as, for example, a current glucose level of the user, a graph or chart of the user's glucose level versus time, device status indicators, alert messages, or the like. In other embodiments, the infusion device 102, the CCD 106 and/or the computer 108 may include electronics and software that are configured to analyze sensor data and operate the infusion device 102 to deliver fluid to the body of the user based on the sensor data and/or preprogrammed delivery routines. Thus, in exemplary embodiments, one or more of the infusion device 102, the sensing arrangement 104, the CCD 106, and/or the computer 108 includes a transmitter, a receiver, and/or other transceiver electronics that allow for communication with other components of the infusion system 100, so that the sensing arrangement 104 may transmit sensor data or monitor data to one or more of the infusion device 102, the CCD 106 and/or the computer 108).
The combination of Palerm and Rollins fails to teach “…and are configured to form a single part which is attached on only one position on a skin”.
Stafford teaches “…the detection module, the program module and the infusion module are connected together, and are configured to form a single part which is attached on only one position on a skin” ([0018] FIG. 1 shows a top view of an exemplary embodiment of a combined fluid delivery and analyte monitoring system 10 constricted according to some aspects of the present invention, while FIG. 2 shows an elevational end view of system 10 mounted on the skin of patient P. Flexible fabric patch 12 forms the base of system 10. Flexible patch 12 may be provided with an adhesive on a bottom surface to secure patch 12 to the skin of the patient during use; [0021] Circuitry for controller and transmitter 16 may be directly integrated into flexible patch 12. Alternatively, controller and transmitter 16 can be constructed using traditional electronic component assembly techniques then physically and electronically attached to patch 12. [0023] Flexible patch 12 may be provided with one or more sensor sites 34 for receiving transcutaneous analyte sensors. Multiple sensors can be used simultaneously to provide redundant analyte readings.... An inserted sensor can be electrically connected to controller and transmitter module 16 directly, with external conductors or through internal electrical pathways within flexible patch 12; [0026] A fluid pump 22, such as for delivering insulin or other medicine, can also be located on flexible patch 12. In this exemplary embodiment, fluid pump 22 includes a removable fluid reservoir 36. Reservoir 36 may be a disposable or refillable vial that is replaced by another vial when depleted; wherein when controller, sensors and delivery system are integrated into one patch, they are attached at only one position on the skin).
It would have been obvious to a person having ordinary skill in the art before the effective file date of the claimed invention to have modified the insulin infusion system as taught by Palerm and Rollins which is attached to the skin, and modify it to incorporate the controller, infusion and sensor systems into a flexible patch/integral device that is attached at a single location such as taught by Stafford, because it would gain the stated benefit of Stafford, namely that of increased comfort and adherence to the body ([[0003]-[0009]). By combining these elements, it can be considered taking the known detection module, program module, and infusion modules of Palerm and Rollins, and combining them into the flexible patch that gets attached at single location on skin as taught by Stafford in a known way that achieves predictable results.
Claim 1 is rejected in the alternative under 35 U.S.C. 103 as being unpatentable over Palerm et al. (US 20190015590, hereinafter Palerm) in view of Blevins et al. (US 6445963, hereinafter Blevins). As noted above, claim 1 is recited in such a way that only one of the cPID or cMPC algorithms is required by the claim. As the cPID algorithm is taught by Palerm in view of Rollins, the cMPC algorithm is being taught by Palerm in view of Blevins.
In regards to Claim 1, Palerm teaches “A closed-loop artificial pancreas insulin infusion control system, comprising:” ([0044] In the illustrated embodiment of FIG. 1, the infusion device 102 is designed as a portable medical device suitable for infusing a fluid, a liquid, a gel, or other agent into the body of a user. In exemplary embodiments, the infused fluid is insulin, [0049] In some embodiments, the sensing arrangement 104 and/or the infusion device 102 are cooperatively configured to utilize a closed-loop system for delivering fluid to the user) “a detection module, configured to detect a current blood glucose level G continuously;” ([0045] The sensing arrangement 104 generally represents the components of the infusion system 100 configured to sense, detect, measure or otherwise quantify a condition of the user, and may include a sensor, a monitor, or the like, for providing data indicative of the condition that is sensed, detected, measured or otherwise monitored by the sensing arrangement. In this regard, the sensing arrangement 104 may include electronics and enzymes reactive to a biological condition, such as a blood glucose level, or the like, of the user, and provide data indicative of the blood glucose level to the infusion device 102, the CCD 106 and/or the computer 108. [0049] the sensing arrangement 104 continues to sense or otherwise quantify a current condition of the user, thereby allowing the infusion device 102 to deliver fluid continuously in response to the condition currently (or most recently) sensed by the sensing arrangement 104 indefinitely) “program module, connected to the detection module, and configured to preset with a hybrid artificial pancreas algorithm, the and to calculate an insulin infusion amount required by an user” ([0043] Turning now to FIG. 1, one exemplary embodiment of an infusion system 100 includes, without limitation, a fluid infusion device (or infusion pump) 102, a sensing arrangement 104, a command control device (CCD) 106, and a computer 108; [0047] the CCD 106 and/or the computer 108 may include electronics and other components configured to perform processing, delivery routine storage, and to control the infusion device 102 in a manner that is influenced by sensor data measured by and/or received from the sensing arrangement 104. [0063] [0063] In the illustrated embodiment, the infusion device 502 includes a motor control module 512 coupled to a motor 507 (e.g., motor assembly 207) that is operable to displace a plunger 517 (e.g., plunger 217) in a reservoir (e.g., reservoir 205) and provide a desired amount of fluid to the body 501 of a user...The motor control module 512 is coupled to the motor driver module 514, and the motor control module 512 generates or otherwise provides command signals that operate the motor driver module 514 to provide current (or power) from the energy source 503 to the motor 507 to displace the plunger 517 in response to receiving, from a pump control system 520, a dosage command indicative of the desired amount of fluid to be delivered. In this regard, the pump control system 520 generally represents the electronics and other components that control operation of the fluid infusion device 502 according to a desired infusion delivery program in a manner that is influenced by sensor data pertaining to a condition of a user (e.g., the user's current glucose level) received from the sensing arrangement 504 and/or in a manner that is dictated by the user. To support closed-loop control, the pump control system 520 receives or otherwise obtains a desired value (e.g., a target or command blood glucose value) for the condition in the body 501 of the user. For example, the infusion device 502 may store or otherwise maintain the target value in a data storage element accessible to the pump control system 520. Alternatively, the target value may be received from an external component (e.g., CCD 106 and/or computer 108)) “the hybrid artificial pancreas algorithm comprises a cPID algorithm and/or a cMPC algorithm…” ([0123] if the current delivery mode is a PID closed-loop delivery mode, the command generation application 1114 continues generating delivery commands using the current glucose measurement value and/or the predicted blood glucose value. For example, if the current glucose measurement value is valid and usable, the command generation application 1114 may calculate or otherwise determine a difference between the current glucose measurement value and a target blood glucose reference value (or glucose setpoint) and apply proportional-integral-derivative (PID) control parameters to the difference to arrive at a delivery command configured to regulate the current glucose measurement value to the target blood glucose reference value, as described in greater detail below in the context of FIG. 22) “and an infusion module, connected to the program module, and configured to infuse insulin, controlled by the program module, according to the insulin infusion amount calculated by the hybrid artificial pancreas algorithm” ([0061] FIG. 5 depicts an exemplary embodiment of a control system 500 suitable for use with an infusion device 502, such as the infusion device 102 in FIG. 1 or the infusion device 200 of FIG. 2. The control system 500 is configured to control or otherwise regulate a condition in the body 501 of a user to a desired (or target) value or otherwise maintain the condition within a range of acceptable values. In one or more exemplary embodiments, the condition being regulated is sensed, detected, measured or otherwise quantified by a sensing arrangement 504 (e.g., sensing arrangement 104) communicatively coupled to the infusion device 502. [0063] In the illustrated embodiment, the infusion device 502 includes a motor control module 512 coupled to a motor 507 (e.g., motor assembly 207) that is operable to displace a plunger 517 (e.g., plunger 217) in a reservoir (e.g., reservoir 205) and provide a desired amount of fluid to the body 501 of a user).
Palerm fails to explicitly teach “the hybrid artificial pancreas algorithm comprises a cPID algorithm and/or a cMPC algorithm, where an input of the cPID algorithm is a intermediate value of a MPC algorithm, and an input of the cMPC algorithm is an output value of a PID algorithm”.
Blevins teaches “the hybrid artificial pancreas algorithm comprises a cPID algorithm and/or a cMPC algorithm, where an input of the cPID algorithm is a intermediate value of a MPC algorithm, and an input of the cMPC algorithm is an output value of a PID algorithm” (Fig. 5 and [col 12 line 6] The MPC function block 80 provides a control output to an AO function block 90 associated with a manipulated valve and provides a set point output to the cascade input (CAS_IN) of a PID function block 92 within a control loop 94. The AO function block 90 and the PID function block 92 provide back calibration outputs to the back calibration inputs of the MPC function block 80).
It would have been obvious to a person having ordinary skill in the art before the effective file date of the claimed invention to have modified the system for closed-loop insulin infusion which uses a PID loop for controlling the amount of insulin delivered by an infusion device, and improving it with the use of a PID loop that outputs a value for a MPC controller so that the MPC controller can be provided a back calibration because it can be considered the simple substitution a portion of a control algorithm with another. Furthermore, the claim recites “the hybrid artificial pancreas algorithm comprises a cPID and/or cMPC algorithm” thus requiring only one of the cPID or cMPC algorithms, as both are not required. By combining these elements, it can be considered taking the known use of a closed-loop control system that uses a PID loop, and improve it by replacing the PID loop with a MPC using a model predictive controller that takes as an input an output from a PID for back calibration as this can be a simple substitution one form of control algorithm with another.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
CA 3210305 – teaches a risk assessment for glycemic risk for controlling an insulin delivery rate
US 10617822 – teaches an MPC based insulin control loop that weights actions on the basis of increasing or decreasing glucose readings
US 10332633 – teaches a risk-based factor that is added to a MPC control loop for insulin infusion
US 20160038673 – teaches an insulin injection system that uses a MPC control scheme
US 20140180240 – teaches an MPC based insulin control in which either a target value or target range is utilized as a control target
“Closed-Loop Control and Advisory Mode Evaluation of an Artificial Pancreatic β Cell: Use of Proportional–Integral–Derivative Equivalent Model-Based Controllers” – teaches how a MPC and PID control loop can be formulated with similar response
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/JONATHAN MICHAEL SKRZYCKI/Examiner, Art Unit 2116
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