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 .
Specification
The abstract of the disclosure is objected to because it is over 150 words in length. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Applicant is reminded of the proper content of an abstract of the disclosure.
A patent abstract is a concise statement of the technical disclosure of the patent and should include that which is new in the art to which the invention pertains. The abstract should not refer to purported merits or speculative applications of the invention and should not compare the invention with the prior art.
If the patent is of a basic nature, the entire technical disclosure may be new in the art, and the abstract should be directed to the entire disclosure. If the patent is in the nature of an improvement in an old apparatus, process, product, or composition, the abstract should include the technical disclosure of the improvement. The abstract should also mention by way of example any preferred modifications or alternatives.
Where applicable, the abstract should include the following: (1) if a machine or apparatus, its organization and operation; (2) if an article, its method of making; (3) if a chemical compound, its identity and use; (4) if a mixture, its ingredients; (5) if a process, the steps.
Extensive mechanical and design details of an apparatus should not be included in the abstract. The abstract should be in narrative form and generally limited to a single paragraph within the range of 50 to 150 words in length.
See MPEP § 608.01(b) for guidelines for the preparation of patent abstracts.
Claim Objections
Claims 8, 15, 22, and 24 are objected to because of the following informalities:
Regarding claim 8, the phrase “insulin information“ once in lines 4-5 and second in line 5 should read “insulin infusion information” for consistency,
Regarding claim 15, the phrase “also perform calculation” in lines 3-4 should read “also performs calculation” for proper grammar.
Regarding claim 22, the phrase “after the detection module, the detection module, or the electronic module” in lines 3-4 should read “after the detection module, the infusion module, or the electronic module”.
Regarding claim 24, the phrase “the insulin information” in line 6 should read “the insulin infusion information” for consistency.
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:
“a detection module” in claims 1, 18, and 25
“an infusion module” in claims 1, 18, and 25
“an electronic module” in claims 9, 18, and 25
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.
Regarding “a detection module”, “infusion module”, and “electronic module”, 112(f) is invoked because: (i) it uses a generic placeholder (module), (ii) it is coupled with functional language (detection, infusion, electronic), and (iii) it is not associated with structure in the claim. The specification is referenced for the corresponding structure. Para. 0070 discloses the detection module (100) is a continuous glucose monitor for detecting real-time BG. Para. 0298 discloses the infusion module (102) may be a conventional insulin pump or tubeless patch insulin pump from Medtrum. Para. 0271 discloses the electronic module (103) is an external electronic device such as a mobile phone, or a handset. Examiner is interpreting the limitations as these structures and equivalents thereof.
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 1-24 and 28-33 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 1, the phrase “and/or further processing different insulin infusion information” in line 12 renders the claim indefinite because it is unclear. Para. 0311-0312 discuss the embodiment of the system in Fig. 10, where using the detection module (100) as an example, para. 0311 – “ calculation control unit 1 may… at the same time, it also can receive information from the external device and perform further processing of the information, such as receiving insulin infusion information I₂ sent by the infusion module 102 and performing further processing for I₁ and I₂ … In addition, since the history information of the user is also stored in the detection module 100, the calculation control unit 1 can also further process the insulin infusion information I₁ calculated by the detection module 100 and the history information I4, or receive the insulin infusion information I₂ sent by the infusion module 102 and further process the insulin infusion information I₂ and the history information I4.” Thus, from the specification it appears that the “further processing” is performed on “different insulin infusion information I2” which would be the insulin infusion information calculated by the insulin module or further processing the insulin infusion information I1 with the history information. Thus, the only “different insulin infusion information” would be I2 which would require that both the infusion module and detection module have their calculation units and preset algorithms. Claim 1 supports an unclear scenario where only one of the modules has a calculation control unit that has the preset algorithm that may perform furthering processing on different insulin infusion information, but different insulin infusion information cannot be provided if I2 is not calculated. Examiner suggests amending the state “and/or further processing the insulin infusion information” to remove the term “different”.
Regarding claim 10, the phrase “one of the detection module, the infusion module, or the electronic module determines the insulin infusion information” in lines 3-4 renders the claim indefinite for the above discussed reasons. Claim 10, dependent upon claim 9, discloses that the third calculation control unit may perform further processing of different insulin infusion information which as discussed above is understood to be I1 or I2. Thus, claim 10 becomes unclear if I1 or I2 must be calculated to be able to process different insulin infusion information but only one of the modules calculates the insulin infusion information. Examiner suggests amending claim 9 to state “and/or further processing the insulin infusion information” to remove the term “different”.
Regarding claim 18, the phrase “and/or further processing different insulin infusion information” in line 13 renders the claim indefinite for the above discussed reasons. Claim 18 states in lines 10-11 that “at least one of the infusion module, the detection module, and the electronic module is provided with a calculation control unit”. Claim 18 supports a scenario where only one of the modules comprises a calculation control unit which would create confusion for further processing different insulin infusion information. The examiner suggests either (1) amending to state “at least two” or (2) amending to state “and/or further processing insulin infusion” to remove the term “different”. Regarding claim 20, the phrase “one of the infusion module, the detection module, and the electronic module determines the insulin infusion information” in lines 3-4 renders the claim indefinite for the above discussed reasons as it is unclear how the different insulin infusion information can be processed if only one module is calculating the insulin infusion information. Examiner suggests amending claim 18 as discussed above.
Regarding claim 20, the phrase “a determination method of the insulin infusion information is an independent determination method or a jointly determination method” in lines 4-5 renders the claim indefinite because it is unclear. It is unclear because the claim lacks a linking of the modules determining the insulin infusion information and said determination method. Examiner suggests amending to state “the infusion module, the detection module, or the electronic module is configured to execute the a determination method of the insulin infusion information, wherein the determination method is an independent determination method or a jointly determination method.”
Regarding claim 28, the phrase “the infusion processor executes a conversion method of blood glucose risk space of the rMPC algorithm and the rPID algorithm includes” in lines 4-5 renders the claim indefinite because it is unclear. Claim 28 is dependent upon claim 27 which states “the preset algorithm is one of..” and thus discloses that the algorithm is one of the given algorithm options. Claim 28 becomes unclear as the infusion processor is executing a method on two of the given algorithm options. Examiner is interpreting this claim as the infusion processor executes a conversion method of blood glucose risk space of the rMPC algorithm or the rPID algorithm, wherein the method includes one or more of…
Regarding claim 29, the phrase “of the rMPC algorithm and the rPID algorithm” in lines 5-6 render the claim indefinite because it is unclear for the above discussed reasons regarding claim 28.
Claim 29 recites the limitation "the predicted plasma insulin concentration" in lines 7-8. There is insufficient antecedent basis for this limitation in the claim.
Claim 29 recites the limitation "the amount of insulin” in line 9. There is insufficient antecedent basis for this limitation in the claim.
Claim 29 recites the limitation "the autoregressive method" in line 10. There is insufficient antecedent basis for this limitation in the claim.
Claim 29 recites the limitation "the detecting delay" in line 10. There is insufficient antecedent basis for this limitation in the claim.
Claim 30 recites the limitation "the first insulin infusion amount I1 " in lines 4-5. There is insufficient antecedent basis for this limitation in the claim.
Claim 30 recites the limitation "the second insulin infusion amount I2 " in lines 4-5. There is insufficient antecedent basis for this limitation in the claim.
Regarding claims 2-9, 11-17, 19, 21-24, and 31-33, these claims are rejected due to being dependent upon a rejected base claim.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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, 3-5, 7, 9-12, 18, 20-21, 25, and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Yang (C.N Patent Pub. No. 108261591 A) in view of Lee et al. (U.S Patent Pub. No. 20210244881 A1, “Lee”) in view of Metzmaker et al. (U.S Patent Pub. No. 20210259590 A1, “Metzmaker”).
Regarding claim 1, Yang discloses the limitations (Claim 1) a closed-loop artificial pancreas insulin infusion control system (see Fig. 2 and para. 01-03) comprising,
a detection module (1 in Fig. 2, examiner notes the detection module is interpreted under 112(f) as a continuous glucose monitor or equivalents thereof, see para. 023 and 045); and
an infusion module (2 in Fig. 2), provided with an infusion control unit (202 in Fig. 2, examiner notes the infusion module is being interpreted under 112(f) as an insulin pump or equivalents thereof, see para. 045), used to control the infusion module (2) to infuse currently needed insulin into a user's body (see para. 045); wherein
the infusion module (2) is provided with a first calculation control unit and/or the detection module (1) is provided with a second calculation control unit (see para. 044-046 – the system may comprise a controller that implements the algorithm of Fig. 4 for calculating an insulin infusion amount, said controller and algorithm can be a processor in the glucose sensor 1 or the insulin pump 2 such that either the detection module or infusion module may comprise a calculation control unit), the first calculation control unit and/or the second calculation control unit are preset with algorithms for calculating insulin infusion information based on the blood glucose value detected by the detection module (1) through the preset algorithms (see Fig. 4 and para. 048).
While Yang discloses that either the detection module (1) or the infusion module (2) or a separate electronic device (3 in Fig. 2) may comprise the calculation control unit with the preset algorithm (see Fig. 4 and para. 046 and 048), Yang fails to explicitly that both module each comprises their own calculation control unit and (Claim 1) the detection module provided with a detection control unit, used to control the detection module to detect blood glucose and communicate with external devices, the infusion module provided with the infusion control unit used to communicate with the external devices.
Lee discloses a similar closed loop artificial pancreas system (200 in Fig. 2) comprising an infusion module (202 in Fig.2), a detection module (204 in Fig. 2), and an electronic module (206 in Fig. 2), wherein each module comprises its own processor or controller (221, 241, 261, respectively), and its own calculation unit in the form of the AP App (229, 249, 269, respectively, see para. 0022 and 0031 and 0061). Lee teaches (Claim 1) the detection module (204) provided with a detection control unit (241, see para. 0048), used to control the detection module (204) to detect blood glucose (see para. 0042 and 0048).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the infusion module and detection module of Yang to each comprise a control unit and a calculation unit comprising the preset algorithm and that the detection module explicitly is controlled by the detection control unit to detect glucose as taught by Lee. Lee provides a system with increased redundancy such that any of the modules is capable of receiving the glucose measurements and calculating the insulin amount which provides a more reliable system (see para. 0061).
Metzmaker discloses a similar, closed loop artificial pancreas system (400 in Fig. 4, see para. 0044 and 0074), wherein the system (400) comprises an infusion module (402 in Fig. 4), a detection module (404 in Fig. 4), and an electronic module (406 in Fig. 4, see para. 0045), wherein Metzmaker teaches (Claim 1) the detection module (404) provided with a detection control unit (441 in Fig. 4) used to communicate with external devices (407, 411 in Fig. 4, see para. 0054, 0058 and 0066), and the infusion module (402) is provided with an infusion control unit (421 in Fig. 4) used to communicate with the external devices (407, 411 in Fig. 4, see para. 0051, 0054, and 0066).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of modified Yang to further comprise external devices in communication with the detection module and infusion module as taught by Metzmaker. Metzmaker teaches that the system further comprises a smart accessory device (407) such as a wearable smart device providing global positioning information for the system (see para. 0054), and cloud-based services (411) utilizing servers and data storage for user-specific information from multiple users which are used as parameters in the algorithm models (see para. 0066). Thus, Metzmaker provides communication to additional external devices which increases the capabilities of the system.
Regarding claim 3, modified Yang discloses the system of claim 1, as discussed above. In modified Yang, Yang discloses (Claim 3) wherein the insulin infusion information is determined by the detection module (1) or the infusion module (2, see para. 044-046 – the system may comprise a controller that implements the algorithm of Fig. 4 for calculating an insulin infusion amount in the glucose sensor 1 or the insulin pump 2 such that either the detection module or infusion module may determine the insulin infusion information).
Regarding claim 4, modified Yang discloses the system of claim 3, as discussed above. In modified Yang, Yang discloses (Claim 4) wherein at least one of the detection module (1) and the infusion module (2) is configured to execute a determination method of the insulin infusion information, wherein the determination method is an independent determination method or a jointly determination method (see para. 046 and 048 – the processor on either the detection module 1 or the infusion module 2 comprises the algorithm in Fig. 4 interpreted as the determination method which is executed independently on a single module).
Regarding claim 5, modified Yang discloses the system of claim 4, as discussed above. In modified Yang, Yang discloses (Claim 5) wherein the detection module (1) or the infusion module (2) is configured to execute the independent determination method to calculate a current insulin infusion information based on the blood glucose value provided by the detection module (2) through the preset algorithms, respectively (see para. 046 and 048).
Regarding claim 7, modified Yang discloses the system of claim 4, as discussed above. In modified Yang, Yang discloses the determination method to perform calculation of the insulin infusion information (see para. 048) and further processing to determine the insulin infusion information (see para. 048 – the algorithm of Yang comprises an autoregressive model which performs the calculation of the insulin infusion information, the algorithm further comprises a PID controller which further processes the insulin infusion information the provide an optimized insulin infusion amount).
In modified Yang, Lee discloses that both the detection module (204) and the infusion module (202) are configured to execute the jointly determination method to perform calculation of the insulin infusion information (see para. 0061 – both the detection module 204 and the infusion module 202 execute the algorithm for determining the insulin dose and thus perform a jointly determination method).
Regarding claim 9, modified Yang discloses the system of claim 1, as discussed above. In modified Yang, Yang discloses (Claim 9) further comprising an electronic module (3 in Fig. 2, examiner notes the electronic module is being interpreted under 112(f) as an external electronic device such as a mobile phone, handset, or equivalents thereof, see para. 045), provided with a third calculation control unit (302 in Fig. 2) which is preset with the algorithm for calculating the insulin infusion information based on the blood glucose value detected by the detection module (1) through the preset algorithm and/or further processing different insulin infusion information (see para. 045 and 048).
Regarding claim 10, modified Yang discloses the system of claim 9, as discussed above. In modified Yang, Yang discloses (Claim 10) wherein one of the detection module (1), the infusion module (2) or the electronic module (3) determines the insulin infusion information (see para. 045-046).
Regarding claim 11, modified Yang discloses the system of claim 10, as discussed above. In modified Yang, Yang discloses (Claim 11) wherein at least one of the detection module (1), the infusion module (2) and the electronic module (3) is configured to execute a determination method of the insulin infusion information (see para. 045-046), wherein the determination method is an independent determination method or a jointly determination method (see para. 044-046 – the processor on either the detection module 1, the infusion module 2, or the handset 3 comprises the algorithm in Fig. 4 interpreted as the determination method which is executed independently on a single module).
Regarding claim 12, modified Yang discloses the system of claim 11, as discussed above. In modified Yang, Yang discloses (Claim 12) wherein the detection module (1), the infusion module (2) or the electronic module (3) is configured to execute the independent determination method to calculate a current insulin infusion information based on the blood glucose value provided by the detection module through the preset algorithms, respectively (see para. 045-046 and 048).
Regarding claim 18, Yang discloses the limitations (Claim 18) a closed-loop artificial pancreas insulin infusion control system (see Fig. 2 and para. 01-03) comprising,
a detection module (1 in Fig. 2, examiner notes the detection module is interpreted under 112(f) as a continuous glucose monitor or equivalents thereof, see para. 023 and 045); and
an infusion module (2 in Fig. 2), provided with an infusion control unit (202 in Fig. 2, examiner notes the infusion module is being interpreted under 112(f) as an insulin pump or equivalents thereof, see para. 045), used to control the infusion module (2) to infuse currently needed insulin into a user's body (see para. 045); and
an electronic module (3 in Fig. 2, examiner notes the electronic module is being interpreted under 112(f) as an external electronic device such as a mobile phone, handset, or equivalents thereof, see para. 045), communicating with the detection module (1) and the infusion module (2, see para. 045); wherein
at least one of the infusion module (2), the detection module (1), and the electronic module (3) is provided with a calculation control unit (see para. 044-046 – the system may comprise a controller that implements the algorithm of Fig. 4 for calculating an insulin infusion amount, said controller and algorithm can be a processor in the glucose sensor 1, the insulin pump 2, or handset 3), which is preset with an algorithm for calculating insulin infusion information based on the blood glucose value detected by the detection module (1) through the preset algorithms (see Fig. 4 and para. 048).
Yang fails to explicitly that each module comprises their own calculation control unit and (Claim 18) the detection module provided with a detection control unit, used to control the detection module to detect blood glucose and communicate with external devices, the infusion module provided with the infusion control unit used to communicate with the external devices.
Lee discloses a similar closed loop artificial pancreas system (200 in Fig. 2) comprising an infusion module (202 in Fig.2), a detection module (204 in Fig. 2), and an electronic module (206 in Fig. 2), wherein each module comprises its own processor or controller (221, 241, 261, respectively), and its own calculation unit in the form of the AP App (229, 249, 269, respectively, see para. 0022 and 0031 and 0061). Lee teaches (Claim 18) the detection module (204) provided with a detection control unit (241, see para. 0048), used to control the detection module (204) to detect blood glucose (see para. 0042 and 0048).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the infusion module, the detection module, and the electronic module of Yang to each comprise a control unit and a calculation unit comprising the preset algorithm and that the detection module explicitly is controlled by the detection control unit to detect glucose as taught by Lee. Lee provides a system with increased redundancy such that any of the modules is capable of receiving the glucose measurements and calculating the insulin amount which provides a more reliable system (see para. 0061).
Metzmaker discloses a similar, closed loop artificial pancreas system (400 in Fig. 4, see para. 0044 and 0074), wherein the system (400) comprises an infusion module (402 in Fig. 4), a detection module (404 in Fig. 4), and an electronic module (406 in Fig. 4, see para. 0045), wherein Metzmaker teaches (Claim 18) the detection module (404) provided with a detection control unit (441 in Fig. 4) used to communicate with external devices (407, 411 in Fig. 4, see para. 0054, 0058 and 0066), and the infusion module (402) is provided with an infusion control unit (421 in Fig. 4) used to communicate with the external devices (407, 411 in Fig. 4, see para. 0051, 0054, and 0066).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of modified Yang to further comprise external devices in communication with the detection module and infusion module as taught by Metzmaker. Metzmaker teaches that the system further comprises a smart accessory device (407) such as a wearable smart device providing global positioning information for the system (see para. 0054), and cloud-based services (411) utilizing servers and data storage for user-specific information from multiple users which are used as parameters in the algorithm models (see para. 0066). Thus, Metzmaker provides communication to additional external devices which increases the capabilities of the system.
Regarding claim 20, modified Yang discloses the system of claim 18, as discussed above. In modified Yang, Yang discloses (Claim 20) wherein one of the infusion module (2), the detection module (1) and the electronic module (3) determines the insulin infusion information (see para. 045-046), a determination method of the insulin infusion information is an independent determination method or a jointly determination method (see para. 044-046 – the processor on either the detection module 1, the infusion module 2, or the handset 3 comprises the algorithm in Fig. 4 interpreted as the determination method which is executed independently on a single module).
Regarding claim 21, modified Yang discloses the system of claim 20, as discussed above. In modified Yang, Yang discloses (Claim 21), wherein the detection module (1), the infusion module (2) or the electronic module (3) is configured to execute the independent determination method to calculate a current insulin infusion information based on the blood glucose value provided by the detection module (1) through the preset algorithms, respectively (see para. 045-046 and 048).
Regarding claim 25, Yang discloses the limitations (Claim 25) a closed-loop artificial pancreas insulin infusion control system (see Fig. 2 and para. 01-03) comprising,
a detection module (1 in Fig. 2, examiner notes the detection module is interpreted under 112(f) as a continuous glucose monitor or equivalents thereof, see para. 023 and 045); and
an infusion module (2 in Fig. 2), provided with an infusion control unit (202 in Fig. 2, examiner notes the infusion module is being interpreted under 112(f) as an insulin pump or equivalents thereof, see para. 045), used to control the infusion module (2) to infuse currently needed insulin into a user's body (see para. 045); and
an electronic module (3 in Fig. 2, examiner notes the electronic module is being interpreted under 112(f) as an external electronic device such as a mobile phone, handset, or equivalents thereof, see para. 045), communicating with the detection module (1) and the infusion module (2, see para. 045); wherein
at least one of the infusion module (2), the detection module (1), and the electronic module (3) is provided with a calculation control unit (see para. 044-046 – the system may comprise a controller that implements the algorithm of Fig. 4 for calculating an insulin infusion amount, said controller and algorithm can be a processor in the glucose sensor 1, the insulin pump 2, or handset 3), which is preset with an algorithm for calculating insulin infusion information based on the blood glucose value detected by the detection module (1) through the preset algorithms (see Fig. 4 and para. 048).
Yang fails to explicitly discloses the detection module provided with a detection control unit, used to control the detection module to detect blood glucose and communicate with external devices, the infusion module provided with the infusion control unit used to communicate with the external devices, that at least two of the modules comprises their own calculation control unit, and the module that determines the insulin infusion information is one of the modules provided with the calculation control unit, and can be switched according to different conditions.
Lee discloses a similar closed loop artificial pancreas system (200 in Fig. 2) comprising an infusion module (202 in Fig.2), a detection module (204 in Fig. 2), and an electronic module (206 in Fig. 2), wherein each module comprises its own processor or controller (221, 241, 261, respectively), and its own calculation unit in the form of the AP App (229, 249, 269, respectively, see para. 0022 and 0031 and 0061). Lee teaches (Claim 25) the detection module (204) provided with a detection control unit (241, see para. 0048), used to control the detection module (204) to detect blood glucose (see para. 0042 and 0048), and wherein the infusion module (202) may be the module that determines the insulin infusion information and is provided with the calculated control unit and can be switched into different operational modes according to different conditions (see para. 0058 and 0061 – infusion module 202 may be set to different operation modes such as activity mode, hyperglycemia protect mode, hypoglycemia protect mode, deliver an insulin bolus, or the like).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the infusion module, the detection module, and the electronic module of Yang to each comprise a control unit and a calculation unit comprising the preset algorithm, the detection module explicitly is controlled by the detection control unit to detect glucose, and the infusion module can be switched into different modes as taught by Lee. Lee provides a system with increased redundancy such that any of the modules is capable of receiving the glucose measurements and calculating the insulin amount which provides a more reliable system (see para. 0061), and Lee provides that the operational modes of the infusion module allow the algorithms to be tailored towards the patient’s specific condition such as using age-base general target BG values related to activity levels or particular exercises which may be useful when in activity mode (see para. 0062).
Metzmaker discloses a similar, closed loop artificial pancreas system (400 in Fig. 4, see para. 0044 and 0074), wherein the system (400) comprises an infusion module (402 in Fig. 4), a detection module (404 in Fig. 4), and an electronic module (406 in Fig. 4, see para. 0045), wherein Metzmaker teaches (Claim 25) the detection module (404) provided with a detection control unit (441 in Fig. 4) used to communicate with external devices (407, 411 in Fig. 4, see para. 0054, 0058 and 0066), and the infusion module (402) is provided with an infusion control unit (421 in Fig. 4) used to communicate with the external devices (407, 411 in Fig. 4, see para. 0051, 0054, and 0066).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of modified Yang to further comprise external devices in communication with the detection module and infusion module as taught by Metzmaker. Metzmaker teaches that the system further comprises a smart accessory device (407) such as a wearable smart device providing global positioning information for the system (see para. 0054), and cloud-based services (411) utilizing servers and data storage for user-specific information from multiple users which are used as parameters in the algorithm models (see para. 0066). Thus, Metzmaker provides communication to additional external devices which increases the capabilities of the system.
Regarding claim 27, modified Yang discloses the system of claim 1, as discussed above. In modified Yang, Yang discloses (Claim 27) wherein the preset algorithm is one of a classic PID algorithm (see para. 048).
Claim(s) 2, 19, and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Yang in view of Lee in view of Meztmaker as applied to claims 1, 18, and 25, respectively, above, and further in view of Dassau et al. (U.S Patent Pub. 20220257857 A1, “Dassau”).
Regarding claim 2, modified Yang discloses the system of claim 1, as discussed above.
However, modified Yang fails to disclose (Claim 2) wherein at least one of the calculation control units is activated.
Dassau discloses a closed-loop, artificial pancreas system (see Fig. 9 and para. 0037 and 0041) comprising a detection module in the form of a continuous blood glucose system (130 and 140 in Fig. 9, see para. 0037), an infusion module in the form of an insulin infusion pump (110 in Fig. 9, see para. 0037), and an electronic module in the form of a mobile device (165 in Fig. 9, see para. 0038), wherein a control algorithm interpreted as the calculation control unit comprises processing steps for calculating an insulin amount instruction based on glucose data can be implemented on any one of the modules (see para. 0042). Dassua discloses (Claim 2) wherein at least one of the calculation control units is activated (see Fig. 10 and para. 0048-0049 – the control algorithm seen in Fig. 10 and implemented on at least one of the modules and interpreted as the calculation control unit is activated through the sensing of an event which triggers activation of the MPC algorithm).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the calculation control units of the modules taught by modified Yang to be activated upon the detection of a triggering event as taught by Dassau. Dassau provides that this event-triggered algorithm provides a system that significantly lowers the number of controller model updates and processor runtime, while respecting constraints arising from a clinical perspective (see para. 0052).
Regarding claim 19, modified Yang discloses the system of claim 18, as discussed above.
However, modified Yang fails to disclose (Claim 19) wherein at least one of the calculation control units is activated.
Dassau discloses a closed-loop, artificial pancreas system (see Fig. 9 and para. 0037 and 0041) comprising a detection module in the form of a continuous blood glucose system (130 and 140 in Fig. 9, see para. 0037), an infusion module in the form of an insulin infusion pump (110 in Fig. 9, see para. 0037), and an electronic module in the form of a mobile device (165 in Fig. 9, see para. 0038), wherein a control algorithm interpreted as the calculation control unit comprises processing steps for calculating an insulin amount instruction based on glucose data can be implemented on any one of the modules (see para. 0042). Dassua discloses (Claim 19) wherein at least one of the calculation control units is activated (see Fig. 10 and para. 0048-0049 – the control algorithm seen in Fig. 10 and implemented on at least one of the modules and interpreted as the calculation control unit is activated through the sensing of an event which triggers activation of the MPC algorithm).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the calculation control units of the modules taught by modified Yang to be activated upon the detection of a triggering event as taught by Dassau. Dassau provides that this event-triggered algorithm provides a system that significantly lowers the number of controller model updates and processor runtime, while respecting constraints arising from a clinical perspective (see para. 0052).
Regarding claim 26, modified Yang discloses the system of claim 25, as discussed above.
In modified Yang, Lee discloses wherein at least two of modules comprise the calculation control units that determines the insulin infusion information (see para. 0061).
However, modified Yang fails to disclose (Claim 26) wherein at least one of the calculation control units is activated.
Dassau discloses a closed-loop, artificial pancreas system (see Fig. 9 and para. 0037 and 0041) comprising a detection module in the form of a continuous blood glucose system (130 and 140 in Fig. 9, see para. 0037), an infusion module in the form of an insulin infusion pump (110 in Fig. 9, see para. 0037), and an electronic module in the form of a mobile device (165 in Fig. 9, see para. 0038), wherein a control algorithm interpreted as the calculation control unit comprises processing steps for calculating an insulin amount instruction based on glucose data can be implemented on any one of the modules (see para. 0042). Dassua discloses (Claim 26) wherein the calculation control units are activated (see Fig. 10 and para. 0048-0049 – the control algorithm seen in Fig. 10 and implemented on at least one of the modules and interpreted as the calculation control unit is activated through the sensing of an event which triggers activation of the MPC algorithm).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the calculation control units of the modules taught by modified Yang to be activated upon the detection of a triggering event as taught by Dassau such that the module that determines the insulin infusion information in modified Yang is one of the modules that the calculation control unit is activated as taught by Dassau. Dassau provides that this event-triggered algorithm provides a system that significantly lowers the number of controller model updates and processor runtime, while respecting constraints arising from a clinical perspective (see para. 0052).
Claim(s) 6, 8, 13, 17, 22, and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Yang in view of Lee in view of Metzmaker as applied to claims 4, 11, and 21, respectively, above, and further in view of Hayter et al. (W.O Patent Pub. No. 2022169856 A1, “Hayter”).
Regarding claim 6, modified Yang discloses the system of claim 4, as discussed above.
In modified Yang, Yang discloses (Claim 6) the detection module (1) or the infusion module (2) is configured to execute the independent determination method to calculate a current insulin infusion information based on the blood glucose value provided by the detection module (1) through the preset algorithms, respectively (see Fig. 4 and para. 045-046 and 048).
However, modified Yang fails to disclose that after said independent determination method is execute, further processing the insulin infusion information and history information.
Hayter discloses an insulin dose guidance system (100 in Fig. 1B) comprising a detection module in the form of a sensor control device (102 in Fig. 1B) that uses continuous analyte monitoring of a patient’s glucose (see para. 0064, 0072, 0075), an infusion module in the form of a medication delivery device (152 in Fig. 1B) such as an insulin pump in a closed-loop artificial pancreas system (see para. 0064 and 0091), and an electronic module (120 in Fig. 1B) in the form of a smartphone, handset, smart watch, etc..(see para. 0066), wherein a calculation for appropriate drug dosage based on the patient’s sensed analyte level can occur within the infusion module (152) or any other device of system (100) with the resulted determined dosage being communicated to the infusion module (152, see para. 0091). Hayter teaches that after one of the modules determines the insulin dosage and communicates it to the infusion module (152), the infusion module (152) performs further processing of the insulin infusion information and history information by broadcasting the record of said insulin dose once administered (see para. 00106).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of modified Yang to further processing the insulin infusion information and history information by having the infusion module broadcast the record of said insulin dose once administered to store as history information as taught by Hayter. Hayter teaches that further processing the insulin dose by broadcasted said dose after administration allows for dose logging functions (see para. 00106).
Regarding claim 8, modified Yang discloses the system of claim 4, as discussed above. In modified Yang, Yang teaches wherein one of the detection module (1) and the infusion module (2) is configured to execute the determination method to calculate the insulin infusion information (see para. 046 and 048).
However, modified Yang fails to disclose the (Claim 8) the jointly determination method where one module is configured to calculate the insulin infusion information and the other one further processes the insulin information and historical information after receiving the insulin information.
Hayter discloses an insulin dose guidance system (100 in Fig. 1B) comprising a detection module in the form of a sensor control device (102 in Fig. 1B) that uses continuous analyte monitoring of a patient’s glucose (see para. 0064, 0072, 0075), an infusion module in the form of a medication delivery device (152 in Fig. 1B) such as an insulin pump in a closed-loop artificial pancreas system (see para. 0064 and 0091), and an electronic module (120 in Fig. 1B) in the form of a smartphone, handset, smart watch, etc..(see para. 0066), wherein a calculation for appropriate drug dosage based on the patient’s sensed analyte level can occur within the infusion module (152) or any other device of system (100) with the resulted determined dosage being communicated to the infusion module (152, see para. 0091). Hayter teaches that after one of the modules determines the insulin dosage and communicates it to the infusion module (152), the infusion module (152) performs further processing of the insulin infusion information and history information by broadcasting the record of said insulin dose once administered (see para. 00106).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of modified Yang to perform the jointly determination method where the detection module calculates the insulin infusion information and the infusion modules performs further processing the insulin infusion information and history information by having the infusion module broadcast the record of said insulin dose once administered to store as history information as taught by Hayter. Hayter teaches that further processing the insulin dose by broadcasted said dose after administration allows for dose logging functions (see para. 00106).
Regarding claim 13, modified Yang discloses the system of claim 11, as discussed above.
In modified Yang, Yang discloses (Claim 13) the detection module (1), the infusion module (2), or the electronic module (3) is configured to execute the independent determination method to calculate a current insulin infusion information based on the blood glucose value provided by the detection module (1) through the preset algorithms, respectively (see Fig. 4 and para. 045-046 and 048).
However, modified Yang fails to disclose that after said independent determination method is executed, further processing the insulin infusion information and history information.
Hayter discloses an insulin dose guidance system (100 in Fig. 1B) comprising a detection module in the form of a sensor control device (102 in Fig. 1B) that uses continuous analyte monitoring of a patient’s glucose (see para. 0064, 0072, 0075), an infusion module in the form of a medication delivery device (152 in Fig. 1B) such as an insulin pump in a closed-loop artificial pancreas system (see para. 0064 and 0091), and an electronic module (120 in Fig. 1B) in the form of a smartphone, handset, smart watch, etc..(see para. 0066), wherein a calculation for appropriate drug dosage based on the patient’s sensed analyte level can occur within the infusion module (152) or any other device of system (100) with the resulted determined dosage being communicated to the infusion module (152, see para. 0091). Hayter teaches that after one of the modules determines the insulin dosage and communicates it to the infusion module (152), the infusion module (152) performs further processing of the insulin infusion information and history information by broadcasting the record of said insulin dose once administered (see para. 00106).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of modified Yang to further processing the insulin infusion information and history information by having the infusion module broadcast the record of said insulin dose once administered to store as history information as taught by Hayter. Hayter teaches that further processing the insulin dose by broadcasted said dose after administration allows for dose logging functions (see para. 00106).
Regarding claim 17, modified Yang discloses the system of claim 11, as discussed above. In modified Yang, Yang teaches wherein one of the detection module (1) ,the infusion module (2), and the electronic module (3) is configured to execute the determination method to perform calculation of the insulin infusion information based on the blood glucose value detected by the detection module (1) through the preset algorithm (see para. 046 and 048).
However, modified Yang fails to disclose the (Claim 17) the jointly determination method where one module is configured to calculate the insulin infusion information and the another module further processes the insulin information and historical information.
Hayter discloses an insulin dose guidance system (100 in Fig. 1B) comprising a detection module in the form of a sensor control device (102 in Fig. 1B) that uses continuous analyte monitoring of a patient’s glucose (see para. 0064, 0072, 0075), an infusion module in the form of a medication delivery device (152 in Fig. 1B) such as an insulin pump in a closed-loop artificial pancreas system (see para. 0064 and 0091), and an electronic module (120 in Fig. 1B) in the form of a smartphone, handset, smart watch, etc..(see para. 0066), wherein a calculation for appropriate drug dosage based on the patient’s sensed analyte level can occur within the infusion module (152) or any other device of system (100) with the resulted determined dosage being communicated to the infusion module (152, see para. 0091). Hayter teaches that after one of the modules determines the insulin dosage and communicates it to the infusion module (152), the infusion module (152) performs further processing of the insulin infusion information and history information by broadcasting the record of said insulin dose once administered (see para. 00106).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of modified Yang to perform the jointly determination method where the detection module or electronic module calculates the insulin infusion information and the infusion module performs further processing the insulin infusion information and history information by having the infusion module broadcast the record of said insulin dose once administered to store as history information as taught by Hayter. Hayter teaches that further processing the insulin dose by broadcasted said dose after administration allows for dose logging functions (see para. 00106).
Regarding claim 22, modified Yang discloses the system of claim 21, as discussed above. In modified Yang, Yang teaches wherein one of the detection module (1), the infusion module (2), and the electronic module (3) is configured to execute the independent determination method to calculate the insulin infusion information based on the blood glucose value provided by the detection module (1) through the preset algorithms, respectively (see para. 046 and 048).
However, modified Yang fails to disclose the (Claim 22) further processing the insulin information and historical information after receiving the insulin information.
Hayter discloses an insulin dose guidance system (100 in Fig. 1B) comprising a detection module in the form of a sensor control device (102 in Fig. 1B) that uses continuous analyte monitoring of a patient’s glucose (see para. 0064, 0072, 0075), an infusion module in the form of a medication delivery device (152 in Fig. 1B) such as an insulin pump in a closed-loop artificial pancreas system (see para. 0064 and 0091), and an electronic module (120 in Fig. 1B) in the form of a smartphone, handset, smart watch, etc..(see para. 0066), wherein a calculation for appropriate drug dosage based on the patient’s sensed analyte level can occur within the infusion module (152) or any other device of system (100) with the resulted determined dosage being communicated to the infusion module (152, see para. 0091). Hayter teaches that after one of the modules determines the insulin dosage and communicates it to the infusion module (152), the infusion module (152) performs further processing of the insulin infusion information and history information by broadcasting the record of said insulin dose once administered (see para. 00106).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of modified Yang to perform the determination method where one of the modules calculates the insulin infusion information and the infusion module performs further processing the insulin infusion information and history information by having the infusion module broadcast the record of said insulin dose once administered to store as history information as taught by Hayter. Hayter teaches that further processing the insulin dose by broadcasted said dose after administration allows for dose logging functions (see para. 00106).
Regarding claim 24, modified Yang discloses the system of claim 21, as discussed above. In modified Yang, Yang teaches wherein one of the detection module (1) ,the infusion module (2), and the electronic module (3) is configured to execute the determination method to perform calculation of the insulin infusion information based on the blood glucose value detected by the detection module (1) through the preset algorithm (see para. 046 and 048).
However, modified Yang fails to disclose the (Claim 24) the jointly determination method where one module is configured to calculate the insulin infusion information and the another module further processes the insulin information and historical information.
Hayter discloses an insulin dose guidance system (100 in Fig. 1B) comprising a detection module in the form of a sensor control device (102 in Fig. 1B) that uses continuous analyte monitoring of a patient’s glucose (see para. 0064, 0072, 0075), an infusion module in the form of a medication delivery device (152 in Fig. 1B) such as an insulin pump in a closed-loop artificial pancreas system (see para. 0064 and 0091), and an electronic module (120 in Fig. 1B) in the form of a smartphone, handset, smart watch, etc..(see para. 0066), wherein a calculation for appropriate drug dosage based on the patient’s sensed analyte level can occur within the infusion module (152) or any other device of system (100) with the resulted determined dosage being communicated to the infusion module (152, see para. 0091). Hayter teaches that after one of the modules determines the insulin dosage and communicates it to the infusion module (152), the infusion module (152) performs further processing of the insulin infusion information and history information by broadcasting the record of said insulin dose once administered (see para. 00106).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of modified Yang to perform the jointly determination method where the detection module or electronic module calculates the insulin infusion information and the infusion module performs further processing the insulin infusion information and history information by having the infusion module broadcast the record of said insulin dose once administered to store as history information as taught by Hayter. Hayter teaches that further processing the insulin dose by broadcasted said dose after administration allows for dose logging functions (see para. 00106).
Claim(s) 14-15 and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Yang in view of Lee in view of Metzmaker as applied to claims 11 and 21, respectively, above, and further in view of Hayter et al. (U.S Patent Pub. No. 20210402093 A1, “Hayter 2”).
Regarding claim 14, modified Yang discloses the system of claim 11, as discussed above.
In modified Yang, Yang discloses that one of the modules (1, 2, 3) executes the determination method to calculate the infusion information by first using an autoregressive model to calculate the insulin infusion information then uses a PID controller which further processing the insulin infusion information to provide an optimized insulin infusion amount (see para. 048).
While Lee in modified Yang discloses that each of the detection module, infusion module, and electronic module can perform the determination method to calculate the insulin infusion information, modified Yang fails to disclose (Claim 14) wherein at least two modules of the electronic module, the detection module and the infusion module are configured to execute the jointly determination method to simultaneously calculate the insulin infusion information based on the blood glucose value provided by the detection module through their respective preset algorithms, respectively, and the module that ultimately determines the insulin infusion information performs further processing.
Hayter 2 discloses an artificial pancreas system (see Fig. 1) comprising a detection module in the form of a continuous glucose sensor (102 in Fig. 1, see para. 0002 and 0015), an infusion module in the form of an insulin pump (103 in Fig. 1, see para. 0015), and an electronic module in the form of a smartphone (120 in Fig. 1, see para. 0021), wherein the system executes a closed-loop algorithm to calculate insulin infusion information for the infusion module (103) based on glucose levels from the detection module (102, see para. 0015). Hayter 2 teaches that the closed-loop algorithm can be redundantly stored on each of the modules (102, 103, 120) so that the insulin infusion information can be redundantly and independently transmitted to the infusion module (103, see para. 0015 and 0025), therefore Hayter 2 teaches (Claim 14) wherein at least two modules of the electronic module (120), the detection module (102) and the infusion module (103) are configured to execute the jointly determination method to simultaneously calculate the insulin infusion information based on the blood glucose value provided by the detection module (102) through their respective preset algorithms, respectively (see para. 0025).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of modified Yang such that each of modules calculating the insulin infusion information calculates said information simultaneously as taught by Hayter 2 to ensure that even if a communication path between two of the modules is interrupted, another communication path is available for transmitting the insulin infusion information (see para. 0024). Thus, in combination, each of the modules comprising the calculation control units as taught by Lee would simultaneously perform the determination method with said algorithm of Yang as taught by Hayter 2 such that the module that determines the insulin infusion information from the autoregressive model of Yang would also perform the further processing with the PID controller of Yang.
Regarding claim 15, modified Yang discloses the system of claim 14, as discussed above.
In modified Yang, Yang discloses (Claim 15) wherein the module that ultimately determines the insulin infusion information itself also perform calculation of the insulin infusion information through the preset algorithm based on the blood glucose value provided by the detection module (1, see para. 046 and 048).
Regarding claim 23, modified Yang discloses the system of claim 21, as discussed above.
In modified Yang, Yang discloses that one of the modules (1, 2, 3) executes the determination method to calculate the infusion information by first using an autoregressive model to calculate the insulin infusion information then uses a PID controller which further processing the insulin infusion information to provide an optimized insulin infusion amount (see para. 048).
While Lee in modified Yang discloses that each of the detection module, infusion module, and electronic module can perform the determination method to calculate the insulin infusion information, modified Yang fails to disclose (Claim 23) wherein at least two modules of the electronic module, the detection module and the infusion module are configured to execute the jointly determination method to simultaneously calculate the insulin infusion information based on the blood glucose value provided by the detection module through their respective preset algorithms, respectively, and the module that ultimately determines the insulin infusion information performs further processing.
Hayter 2 discloses an artificial pancreas system (see Fig. 1) comprising a detection module in the form of a continuous glucose sensor (102 in Fig. 1, see para. 0002 and 0015), an infusion module in the form of an insulin pump (103 in Fig. 1, see para. 0015), and an electronic module in the form of a smartphone (120 in Fig. 1, see para. 0021), wherein the system executes a closed-loop algorithm to calculate insulin infusion information for the infusion module (103) based on glucose levels from the detection module (102, see para. 0015). Hayter 2 teaches that the closed-loop algorithm can be redundantly stored on each of the modules (102, 103, 120) so that the insulin infusion information can be redundantly and independently transmitted to the infusion module (103, see para. 0015 and 0025), therefore Hayter 2 teaches (Claim 23) wherein at least two modules of the electronic module (120), the detection module (102) and the infusion module (103) are configured to execute the jointly determination method to simultaneously calculate the insulin infusion information based on the blood glucose value provided by the detection module (102) through their respective preset algorithms, respectively (see para. 0025).
Therefore, it would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the system of modified Yang such that each of modules calculating the insulin infusion information calculates said information simultaneously as taught by Hayter 2 to ensure that even if a communication path between two of the modules is interrupted, another communication path is available for transmitting the insulin infusion information (see para. 0024). Thus, in combination, each of the modules comprising the calculation control units as taught by Lee would simultaneously perform the determination method with said algorithm of Yang as taught by Hayter 2 such that the module that determines the insulin infusion information from the autoregressive model of Yang would also perform the further processing with the PID controller of Yang.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Breton et al. (U.S Patent Pub. No. 20220203029) – teaches a modified MPC algorithm (“MS-MPC”) for use in a closed-loop artificial pancreas system during exercise.
Finan et al. (U.S Patent Pub. No. 20140276554) – teaches a modified MPC algorithm (“zone MPC”) for use in a closed-loop artificial pancreas system aiming to keep the glucose values in a predefined zone.
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/KAYLA M. TURKOWSKI/Examiner, Art Unit 3783
/COURTNEY FREDRICKSON/Primary Examiner, Art Unit 3783
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