DETAILED ACTION
Applicant’s response, filed 02 Feb. 2026, has been fully considered. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of Claims
Claims 1-34 are pending.
Claims 1-34 are rejected.
Priority
Applicant’s claim for the benefit of a prior-filed application, U.S. Non-Provisional App. No. 13/380,839 filed 10 Feb. 2012 and U.S. Provisional App. No. 61/220,839 filed 26 June 2009 under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged.
Accordingly, the effective filing date of the claimed invention is 26 June 2009.
Drawings
The drawings filed 01 Feb. 2022 are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the following reference sign(s) mentioned in the description: #524 with reference to FIG. 5.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). 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. The objection to the drawings will not be held in abeyance.
Response to Arguments
Applicant's arguments filed 02 Feb. 2026 regarding the drawing objections have been fully considered but they are not persuasive.
Applicant remarks the specification has been amended and the objection should be withdrawn (Applicant’s remarks at pg. 18, para. 3).
This argument is not persuasive because while the amendment to the specification amended one instance of “communications interface 524” to recite “communications interface 534”, the same paragraph later recites “communications interface 524” throughout the paragraph. The specification should be amended to replace “524” with “534”.
Specification
The amendments to the specification filed 02 Feb. 2026 have been entered.
Reference to Applicant’s specification throughout the application is made with reference to the U.S. pre-grant publication, US 2022/0230762 A1.
Claim Objections
The objection to claims 1, 4-6, 8, 12, 16-18, 20, 24, 28-30, and 32 in the Office action mailed 06 Aug. 2025 has been withdrawn in view of claim amendments received 02 Feb. 2026.
Claim Interpretation
Regarding claims 3-9, 14-20, and 26-32, Applicant’s specification at para. [0037]-[0045] defines the variables recited in the various equations. Therefore, the variables will be interpreted accordingly (e.g. Gp and Gt are glucose in plasma and glucose in rapidly-equilibrating tissues, respectively, Uii and Uid are insulin-independent and dependent glucose utilizations, respectively, k1 and k--2 are rate parameters, etc.).
Claim Interpretation-35 USC § 112(f)
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 limitations are:
one or more electronic code modules that respectively model one or more items corresponding to dynamic glucose concentration… in claims 12 and 24;
electronic code module that respectively models at least one item corresponding to dynamic insulin… in claims 12 and 24;
Specifically, the claims recite the generic placeholder “module”, modified by functional language “that respectively model(s)…”, and is not modified by sufficient structure or acts to perform the recited function.
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.
In cases involving a special purpose computer-implemented means-plus-function limitation, the Federal Circuit has consistently required that the structure be more than simply a general purpose computer or microprocessor and that the specification must disclose an algorithm for performing the claimed function. See, e.g., Noah Systems Inc. v. Intuit Inc., 675 F.3d 1302, 1312, 102 USPQ2d 1410, 1417 (Fed. Cir. 2012); Aristocrat, 521 F.3d at 1333, 86 USPQ2d at 1239. See MPEP 2181.
The structures for the electronic modules in claims 12 and 24 are as follows:
Applicant’s specification at [0081], [0088], and FIG. 5 discloses a computer system including a processor for implementation of the present invention, and that the present invention may be implemented using one or more computer systems or processing systems. Applicant’s specification at para. [0087] discloses in an embodiment, the invention is implemented using software stored in a computer program product. Therefore, the structure for the electronic module is interpreted to be software stored in a memory or a computer configured to perform the function, or equivalents thereof. Since claim 24 is a computer-executable program product, the structure will be interpreted as software stored in memory, as also recited in the preamble of claim 24, or equivalents thereof.
Regarding the algorithm for “one or more electronic code modules that respectively model one or more items corresponding to dynamic glucose concentration”, Applicant’s specification at para. [0016] discloses the electronic code modules are one or more of: an electronic code module that models endogenous glucose production (EGP(t)), an electronic code module that models meal glucose rate of appearance (Ra(t)), an electronic code module that models glucose utilization (U(t)), an electronic code module that models renal excretion of glucose (E(t)).The algorithms for modeling each of these items are described at Applicant’s specification at para. [0041], [0042], [0043], and [0045], respectively. This is also described at claims 13-19 and also claims 25-31. Accordingly, the limitation will be interpreted to require at least one of the items according to the disclosed equations for the respective at least one item, including equivalents thereof.
Regarding the algorithm for electronic code module that respectively models at least one item corresponding to dynamic insulin… in claims 12 and 24, Applicant’s specification at para. [0012] discloses this includes an electronic module that models insulin secretion (S(t)). Applicant’s specification at para. [0044] discloses the algorithm for modeling insulin secretion S(t), also described at claims 20 and 32. Accordingly, the limitation will be interpreted accordingly, including 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.
Response to Arguments
Applicant's arguments filed 02 Feb. 2026 regarding 35 U.S.C. 112(f) have been fully considered and are acknowledged, but they do not present any arguments.
Applicant remarks the claims provide such structure for the aforementioned systems implementation such that they may be read commensurately in view of the specification (Applicant’s remarks at pg. 18, para. 5 to pg. 19, para. 1).
It is agreed the specification provides sufficient structure for the above limitations invoking 35 U.S.C. 112(f).
Claim Rejections - 35 USC § 112(b)
The rejection of claims 1-34 under 35 U.S.C. 112(b) in the Office action mailed 06 Aug. 2025 has been withdrawn in view of claim amendments received 02 Feb. 2026.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-34 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. This rejection is previously recited.
The Supreme Court has established a two-step framework for this analysis, wherein a claim does not satisfy § 101 if (1) it is “directed to” a patent-ineligible concept, i.e., a law of nature, natural phenomenon, or abstract idea, and (2), if so, the particular elements of the claim, considered “both individually and as an ordered combination,” do not add enough to “transform the nature of the claim into a patent-eligible application.” Elec. Power Grp., LLC v. Alstom S.A., 830 F.3d 1350, 1353 (Fed. Cir. 2016) (quoting Alice, 134 S. Ct. at 2355). Applicant is also directed to MPEP 2106.
Step 1: The instantly claimed invention (claims 1, 12, and 24 being representative) is directed a method, system, and product. Therefore, the instantly claimed invention falls into one of the four statutory categories. [Step 1: YES]
Step 2A: First it is determined in Prong One whether a claim recites a judicial exception, and if so, then it is determined in in Prong Two if the recited judicial exception is integrated into a practical application of that exception.
Step 2A, Prong 1: Under the MPEP § 2106.04, the Step 2A (Prong 1) analysis requires determining whether a claim recites an abstract idea, law of nature, or natural phenomenon.
Claims 1, 12, and 24 recite the following steps which fall under the mathematical concepts and mental processes groupings of abstract ideas:
modeling one or more items corresponding to dynamic glucose/glucose concentration in a T2DM or prediabetic subject, by modeling one or more items corresponding to glucose concentration of a T2DM or prediabetic subject (claim 1); or model one or more items corresponding to glucose concentration of a T2DM or prediabetic subject (claims 12 and 24);
modeling dynamic insulin concentration in said T2DM or prediabetic subject by modeling at least one item corresponding to insulin concentration of a T2DM or prediabetic subject (claim 1); or model at least one item corresponding to insulin concentration of a T2DM or prediabetic subject (claims 12 and 24); and
calculating/calculate an effect of variation of at least one metabolic parameter value on the glucose-insulin metabolic system of a virtual T2DM or prediabetic subject by inputting said plurality of metabolic parameter values of said virtual T2DM or prediabetic subject into said glucose concentration and insulin concentration modelings/subsystems and varying at least one of said metabolic parameter values to determine its effect on the glucose-insulin metabolic system of said virtual T2DM or prediabetic subject.
The identified claim limitations falls into one of the groups of abstract ideas of mathematical concepts and mental processes, for the following reasons. First, modeling items corresponding to glucose concentration and modeling items corresponding to insulin concentration each amount to a textual equivalent of performing mathematical calculations, in light of Applicant’s specification at para. [0036]-[0045] and also the dependent claims. Particularly with respect to claims 12 and 24 the modules for modeling are interpreted to recite the particular mathematical formulas used for the modeling, as discussed in claim interpretation, and therefore recite a mathematical formula. Furthermore, the human mind is practically capable of carrying out the required mathematical calculations, including multiplication, division, addition, and subtraction, and thus these limitations also recite a mental process. Last, regarding the step of calculating an effect of variation, this limitation recites the mathematical calculation of inputting parameter values into the glucose and insulin concentration models (i.e. equations) and calculating an output, and then analyzing a change in the output based on varying inputs. As discussed above, performing the mathematical calculations required to generate the output can be practically performed in the mind, and furthermore, the human mind is capable of performing comparisons to analyze how the output of models change. That is, other than reciting the limitations are carried out by a computer, nothing in the claims precludes the steps from being practically performed in the mind. See MPEP 2106.04(a)(2) I. and III.
Dependent claims 2-11, 13-23, and 25-34 further recite an abstract idea and/or further limit the abstract idea in the independent claims. Dependent claims 2, 14, and 26 further limits the mental process and mathematical concept of modeling the glucose concentrations and insulin concentrations in the independent claims. Dependent claims 3-8, 15-19, and 26-31 further limit mental process and mathematical concept of the glucose concentration model of the independent claims to include particular equations, thus additionally reciting a mathematical formula. Dependent claims 9, 20, and 32 further limit the mental process and mathematical concept of the insulin concentration model to include particular equations, thus additionally reciting a mathematical formula. Dependent claims 10, 21, and 33 further limit abstract idea of modeling data for a particular type of prediabetic subject, including a subject with impaired fasting glucose and/or impaired glucose tolerance. Dependent claims 11, 22, and 34 further limit the mental process and mathematical concept of calculating an effect of varying at least one metabolic parameter to include particular metabolic parameters. Therefore, claims 1-34 recite an abstract idea. [Step 2A, Prong 1: YES]
Step 2A: Prong 2: Under the MPEP § 2106.04, the Step 2A, Prong 2 analysis requires identifying whether there are any additional elements recited in the claim beyond the judicial exception(s), and evaluating those additional elements to determine whether they integrate the exception into a practical application of the exception. This judicial exception is not integrated into a practical application for the following reasons.
Dependent claims 2-11, 13-22, and 25-34 do not recite any elements in addition to the judicial exception.
The additional elements of claims 1, 12, and 23-24 include:
computer (claim 1);
a processor (claim 12);
a non-transitory computer-readable storage medium (claim 24);
a subsystem code comprising one or more electronic code modules (i.e. software stored in memory) (claims 12 and 24);
a subsystem code comprising at least one electronic code module (i.e. software stored in memory) (claims 12 and 24);
an electronic database containing a population of virtual T2DM or prediabetic subjects representative of a T2DM and prediabetic population, each virtual subject having a plurality of metabolic parameters with values encompassing a distribution of parameters observed in vivo across the population of T2DM or prediabetic subjects (i.e. storing data) (claims 1, 12, and 24); and
wherein said subsystems and modules are implemented as (a) computer executable software stored on a computer-readable storage medium and loaded into an electronic programmable computer or (b) application specific integrated circuit modules (claim 23).
The additional elements of a computer or processor, non-transitory computer readable storage medium storing instructions, computer executable software stored on computer-readable storage medium (i.e. the subsystems and modules), and storing data are generic computer components and/or functions. The courts have found the use of a computer or other machinery in its ordinary capacity for economic or other tasks (e.g., to receive, store, or transmit data) or simply adding a general purpose computer or computer components after the fact to an abstract idea (e.g., a fundamental economic practice or mathematical equation) does not integrate a judicial exception into a practical application. See MPEP 2106.05(f).
With further regard to the electronic database storing data and the computer components discussed above, these limitations only serve to store data used by the abstract idea in a computer and link the abstract idea to the computer environment. As a result, the limitation only serves to generally link the abstract idea to the computer environment, which is not sufficient to integrate the abstract idea into a practical application. See MPEP 2106.05(h).
Therefore, the additionally recited elements amount to mere instructions to apply an exception, and as such, the claims as a whole do no integrate the abstract idea into practical application. Thus, claims 1-34 are directed to an abstract idea. [Step 2A, Prong 2: NO]
Step 2B: In the second step it is determined whether the claimed subject matter includes additional elements that amount to significantly more than the judicial exception. See MPEP § 2106.05.
The claims do not include any additional steps appended to the judicial exception that are sufficient to amount to significantly more than the judicial exception.
Dependent claims 2-11, 13-22, and 25-34 do not recite any elements in addition to the judicial exception.
The additional elements of claims 1, 12, and 23-24 include:
computer (claim 1);
a processor (claim 12);
a non-transitory computer-readable storage medium (claim 24);
a subsystem code comprising one or more electronic code modules (i.e. software stored in memory) (claims 12 and 24);
a subsystem code comprising at least one electronic code module (i.e. software stored in memory) (claims 12 and 24);
an electronic database containing a population of virtual T2DM or prediabetic subjects representative of a T2DM and prediabetic population, each virtual subject having a plurality of metabolic parameters with values encompassing a distribution of parameters observed in vivo across the population of T2DM or prediabetic subjects (i.e. storing data) (claims 1, 12, and 24); and
wherein said subsystems and modules are implemented as (a) computer executable software stored on a computer-readable storage medium and loaded into an electronic programmable computer or (b) application specific integrated circuit modules (claim 23).
The additional elements of a computer or processor, non-transitory computer readable storage medium storing instructions, computer executable software stored on computer-readable storage medium (i.e. the subsystems and modules), and storing data are conventional computer components and/or functions. The courts have found the use of a computer or other machinery in its ordinary capacity for economic or other tasks (e.g., to receive, store, or transmit data) or simply adding a general purpose computer or computer components after the fact to an abstract idea (e.g., a fundamental economic practice or mathematical equation) does not provide significantly more. See Affinity Labs v. DirecTV, 838 F.3d 1253, 1262, 120 USPQ2d 1201, 1207 (Fed. Cir. 2016) (cellular telephone); TLI Communications LLC v. AV Auto, LLC, 823 F.3d 607, 613, 118 USPQ2d 1744, 1748 (Fed. Cir. 2016) (computer server and telephone unit).
Furthermore, the courts have found the following computer functions as well-understood, routine, and conventional: Storing and retrieving information in memory, Versata Dev. Group, Inc. v. SAP Am., Inc., 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015); OIP Techs., 788 F.3d at 1363, 115 USPQ2d at 1092-93;
Therefore, taken alone, the additional elements do not amount to significantly more than the above-identified judicial exception(s). Even when viewed as a combination, the additional elements fail to transform the exception into a patent-eligible application of that exception. Thus, the claims as a whole do not amount to significantly more than the exception itself. [Step 2B: NO]
Therefore, the instantly rejected claims are not drawn to eligible subject matter as they are directed to an abstract idea without significantly more. For additional guidance, applicant is directed generally to applicant is directed generally to the MPEP § 2106.
Response to Arguments
Applicant's arguments filed 02 Feb. 2026 regarding 35 U.S.C. 101 have been fully considered but they are not persuasive.
Applicant remarks that it is readily appreciated that each of instant claim 12 and claim 1 of parent application number 13/380,839 is directed to simulation of glucose-insulin dynamics, and these dynamics are dependent on operation of receipt of varied parameters relative to input for each recited glucose and insulin subsystem, and as such, findings by the Board are equally applicable to find eligibility here (Applicant’s remarks at pg. 19, para. 3 to pg. 21, para. 1). Applicant remarks that the Board Decision for the parent app. stated that the clams are directed to a sufficiently concrete technological improvement- an electronic system that models or simulates the metabolic system of subjects with diabetes or pre-diabetic subjects, and the claims are directed to an ordered combination of specific electronic modules with specific functionalities, and eligibility is warranted in the instant Application for the same reasons as the parent (Applicant’s remarks at pg. 21, para. 2 to pg. 22, para. 1).
This argument is not persuasive. MPEP 2106.05(f) states the use of a computer or other machinery in its ordinary capacity for economic or other tasks (e.g., to receive, store, or transmit data) or simply adding a general purpose computer or computer components after the fact to an abstract idea (e.g., a fundamental economic practice or mathematical equation) does not integrate a judicial exception into a practical application or provide significantly more. See Affinity Labs v. DirecTV, 838 F.3d 1253, 1262, 120 USPQ2d 1201, 1207 (Fed. Cir. 2016) (cellular telephone); TLI Communications LLC v. AV Auto, LLC, 823 F.3d 607, 613, 118 USPQ2d 1744, 1748 (Fed. Cir. 2016) (computer server and telephone unit).
MPEP 2106.05(a) explains it is important to keep in mind that an improvement in the abstract idea itself (e.g. a recited fundamental economic concept) is not an improvement in technology, and furthermore, in computer-related technologies, the examiner should determine whether the claim purports to improve computer capabilities or, instead, invokes computers merely as a tool. Enfish, LLC v. Microsoft Corp., 822 F.3d 1327, 1336, 118 USPQ2d 1684, 1689 (Fed. Cir. 2016).
In the instant case, the various “modules” of the claims are simply implemented on a single computer system including a processor, or one or more computer systems or processing systems, as discussed above under the 35 U.S.C. 112(f) claim interpretation and discussed in Applicant’s specification at [0081], [0088], and FIG. 5. Alternatively, the modules may be implemented using software stored in a computer program product, as discussed in Applicant’s specification at para. [0087] and in the 35 U.S.C. 112(f) interpretation above. Therefore, the structure for the electronic module is interpreted to be software stored in a memory or a computer configured to perform the functions. Claim 24 is a computer-executable program product, and thus the structure is interpreted to be software stored in memory, as also recited in the preamble of claim 24, or equivalents thereof.
Therefore, the claim encompass simply using a single generic computer to implement the specific order of abstract ideas of “modeling…dynamic glucose concentration…”, “modeling…dynamic insulin concentration…”, “calculating…an effect of variation…by inputting…parameter values…into said glucose concentration and insulin concentration modeling and varying at least one of said metabolic parameter values…”. These modeling and calculating steps clearly recite a mental process and/or a mathematical concept as discussed in the above rejection, and made clear in the dependent claims reciting specific mathematical formulas for the modeling. As discussed above, MPEP 2106.05(f) and 2106.05(a) state that simply carrying out an abstract idea on a generic computer does not integrate a judicial exception into a practical application of an improvement to computer technology because the claims merely invoke computers as a tool rather than improving the computers capabilities. Last, any alleged improvement in the glucose and insulin modeling itself (e.g. the simulations referred to by applicant) is merely an improvement in the abstract idea itself, which is not an improvement to technology.
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 1-34 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Schlessinger (2007) in view of Stocker (2006) and Man (2007). This rejection is previously recited.
Cited references:
Schlessinger et al, US 2007/0038475 A1 (previously cited);
Stocker et al., US 2006/0272652 A1 (previously cited); and
Man et al., Meal Simulation Model of the Glucose-Insulin System, 2007, IEEE Transactions on Biomedical Engineering, 54(10), pg. 1740-1748 (previously cited).
Regarding claims 1, 12, and 24¸ Schlessinger discloses a method for simulating clinical trials in prediabetic or Type 2 diabetic patients (Abstract; [0047], e.g. type 2 diabetes; [0060], e.g.. people at risk for type II diabetes but did not yet have the disease; FIG. 4, e.g. fraction with diabetes), comprising the following steps.
Schlessinger discloses modeling, using differential equations, dynamic glucose concentration in a prediabetic or type 2 diabetic (T2DM) subject ([0036]-[0037], e.g. dynamic modeling approach; [0055], e.g. equations for glucose; [0060] and FIG. 4, e.g. simulated trial for prediabetic patients, with a fraction developing type 2 diabetes throughout the simulated trial; FIG. 5-6, e.g. glucose concentration over time).
Schlessinger discloses modeling dynamic insulin in the prediabetic or T2DM subject ([0036]-[0037], e.g. dynamic model; [0055], e.g. equations for insulin).
Schlessinger discloses providing a simulated population of virtual subjects representing a diseased population ([0040], e.g. broad spectrum of patients with disease represented; FIG. 1), wherein the diseased population is type 2 diabetic patients or pre-diabetic patients ([0047]). Schlessinger discloses each virtual subject has a plurality of metabolic parameters ([0010], e.g. fasting plasma glucose; [0047], e.g. blood pressure, LDL, etc.), and that the parameters have a distribution that match in vivo measurements determined in a clinical trial (i.e. across the population of 2DM or prediabetic subjects) ([0042]).
Schlessinger discloses using the clinical trial simulations to calculate changes in glucose and insulin (i.e. the glucose and insulin modeling’s) in a virtual subject of the simulated population by directly changing the values of one or more metabolic parameters in response to a simulated treatment or diet ([0030], e.g. features changing over time causes every feature in an individual to have trajectory; [0032], e.g. LDL lowered by treatment, blood pressure; [0055], e.g. glucose and insulin modeled; Fig. 2, e.g. blood pressure, cardiac output; FIG. 5-6, e.g. glucose changes by changing features related to treatment).
Further regarding claims 12 and 24¸ and additionally claim 23, Schlessinger the method is carried out by a computer that executes instructions for carrying out the above steps ([0068]) or a computer readable medium that tangibly embodies a computer program for carrying out the above steps ([0068]).
Regarding claims 10, 21, and 33, Schlessinger discloses an embodiment in which the glucose and insulin are modeled in a Type 2 Diabetes patient ([0047]-[0055]), and therefore, the embodiment in which glucose and insulin is modeled in a prediabetic subject with impaired fasting glucose and/or impaired glucose tolerance is not required. Regardless, Schlessinger also discloses that modeling glucose and insulin in prediabetic patients involves tracking fasting blood glucose ([0054] and [0061]) and “diabetes” is present when fasting plasma glucose is >6.9375 ([0030]), demonstrating prediabetic patients have impaired fasting glucose.
Regarding claims 11, 22, and 34, Schlessinger further discloses the plurality of metabolic parameters for each virtual subject include body weight and fasting plasma glucose (i.e. basal plasma glucose concentration) (FIG. 2; [0054]; claim 3).
Schlessinger does not disclose the following limitations:
Regarding claims 1, 12, and 24, while Schlessinger discloses this simulated population in provided on a processor with memory ([0017]), which would require virtual population data is stored on the computer, Schlessinger does not explicitly disclose the population of virtual T2DM or prediabetic subjects with metabolic parameters are stored in an electronic database.
However, Stocker discloses a virtual patient software system for assisting patients and physicians in managing diabetes (Abstract; Fig. 1), which includes a virtual patient parameter library (i.e. electronic database) that stores different parameters for different patient metabolic models of virtual patients (i.e. metabolic parameters for virtual patients) ([0038]; [0043]; [0044], e.g. patient parameters are for virtual patients; FIG. 1 #115; Fig. 5-6), wherein the different patient metabolic models correspond to different metabolic models of different humans, including a child, women, middle aged man, etc. ([0043]). Stocker further discloses the patient parameter library provides a user with the ability to select from a number of metabolic models and utilize the stored parameters of the metabolic model to the simulation engine to generate glucose predictions ([0043]-[0044]; [0052]), and allows a patient or medical professional with simulated information regarding the effects of certain intakes or treatments on a patient’s blood glucose ([0008]).
It would have been prima facie obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the method of Schlessinger to have utilized an electronic database containing the population of virtual T2DM or prediabetic patients each having a plurality of metabolic parameters, as shown by Stocker ([0038]; [0043]; [0044], FIG. 1 #115). One of ordinary skill in the art would have been motivated to combine the methods of Schlessinger and Stocker in order to provide the user with the ability to select metabolic parameters of a virtual patient from the database for use in a simulation of blood glucose, thus facilitating providing simulated information regarding the effects of certain intakes or treatments on blood glucose, as shown by Stocker ([0043]-[0044]; [0052]), given Schlessinger also utilizes metabolic parameters of virtual patients in a model to simulate blood glucose values, as discussed above. This modification would have had a reasonable expectation of success given Schlessinger generates a virtual patient population of T2DM or prediabetic patients with metabolic parameters, and thus the method of storing parameters of virtual patients of Stocker is applicable to Schlessinger.
Regarding claims 1, 12, and 24, Schlessinger in view of Stocker does not explicitly disclose the modeled insulin is a dynamic insulin concentration. Schlessinger in view of Stocker further does not disclose modeling one or more items corresponding to the glucose concentration or at least one item corresponding to the insulin concentration.
Further regarding claims 2-9, 12-20, and 24-32:
While Schlessinger broadly discloses using dynamic modeling of differential equations to model glucose and insulin, as discussed above, Schlessinger does not disclose said one or more items corresponding to glucose concentration of a T2DM or prediabetic subject comprise (a) endogenous glucose production (EGP(t)), (b) meal glucose rate of appearance (Ra(t)), (c) glucose utilization (U(t)), (d) renal excretion of glucose (E(t)), or (e) any combination thereof, and said at least one item corresponding to insulin concentration of a T2DM or prediabetic subject comprises insulin secretion (S(t)), as recited in claims 2, 13, and 25.
Schlessinger further does not disclose modeling prediabetic glucose concentration G(g) according to the recited equations (claims 3, 14, 26), the one or more items comprise EGP(t) modeled according to the recited equations (claims 4, 15, 27), the one or more items comprise said Ra(t) modeled according to the recited equations (claims 5, 16, 28), the one or more items comprise U(t) modeled according to the recited equations (claims 6, 17, 29), wherein Vm(X(t)) is assumed linearly dependent from a remote insulin X(t) according to the recited equation and X is insulin described by the recited equation (claims 7, 18, 30), wherein the one or more items comprise said E(t) modeled according to the recited equations (claims 8, 19, 31), wherein the insulin concentration I(t) is modeled according to the recited equation and said S(t) is modeled according to the recited equation (claims 9, 20, and 32).
It is noted that, as the part of the electronic modules, claims 12 and 24 are also interpreted under 35 U.S.C. 112(f) above to require modeling one of the items for each of glucose and insulin described in Applicant’s specification and similarly recited in claims 2, 13, and 25 by the respective algorithm/equations described in the specification and recited in the respective dependent claims in claims 3-9, 14-20, and 26-32 for the various items.
However, Man discloses the above limitations as follows:
Man discloses a simulation model of the glucose-insulin system for type 2 diabetes (Abstract).
Regarding claims 1-2, 12-13, and 24-15, Man discloses the model of the glucose-insulin system models dynamic glucose concentrations (Figure 3) by modeling the items endogenous glucose production (EGP), glucose rate of appearance (Ra), glucose utilization (U(t)), and renal excretion of glucose E(t). (Figure 2, e.g. see parameters in glucose system; Figure 3; pg. 1741, col. 1, para. 1 to col. 2, para. 1). Man discloses the insulin concentrations are modeled by modeling at least one item corresponding to insulin secretion S(t) (Figure 2-3; pg. 1742, col. 1, para. 3).
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Further regarding claims 3, 14, 26, Man discloses the glucose concentration modeling system models a glucose concentration G(t) (Figures 2-3 and eqn. 1) according to equations:
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Regarding claims 4, 15, and 27, Man discloses the EGP(t) is modeled (Figures 2-3; pg. 1744, col. 1, para. 2; eqn. 10) according to :
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Regarding claims 5, 16, and 28, Man discloses the Ra(t) is modeled (pg. 1744, col. 2, para. 3 and eqn. 13) according to equations:
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Regarding claims 6, 17, and 29, Man discloses the U(t) is modeled as two compartments including a constant insulin independent utilization (Uii) and insulin dependent utilization (Uid) (pg. 1745, col. 1, para. 3-4), according to the following equations (eqns 14-15):
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Regarding claims 7, 18, and 30, Man discloses Vm(X(t)) is assumed linearly dependent from a remote insulin, X(t), in the model (pg. 1745, col. 1, para. 4), where X(pmol/L) is insulin in the interstitial fluid (pg. 1745, col. 1, para. 5). Man discloses Vm(X(t)) and X(t) are modeled as follows:
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Regarding claims 8, 19, and 31, Man discloses the E(t) is modeled (pg. 1745, col. 2, para. 5, eqn. 27) according to the following equations:
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Regarding claims 9, 20, and 32, Man discloses the insulin concentration I(t) (pg. 1742, col. 1, para. 3, eqn. 3) and the S(t) (pg. 1745, col. 2, para. 3-4, eqn 23-25), are modeled according to the following equations:
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As discussed above, as the part of the electronic modules, the above teachings of Man for dependent claims 3-9, 14-20, and 26-32 are also applicable to claims 12 and 24, which requires modeling one of the items for glucose and insulin as interpreted under 35 U.S.C. 112(f).
Man further discloses the above model fits a type 2 diabetic subject very well (pg. 1747, col. 2, para. 4) and further discloses the model simulates in the human, a meal and daily life, which allows for simulating parametric changes in insulin action and beta cell secretion (pg. 1747, col. 2, para. 3). Man discloses the model is valuable as a similar in several situations dealing with the pathology of diabetes (pg. 1748, col. 1, para. 2).
It would have been prima facie obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified the glucose and insulin model of Schlessinger in view of Stocker to have utilized the glucose and insulin system model of Man, discussed above, thus arriving at the claimed invention. One of ordinary skill in the art would have been motivated to combine the methods of Schlessinger in view of Stocker and Man in order to utilize a model that fits a type 2 diabetic subject well, to allow modeling glucose and insulin changes in responses to meal and life, and to facilitate the study of the effect of parametric changes on the pathology of diabetes, as shown by Man (pg. 1747, col. 2, para. 3-4; pg. 1748, col. 1, para. 2), given Schlessinger also models the effect of parameter changes on insulin and glucose in type 2 diabetic or prediabetic subjects. This modification would have had a reasonable expectation of success given Schlessinger also utilizes mathematical models for insulin and glucose, and thus the model of Man is applicable to the method of Schlessinger in view of Stocker.
Therefore, the invention is prima facie obvious.
Response to Arguments
Applicant's arguments filed 02 Feb. 2026 regarding 35 U.S.C. 103 have been fully considered but they are not persuasive.
Applicant remarks that Applicant’s “virtual subject(s) having a plurality of metabolic parameters with values encompassing a distribution of parameters observed in vivo across the population of T2DM or prediabetic subjects”, and any subject in Schlessinger is generated to have ONLY observed, simulated parameters due to their “growing up” events which are a function of their initial generation, and thus no subject in Schlessinger is imparted any in vivo observed parameter (Applicant’s remarks at pg. 22, para. 2 to 24, para. 2). Applicant further remarks that the fact that Schlessinger filters for selection of already simulated subjects having simulated parameters, and similarly applicable portions of Stocker and Man, do not cure Schlessinger’s failure to disclose Applicant’s recited virtual subject’s (Applicant’s remarks at pg. 24, para. 2 to pg. 25, para. 1).
This argument is not persuasive. Claim 1 recites “…providing an electronic database containing a population of virtual T2DM or prediabetic subjects…,each virtual subject having a plurality of metabolic parameters with values encompassing a distribution of parameters observed in vivo across the population of T2DM or prediabetic subjects”. Furthermore, the claim uses the transitional phrase “comprising”, which is synonymous with "including," "containing," or "characterized by," is inclusive or open-ended and does not exclude additional, unrecited elements or method steps. See, e.g., Mars Inc. v. H.J. Heinz Co., 377 F.3d 1369, 1376, 71 USPQ2d 1837, 1843 (Fed. Cir. 2004). See MPEP 2111.03 I. Therefore, under the broadest reasonable interpretation of the claim, claim 1 requires a database containing, but not limited to, virtual T2DM or prediabetic subjects having metabolic parameters with values that surround or include as a part of a whole or group (i.e. the plain meaning of encompassing) a distribution of parameters observed in vivo.
Regarding Applicant’s argument that no subject in Schlessinger is “imparted any in vivo observed parameter”, it is first noted that claim 1 does actually require directly assigning/imparting observed in vivo parameters directly to virtual subjects. Claim 1 only requires the values of the metabolic parameters of the virtual subjects encompass (surround or include) a distribution of parameters observed in vivo. Therefore, even virtual subjects with values of metabolic parameters encompassing a range and standard deviation of values metabolic parameters observed in vivo would read on the claims, even if the values of the metabolic parameters of the virtual subjects were not identical to specific values of observed in-vivo parameters.
Schlessinger discloses providing a simulated population of virtual subjects representing a diseased population ([0040], e.g. broad spectrum of patients with disease represented; FIG. 1), and discloses that each virtual subject has a plurality of metabolic parameters ([0010], e.g. fasting plasma glucose; [0047], e.g. blood pressure, LDL, etc.), wherein the parameters have a distribution that match in vivo measurements determined in a clinical trial (i.e. the values encompass a distribution of parameters observed in vivo) ([0042]). Schlessinger explicitly states that “One can confirm that their characteristics….match the distribution of characteristics published in the description of the trial….” and “characteristics, biological variables, current and past medical histories, medications, behaviors of the people in the virtual trial should be comparable (e.g., within the sampling error) to what is generally known as “Table 1” of a corresponding real trial”. Therefore, the virtual subjects of Schlessinger clearly have a plurality of metabolic parameters with values “encompassing a distribution of parameters observed in vivo…”, given Schlessinger discloses the virtual subject parameters match those of the clinical trial.
Regarding Applicant’s argument that the selection of already created subjects in Schlessinger is merely a filtering process for which Table 1 simply provides filtering characteristics for Schlessinger’s clinical trial selection, this does not negate the fact that Schlessinger does disclose a population of T2DM subjects that have a plurality of metabolic parameters with values encompassing a distribution of parameters observed in vivo. As discussed above, claim 1 simply requires an electronic database containing the recited population of virtual T2DM subjects, but the database is not closed off to unrecited virtual subjects. So even if Schlessinger is filtering virtual patients from a larger population of virtual patients in order to select a subset (i.e. population) of virtual patients with metabolic parameters having values encompassing the distribution of parameters observed in vivo, this still discloses the recited virtual population of subjects. Therefore, even if the combination of Schlessinger and Stocker applied in the above rejection provides an electronic database containing additional virtual subjects not having the recited distribution of parameters, this would still read on the claimed electronic database containing the recited “filtered” population of subjects, even if the database includes the other virtual subjects of Schlessinger.
Last, it is noted that claim 1 does not actually requiring simulating or generating the virtual subjects. Instead, claim 1 is merely describing a database of already generated virtual subjects with a particular distribution of metabolic parameters. As discussed in MPEP 2113 I, The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted). Therefore, Applicant’s arguments pertaining to how the virtual subjects of Schlessinger were obtained (e.g. simulated parameters due to “growing up” events, and subsequent filtering to obtain a population with parameters matching a clinical trial) are not persuasive because the virtual subjects of Schlessinger are still the same “product” (virtual subjects) as those recited in the claims for the reasons already discussed above. Both the virtual subjects of the claims and of Schlessinger have metabolic parameters that encompass a distribution of parameters observed in vivo in a population of T2DM or prediabetic subjects.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-34 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-32 of U.S. Patent No. US 11,238,990 B2. This rejection is previously recited.
Although the claims at issue are not identical, they are not patentably distinct from each other because:
Regarding instant claims 1, 12, and 24, reference claims 1 and 18 disclose system and compute program product configured to execute a method comprising the limitations recited in claims 1, 12, and 24. Specifically, reference claims 1 and 18 carry out a method that anticipates the instant invention by requiring the dynamic glucose and insulin modeling is performed by modeling each of the items recited in instant claims 2, 13, and 25, rather than only one item.
Regarding instant claims 2, 13, and 25, reference claims 1 and 18 disclose modeling each of the recited items.
Regarding instant claims 3-9, 14-20, and 26-32, reference claims 2-3, 6-12, 19-21, and 23-29 disclose these limitations.
Regarding instant claims 10, 21, and 33, reference claims 13-14 and 30-31 disclose these limitations.
Regarding instant claims 11, 22, and 34, reference claims 15 and 32 disclose these limitations.
Regarding instant claim 23, reference claim 16 discloses this limitation.
Response to Arguments
Applicant's arguments filed 02 Feb. 2026 have been fully considered but they do not present any arguments regarding the double patenting rejections.
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Inquiries
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAITLYN L MINCHELLA whose telephone number is (571)272-6485. The examiner can normally be reached 7:00 - 4:00 M-Th.
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/KAITLYN L MINCHELLA/Primary Examiner, Art Unit 1685
/OLIVIA M. WISE/Supervisory Patent Examiner, Art Unit 1685 /YVONNE L EYLER/Director, Art Unit 1600
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