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 .
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 05/12/2026 and 07/13/2026 has been entered.
Claims 1, 4-9, 11, 22, and 35 are pending for examination. Claims 2-3, 10, 12-21, 23-34, and 36-53 are cancelled.
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, 4-9, 11, 22, and 35 are rejected under 35 U.S.C. 101 because the claimed invention is directed to judicial exceptions of abstract idea without significantly more. Claims 1, 4-9, 11, 22, and 35 recite methods, which fall within one of statutory categories (i.e. process/ machine) (Step 1: YES).
Step 2A Prong One analysis: Claim 1 recites “determining the subject's blood glucose concentration, wherein the subject's blood glucose concentration is measured continuously under physiological conditions, determining the subject's blood or urinary C-peptide concentration level, calculating a ratio of the subject's blood glucose concentration to the subject's blood or urinary C-peptide concentration, identifying the subject with insulin resistance if the ratio is high; or identifying the subject with normal insulin sensitivity if the ratio is low”; claim 11 recites “determining the subject's urinary C-peptide concentration, normalizing the subject's urinary C-peptide concentration for the subject's blood glucose concentration, identifying the subject as having insulin resistance if the subject's normalized blood or urinary C-peptide level concentration is above a threshold”; claim 22 recites “determining the subject's blood glucose concentration, wherein the subject's blood glucose concentration is measured continuously under physiological conditions, determining the subject's urinary C-peptide concentration, calculating a ratio of the subject's blood glucose concentration to the subject's r urinary C-peptide level concentration, thereby identifying a subject with or at risk of a disease characterized by insulin resistance if the ratio is high”; and claim 35 recites “determining the subject's urinary C-peptide level concentration, normalizing the subject's blood or urinary C-peptide concentration for the subject's blood glucose concentration, wherein the subject's blood glucose concentration is measured continuously under physiological conditions, identifying the subject as having insulin resistance if the subject's normalized urinary C-peptide level concentration is above a threshold”. The claims involve calculation/ determination of parameter(s) constitutes an abstract idea of mathematical relationships/ calculations and/or mental process, which fall within at least one of the groupings of abstract ideas enumerated in the 2019 Revised Patent Subject Matter Eligibility Guidance (Mathematical Concepts) (Step 2A Prong One: YES).
Step 2A Prong Two analysis: Claim 9 recites “transcutaneous glucose monitor (CGM)”. This judicial exception is not integrated into a practical application because the CGM is generic sensing equivalent for obtaining glucose measurements of a subject calculations/ determinations operate. Thus, there is no improvement or change in the function of the device (see at least MPEP 2106.05(a), (f) and (g)). And the determining/ steps and treating step are considered as data gathering or generic treating steps to be insignificant extra-solution activity. It is noted that the determining steps may be directed to simple observations of measurements results and related to metal processes for determining a number/ value associated with the glucose or C-peptide concentrations. And/ or the abstract idea (mental process) is directed as “If a claim recites a limitation that can practically be performed in the human mind, with or without the use of a physical aid such as pen and paper, the limitation falls within the mental processes grouping, and the claim recites an abstract idea” (see MPEP 2106.04(a)(2).III.B). “(Step 2A Prong Two: YES).
Step 2B: The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the additional element(i.e. CGM), when considered separately and in combination, are associated with data gathering steps of insignificant extra-solution activity (see MPEP 2106.05(g)). The claims merely cover the collection of data obtained from known and existing technology and then using the data to make a correlation (s) (Step 2B: No). Dependent claims do not recite additional elements/ features and do not add significantly more (i.e. an “inventive concept”) to the exception.
The dependent claims 4-9 further limit the judicial exception and/or are reciting elements that are well understood, routine, and conventional. Therefore claims 1, 4-9, 11, 22, and 35 are not patent eligible under 35 USC 101.
It is noted that the steps of “treating the subject” are considered as insignificant extra-solution activity since they are directed to generic treatments. According to MPEP 2106.04(d)(2).a: “The treatment or prophylaxis limitation must be "particular," i.e., specifically identified so that it does not encompass all applications of the judicial exception(s). For example, consider a claim that recites mentally analyzing information to identify if a patient has a genotype associated with poor metabolism of beta blocker medications. This falls within the mental process grouping of abstract ideas enumerated in MPEP § 2106.04(a). The claim also recites "administering a lower than normal dosage of a beta blocker medication to a patient identified as having the poor metabolizer genotype." This administration step is particular, and it integrates the mental analysis step into a practical application. Conversely, consider a claim that recites the same abstract idea and "administering a suitable medication to a patient." This administration step is not particular, and is instead merely instructions to "apply" the exception in a generic way. Thus, the administration step does not integrate the mental analysis step into a practical application”. Examiner found that the specification describes “treating the subject comprises administering to the subject one or more insulin sensitizers”, see paragraph [0007] of the PGPUB. It is suggested that incorporation of the specific type of treatments in response to the ratio/ threshold identification steps into the claims would overcome the 35 USC 101 rejections.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1, 4-6, 8-9, and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Zhang et al. “OGTT 1h serum C-peptide to plasma glucose concentration ratio is more related to beta cell function and diabetes mellitus. Oncotarget, Vol. 8, No. 31, pp. 51786-51791 (2017) - applicant cited, in view of Sekimoto et al. (USPGPUB 2012/027/1557) in view of McCamish (USPGPUB 2008/0280955 – applicant cited) and further in view of Faustian (USPGPUB 2016/0245808). In regard to claim 1, Zhang discloses a method of identifying a subject with insulin resistance (Pg. 51787, Col. 1, Para. 3, 1021 patients were non-diabetic and aged 27 to 80 years old. They all underwent a 75-g oral glucose tolerance test (OGTT) to determine whether they were suffering from diabetes according to WHO 1999 diagnostic criteria; Pg. 51788, Col. 1, Para. 2, of all the 1021 studied subjects, 324 were diagnosed with diabetes after OGTT according to WHO 1999 diagnostic criteria; Pg. 51786, Col. 1, Para. 1, Progressive pancreatic β-cell function failure and insulin resistance are the key characteristics of type 2 diabetes mellitus (T2DM)), the method comprising: determining the subject's blood glucose concentration, wherein the subject's blood glucose concentration is measured under physiological conditions (Pg. 51787, Col. 1, Para. 4, Blood samples were drawn at 0, 30, 60, 120 and 180 min after the glucose load to determine glucose concentrations; Pg. 51787, Col. 2, Para. 2, Plasma glucose was measured by enzymatic hexokinase hotometric assay), determining the subject's blood or urinary C-peptide level (Pg. 51787, Col. 1, Para. 4, Blood samples were drawn at 0, 30, 60, 120 and 180 min after the glucose load to determine ... C-peptide levels; Pg. 51787, Col. 2, Para. 2, C-peptide was determined by Luminescent immunoassays); calculating the ratio of the subject's blood glucose concentration to the blood or urinary C-peptide concentration (Pg. 51787, Col. 2, Para. 3, CPI was calculated as: 100 x serum C-peptide level (ng/mL)/ plasma glucose level (mg/dL); it is noted that A/B and B/A are inverse correlated; it is interpreted according to paragraph [0135] of the specification of the PGPUB of current application, which indicates “24 h C-peptide urinary levels/24 h circulating glucose ratio”, paragraphs [0222] and [0224] indicate “24 urinary C-peptide/24 h serum glucose levels ratio”; and paragraph [0072] indicates possible ratio ranges ); identifying a subject with insulin resistance if this ratio is high; or identifying a subject with normal insulin sensitivity if this ratio is low (Pg. 51788, Col. 1, Para. 2, Of all the 1021 studied subjects, 324 were diagnosed with diabetes after OGTT according to WHO 1999 diagnostic criteria; Pg. 51786, Col. 1, Para. 1, Progressive pancreatic β-cell function failure and insulin resistance are the key characteristics of type 2 diabetes mellitus (T2DM); Pg. 51789, Col. 1, Para. 3, CPI 1 h has the highest diagnostic value to predict diabetes mellitus (AROC = 0.937, sensitivity = 90%, specificy = 85.2%); see also Fig. 1, Blood glucose and serum C-peptide levels in DM and non-DM group).
Zhang does not specifically disclose the subject's blood glucose is measured continuously.
Sekimoto teaches a CGM measuring apparatus for performing the continuous blood sugar measurement (Figs. 1-3, 15-22, 24-26, and 28-31 and associated descriptions) comprising measuring the subject's blood glucose continuously (rejected as best understood, see the 35 USC 112(b) rejection above; before, during and after an OGTT measurement: in the case of the CGM measuring apparatus, a glucose sensor is retained subcutaneously over a span of about several days to several weeks to continuously measure the blood sugar level, [0007] and [0108]; continuously measure during an OGTT measurement period, Figs. 27-30 and associated descriptions; [0208-0214]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method (Zhang) to incorporate the CGM and associated elements/functions/steps as taught by Sekimoto, since both methods are OGTT related glucose measurements and one of ordinary skill in the art would have recognized that in addition to or alternatively for the blood sampling periods during the OGTT, glucose information can be monitored continuously before, during and/or after the OGTT (see Sekimoto). The rationale would have been to obtain more glucose information before, during and/or after the OGTT.
Zhang as modified by Sekimoto does not specifically disclose treating the subject.
McCamish is also in the field of methods of screening for insulin resistance (Abstract) and teaches treating the subject ([0017], methods of screening and treatment of an individual suffering from a disorder of blood glucose regulation, e.g., an insulin resistance disorder; [0004], methods can also further include administering or not administering an insulin sensitizer to the individual based on the results of the screening of the individual).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method (Zhang as modified by Sekimoto) to incorporate treating the subject with associated treating steps as taught by McCamish. The rationale would have been to encourage insulin production in a subject and thereby affect therapeutic benefit in the subject having a metabolic disorder ([0030]).
Zhang as modified by Sekimoto and McCamish does not specifically disclose McCamish does not specifically discloses the subject’s C-peptide concentration is an urinary C-peptide concentration.
Faustian teaches C-peptide levels may be assayed using a sample from the subject, such as blood, a blood component (serum or plasma), or urine ([0054]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the serum C-peptide concentration of the method (Zhang as modified by Sekimoto and McCamish) with urinary C-peptide concentration as taught by Faustian to yield predictable results, since one of ordinary skill in the art would have recognized that C-peptide levels may be assayed using a sample from the subject, such as blood, a blood component (serum or plasma), or urine (see Faustian). The rationale would have been the simple substitution of one known, equivalent element for another to obtain predictable results (obvious to substitute elements, devices, etc.), KSR, 550, U.S. at 417.
In regard to claim 4, Zhang as modified by Sekimoto, McCamish and Faustian discloses the blood glucose concentration is continuously measured over a period of time (Pg. 51787, Col. 1, Para. 4, Blood samples were drawn at 0, 30, 60, 120 and 180 min after the glucose load to determine glucose concentrations; Pg. 51787, Col. 2, Para. 2, Plasma glucose was measured by enzymatic hexokinase hotometric assay of Zhang; continuously measured during OGTT, Figs. 27-31 and associated descriptions of Sekimoto; referring to claim 1 above).
In regard to claim 5, Zhang as modified by Sekimoto, McCamish and Faustian discloses the period of time comprises about 24 hours (referring to claim 1 above; days to several weeks; [0007] and [0108] of Sekimoto).
In regard to claim 6, Zhang as modified by Sekimoto, McCamish and Faustian discloses the subject’s blood or urinary C-peptide concentration is measured over a period of time (Pg. 51787, Col. 1, Para. 4, Blood samples were drawn at 0, 30, 60, 120 and 180 min after the glucose load to determine ... C-peptide levels; Pg. 51787, Col. 2, Para. 2, C-peptide was determined by Luminescent immunoassays of Zhang).
In regard to claim 8, Zhang as modified by Sekimoto, McCamish and Faustian discloses the blood glucose concentration and the urinary C-peptide concentration are measured simultaneously or sequentially (Pg. 51787, Col. 1, Para. 4, Blood samples were drawn at 0, 30, 60, 120 and 180 min after the glucose load to determine glucose concentrations, serum insulin levels, C-peptide levels of Zhang).
In regard to claim 9, Zhang as modified by Sekimoto, McCamish and Faustian discloses the subject's blood glucose concentration is measured using a transcutaneous glucose monitor (CGM) (referring to claim 1 above).
In regard to claim 22, Zhang as modified by Sekimoto, McCamish and Faustian discloses a method of identifying a subject with or at risk of a disease characterized by insulin resistance (referring to claim 1 above), the method comprising: determining the subject's blood glucose concentration, wherein the subject’s glucose concentration is measured continuously under physiological conditions (referring to claim 1 above), determining the subject's urinary C-peptide concentration (referring to claim 1 above), calculating a ratio of the subject's blood glucose concentration to the subject's urinary C-peptide concentration (referring to claim 1 above), thereby identifying a subject with or at risk of a disease characterized by insulin resistance if the ratio is high (referring to claim 1 above), and treating the subject (referring to claim 1 above).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over the combination of Zhang, Sekimoto, McCamish and Faustian as applied to claims 1, 4-6, 8-9, and 22 above, and further in view of Saisho et al. “Postprandial serum C-peptide to plasma glucose ratio as a predictor of subsequent insulin treatment in patients with type 2 diabetes”. Endocrine Journal, Vol. 58, No. 4, pp. 315-322 (2011) – applicant cited). In regard to claim 7, Zhang as modified by Sekimoto, McCamish and Faustian discloses all the claimed limitation except the subject’s urinary C-peptide concentration is measured over a period of time comprises about 24 hours.
Saisho is also in the field of methods of measuring C-peptide concentrations (Saisho, Abstract) and teaches wherein the period of time comprises about 24 hours (Saisho Pg. 316, Col. 2, Para. 3, … Urinary CPR index was calculated as 24 h urinary CPR (µg/day) / FPG (mg/dL)).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method (Zhang as modified by Sekimoto and McCamish) to incorporate a period of time comprises about 24 hours as taught by Saisho. The motivation for doing so would have been to obtain more information in the subject (Saisho Pg. 316, Col. 2, Para. 3).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Kruszynska, in view of McCamish and further in view of Faustian. In regard to claim 11, Kruszynska discloses a method of identifying a subject with insulin resistance (Pg. 104, Col. 1, Para. 2, To assess the relative contributions of insulin resistance and impaired insulin secretion to glucose intolerance, we also measured insulin sensitivity in these patients (29) and examined the relationships between insulin sensitivity, insulin secretion and glucose tolerance), the method comprising: determining the subject's blood or urinary C-peptide concentration (Pg. 104, Col. 2, Para. 3, Blood samples (10 ml) for glucose, insulin and C-peptide estimation were taken at 15-min intervals until min 60 and then at 30-min intervals until min 180), normalizing the subject's blood or urinary C-peptide concentration for the subject's blood glucose concentration (Pg. 109, Col. 2, Para. 3, Because C-peptide concentrations were similar during this period, it would appear that the early hyperinsulinemia is essentially due to impaired insulin clearance. When the 3-hr insulin secretion rates after oral glucose were normalized for the differing blood glucose concentrations, identical values were obtained in cirrhotic patients and controls, suggesting that the increased insulin output after oral glucose intake in cirrhotic patients was a consequence of the hyperglycemia), identifying the subject as having insulin resistance if the subject's normalized blood or urinary C-peptide level is above a threshold (Pg. 104, Col. 1, Para. 2, we used recombinant human C-peptide to measure C-peptide metabolic clearance rate in clinically stable cirrhotic patients, and applied the C-peptide kinetic data to the integrated peripheral C-peptide concentrations in the same individuals to calculate pancreatic insulin secretion rates ... To assess the relative contributions of insulin resistance and impaired insulin secretion to glucose intolerance, we also measured insulin sensitivity in these patients (29) and examined the relationships between insulin sensitivity, insulin secretion and glucose tolerance; Pg. 109, Col. 1, Para. 2, Applying the C-peptide MCR to the calculation of insulin secretion rates, we found that in cirrhotic patients with normal fasting blood glucose concentrations, fasting C-peptide (and hence insulin) secretion rates were approximately double those of normal controls)
Kruszynska does not specifically disclose treating the subject.
McCamish is also in the field of methods of screening for insulin resistance ( Abstract) and teaches treating the subject ([0017], methods of screening and treatment of an individual suffering from a disorder of blood glucose regulation, e.g., an insulin resistance disorder; Para. [0004], methods can also further include administering or not administering an insulin sensitizer to the individual based on the results of the screening of the individual).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method (Kruszynska) to incorporate treating the subject as taught by McCamish. The motivation for doing so would have been to encourage insulin production in a subject and thereby affect therapeutic benefit in the subject having a metabolic disorder (McCamish Para. [0030]).
Kruszynska as modified by McCamish does not specifically disclose the subject’s C-peptide concentration is an urinary C-peptide concentration.
Faustian teaches C-peptide levels may be assayed using a sample from the subject, such as blood, a blood component (serum or plasma), or urine ([0054]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the serum C-peptide concentration of the method (Kruszynska as modified by McCamish) with urinary C-peptide concentration as taught by Faustian to yield predictable results, since one of ordinary skill in the art would have recognized that C-peptide levels may be assayed using a sample from the subject, such as blood, a blood component (serum or plasma), or urine (see Faustian). The rationale would have been the simple substitution of one known, equivalent element for another to obtain predictable results (obvious to substitute elements, devices, etc.), KSR, 550, U.S. at 417.
Claim 35 is rejected under 35 U.S.C. 103 as being unpatentable over Kruszynska et al. “Relationship between Insulin Sensitivity, Insulin Secretion and Glucose Tolerance in Cirrhosis”. Hepatology, Vol. 14, No 1, pp. 103-111 (1991) – applicant cited, in view of McCamish, in view of Sekimoto and further in view of Faustian. In regard to claim 35, Kruszynska discloses a method of identifying a subject with insulin resistance (Pg. 104, Col. 1, Para. 2, To assess the relative contributions of insulin resistance and impaired insulin secretion to glucose intolerance, we also measured insulin sensitivity in these patients (29) and examined the relationships between insulin sensitivity, insulin secretion and glucose tolerance), the method comprising: determining the subject's blood or urinary C-peptide concentration (Pg. 104, Col. 2, Para. 3, Blood samples (10 ml) for glucose, insulin and C-peptide estimation were taken at 15-min intervals until min 60 and then at 30-min intervals until min 180), normalizing the subject's blood or urinary C-peptide concentration for the subject's blood glucose concentration (Pg. 109, Col. 2, Para. 3, Because C-peptide levels were similar during this period, it would appear that the early hyperinsulinemia is essentially due to impaired insulin clearance. When the 3-hr insulin secretion rates after oral glucose were normalized for the differing blood glucose concentrations, identical values were obtained in cirrhotic patients and controls, suggesting that the increased insulin output after oral glucose intake in cirrhotic patients was a consequence of the hyperglycemia), wherein the subject’s glucose concentration is measured under physiological conditions (glucose tolerance, Pg. 109, Col. 2, Para. 3)’ identifying the subject as having insulin resistance if the subject's normalized blood or urinary C-peptide level is above a threshold (Pg. 104, Col. 1, Para. 2, we used recombinant human C-peptide to measure C-peptide metabolic clearance rate in clinically stable cirrhotic patients, and applied the C-peptide kinetic data to the integrated peripheral C-peptide concentrations in the same individuals to calculate pancreatic insulin secretion rates ... To assess the relative contributions of insulin resistance and impaired insulin secretion to glucose intolerance, we also measured insulin sensitivity in these patients (29) and examined the relationships between insulin sensitivity, insulin secretion and glucose tolerance; Pg. 109, Col. 1, Para. 2, Applying the C-peptide MCR to the calculation of insulin secretion rates, we found that in cirrhotic patients with normal fasting blood glucose concentrations, fasting C-peptide (and hence insulin) secretion rates were approximately double those of normal controls)
Kruszynska does not specifically disclose treating the subject.
McCamish is also in the field of methods of screening for insulin resistance ( Abstract) and teaches treating the subject ([0017], methods of screening and treatment of an individual suffering from a disorder of blood glucose regulation, e.g., an insulin resistance disorder; Para. [0004], methods can also further include administering or not administering an insulin sensitizer to the individual based on the results of the screening of the individual).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method (Kruszynska) to incorporate treating the subject as taught by McCamish. The motivation for doing so would have been to encourage insulin production in a subject and thereby affect therapeutic benefit in the subject having a metabolic disorder (McCamish Para. [0030]).
Kruszynska as modified by McCamish does not specifically disclose the subject's blood glucose is measured continuously.
Sekimoto teaches a CGM measuring apparatus for performing the continuous blood sugar measurement (Figs. 1-3, 15-22, 24-26, and 28-31 and associated descriptions) comprising measuring the subject's blood glucose concentration continuously; before, during and after an OGTT measurement: in the case of the CGM measuring apparatus, a glucose sensor is retained subcutaneously over a span of about several days to several weeks to continuously measure the blood sugar level, [0007] and [0108]; continuously measure during an OGTT measurement period, Figs. 27-30 and associated descriptions; [0208-0214]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method (Kruszynska as modified by McCamish) to incorporate the CGM and associated elements/functions/steps as taught by Sekimoto, since both methods are OGTT related glucose measurements and one of ordinary skill in the art would have recognized that CGM can provide continuous glucose measurements before, during and/or after the OGTT (see Sekimoto). The rationale would have been to obtain more glucose information before, during and/or after the OGTT.
Kruszynska as modified by McCamish and Sekimoto does not specifically disclose discloses the subject’s C-peptide concentration is an urinary C-peptide concentration.
Faustian teaches C-peptide levels may be assayed using a sample from the subject, such as blood, a blood component (serum or plasma), or urine ([0054]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the serum C-peptide concentration of the method (Kruszynska as modified by McCamish and Sekimoto) with urinary C-peptide concentration as taught by Faustian to yield predictable results, since one of ordinary skill in the art would have recognized that C-peptide levels may be assayed using a sample from the subject, such as blood, a blood component (serum or plasma), or urine (see Faustian). The rationale would have been the simple substitution of one known, equivalent element for another to obtain predictable results (obvious to substitute elements, devices, etc.), KSR, 550, U.S. at 417.
Response to Arguments
Applicant’s arguments, see page 5 of Remarks, filed on 05/12/2026, with respect to claims 1, 4-10, 22 and 35 have been fully considered and are persuasive. The 35 USC 112(b) rejections of claims 1, 4-10, 22 and 35 have been withdrawn.
Applicant’s amendment and argument with respect to “urinary C-peptide concentration” in claims 1, 11, 22, and 35 filed on 05/12/2026 have been fully considered but they are deemed to be moot in views of the new grounds of rejection.
Applicant's arguments filed on 05/12/2026 have been fully considered but they are not persuasive. In regard to the limitations of “under physiological conditions” in claims 1, 22 and 35, applicant’s alleged that “the presently claimed methodology provides a method to more safely measure both serum glucose concentration and urinary c-peptide level in physiologically relevant conditions (e.g., without the requirement of intravenous or oral glucose loading)” see page 6 of Remarks. In response, under the BRI, the term of “physiological conditions” are generally considered as all conditions associated with physiological status of the patient/ subject”. It is noted that glucose concentration measurements under OGTT procedure, e.g. administration of oral glucose solution in a time period, are considered as measuring glucose concentration measurements under physiological conditions since the physiological conditions of glucose concentrations of the patient/ subject are modified during OGTT. Furthermore, the arguments of “without the requirement of intravenous or oral glucose loading” cannot be found in the claims. If any specific glucose measurements related physiological conditions are essential to the invention, applicant should consider incorporate the limitations in all the claims.
Conclusion
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/CHU CHUAN LIU/Primary Examiner, Art Unit 3791
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