DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of the Claims
Claims 28-32 and 34-37 have been amended. Claims 38-54 have been withdrawn. Claims 1-27 have been previously canceled. Claims 28-37 are currently examined herein.
Status of the Rejection
All claim objections, U.S.C. § 103, and U.S.C. § 112 rejections from the previous office action are withdrawn in view of the amendments.
All 35 § U.S.C 101 are essentially maintained and modified only in response to the Applicant’s amendments.
New grounds of claim objection are necessitated by Applicant’s amendments.
Claim Objections
Claim 28 is objected to because of the following informalities:
Claim 28, please amend “of the at least two groups all biosensors” to “of the at least two groups of all biosensors” in line 39.
Appropriate correction is required.
Claim Rejections - 35 USC § 101
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 28-37 are rejected under 35 U.S.C. 101.
Regarding Independent Claim 28, claim 28 is rejected under 35 U.S.C 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. Claim 28 is directed a method “for determining, over the course of time, a region in which an actual concentration is located, in a medium, of a substrate made up of any molecule able to undergo catalyzed oxidation-reduction by a catalyst, the method comprising: comparing all the signal values produced by all the biosensors, if all signal values in each group are equal, the concentration of the substrate is less than or equal to a lowest separation concentration; if all the signal values are different in all groups, the concentration of the substrate is higher than a highest separation concentration; if a part of the at least two biosensors in a group has the same signal values, the concentration of the substrate is less than or equal to a lowest separation concentration of the at least two biosensors in that part and greater than the separation concentration of the biosensor with a next lowest separation concentration in the relevant group; if in one part of the at least two groups of biosensors all biosensors in a group have the same signal value and in the remaining part of the at least two groups all biosensors in each group have a different signal value, the concentration is less than or equal to the lowest separation concentration of the group of the part of groups with the same signal values in each group, and greater than the highest separation concentration of the group of the part of groups with different signal values in each group”. Determining the actual concentration by comparing all signal values of multiple biosensors based on their signals is an abstract idea in the form of a mental step. The additional steps of “taking at least two groups of at least biosensors in each group, each biosensor having a calibration curve of a signal induced by the oxidation reduction reaction: the at least two biosensors in a group having identical initial portions of their calibration curves up to a concentration value of the substrate, referred to as a separation concentration, from which a measurement of the signal differs from one biosensor in the group to another; measuring the signal induced by the oxidation or reduction reaction for each of the biosensors in the at least two groups” are steps to gather data and are insignificant steps. Section 2106.04(a)(2) of MPEP states: “Certain Methods of Organizing Human Activity, including managing relationships and legal obligations, advertising and marketing, managing human behavior, and collecting, analyzing, classifying, and storing data” is directed to an abstract idea.
Claim 1 is Ineligible due to the following analysis:
Step 1 (Statutory Category): Claim 28 is directed to “a method for determining…an actual concentration…of any molecule”, therefore, it is directed to a statutory category, i.e., a method/process (Step 1: YES).
Step 2A, Prong-1 (the claim is evaluated to determine whether it is directed to a judicial-exception/abstract-idea): Claim 28 recites: “for determining, over the course of time, a region in which an actual concentration is located, in a medium, of a substrate made up of any molecule able to undergo catalyzed oxidation-reduction by a catalyst, the method comprising: comparing all the signal values produced by all the biosensors, if all signal values in each group are equal, the concentration of the substrate is less than or equal to a lowest separation concentration; if all the signal values are different in all groups, the concentration of the substrate is higher than a highest separation concentration; if a part of the at least two biosensors in a group has the same signal values, the concentration of the substrate is less than or equal to a lowest separation concentration of the at least two biosensors in that part and greater than the separation concentration of the biosensor with a next lowest separation concentration in the relevant group; if in one part of the at least two groups of biosensors all biosensors in a group have the same signal value and in the remaining part of the at least two groups all biosensors in each group have a different signal value, the concentration is less than or equal to the lowest separation concentration of the group of the part of groups with the same signal values in each group, and greater than the highest separation concentration of the group of the part of groups with different signal values in each group, where “determining” and “comparing” are abstract ideas in the form of a mental step. Therefore, it is directed to a judicial exception/abstract-idea (Step 2A, Prong-1: YES).
Step 2A, Prong-2 (the claim is evaluated to determine whether the judicial-exception/abstract-idea is integrated into a Practical Application): the abstract ideas related to “determining, over the course of time, a region in which an actual concentration is located” and “comparing all the signal values produced by all the biosensors”, are not used into a practical application, and do not belong to a particular technological environment, industry or field since nothing is done after the mental step. Consequently, the aforesaid abstract idea is not integrated into a practical application and/or apply, rely on, and/or use to an additional step or steps in a manner that imposes a meaningful limit, thus, monopolizing the steps (Step 2A, Prong-2: NO, because there is no integration of the abstract idea into a practical application).
Step 2B (the claim is evaluated to determine whether recites additional elements that amount to an inventive concept, or also, the additional elements are significantly more than the recited the judicial-exception/abstract-idea): Claim 28 recites the additional step(s): “taking at least two groups of at least biosensors in each group, each biosensor having a calibration curve of a signal induced by the oxidation reduction reaction: the at least two biosensors in a group having identical initial portions of their calibration curves up to a concentration value of the substrate, referred to as a separation concentration, from which a measurement of the signal differs from one biosensor in the group to another; the at least two biosensors in different groups having different calibration curves, without having identical initial portions between the groups; placing all the biosensors in contact with the medium; measuring the signal induced by the oxidation or reduction reaction for each of the biosensors in the at least two groups”, which are known to one of ordinary skill that only serves to collect/gather the data of the analyte signal, which is then used to perform the mental step of “determining” the concentration of the substrate. Section 2106.04(a)(2) of MPEP states “Certain Methods of Organizing Human Activity, including managing relationships and legal obligations, advertising and marketing, managing human behavior, and collecting, analyzing, classifying, and storing data” is directed to an abstract idea. Therefore, the additional steps of data collecting, “placing the biosensors in contact with the medium”, and “measuring the signal induced by the oxidation or reduction reaction for each of the biosensors…” does not include additional element(s) significantly more, and/or, does not amount to more than the judicial-exception/abstract-idea itself and the claim is not patent eligible (Step 2B: NO).
Regarding dependent claims 29-37, claims 29-37 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. Claims 29-37 depend on the independent claim 28, therefore, have the abstract idea of claim 28.
Claim 29 recites “wherein the signal is an electrochemical signal” and “each biosensor of the at least two biosensors of each group then comprising a working electrode, a reference electrode, and a counter-electrode…the electrochemical signal being either an intensity of the current or a potential difference between the working electrode and the reference electrode during the oxidation-reduction reaction of the substrate”. Measuring electrochemical signal using a biosensor comprising a working electrode, reference electrode and counter-electrode is well known in the art as taught by Murase (see claim 29 rejection in Non-final dated 12/18/2025 ). Furthermore, the additional structural elements are used to measure the signal which is further used to perform the abstract idea, and the determined concentration of the substrate is not further used.
Claim 30 recites limitations related to the material the electrodes are made of (gold, carbon, or platinum), which are well known materials for biosensors and taught by Murase (see claim 30 rejection in Non-final dated 12/18/2025).
Claim 31-33 further limit catalyst (Claim 31- catalyst is an enzymatic or chemical catalyst; Claim 32- a mediator is associated with the enzymatic catalyst; Claim 33- a substrate transporter), which are well known in the art (see rejections of Claims 31-33 in Non-final dated 12/18/2025), and the concentration of the substrate determined from the abstract idea is not used in claims 31-33.
Claim 34 recites “wherein the at least two biosensors of each group differ in at least one parameter selected from: p1: the amount of the catalyst; p2: the Michaelis constant of the catalyst, in case the catalyst is an enzymatic catalyst or the saturation limit of the catalyst in case the catalyst is a chemical catalyst; p3: the amount of a mediator of the catalyst, if present, in case the catalyst is an enzymatic catalyst; or p4: the Michaelis constant of a substrate transporter if present”, which is just a way to generate different signals from the biosensors and used only to gather data.
Claim 35, claim 35 denotes the biosensors in groups and recites “between each biosensor in a group, a parameter selected from p1 to p4 is varied; and between the biosensors of two different groups, another of these parameters p1 to p4 is varied”, which is just a way to generate different signals from the biosensors and used only to gather data, as well as to group the data by biosensor.
Claim 36 recites “the substrate is glucose; the catalyst is an enzymatic catalyst selected from a glucose oxidase, a glucose dehydrogenase, and a cellobiose dehydrogenase”, which is a biosensor used to measure glucose well known in the art by Murase (see claim 36 rejection in Non-final dated 12/18/2025).
Claim 37 recites “the substrate is lactate; the catalyst is an enzymatic catalyst selected from a lactate oxidase or a lactate dehydrogenase”, which is a biosensor used to measure glucose well known in the art by Weigelt (see claim 37 rejection in Non-final dated 12/18/2025).
In summary, dependent claims 29-37 do not include additional steps that are sufficient to amount to significantly more than the judicial exception.
Response to Arguments
Applicant's arguments, see Remarks pgs. 11-17, filed 04/17/2026, with respect to the 35 U.S.C. 101 and 35 U.S.C 103 rejections and amended claims have been fully considered.
Applicant’s Argument #1:
Applicant argues on pages 11-14 that the 101 rejection is traversed as at least the claim steps of “placing all the biosensors in contact with the medium; measuring the signal induced by the oxidation or reduction reaction for each of the biosensors in the group or groups” as these steps cannot be performed by the human mind or with pen and paper. In addition, the claim should be evaluated as a whole whether the claim integrates the recited judicial exceptions into a practical application of the exception in Step 2A, Prong 2. The involvement of the groups of biosensors, which can provide a self-calibration function is more than just a field of use or other insignificant limitations. The groups of biosensors are a particular machine that performs the measurements and determination of the concentration range in a meaningful way that integrates the alleged mental process into a practical application. This allows for improvement of concentration measurements over time.
Examiner’s Response #1:
Applicant’s arguments have been fully considered, but are not persuasive. First, the claim steps of “placing all the biosensors in contact with the medium; measuring the signal induced by the oxidation or reduction reaction for each of the biosensors in the group or groups” are steps to gather data and are insignificant steps. Section 2106.04(a)(2) of MPEP states: “Certain Methods of Organizing Human Activity, including managing relationships and legal obligations, advertising and marketing, managing human behavior, and collecting, analyzing, classifying, and storing data” is directed to an abstract idea. In addition, comparing all the signal values produced by all the biosensors is a mental step and can be done by the human mind, and independent claim 28 does not limit the “comparing all the signal values produced by all the biosensors” step to a structural component of the at least two groups of at least two biosensors via, for example, a computer or processor. In addition, although there may be benefits of self-calibration of biosensors using the method recited in independent claim 28, no additional steps incorporating the “comparing all the signal values produced by all the biosensors” are recited in claim 28. Thus, the 35 U.S.C. 101 rejection is maintained.
Applicant’s Argument #2:
Applicant argues on pages 14-17 that the prior art reference of Murase does not disclose identical portions of the calibration curves, as both curves of Murase begin at (0,0) and then separate at (0,0), nor disclose the at least two groups of biosensors.
Examiner’s Response #2:
Applicant’s arguments have been fully considered. Although Applicant argues Murase does not disclose identical portions of the calibration curves, Figure 5 of Murase shows sensor output (nA/mm2) vs glucose concentration (mg/dl), with a glucose concentration ranging from 0-150 mg/dl, whereas the instant application uses a current (µA) vs glucose concentration (nM) on the nanomolar scale from 0-20 nM. It would be obvious to one of ordinary skill in the art that the calibration curves for different types of GDH would remain the same or similar at very small glucose concentrations (nM) before deviating at larger glucose concentrations. However, Applicant’s arguments are convincing as Murase does not teach using at least two groups of biosensors. As such, the U.S.C 103 rejection has been withdrawn.
Conclusion
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.
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/R.L.G./Examiner, Art Unit 1795
/SHIZHI QIAN/Primary Examiner, Art Unit 1795
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