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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12/12/2022 has been considered by the examiner.
Election/Restrictions
REQUIREMENT FOR UNITY OF INVENTION
As provided in 37 CFR 1.475(a), a national stage application shall relate to one invention only or to a group of inventions so linked as to form a single general inventive concept (“requirement of unity of invention”). Where a group of inventions is claimed in a national stage application, the requirement of unity of invention shall be fulfilled only when there is a technical relationship among those inventions involving one or more of the same or corresponding special technical features. The expression “special technical features” shall mean those technical features that define a contribution which each of the claimed inventions, considered as a whole, makes over the prior art.
The determination whether a group of inventions is so linked as to form a single general inventive concept shall be made without regard to whether the inventions are claimed in separate claims or as alternatives within a single claim. See 37 CFR 1.475(e).
When Claims Are Directed to Multiple Categories of Inventions:
As provided in 37 CFR 1.475 (b), a national stage application containing claims to different categories of invention will be considered to have unity of invention if the claims are drawn only to one of the following combinations of categories:
(1) A product and a process specially adapted for the manufacture of said product; or
(2) A product and a process of use of said product; or
(3) A product, a process specially adapted for the manufacture of the said product, and a use of the said product; or
(4) A process and an apparatus or means specifically designed for carrying out the said process; or
(5) A product, a process specially adapted for the manufacture of the said product, and an apparatus or means specifically designed for carrying out the said process.
Otherwise, unity of invention might not be present. See 37 CFR 1.475 (c).
Restriction is required under 35 U.S.C. 121 and 372.
This application contains the following inventions or groups of inventions which are not so linked as to form a single general inventive concept under PCT Rule 13.1.
In accordance with 37 CFR 1.499, applicant is required, in reply to this action, to elect a single invention to which the claims must be restricted.
Group I, Claims 28-37, drawn to a method for determining a region in which the actual concentration is located.
Group II, Claims 38-54, drawn to a device.
The groups of inventions listed above do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2, they lack the same or corresponding special technical features for the following reasons:
Groups I-II lack unity of invention because even though the inventions of these groups require the technical feature of a method of claim 28.
This technical feature is not a special technical feature as it does not make a
contribution over the prior art in view of Murase (US 2011/0259741 A1).
Murase teaches a method for determining, in a stable manner over the course of time, a region in which the actual concentration is located (monitoring apparatus 1 is used for automatically continuously measuring a glucose concentration [para. 0056]), in a medium (glucose is from blood or interstitial liquid [para. 0056]), of a substrate made up of any molecule likely to undergo catalyzed oxidation-reduction by a catalyst (substrate that can undergo catalyzed oxidation is glucose [para. 0056]),
wherein the method comprises the following steps:
taking at least one group of at least two biosensors (glucose sensor 4 includes electrode 42, which contains first working electrode 42A and second working electrode 42B [para. 0070]), each biosensor having a calibration curve of the signal induced by the oxidation-reduction reaction (in one embodiment, enzyme-immobilized portion 43A and second enzyme-immobilized portion 43B of biosensor of glucose sensor 4 [para. 0094-0095], each of which have calibration curves [para. 0097]):
the biosensors in a group having identical initial portions of their calibration curves up to a concentration value of the substrate (as seen in Fig. 5, calibration curve for first working electrode 42A with Wild GDH and the calibration curve for the second working electrode 42B with Mutant GDH both begin at a glucose concentration of 0 mg/dl), referred to as the separation concentration, from which the measurement of the signal differs from one biosensor in the group to another (as illustrated in Fig. 5, calibration curves for first working electrode 42A and 42B differ as the glucose concentration is increased);
placing the biosensors in contact with the medium (glucose concentration is measured using first enzyme-immobilized electrode 42A and second working electrode 42B [paras. 0096, 0103]);
measuring the signal induced by the oxidation or reduction reaction for each of the biosensors in the group (as illustrated in Figs. 7 and 8, signal is measured by both the firs working electrode 42A and second working electrode 42B [para. 0104]); comparing all the signal values produced by all the biosensors (signal value currents are measured from first working electrode 42A and second working electrode 42B [para. 0080], and a control unit 12 compares the first response current and the second response current [para. 0083]);
the limitation “in the case of a single group of biosensors: if all signal values are equal, the concentration of the substrate is less than or equal to the lowest separation concentration; if all signal values are different, the concentration of the substrate is higher than the highest separation concentration; if a part of the biosensors have the same signal values, the concentration of the substrate is less than or equal to the lowest separation concentration of the biosensors in that part and greater than the separation concentration of the biosensor with the next lowest separation concentration” is an intended result of a positively recited step. The court noted that a "‘whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.’" Id. (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)). In addition, comparing all the signal values from the biosensors to determine whether the concentration of the substrate is greater than, less than, or equal to the separation concentration based on the signal values from the biosensors is a mental step.
A telephone call was made to Attorney Joel Armstrong (Reg #36,430) on 11/24/2025 to request an oral election, a provision election via telephone was made on 11/25/2025 with traverse to prosecute Group I, Claims 28-37. Affirmation of this election must be made by applicant in replying to this Office action. Claims 38-54 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
The examiner has required restriction between product or apparatus claims and process claims. Where applicant elects claims directed to the product/apparatus, and all product/apparatus claims are subsequently found allowable, withdrawn process claims that include all the limitations of the allowable product/apparatus claims should be considered for rejoinder. All claims directed to a nonelected process invention must include all the limitations of an allowable product/apparatus claim for that process invention to be rejoined.
In the event of rejoinder, the requirement for restriction between the product/apparatus claims and the rejoined process claims will be withdrawn, and the rejoined process claims will be fully examined for patentability in accordance with 37 CFR 1.104. Thus, to be allowable, the rejoined claims must meet all criteria for patentability including the requirements of 35 U.S.C. 101, 102, 103 and 112. Until all claims to the elected product/apparatus are found allowable, an otherwise proper restriction requirement between product/apparatus claims and process claims may be maintained. Withdrawn process claims that are not commensurate in scope with an allowable product/apparatus claim will not be rejoined. See MPEP § 821.04. Additionally, in order for rejoinder to occur, applicant is advised that the process claims should be amended during prosecution to require the limitations of the product/apparatus claims. Failure to do so may result in no rejoinder. Further, note that the prohibition against double patenting rejections of 35 U.S.C. 121 does not apply where the restriction requirement is withdrawn by the examiner before the patent issues. See MPEP § 804.01.
Claim Objections
Claims 28-32 and 34-35 are objected to because of the following informalities:
Claim 28, please amend “a region in which the actual concentration” to a region in which an actual concentration”; “curve of the signal induced” to “curve of a signal induced”; “the biosensors “ to “the at least two biosensors”; “the separation concentration” to “[[the]] a separation concentration”; “the measurement of the signal“ to “[[the]] a measurement of [[the]] a signal“; “when more than one group is present” to “when more than one group of the at least two biosensors is present”; “placing the biosensors in contact” to “placing all the biosensors in contact”; “a single group of biosensors” to “a single group of the at least two biosensors”; “if a part of the biosensors has the same” to “if a part of the at least two biosensors has the same”; “in the case of more than one group of biosensors” to “in the case of more than one group of the at least two biosensors”; “if a part of the biosensors in a group” to “if a part of the at least two biosensors in a group”; “all signal values” to “all the signal values”.
Claim 29, please amend “each biosensor” to “each biosensor of the at least two biosensors”; “this current” to “the .
Claim 30, please amend “each biosensor” to “each biosensor of the at least two biosensors”.
Claim 31, please amend “A process according to claim 29” to “The method according to claim 29”.
Claim 32, please amend “The process according to claim 31” to “The method according to claim 31”; “an enzymatic catalyst” to “[[an]] the enzymatic catalyst”.
Claim 34, please amend “the biosensors” to “the at least two biosensors”; “the amount of catalyst” to “the amount of the catalyst”.
Claim 35, please amend “wherein the biosensors are” to “wherein the at least two biosensors are”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 28-37 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding Claim 28, the limitations “any molecule likely to undergo catalyzed oxidation-reduction by a catalyst” and “in a stable manner” are unclear as the phrases “likely” and “stable” are relative terminology. Thus, the scope of the claim is unclear. In addition, “the lowest separation concentration”, “the highest separation concentration”, “the next lowest separation concentration”, “the biosensor with the next lowest separation concentration in the relevant group” lack antecedent basis.
The limitations “the concentration of the substrate is less than or equal to the lowest separation concentration of the group of groups with the same signal value in each group, and greater than the highest separation concentration of the group or groups with different signal values in each group” are also not clear as the underlined limitations are difficult to determine exactly what biosensors each phrase refers too. Claims 29-37 are further rejected by virtue of their dependence upon and because they fail to cure the deficiencies of indefinite claim 28.
Regarding Claim 29, the limitations “the potential difference” and “the electrodes” lack antecedent basis. Claims 30-32 are further rejected by virtue of their dependence upon and because they fail to cure the deficiencies of indefinite claim 29.
Regarding Claim 30, it is unclear if the limitation “the reference electrode is a platinum, gold or diamond electrode and the reference electrode is a silver chloride electrode” should read “the
Regarding Claim 33, the limitation “arranged on the biosensor or biosensors” is unclear as “the biosensor or biosensors” could refer to all biosensors, biosensors of a specific group, or only some biosensors in a group”.
Regarding Claim 36, the limitations “the enzymatic catalyst mediator” and “the substrate transporter” lack antecedent basis.
Regarding Claim 37, the limitations “the enzymatic catalyst mediator” and “the substrate transporter” lack antecedent basis.
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 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, in a stable manner over the course of time, a region in which the actual concentration is located, in a medium, of a substrate made up of any molecule likely to undergo catalyzed oxidation-reduction by a catalyst, the method comprising: comparing all the signal values produced by all the biosensors, and in the case of a single group of biosensors: if all signal values are equal, the concentration of the substrate is less than or equal to the lowest separation concentration; if all signal values are different, the concentration of the substrate is higher than the highest separation concentration; if part of the biosensors has the same signal values, the concentration of the substrate is less than or equal to the lowest separation concentration of the biosensors in that part and greater than the separation concentration of the biosensor with the next lowest separation concentration; and in the case of more than one group of biosensors: if all signal values in each group are equal, the concentration of the substrate is less than or equal to the lowest separation concentration; if all signal values are different in all groups, the concentration of the substrate is higher than the highest separation concentration; if a part of the biosensors in a group has the same signal values, the concentration of the substrate is less than or equal to the lowest separation concentration of the biosensors in that part and greater than the separation concentration of the biosensor with the next lowest separation concentration in the relevant group; if in one part of the groups of biosensors all biosensors in a group have the same signal value and in the remaining part all biosensors in a group have a different signal value, the concentration is less than or equal to the lowest separation concentration of the group of groups with the same signal values in each group, and greater than the highest separation concentration of the group or 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 one group of at least biosensors, each biosensor having a calibration curve of the signal induced by the oxidation reduction reaction: the biosensors in a group having identical initial portions of their calibration curves up to a concentration value of the substrate, referred to as the separation concentration, from which the 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 group or groups” is known as evidenced by Murase (US 2011/0259741 A1) in the rejection of claim 28 below. Furthermore, the additional step is to gather data and is insignificant step. 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…the 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, in a stable manner over the course of time, a region in which the actual concentration is located, in a medium, of a substrate made up of any molecule likely to undergo catalyzed oxidation-reduction by a catalyst, the method comprising…comparing all the signal values produced by all the biosensors, and in the case of a single group of biosensors: if all signal values are equal, the concentration of the substrate is less than or equal to the lowest separation concentration; if all signal values are different, the concentration of the substrate is higher than the highest separation concentration; if part of the biosensors has the same signal values, the concentration of the substrate is less than or equal to the lowest separation concentration of the biosensors in that part and greater than the separation concentration of the biosensor with the next lowest separation concentration; and in the case of more than one group of biosensors: if all signal values in each group are equal, the concentration of the substrate is less than or equal to the lowest separation concentration; if all signal values are different in all groups, the concentration of the substrate is higher than the highest separation concentration; if a part of the biosensors in a group has the same signal values, the concentration of the substrate is less than or equal to the lowest separation concentration of the biosensors in that part and greater than the separation concentration of the biosensor with the next lowest separation concentration in the relevant group; if in one part of the groups of biosensors all biosensors in a group have the same signal value and in the remaining part all biosensors in a group have a different signal value, the concentration is less than or equal to the lowest separation concentration of the group of groups with the same signal values in each group, and greater than the highest separation concentration of the group or 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, in a stable manner over the course of time, a region in which the 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 one group of at least two biosensors, each biosensor having a calibration curve of the signal induced by the oxidation-reduction reaction: the biosensors in a group having identical initial portions of their calibration curves up to a concentration value of the substrate, referred to as the separation concentration, from which the measurement of the signal differs from one biosensor in the group to another; and when more than one group is present, the biosensors in different groups having different calibration curves, without having identical initial portions; placing the biosensors in contact with the medium”; “placing 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”, 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 then comprising a working electrode, a reference electrode, and a counter-electrode…the electrochemical signal being either the intensity of this current or the potential difference between the electrodes 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 below). 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 below).
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 below), and the concentration of the substrate determined from the abstract idea is not used in claims 31-33.
Claim 34 recites “wherein the biosensors of each group differ in at least one parameter selected from: p1: the amount of 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 below).
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 below).
In summary, dependent claims 29-37 do not include additional steps that are sufficient to amount to significantly more than the judicial exception.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 28-31 and 34-36 are rejected under 35 U.S.C. 103 as being unpatentable over Murase (US 2011/0259741 A1).
Regarding Claim 28, Murase teaches a method for determining, in a stable manner over the course of time, a region in which the actual concentration is located (monitoring apparatus 1 is used for automatically continuously measuring a glucose concentration [para. 0056]), in a medium (glucose is from blood or interstitial liquid [para. 0056]), of a substrate made up of any molecule likely to undergo catalyzed oxidation-reduction by a catalyst (substrate that can undergo catalyzed oxidation is glucose [para. 0056]),
wherein the method comprises the following steps:
taking at least one group of at least two biosensors (glucose sensor 4 includes electrode 42, which contains first working electrode 42A and second working electrode 42B [para. 0070]), each biosensor having a calibration curve of the signal induced by the oxidation-reduction reaction (in one embodiment, enzyme-immobilized portion 43A and second enzyme-immobilized portion 43B of biosensor of glucose sensor 4 [para. 0094-0095], each of which have calibration curves [para. 0097]):
the biosensors in a group having identical initial portions of their calibration curves up to a concentration value of the substrate (as seen in Fig. 5, calibration curve for first working electrode 42A with Wild GDH and the calibration curve for the second working electrode 42B with Mutant GDH both begin at a glucose concentration of 0 mg/dl), referred to as the separation concentration, from which the measurement of the signal differs from one biosensor in the group to another (as illustrated in Fig. 5, calibration curves for first working electrode 42A and 42B differ as the glucose concentration is increased);
placing the biosensors in contact with the medium (glucose concentration is measured using first enzyme-immobilized electrode 42A and second working electrode 42B [paras. 0096, 0103]);
measuring the signal induced by the oxidation or reduction reaction for each of the biosensors in the group (as illustrated in Figs. 7 and 8, signal is measured by both the firs working electrode 42A and second working electrode 42B [para. 0104]);
comparing all the signal values produced by all the biosensors (signal value currents are measuring from first working electrode 42A and second working electrode 42B [para. 0080], and a control unit 12 compares the first response current and the second response current [para. 0083]);
the limitation “in the case of a single group of biosensors: if all signal values are equal, the concentration of the substrate is less than or equal to the lowest separation concentration; if all signal values are different, the concentration of the substrate is higher than the highest separation concentration; if a part of the biosensors have the same signal values, the concentration of the substrate is less than or equal to the lowest separation concentration of the biosensors in that part and greater than the separation concentration of the biosensor with the next lowest separation concentration” is an intended result of a positively recited step. The court noted that a "‘whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.’" Id. (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)). In addition, comparing all the signal values from the biosensors to determine whether the concentration of the substrate is greater than, less than, or equal to the separation concentration based on the signal values from the biosensors is a mental step.
Regarding Claim 29, Murase teaches the method according to claim 28.
Murase teaches wherein the signal is an electrochemical signal (electrochemical signal made by applying a voltage and measuring a signal [para. 0015]), each biosensor then comprising a working electrode (first working electrode 42A and second working electrode 42B [para. 0070]), a reference electrode (reference electrode 42D [para. 0070]), and a counter-electrode (counter electrode 42C [para. 0070]) between which a current induced by the oxidation or reduction reaction passes (potentiostat 3A measures a response current from first working electrode 42A and second working electrode 42B [para. 0077], which have enzyme-immobilized layers containing GDH [para. 0071]), the electrochemical signal being either the intensity of this current or the potential difference between the electrodes during the oxidation-reduction reaction of the substrate (output is the current as illustrated in Figures 11-14).
Regarding Claim 30, Murase teaches the method according to claim 29.
Murase teaches wherein for each biosensor the working electrode is a carbon, gold or platinum electrode (working electrodes can be made using Au [para. 0115]), the counter electrode is a platinum, gold or diamond electrode (counter electrode can be made using Au [para. 0115]) and the reference electrode is a silver chloride electrode (reference electrode is a silver-silver chloride [para. 0116]).
Regarding Claim 31, Murase teaches the method according to claim 29.
Murase teaches wherein the catalyst is an enzymatic catalyst (enzyme can be glucose oxidase or glucose dehydrogenase [para. 0019]).
Regarding Claim 34, Murase teaches the method according to claim 28.
Murase teaches wherein the biosensor of each group differ in at least one parameter selected from:
p2: the Michaelis constant of the catalyst, in case the catalyst is an enzymatic catalyst (the GDH applied to the first enzyme-immobilized portion 43A and the GDH applied to the second enzyme-immobilized portion 43B are different in their Michaelis constants Km [para. 0096]).
Regarding Claim 35, Murase teaches the method according to claim 34, wherein the biosensors (BC) are noted:
BC11….BC1i……BC1n… (Murase teaches two biosensors in a group BC11…BC12; illustrated in Figure 2),
between each biosensor in a group, a parameter selected from p1 to p4 is varied (the GDH applied to the first enzyme-immobilized portion 43A and the GDH applied to the second enzyme-immobilized portion 43B are different in their Michaelis constants Km [para. 0096]).
Regarding Claim 36, Murase teaches the method according to claim 28.
Murase teaches wherein;
the substrate is glucose (glucose sensor 4 measures glucose [para. 0058]);
the catalyst is an enzymatic catalyst selected from a glucose oxidase, a glucose dehydrogenase (enzyme can be glucose oxidase or glucose dehydrogenase [para. 0019]).
Claim 32 is rejected under 35 U.S.C. 103 as being unpatentable over Murase, as applied to claim 31 above, and in view of Nagata (A glucose sensor fabricated by the screen printing technique Biosensors & Bioelectronics 1995, 261-267).
Regarding Claim 32, Murase teaches the method according to claim 31.
Murase teaches in which the catalyst is an enzymatic catalyst (as outlined in the claim 31 rejection above, Murase teaches the enzyme can be glucose oxidase or glucose dehydrogenase [para. 0019]).
Murase is silent on wherein a mediator is associated with the enzymatic catalyst, the mediator being chosen from ferrocene, ferrocyanide, osmium complexes, quinone derivatives, and phenothiazine derivatives.
Nagata teaches a glucose sensor employing ferrocene-modified glucose oxidase (abstract), and teaches wherein a mediator is associated with the enzymatic catalyst (glucose oxidase is modified with ferrocene [second para. col. 2, page 262]), the mediator being ferrocene (glucose oxidase is modified with ferrocene [second para. col. 2, page 262]).
Murase and Nagata are considered analogous art to the claimed invention because they are in the same field of methods for detecting substrate concentration. It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the method of Murase to include a mediator associated with the enzymatic catalyst, the mediator being chosen from ferrocene, as taught by Nagata, as glucose oxidase modified by ferrocene allows for a high sensitivity to glucose (Nagata, [second para. col. 2, page 262]).
Claim 33 is rejected under 35 U.S.C. 103 as being unpatentable over Murase, as applied to claim 31 above, and in view of Takanaga (GLUT1 and GLUT9 as major contributors to glucose influx in HepG2 cells identified by a high sensitivity intramolecular FRET glucose sensor. Biochemica et Biophysica Acta 2008, 1091-1099).
Regarding Claim 33, Murase teaches the method according to claim 28.
Murase is silent on wherein a substrate transporter is arranged on the biosensor or biosensors.
Takanaga teaches genetically encoded FRET glucose nanosensors (abstract), and teaches wherein a substrate transporter is arranged on the biosensor or biosensors (GLUT1 and GLUT9 [second para. col. 2, page 1092], which were extracted and transferred onto nanosensors [fourth para. col. 2, page 1092]).
Murase and Takanaga are considered analogous art to the claimed invention because they are in the same field of methods for detecting glucose concentration. It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the method of Murase to include a substrate transporter arranged on the biosensor or biosensors, as taught by Murase, as using glucose transporters such as GLUT1 for glucose concentration measurements allows for improved sensitivity and dynamic range of the glucose nanosensor (Takanaga, [Conclusion, first para. col. 1 page 1099]).
Claim 37 is rejected under 35 U.S.C. 103 as being unpatentable over Murase, as applied to claim 28 above, and in view of Weigelt (Enzyme Sensor for the Determination of Lactate and Lactate Dehydrogenase Activity. Analyst 1987; 112, pages 1155-1158).
Regarding Claim 37, Murase teaches the method according to claim 28.
Murase is silent on the substrate is lactate;
the catalyst is an enzymatic catalyst selected from a lactate oxidase or a lactate dehydrogenase;
the enzymatic catalyst mediator, if present, is selected from ferrocene, ferrocyanide, osmium complexes, quinone derivatives, and phenothiazine derivatives;
the substrate transporter, if present, is a lactate transporter which is chosen from MCT1, MCT2, MCT3, MCT4.
Weigelt teaches an enzyme sensor for determination of lactate (abstract), and teaches the substrate is lactate (lactate [fourth para. col. 1, page 1155; second para. col. 1, page 1156]); the catalyst is lactate dehydrogenase (lactate dehydrogenase [fourth para. col. 1, page 1155]).
Murase and Weigelt are considered analogous art to the claimed invention because they are in the same field of methods for sensors detecting substrate concentration. It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to substitute the substrate glucose and enzymatic catalyst of Murase with the substrate of lactate and the enzymatic catalyst selected from a lactate oxidase or a lactate dehydrogenase, respectively, as taught by Weigelt, as using lactate dehydrogenase and lactate in an enzymatic sensor allow for rapid and accurate measurement in human plasma (Weigelt, [Conclusion, page 1158]).
Conclusion
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/R.L.G./Examiner, Art Unit 1795
/LUAN V VAN/Supervisory Patent Examiner, Art Unit 1795