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 .
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, claim(s) 1-13, drawn to a reagent layer and an electrochemical sensor.
Group II, claim(s) 14-19, drawn to a method for forming a reagent layer.
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 and II lack unity of invention because even though the inventions of these groups require the technical feature of a reagent layer comprising a conductive carbon filler, an anionic dispersant, and a cationic mediator, these technical features are not special technical features as they do not make a contribution over the prior art in view of Haneda et al. (JP 2021082394 A) (provided in Applicant’s IDS filed on January 9, 2026 and references herein made with respect to the provided English machine translation) and further in view of Hiraishi et al. (JP 2015128006 A) (provided in Applicant’s IDS filed on January 9, 2026 and references herein made with respect to the provided English machine translation).
Haneda teaches a reagent layer (a reagent layer, Haneda, para. [0015]) comprising: a conductive carbon filler (a conductive carbon filler, Haneda, para. [0015]), a dispersant (a cellulose derivative which improves the dispersibility and dispersion stability of the conductive carbon filler, Haneda, para. [0015], [0023]), and a cationic mediator (a mediator that mediates electron transfer and is responsible for transferring electrons, Haneda, para. [0015], [0021]; Examiner interprets the mediator to be cationic since it mediates electron transfer and is responsible for transferring electrons).
Haneda teaches the cellulose derivative which improves the dispersibility and dispersion stability of the conductive carbon filler (Haneda, para. [0015], [0023]), but fails to teach that the dispersant is anionic.
Hiraishi teaches an aqueous conductive paste comprising a carbon material, a dispersant, and an aqueous medium (Hiraishi, abstract). Hiraishi teaches that the dispersant contains an anionic polymer dispersant having a weight average molecular weight of 5000 to 100000 to achieve both high conductivity and low viscosity of the conductive paste (Hiraishi, abstract, para. [0011]-[0012], [0025], [0027]). Hiraishi teaches that the monomers in the anionic polymer dispersant have an acidic group such as carboxylic acid or sulfonic acid and may be selected from acrylic acid, maleic acid, and styrenesulfonic acid (Hiraishi, para. [0028]-[0029]).
It would have been obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to substitute the cellulose derivative dispersant of Haneda with an anionic polymer dispersant having a weight average molecular weight of 5000 to 100000 and comprising monomers of acrylic acid, maleic acid, or styrenesulfonic acid as taught by Hiraishi in order to yield the predictable result of dispersing the carbon material while achieving both high conductivity and low viscosity of the mixture. Simple substitution of one known element for another is likely to be obvious when predictable results are achieved. See KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 82 U.S.P.Q.2d 1385 (2007); MPEP § 2143(I)(B). Furthermore, the selection of a known material, which is based upon its suitability for the intended use, is within the ambit of one of ordinary skill in the art. MPEP § 2144.07.
During a telephone conversation with Amy Schmid on September 25, 2026 a provisional election was made without traverse to prosecute the invention of Group I, claims 1-13. Affirmation of this election must be made by applicant in replying to this Office action. Claims 14-19 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.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
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 4 and 10 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.
Claim 4 recites the limitation “a polymer” in lines 1-2 of the claim. It is unclear whether “a polymer” in claim 4 is the same as or different from the previously recited “a polymer” in claim 3. For the purpose of examination, Examiner interprets them to be the same.
Claim 10 recites the limitation "the cationic polymer (c2)" in line 2 of the claim. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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 1-5, 7-8, and 10-13 are rejected under 35 U.S.C. 103 as being unpatentable over Haneda et al. (JP 2021082394 A) (provided in Applicant’s IDS filed on January 9, 2026 and references herein made with respect to the provided English machine translation) in view of Hiraishi et al. (JP 2015128006 A) (provided in Applicant’s IDS filed on January 9, 2026 and references herein made with respect to the provided English machine translation).
Regarding claim 1, Haneda teaches a reagent layer (a reagent layer, Haneda, para. [0015]) comprising: a conductive carbon filler (a) (a conductive carbon filler, Haneda, para. [0015]), a dispersant (b) (a cellulose derivative which improves the dispersibility and dispersion stability of the conductive carbon filler, Haneda, para. [0015], [0023]), and a cationic mediator (c) (a mediator that mediates electron transfer and is responsible for transferring electrons, Haneda, para. [0015], [0021]; Examiner interprets the mediator to be cationic since it mediates electron transfer and is responsible for transferring electrons).
Haneda teaches the cellulose derivative which improves the dispersibility and dispersion stability of the conductive carbon filler (Haneda, para. [0015], [0023]), but fails to teach that the dispersant is anionic.
Hiraishi teaches an aqueous conductive paste comprising a carbon material, a dispersant, and an aqueous medium (Hiraishi, abstract). Hiraishi teaches that the dispersant contains an anionic polymer dispersant having a weight average molecular weight of 5000 to 100000 to achieve both high conductivity and low viscosity of the conductive paste (Hiraishi, abstract, para. [0011]-[0012], [0025], [0027]). Hiraishi teaches that the monomers in the anionic polymer dispersant have an acidic group such as carboxylic acid or sulfonic acid and may be selected from acrylic acid, maleic acid, and styrenesulfonic acid (Hiraishi, para. [0028]-[0029]).
It would have been obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to substitute the cellulose derivative dispersant of Haneda with an anionic polymer dispersant having a weight average molecular weight of 5000 to 100000 and comprising monomers of acrylic acid, maleic acid, or styrenesulfonic acid as taught by Hiraishi in order to yield the predictable result of dispersing the carbon material while achieving both high conductivity and low viscosity of the mixture. Simple substitution of one known element for another is likely to be obvious when predictable results are achieved. See KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 82 U.S.P.Q.2d 1385 (2007); MPEP § 2143(I)(B). Furthermore, the selection of a known material, which is based upon its suitability for the intended use, is within the ambit of one of ordinary skill in the art. MPEP § 2144.07.
Regarding claim 2, Modified Haneda teaches wherein the anionic dispersant (b) is a polymer having a weight-average molecular weight of 70000 or smaller (the anionic polymer dispersant has a weight average molecular weight of 5000 to 100000, Hiraishi, abstract, para. [0012], [0025], [0027], see modification supra). Furthermore, in the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). MPEP § 2144.05(I).
Regarding claim 3, Modified Haneda teaches wherein the anionic dispersant (b) is a polymer having a carboxy group and/or a sulfo group at a side chain (the monomers in the anionic polymer dispersant have an acidic group such as carboxylic acid or sulfonic acid, Hiraishi, para. [0028]-[0029], see modification supra).
Regarding claim 4, Modified Haneda teaches wherein the anionic dispersant (b) is a polymer comprising at least one member selected from the group consisting of an acrylic acid- derived unit, a maleic acid-derived unit, and a styrenesulfonic acid-derived unit (the monomers in the anionic polymer dispersant may be selected from acrylic acid, maleic acid, and styrenesulfonic acid, Hiraishi, para. [0028]-[0029], see modification supra).
Regarding claim 5, Modified Haneda teaches wherein the cationic mediator (c) is a compound in which a redox mediator compound (c1) and a cationic polymer (c2) are bound to each other optionally via a linker moiety (c3) (the mediator that mediates electron transfer is a polymerized mediator in which the redox mediator is bound to a polymer via a covalent bond, Haneda, para. [0021], [0030]-[0031]). Examiner further notes that Applicant has written the limitation “optionally via a linker moiety (c3)” as optional, so it is given negligible patentable weight.
Regarding claim 7, Modified Haneda teaches wherein the conductive carbon filler (a) is carbon black (the conductive carbon filler includes carbon black, Haneda, para. [0012]).
Regarding claim 8, Modified Haneda teaches an oxidoreductase (e) that oxidizes or reduces an analyte (an oxidoreductase that oxidizes or reduces an analyte in an oxidation-reduction reaction, Haneda, para. [0015], [0021], [0028]).
Regarding claim 10, Modified Haneda teaches wherein the oxidoreductase (e) is cross- linked to the cationic polymer (c2) (the oxidoreductase and the polymerized cationic mediator polymer with covalent bonds are mixed in a solution and dried to form the reagent layer, Haneda, para. [0015], [0019], [0021], [0030]-[0031], [0082]-[0084]).
Regarding claim 11, Modified Haneda teaches an electrochemical sensor for detecting or quantifying an analyte, the electrochemical sensor having a working electrode, a counter electrode, and the reagent layer according to claim 1 (an electrochemical biosensor for detecting analytes, the biosensor comprising a working electrode, a counter electrode, and the reagent layer of claim 1 formed in contact with the working electrode, Haneda, para. [0025]-[0026], [0087], [0098], see rejection of claim 1 supra).
Regarding claim 12, Modified Haneda teaches a reference electrode (a reference electrode, Haneda, para. [0025], [0087], [0098]).
Regarding claim 13, Modified Haneda teaches a protective film with which at least the reagent layer is coated (a protective film which covers the reagent layer, Haneda, para. [0019]-[0020]).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Haneda in view of Hiraishi as applied to claim 5 above, and further in view of Shimomura et al. (JP 2009294038 A) (provided in Applicant’s IDS filed on January 9, 2026 and references herein made with respect to the provided English machine translation).
Regarding claim 6, Modified Haneda teaches that the mediator that mediates electron transfer is a polymerized mediator in which the redox mediator is bound to a polymer via a covalent bond (Haneda, para. [0021], [0030]-[0031]). Modified Haneda fails to teach wherein the cationic polymer (c2) has a quaternary ammonium cation group.
Shimomura teaches an enzyme sensor containing an electron carrier 200 which is a compound having a structure which has a quaternary ammonium base as a side chain (Shimomura, abstract). Shimomura teaches that a decrease in enzyme activity can be suppressed by using, as the electron carrier, a compound with a structure having a quaternary ammonium base as a side chain, and therefore the enzyme sensor may have excellent long-term stability (Shimomura, para. [0005], [0111]).
It would have been obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to modify the polymer of the cationic mediator of Modified Haneda to include a quaternary ammonium base as a side chain as taught by Shimomura because it would suppress a decrease in enzyme activity and thus achieve excellent long-term stability of the sensor.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Haneda in view of Hiraishi as applied to claim 8 above, and further in view of Nakagawa et al. (US 2015/0280266 A1) (listed in Applicant’s IDS filed on January 9, 2025).
Regarding claim 9, Modified Haneda teaches the oxidoreductase (the oxidoreductase that oxidizes or reduces an analyte in an oxidation-reduction reaction, Haneda, para. [0015], [0021], [0028]). Modified Haneda fails to teach wherein the oxidoreductase (e) is bound to a coenzyme.
Nakagawa teaches an enzyme immobilization electrode capable of easily immobilizing an enzyme while retaining activity (Nakagawa, abstract). Nakagawa teaches that the enzyme usually includes, in addition thereto, a coenzyme oxidase which returns to an oxidant a coenzyme reduced by the oxidase, and by action of the coenzyme oxidase, an electron is generated when the coenzyme returns to the oxidant, and the electron is delivered to the electrode through an electron mediator from the coenzyme oxidase (Nakagawa, Fig. 12, para. [0045], [0081], [0145], [0155]). Nakagawa teaches that the enzyme and the coenzyme are immobilized on the electrode (Nakagawa, Fig. 12, para. [0081], [0145], [0147], [0155]).
It would have been obvious for one having ordinary skill in the art before the effective filing date of the claimed invention to modify the oxidoreductase of Modified Haneda to be bound to a coenzyme as taught by Nakagawa in order to yield the predictable result of facilitating an oxidation-reduction reaction of the analyte. Furthermore, the claimed limitations are obvious because all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results. MPEP § 2143(I)(A). See also MPEP § 2143(I)(C), 2143(I)(D).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to VIVIAN A TRAN whose telephone number is (571)272-3232. The examiner can normally be reached Mon - Fri 9am-5pm.
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/V.T./ Examiner, Art Unit 1794
/JAMES LIN/ Supervisory Patent Examiner, Art Unit 1794
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