DETAILED ACTION
Response to Amendment
This is a final office action in response to a communication filed on July 20, 2026. Claims 1-3 and 5-14 are pending in the application.
Status of Objections and Rejections
All rejections under 35 U.S.C. §103 are maintained.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1-3, 5-8, and 12-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shin (US 2023/0102721) in view of Park (KR 2014/0018168, machine translation used for citation).
Regarding claims 1 and 5, Shin teaches an electrical signal sensing composition (¶90: a sensing layer for an electrochemical biosensor), comprising:
an oxidoreductase (¶90: an enzyme; ¶91: oxidoreductase); and
an amphiphilic molecule (¶100: one or more kinds of additives, such as surfactant; ¶100: sodium dodecyl sulfate), comprising alkyl sulfate (sodium dodecyl sulfate is an alkyl sulfate and is an amphiphilic molecule).
Shin does not disclose wherein the oxidoreductase comprises an aggregated particle aggregated by an oxidoreductase, and wherein the aggregated particle has a particle size from 10 nm to 5000 nm (claim 1) or from 50 nm to 1000 nm (claim 5).
However, Park teaches a bioelectrode comprising a crosslinkable organometallic polymer that is controlled so as to be used in a biosensor ([Abstract]). The electrode comprising an organometallic, a self-assembling block copolymer, and an enzyme ([Abstract]). The enzyme used is preferred embodiment is glucose oxidase (Glucose Oxidase, GOx) (p. 4, para. 1), which is an oxidoreductase. The structural analysis of the electrode shows that the GOx enzymes aggregated in the size of 40 to 80 nanometers (p. 5, para. 6), which overlaps the claimed ranges in claims 1 and 5.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Shin by utilizing the aggregated oxidoreductase (e.g., GOx) particles with adjustable size within the claimed ranges because it is known in the art that GOx is suitable enzyme for sensing glucose and the disclosed sizes of the GOx in an aggregated form are suitable for a bioelectrode. 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). Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985). MPEP 2144.05(I). Here, 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).
Regarding claim 2, Shin teaches wherein the amphiphilic molecule comprises sodium dodecyl sulfate (¶100).
Regarding claim 3, Shin teaches wherein the oxidoreductase comprises glucose oxidase (¶92).
Regarding claim 6, Shin teaches wherein a weight ratio of the oxidoreductase to the amphiphilic molecule is from 1:0.1 to 1:50 (¶101: the reagent composition may contain the surfactant in an amount of 10 to 25 parts by weight, based on 100 parts by weight of the oxidoreductase; e.g., for 100 parts of oxidoreductase and 10 parts of surfactant, the weight ratio of the oxidoreductase to the amphiphilic molecule is 1:0.1).
Regarding claim 7, Shin teaches wherein the weight ratio of the oxidoreductase to the amphiphilic molecule is from 1:0.1 to 1:10 (¶101: the reagent composition may contain the surfactant in an amount of 10 to 25 parts by weight, based on 100 parts by weight of the oxidoreductase; e.g., for 100 parts of oxidoreductase and 10 parts of surfactant, the weight ratio of the oxidoreductase to the amphiphilic molecule is 1:0.1).
Regarding claim 8, Shin teaches an electrical signal sensor (¶17: an electrochemical biosensor), comprising:
an electrode layer (¶101: the electrode); and
a sensing layer (¶90: a sensing layer) located on the electrode layer (¶101: to distribute the composition evenly over the electrode), wherein the sensing layer comprises the electrical signal sensing composition of claim 1 (as described in claim 1).
Regarding claim 12, Shin teaches wherein the amphiphilic molecule comprises sodium dodecyl sulfate (¶100).
Regarding claim 13, Shin teaches wherein the oxidoreductase comprises glucose oxidase (¶92).
Regarding claim 14, Shin teaches wherein a weight ratio of the oxidoreductase to the amphiphilic molecule is from 1:0.1 to 1:50 (¶101: the reagent composition may contain the surfactant in an amount of 10 to 25 parts by weight, based on 100 parts by weight of the oxidoreductase; e.g., for 100 parts of oxidoreductase and 10 parts of surfactant, the weight ratio of the oxidoreductase to the amphiphilic molecule is 1:0.1).
Claim(s) 9-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Shin in view of Park, and further in view of Nazarian (US 2021/0396703).
Regarding claims 9-11, Shin and Park disclose all limitations of claim 8. Shin and Park fail to teach the sensor further comprising an electron transfer layer located between the electrode layer and the sensing layer (claim 9) or wherein the electron transfer layer comprises a conductive carbon material (claim 10) or wherein the conductive carbon material comprises graphene (claim 11).
However, Nazarian teaches an enzyme-based sensor (¶15), including a substrate 1 coated with a layer of sensor elements 2, which in turn is coated with a layer of metallic nanoparticles 3, and a top layer of functionalization coating 7 (Fig. 1A; ¶14). Here, the metallic nanoparticle layer reads on the electron transfer layer located between the electrode layer (Fig. 1A: sensor elements 2) and the sensing layer (Fig. 1A: functionalization layer 7). The metallic nanoparticle layer may be gold-nanoparticles (GNp), or alternatively graphene, carbon-nanotubes CNTs, or a combination thereof (¶36). The outstanding electrical properties of carbon nanomaterials (e.g., graphene & CNT) enable ballistic transport with high electron mobility that offer unprecedented opportunities for efficient sensors (¶36).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Shin and Park by incorporating an electron transfer layer (Fig. 1A: the layer of metallic nanoparticles 3) between the electrode and sensing layer, and substituting the metallic nanoparticle with conductive carbon material, i.e., graphene, as taught by Nazarian because graphene is an alternative conductive material to metal and the outstanding electrical properties of graphene enable ballistic transport with high electron mobility that offer unprecedented opportunities for efficient sensors (¶36). Here, 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).
Response to Arguments
Applicant’s arguments have been considered but are unpersuasive.
Applicant argues Park only disclose the presence of GOx aggregates in a specific PFDMS-b-PI nanowire structure and does not disclose that such GOx aggregates are generally applicable to any biosensor composition (Response, p. 7, para. 2). This argument is unpersuasive because GOx is applicable to biosensor compositions, and Park’s GOx aggregates are present in the sensing layer for glucose biosensor. Applicant further argues there is no motivation to modify Shin’s glucose oxidase/alkyl sulfate system with a nanowire structure (p. 8, para. 1). Applicant asserts that Shin uses a new organic electron transfer mediator to improve the performance of the biosensor, while Park discloses a specific intermixing/interpenetration structure formed by self-assembled block copolymers containing organometallic compounds and a redox enzyme to enhance electron transfer performance, wherein GOx aggregates are merely a byproduct of its specific nanostructure (p. 8, para. 2). These arguments are unpersuasive. In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, both Shin and Park teach using GOx enzyme for glucose sensor, and Park explicitly disclose the enzyme, GOx enzyme, having an aggregated form having a size of 40 to 80 nanometers (Park, p. 5, para. 6). Thus, the aggregated enzyme having a suitable size is a suitable enzyme form for a biosensor to sense analyte, e.g., aggregated GOx for sensing glucose. Here, 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).
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 extension fee 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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/C. SUN/Primary Examiner, Art Unit 1795
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