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 .
Continued Examination Under 37 CFR 1.114
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 February 26, 2026 has been entered.
Status of Objections and Rejections
All rejections from the previous office action are withdrawn in view of Applicant’s amendment.
New grounds of rejection are necessitated by the amendments.
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 adjusting the sizes of aggregated oxidoreductase (e.g., GOx) particles within the claimed ranges because it is known in the art that such sizes of the aggregated enzyme is 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 has/have been considered but are moot because the newly cited reference, Park, is now relied on to teach the aggregated oxidoreductase particles and their sizes.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CAITLYN M SUN whose telephone number is (571)272-6788. The examiner can normally be reached on M-F: 8:30am - 5:30pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Luan V Van can be reached on (571)272-8521. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/C. SUN/Primary Examiner, Art Unit 1795
Prosecution Insights