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 .
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 07/12/2024, 11/01/2023, and 05/24/2023 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Status of Claims
This office action is in response to Applicant's Response to Election / Restriction filed on December 08, 2025.
Claims 1-19 are currently pending, with claims 2, 4, and 10-19 withdrawn.
Claims 1,3 and 5-9 are under examination. This is the first action on the merits.
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-13) in the reply filed on December 8, 2025 is acknowledged 1.
Applicant’s election without traverse of the following species in the reply filed on December 8, 2025 is acknowledged:
Species of reaction unit: B) the reaction unit comprises a biological probe that specifically binds to the target material (claim 3) 2.
Species of biological probe: B19) the biological probe detects one or more miRNAs selected from the group consisting of miRNA21, miRNA1246, and let7b (claim 5) 3;
Species of target material: J) a nucleic acid capable of participating in a sequence- specific hybridization reaction with a complementary sequence (claim 8) 4;
Species of biosensor: L) the biosensor is capable of detecting the target material in a urine sample (claim 9) 5.
Claims 2, 4, and 10-19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention. Examination on the merits commences on claims 1, 3 and 5-9.
Priority
The effective filling date of the instant claims 1,3 and 5-9 is 05/24/2023, the filling date of the instant U.S. nonprovisional application.
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Specifically, Applicant's claim to domestic priority is acknowledged as a 371 national stage entry of PCT/KR2021/017031. Applicant's claim to foreign priority to REPUBLIC OF KOREA Applications 10-2020-0159099 and10-2021-0156070 is also acknowledged. However, none of the submitted document is in English, and English translations have not been submitted.
The domestic benefit date may be the effective filing date of the claimed invention if:
• the earlier application to which domestic benefit is claimed supports the claimed invention under 35 U.S.C. 112(a).
The foreign priority date may be the effective filing date of the claimed invention if:
• the foreign application supports the claimed invention under 35 U.S.C. 112(a), AND
• the applicant has perfected the right of priority by providing a certified copy of the priority application, and a translation of the certified copy (if not in English) along with a statement that the translation of the certified copy is accurate.
See MPEP 213.04 and 216; See also MPEP 2304.01(c)
In this instant case, the priority documents submitted are not in English, without a translation; without a English translation, the examiner is unable to verify whether the earlier applications provide written description support for the claimed invention under 35 U.S.C. 112(a). Thus, since an English translation of the priority application has not been filed, the effective filing date (EFD) of the claimed invention is the filing date of the application.
However, if applicant perfects the right of priority by providing certified English translations of the priority applications that supports the claimed invention under 35 U.S.C. 112(a), the effective filing date will be the filing date of the foreign application.
Claim Interpretation
In evaluating the patentability of the claims presented in this application, claim terms have been given their broadest reasonable interpretation (BRI) consistent with the specification, as understood by one of ordinary skill in the art, as outlined in MPEP§ 2111.
For the purpose of applying prior art, claim 1 recites the term "biosensor." The specification defines the term on page 2 as follows:
"The term “biosensor” as used herein is configured to measure the presence or absence and amount of a specific biological material, and is a device that converts a physical or chemical change caused by a selective interaction between a biological element and an analyte into a recognizable optical or electrical signal."
Accordingly, under this definition, the term “biosensor” encompasses any device having structures capable of performing these functions, namely measuring a biological material by converting a physical or chemical change resulting from a selective interaction into an optical or electrical signal.
For the purpose of applying prior art, claim 1 recites:
A biosensor comprising
a reaction unit in which an interaction occurs physically or chemically with a target material in a sample, wherein the reaction unit comprises reduced graphene oxide (rGO).
MPEP§ 2111.04 states: "Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure."
Therefore, the phrase "in which an interaction occurs physically or chemically with a target material in a sample" is interpreted under BRI as intended use that does not further distinguish the claimed device from prior art devices with the same structure.
Thus, claim 1 broadly recites a “biosensor” with generic “reaction unit” with rGO somewhere/anywhere.
For the purpose of applying prior art, claim 3 recites the term “biological probe,” which is defined in the specification at page 5 as follows:
"The term “biological probe” as used herein refers to a material capable of imparting functionalization to the reaction unit or a material specifically binding to the target material. The biological probe may include DNA, RNA, PNA, a nucleotide, a nucleoside, a protein, a polypeptide, a peptide, an amino acid, a carbohydrate, an enzyme, an antibody, an antigen, a receptor, a virus, a substrate, a ligand, a membrane, or a combination thereof."
According to this definition, the term "biological probe" encompasses any material capable of performing these functions, regardless of whether the material is biological or synthetic in origin.
Claim Rejections - 35 USC § 112(b)
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.
Claims 6-7 are rejected under 35 U.S.C. 112(b), 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 6, it recites "wherein the reaction unit comprises a linker to immobilize the biological probe on a surface of the electrode." This limitation is indefinite because "the electrode" lacks antecedent basis. Neither claim 6 nor its base claims recite or introduce an electrode prior to this limitation. As a result, it is unclear whether the electrode is part of the reaction unit, a separate component of the biosensor, or an element external to the biosensor. This lack of clarity as to the structural relationship between the electrode and the biosensor components renders the scope of the claim indefinite.
Claim 7 is rejected for depending from claim 6 and not remedying the indefiniteness.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1,3 and 5-9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by
Kim 6(Kim et al. Electrical Cartridge Sensor Enables Reliable and Direct Identification of MicroRNAs in Urine of Patients. ACS Sens. 2021 Mar 26;6(3):833-841. doi: 10.1021/acssensors.0c01870. Epub 2020 Dec 7. PMID: 33284011; cited as NPL#1 in IDS filed 07/12/2024).
Regarding claim 1, Kim teaches a biosensor comprising a reaction unit, wherein the reaction unit comprises reduced graphene oxide (rGO) (entire document, see Abstract for example).
Regarding claim 3, Kim teaches reaction unit comprises a biological probe that specifically binds to the target material (Figure 1).
Regarding claim 5, it recites: "wherein the biological probe is for detecting one or more miRNAs selected from the group consisting of miRNA21, miRNA1246, and let7b."
This claim is anticipated by Kim because it does not recite any structural features applicable to the claimed device.
MPEP§ 2111.04 states:
"Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure."
Here, claim 5 recites language describing the intended use of the biological probe for detecting miRNAs but does not specify any structural feature that directly supports or relates to this application. The claim lacks any defined structural characteristics or clear functional relationship between the biological probe and the miRNA. Therefore, the intended use language does not distinguish the claimed device from the prior art.
Regarding claim 6, Kim teaches reaction unit comprises a linker to immobilize the biological probe on a surface of an electrode (Figure 1).
Regarding claim 7, Kim teaches wherein the linker comprises an amine group (Figure 1).
Regarding claim 8, Kim teaches target material comprises a nucleic acid capable of participating in a sequence- specific hybridization reaction with a complementary sequence (Figure 1, miRNA).
Regarding claim 9, it recites "wherein the biosensor is capable of detecting the target material in a urine sample."
This claim is anticipated by Kim because it merely recites intended use and does not recite any structural features applicable to the claimed device.
MPEP§ 2111.04 states:
"Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure."
Here in claim 9, the phrase "capable of detecting the target material in a urine sample" suggest intended use, without claiming specific structures in the device that directly support or relate to this functional language7. The recited intended use fails to distinguish the claimed device over the prior art device with the same structural components. See MPEP § 2111.05.
Claims 1,3 and 5-9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Cai (Cai et al. Gold nanoparticles-decorated graphene field-effect transistor biosensor for femtomolar MicroRNA detection. Biosens Bioelectron. 2015 Dec 15;74:329-34. doi: 10.1016/j.bios.2015.06.068. Epub 2015 Jun 30. PMID: 26159152; cited as NPL #1 in IDS filed on 05/24/2023).
Regarding claim 1, Cai teaches a biosensor comprising a reaction unit, wherein the reaction unit comprises reduced graphene oxide (rGO) (entire document, see Abstract and Fig. 1 for examples).
Regarding claim 3, Cai teaches wherein the reaction unit comprises a biological probe that specifically binds to the target material (Abstract, “The AuNPs-decorated graphene FET biosensor was fabricated by drop-casting the reduced graphene oxide(R-GO suspension onto the sensor surface, and subsequently decorating AuNPs onto the surface of R-GO. After peptide nucleic acid(PNA) probe was immobilized on the AuNPs surface, miRNA detection was carried out via PNA–miRNA hybridization”; Fig. 1, PNA).
Regarding claim 5, it recites: "wherein the biological probe is for detecting one or more miRNAs selected from the group consisting of miRNA21, miRNA1246, and let7b."
This claim is anticipated by Cai because it does not recite any structural features applicable to the claimed device.
MPEP§ 2111.04 states:
"Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure."
Here, claim 5 recites language describing the intended use of the biological probe for detecting miRNAs but does not specify any structural feature that directly supports or relates to this application. The claim lacks any defined structural characteristics or clear functional relationship between the biological probe and the miRNA. Therefore, the intended use language does not distinguish the claimed device from the prior art.
Regarding claim 6, Cai teaches the reaction unit comprises a linker to immobilize the biological probe on a surface of the electrode (Abstract, lines 5-8, AuNPs; see also at page 330, right-hand col, 2.4. Immobilization of PNA on the AuNPs-decorated graphene Surface).
Regarding claim 7, Cai teaches the linker comprises an amine group (page 330, right-hand col, 2.4. Immobilization of PNA on the AuNPs-decorated graphene Surface, cysteamine, amino group) , an aldehyde group (Id. aldehyde; GA is glutaraldehyde).
Regarding claim 8, Cai teaches the target material is a nucleic acid capable of participating in a sequence- specific hybridization reaction with a complementary sequence (entire document, Abstract, miRNA).
Regarding claim 9, it recites "wherein the biosensor is capable of detecting the target material in a urine sample."
This claim is anticipated by Cai because it merely recites intended use and does not recite any structural features applicable to the claimed device.
MPEP§ 2111.04 states:
"Claim scope is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure."
Here in claim 9, the phrase "capable of detecting the target material in a urine sample" suggest intended use, without claiming specific structures in the device that directly support or relate to this functional language. The recited intended use fails to distinguish the claimed device over the prior art device with the same structural components. See MPEP § 2111.05.
Prior Art
Other prior art also teach biosensors comprising reduced graphene oxide and nucleic acid probes:
US20200132684A1 - Method of detecting bio-material ; published 2020-04-30.
Conclusion
No claims are allowed.
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/TIAN NMN YU/Examiner , Art Unit 1681 /AARON A PRIEST/Primary Examiner, Art Unit 1681
1 Claims 14-19 are withdrawn as being drawn to non-elected groups II-III.
2 Claim 2 is withdrawn as being drawn to non-elected species A.
3 Claim 4 is withdrawn as being drawn to non-elected species B1-B19.
4 Claim 10 is withdrawn as being drawn to non-elected species KK.
5 Claims 11-13 are withdrawn as being drawn to non-elected species M.
6 Kim qualifies as prior art, because its publication date in 2020 precedes the currently effective filling data in 2023. Additionally, Kim includes additional authors other than the inventors in this present application.
7 "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus, see MPEP 2114II.