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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 January 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All rejections from the previous office action are withdrawn in view of Applicant’s amendment.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) 1-2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cho (KR 2017/008294) in view of Augustine (S. Augustine, Amine-Functionalized MoO3@RGO Nanohybrid-Based Biosensor for Breast Cancer Detection, ACS Appl. Bio Mater. 2019(2), pp. 5366-78), and further in view of Zhou (US 2012/0097917).
Regarding claims 1-2, Cho teaches an electrochemical biosensor (p. 1, para. 1: nano-biosensor for C-reactive proteins; para. 3: electrochemical biosensor), consisting of a working electrode (p. 3, para. 1: rGO-NP/ITO measuring electrode) with a surface (p. 5, Experimental Example 3. Preparation of BSA/anti-CRP antibody/MPA/rGO-NP/ITO sensing interface) coating with a gold nanocomposite for modifying the working electrode (p. 3, para. 9: a reduced graphene oxide and a gold nanoparticle composite), and a carboxyl-mercapto compound and a N-3-dimethylaminopropyl-N'-ethylcarbodiimide hydrochloride/N-hydroxysuccinimide (EDC/NHS, EN) for modification (Fig. 1: step (2) 3-MPA (i.e., 3-mercaptopropionic acid) and EDC-NHS (EDC: N-3-dimethylaminopropyl-N'-ethylcarbodiimide hydrochloride; NHS: N-hydroxysuccinimide)) modified rGO-NP/ITO electrode; p. 5, Experimental Example 3: the rGO-NP reacts with the MPA to form the SAM layer; the MPA modified electrode is then reacted with EDC/NHS to create a site where the antibody can bind), wherein,
bonds form between mercapto group of the carboxyl-mercapto compound and gold nanocomposites (Fig. 1(c): step (2)-(3) indicating the bond between rGO-NP and the mercapto group of the MPA; p. 5, last para.: fixed on the MDEA surface), and the N-3-dimethylaminopropyl-N'-ethylcarbodiimide hydrochloride/N-hydroxysuccinimide (EDC/NHS, EN) bonds with carboxyl group of the carboxyl-mercapto compound (Fig. 1(c): step (2) indicating the bond of -C(O)-NH- from amine group of the EDC-NHS and the carboxyl group of the MPA; p. 5, last para.: a coupling agent of a carboxyl group and an amine group), and
a marker (p. 5, last para.: the anti-CRP antibody) is attached to the N-3-dimethylaminopropyl-N'-ethylcarbodiimide hydrochloride/N-hydroxysuccinimide (EDC/NHS, EN) (Fig. 1(c): indicating the anti-CRP antibody attached to the coupling agent -C(O)-NH- via the -NH- bond).
Cho does not disclose a molybdenum trioxide nanomaterial to modify the working electrode.
However, Augustine teaches an electrochemical immunosensor based on MoO3@RGO nanohybrid for quantifying of HER-2 levels (p. 5367, col. 1, para. 2). Anchoring of MoO3 (1D) onto the RGO (2D) is an effective strategy leading to better charge transfer ability, increased mechanical stability, and efficient heterogeneous electron activity with improved surface area (p. 5367, col. 1, para. 2). MoO3 prevents restacking of the RGO sheets, providing room for enhanced electron mobility by shuttling mechanism, and the 1D morphology of MoO3 with variable oxygen states facilitates better electron shuttling resulting in improved sensitivity and enhanced detection limit of the biosensor (p. 5367, col. 1, para. 2).
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 Cho by incorporating molybdenum trioxide on the RGO as taught by Augustine, i.e., between the RGO and the AuNPs of Cho, because MoO3 prevents restacking of the RGO sheets, providing room for enhanced electron mobility by shuttling mechanism, and the 1D morphology of MoO3 with variable oxygen states facilitates better electron shuttling resulting in improved sensitivity and enhanced detection limit of the biosensor (p. 5367, col. 1, para. 2).
Cho and Augustine do not disclose wherein the gold nanocomposite is formed by the attachment of a gold nanoparticle on a metal oxide nanomaterial, wherein the metal oxide nanomaterial comprises manganese dioxide (MnO2) or Zinc oxide (ZnO) (claim 1) or wherein the shape of the metal oxide nanomaterials includes rods (claim 2).
However, Zhou teaches aligned nanowire arrays were coated with semiconductor shell layers, and optionally with noble metal nanoparticles for use as three dimensional gas sensors ([Abstract]). The gas sensor is based on vertically-aligned metal oxide nanowire arrays, e.g., ZnO nanowires, with a shell layer on which noble metal nanoparticles are added to further enhance sensitivity and to tune responsiveness to different gases (¶17). Fig. 1-2 indicate that the metal oxide nanowire arrays have shape of nanorods.
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 Cho and Augustine by substituting the gold nanocomposite with the gold nanoparticles attached on ZnO nanorods as taught by Zhou because the ZnO nanorod arrays significantly enlarge the surface area and the decorated noble-metal nanoparticles (e.g., AuNPs) would enhance the sensor sensitivity (¶46).
The designation “sequentially” for coating is product-by-process limitation. Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). MPEP 2113(I). Here, there is no apparent difference between the claimed electrochemical biosensor and the one of the prior art as taught by Cho in view of Augustine and Zhou.
Claim(s) 3-4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cho in view of Augustine and Zhou, and further in view of Li (CN109085225B).
Regarding claims 3-4, Cho, Augustine, and Zhou disclose all limitations of claims 1 and 2 respectively, but fail to teach wherein the carboxyl-mercapto compound is cysteine.
However, Li teaches a protein electrochemical imprinting sensor (p. 1, para. 2). The Au electrode is modified by graphene@Fe3O4 nanomaterials to obtain graphen@Fe3O4@Au modified electrode (p. 3, steps (1)-(2)), and then functionalized in a mixed solution for self-assembly (p. 3, step (3)). In step (3), the mercapto compound mixed solution mercaptophenylboronic acid and cysteine (p. 4, para. 1).
It would 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 Cho, Augustine, and Zhou by substituting the carboxyl-mercapto compound with cysteine as taught by Li. The suggestion for doing so would have been that cysteine is a suitable material for functionalizing the gold as a self-assembled layer and 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.
Claim(s) 5-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Cho in view of Augustine, Zhou, and Li, and further in view of Huff (US 2018/0275088).
Regarding claims 5-6, Cho, Augustine, Zhou, and Li disclose all limitations of claims 3 and 4 respectively. Cho further discloses the marker is anti-CRP antibody for detection of C-reactive protein (CRP) (the bridge para. of pp. 5-6). Cho, Augustine, Zhou, and Li fail to teach wherein the marker is a primary antibody and the primary antibody is a heat shock protein antibody.
However, Huff teaches an analyte detection device (¶2) using a binding member immobilized on a solid support and specifically binds to the analyte (¶5). The non-limiting list of analytes include C-Reactive Protein (CRP) and heat shock protein HSPE1 (¶217)
It would 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 Cho, Augustine, Zhou, and Li by substituting the marker, anti-CRP antibody, with the heat shock protein antibody, e.g., HSPE1 antibody, as suggested by Huff because both CRP and HSPE1 are analytes detectable by its antibody through specific binding. Here, the substitution of one known element for another would yield nothing more than predictable results. MPEP 2141(III)(B). Further, 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 with respect has/have been considered but are moot in light of the new grounds of rejection because the prior art, Zhou, is relied on to teach the gold nanocomposite is formed by the attachment of a gold nanoparticle on a metal oxide nanomaterial, e.g., ZnO (Zhou, ¶17).
Applicant argues Cho and Niu applied the graphene oxide as the main material for the electrode (Response, p. 8, para. 1). This argument is unpersuasive because graphene oxide is a two-dimensional material to be considered as the surface of the electrode, so it is unconvincing that one of ordinary skill in the art would not have to ignore or omit the graphene oxide as alleged by Applicant (p. 9, para. 4). Further, the MoO3 layer on the graphene oxide improved sensitivity and enhanced detection limit of the biosensor (Augustine, p. 5367, col. 1, para. 2), and the gold nanoparticles attached on the ZnO nanowire arrays would further enhance the sensor sensitivity (Zhou, ¶17). Thus, Cho is the base reference to teach an electrode with a graphene oxide surface, and Augustine and Zhou are relied on to teach improving the sensor sensitivity by incorporating MoO3 on the RGO and attached gold nanoparticles on the ZnO nanowire arrays as the gold nanocomposite as taught by Augustine and Zhou.
Conclusion
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/C. SUN/Primary Examiner, Art Unit 1795