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 .
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed on 10 July 2023 .Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Election/Restrictions
Applicant’s election without traverse of Group I, corresponding to claims 1-10 and 12, in the reply filed 06 February 2026 is acknowledged.
Claim 11 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being to allowable generic or linking claim. Election was made without traverse in the reply filed on 06 February 2026.
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.
Claim 3 is 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.
In claim 3, it is unclear the relationship between the anti-SARS-CoV-2 antibody, the fluorescent marker, and the secondary antibody. For the purposes of compact prosecution, the claim will be interpreted consistent with the specification, which discloses “…an antibody in the isolated sample specifically bound to the antigen is reacted with a fluorescence-labeled antibody capable of specifically recognizing the antibody in the sample, thus detecting a fluorescence signal, thereby finally detecting whether the SARS coronavirus 2 antibody is present.” (Figure 1 and ¶0026 and 0033).
It is noted that any interpretation of the claims set forth above does not relieve Applicant of the responsibility of responding to this rejection. If the actual interpretation of the claims is different than that posited by the Examiner, additional rejection and art may be readily applied in a subsequent final Office action.
Claim Rejections - 35 USC § 103
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, 3-5, and 7-10 are rejected under 35 U.S.C. 103 as being unpatentable over Kim, et al. (Biosens Bioelectron. 2014 May 15;55:209-15., NPL-IDS, filed, 07/10.2023, hereinafter “Kim”) and Edouard, et al. (Eur J Clin Microbiol Infect Dis. 2021 Feb;40(2):361-371. Epub 2020 Nov 11., hereinafter “Edouard”) and evidenced by Greene, et al. (Inorg Chem. 2006 Sep 18;45(19):7535-43, hereinafter “Greene”), Law, et al. (Nat Mater. 2005 Jun;4(6):455-9., hereinafter “Law”), and Wang, et al. (Anal Chim Acta. 2009 Oct 19;653(1):109-15., hereinafter “Wang”).
Regarding claims 1 and 10, Kim teaches an immunoassay for the detection of biomolecules comprising high-density vertical ZnO nanowires on a glass substrate and a biomolecule immobilized on the surface of the nanowires (Figure 1). Kim does not teach that the biomolecule is a SARS-CoV-2 antigen.
However, Edouard teaches an indirect immunofluorescence assay for detecting SARS-CoV-2 in patient comprising SARS-CoV-2 antigens immobilized on a plate, before serum was added and then a fluorescently labeled antibody (pg. 362, column 2).
It would have been prima facie obvious before the effective filing date of the invention for one of ordinary skill in the art to have combined the teachings of Kim for an immunoassay utilizing ZnO nanowires with immobilized biomolecules on a glass substrate with the teachings of Edouard for an indirect IFA utilizing patient serum and immobilized SARS-CoV-2 antigens. Kim provides motivation by teaching that the large surface to volume ratio of ZnO nanowires allows for a large surface area for immunoreaction causing a string fluorescence signal than conventional immunoassays (pg. 214, column 2). One of skill in the art would have had a reasonable expectation of success at combining Kim and Edouard because they both teach fluorescent immunoassays.
Regarding claim 3, Kim teaches a fluorescent marker bound to an antibody which recognizes an antibody bound to a biomolecule (Figure 1). and Edouard teaches after adding patient serum, FITC-conjugated IgT anti-human immunoglobulin is used to detect the presence of anti-SARS-CoV-2 antibodies sin the human samples (pg. 362, column 2).
Regarding claim 4, Kim teaches that the substrate is a glass substrate (Figure 1).
Regarding claim 5, Kim teaches that the nanowires are ZnO nanowires (Figure 1).
Regarding claim 7, Kim teaches a precursor solution comprising zinc nitrate hexahydrate, hexamethylene tetramine, and polyethyleneimine (pg. 210, column 1). Kim cites that the method used was previously published by Greene, Greene evidences that 25 mM of zinc nitrate hexahydrate and hexamethylene tetramine (pg. 7537, column 1) and that the polyethyleneimine concentrations used were previously published by Law, Lae evidences that 5mM-7mM of polyethyleneimine was used (pg. 458, column 2).
Regarding claim 8, Kim teaches treating the nanowires with 3-aminopropyltriethoxysilane and glutaraldehyde (pg. 210, column 1). Kim cites that the method used was previously published by Wang. Wang evidences that 4 vol% of 3-aminopropyltriethoxysilane and 2 vol% of glutaraldehyde were used (pg. 110, column 2).
Regarding claim 9, Edouard teaches detecting SARS-CoV-2 antibody from patient serum in an indirect IFA (pg. 362 column 2).
Accordingly, the claimed inventions were prima facie obvious to one of ordinary skill in the art before the effective filing date, especially in the absence of evidence to the contrary.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Kim and Edouard as applied to claims 1, 3-5, and 7-10 above and further in view of Burbelo, et al. (J Infect Dis. 2020 Jun 29;222(2):206-213., hereinafter “Burbelo”).
As discussed above, claims 1, 3-5, and 7-10 were rendered prima facie obvious over Kim and Edouard.
Regarding claim 2, Kim and Edouard do not teach that the SARS-CoV-2 antigen is the nucleocapsid or spike protein. However, Burbelo teaches using both nucleocapsid and spike proteins from SARS-CoV-2 to detect SARS-CoV-2 antibodies in patient serum (Abstract).
It would have been prima facie obvious before the effective filing date of the invention for one of ordinary skill in the art to have substituted the biomolecule antigens taught by Kim for the nucleocapsid or spike protein antigens taught by Burbelo to create an immunoassay that detects SARS-CoV-2 antibodies. Burbelo provides motivation by teaching that detection of SARS-CoV-2 antibodies allows for study of humoral response profiles and detection of SARS-CoV-2 infection (pg. 6 column 2) One of skill in the art would have had a reasonable expectation of success of substituting the biomolecule antigen taught by Kim for the SARS-CoV-2 nucleocapsid or spike antigen taught by Burbelo because they both teach immunoassays.
Accordingly, the claimed invention was prima facie obvious to one of ordinary skill in the art before the effective filing date, especially in the absence of evidence to the contrary.
Claims 6 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Kim and Edouard as applied to claims 1, 3-5, and 7-10 above and further in view of Heo, et al. (Ceramics International. 2014 May; Volume 40 Issue 4 pages 5467-5471., hereinafter “Heo”) and evidenced by Hill, et al. (Material Matters, 2017, 12.1, hereinafter “Hill”).
As discussed above, claims 1, 3-5, and 7-10 were rendered prima facie obvious over Kim and Edouard.
Regarding claim 6, Kim teaches a seed layer to create the ZnO nanowire-based substrates by photolithography. Kim and Edouard do not teach the seed solution. However, Heo teaches methods of creating ZnO nanorod arrays on glass substrates using wet chemical methods including coating plates in a ZnO solution to seed nanorods and further teaches that the seed layer was made with 0.01M zinc acetate and 0.03M sodium hydroxide (pg. 5468 column 1).
It would have been prima facie obvious before the effective filing date of the invention for one of ordinary skill in the art to have substituted the photolithography method of seeding (top-down approach) taught by Kim for the seed solution/chemical reaction method of seeding (bottom-up approach) taught by Heo. The top-down and bottom-up approaches are equivalent in the art as evidenced by Hill (Conclusions). Hill evidences that bottom-up processes are defined as those where structures (nanowires) are assembled from their subcomponents and are additive (Bottom-Up Synthesis) while top-down processes use sculpting to carve structures (nanowires) from larger pieces of material and are subtractive (Top-Down Fabrication). Bottom-up nanowire synthesis allows for the explicit control of the composition of the nanowires during growth (Bottom-Up Synthesis: Benefits and Issues) while top-down nanowire fabrication easily creates ordered arrays of nanowires (Top-Down Fabrication: Benefits and Issues). One of skill in the art would have had a reasonable expectation of success at substituting the top-down approach taught by Kim for the bottom-up approach disclosed by Heo because they are functional equivalents as evidenced by Hill.
Regarding claim 12, Kim and Edouard teach a nanowire array for detecting a SARS-CoV-2 antibody (see claim 1). Kim and Edouard further teach preparing a nanowire precursor solution (see claim 7), growing nanowires on a substrate (see claim 1), introducing functional groups to the nanowires (see claim 8), and immobilizing SARS-CoV-2 antigens to the functional groups (see claim 1) Kim and Edouard do not teach preparing a nanowire seed solution. However, Heo teaches preparing the nanowire seed solution (see claim 6).
Accordingly, the claimed invention was prima facie obvious to one of ordinary skill in the art before the effective filing date, especially in the absence of evidence to the contrary.
Conclusion
NO CLAIMS ARE ALLOWED
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/CASSANDRA SENN GRIZER/Examiner, Art Unit 1672
/THOMAS J. VISONE/Supervisory Patent Examiner, Art Unit 1672