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 .
Response to Amendment
The amendment filed 02 June 2026 in which claims 1 and 10-12 were amended and claims 2-3 cancelled has been entered.
Claims 1, 4-10, and 12 are under examination on the merits.
Claim Rejections - 35 USC § 112(b)
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
(Previous rejection, withdrawn). Claim 3 was 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. Applicant’s cancellation of claim 3 submitted 02 June 2026 has rendered the rejection previously set forth in the Non-Final Office Action mailed 06 March 2026 moot.
(New rejection, necessitated by amendment). Claims 1 and 4-10 are 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 claims 1 and 10, it is unclear relationship between the anti-SARS-CoV-2 antibody, the fluorescent marker, and the secondary antibody. As the claims read currently, it appears that the fluorescence marker recognizes the SARS coronavirus 2 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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
(Previous rejection, withdrawn as to claims 1 , 3-5, and 7-10 due to amendment to claims 1 and 10 and cancellation of claim 3). Claims 1, 3-5, and 7-10 were rejected under 35 U.S.C. 103 as being unpatentable over Kim and Edouard and evidenced by Greene, Law, and Wang. Applicant’s cancellation of claim 3 submitted 02 June 2026 has rendered the rejection previously set forth in the Non-Final Office Action mailed 06 March 2026 moot. Applicant’s amendment of claims 1 and 10 submitted 02 June 2026 has added new limitations to the claim rendering the rejection previously set forth in the Non-Final Office Action mailed 06 March 2026 moot and necessitating a new rejection.
(Previous rejection, withdrawn due to cancellation of claim 2). Claim 2 was rejected under 35 U.S.C. 103 as being unpatentable over Kim and Edouard and further in view of Burbelo. Applicant’s cancellation of claim 3 submitted 02 June 2026 has rendered the rejection previously set forth in the Non-Final Office Action mailed 06 March 2026 moot.
(Previous rejection, withdrawn as to claims 6 and 12 due to amendment to claims 1 and 12). Claims 6 and 12 were rejected under 35 U.S.C. 103 as being unpatentable over Kim and Edouard and further in view of Heo and evidenced by Hill. Applicant’s amendment of claims 1 and 12 submitted 02 June 2026 has added new limitations to the claim rendering the rejection previously set forth in the Non-Final Office Action mailed 06 March 2026 moot and necessitating a new rejection.
(New rejection, as necessitated by amendment to claims 1 and 10). Claims 1, 4-5, and 7-10 are rejected under 35 U.S.C. 103 as being unpatentable over Kim and further in view of Edouard and Burbelo and evidenced by Greene, Law, and 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 further 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). 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 patients 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.
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.
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.
(New rejection, necessitated by amendment to claims 1 and 12). Claims 6 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Kim, Edouard, and Burbelo as applied to claims 1, 4-5, and 7-10 above and in further view of Heo as evidenced by Hill.
As discussed above, claims 1, 4-5, and 7-10 were rendered prima facie obvious over Kim, Edouard, and Burbelo.
Regarding claim 6, Kim teaches a seed layer to create the ZnO nanowire-based substrates by photolithography. Kim, Edouard, and Burbelo 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, Edouard, and Burbelo teach a nanowire array for detecting a SARS-CoV-2 antibody (see claim 1). Kim, Edouard, and Burbelo 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), immobilizing SARS-CoV-2 antigens to the functional groups (see claim 1), and wherein the SARS-CoV-2 antigens are nucleocapsid or spike protein antigens (see claim 1). Kim, Edouard, and Burbelo 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.
Response to Arguments
Applicant contends on pages on 7-10 of the Remarks submitted on 02 June 2026 that the instant application required an immobilized-antigen/patient-antibody/fluorescence-labeld-secondary-antibody architecture while the reference teaches a capture-antibody/target-antigen/detection-antibody sandwich architecture. Applicant further contends that Kim and Edouard do not teach purified SARS-CoV-2 nucleocapsid or spike protein as the antigen and that both references being IFAs is not enough motivation to combine the two references.
In response: Absence evidence to the contrary, what protein is attached to the nanowire is solely based on what is being detected, antibody or antigen, and which assay type suits this purpose. If antibody is being detected, antigen would be attached to the nanowire and if antigen is being detected by the assay, antibody would be attached to the nanowire. As described above, both the reference nanowire and instant nanowires are the same so there is no argument that the reference nanowire cannot be used in the instant application. Second, while Kim and Edouard do not teach purified nucleocapsid or spike antigen of SARS-CoV-2, this is a new limitation that necessitated a new rejection. Lastly, the motivation to combine the two references was not that they were both IFAs, that it just the reason one of skill in the art may have a reasonable expectation of success as antigens that work in one IFA will work in another as they will detect the same antibodies.
Applicant contends on pages 10-11 of the Remarks submitted on 02 June 2026 that Burbelo does not teach immobilizing antigens on ZnO nanowires but rather teaches away from solid-phase assays as it teaches liquid phase assays.
In response: Burbelo teaches that purified SARS-CoV-2 antigens can be used to detected antibodies in patient serum. These antigens were shown to bind to anti-SARS-CoV-2 antibodies making them known antigens to bind and detect these antibodies and therefore, these antigens are known in the art as SARS-CoV-2 antigens that bind anti-SARS-CoV-2 antibodies.
Conclusion
NO CLAIMS ARE ALLOWED
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 nonprovisional extension fee (37 CFR 1.17(a)) 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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/CASSANDRA SENN GRIZER/ Examiner, Art Unit 1672
/THOMAS J. VISONE/ Supervisory Patent Examiner, Art Unit 1672
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