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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 05/14/2026 has been entered.
Response to Amendment
The Amendment filed 04/16/2026 has been entered. Claims 1-19 remain pending in the application. Claims 9-19 are withdrawn. New grounds of rejections necessitated by amendments are discussed below.
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.
Claims 1-8 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.
Regarding claim 1, claim 1 recites “a spike protein” in lines 22 and 23. It is unclear if the spike protein of lines 22 and 23 is the same or different from the “COVID-19 S1 spike protein” established in lines 13 or 17. Claims 2-8 are rejected by virtue of their dependency on claim 1.
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.
Claims 1-5 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Fan (US 20230212589 A1; effectively filed 02/26/2020) in view of Ji (US 20230168245 A1; effectively filed 04/24/2020).
Regarding claim 1, Fan teaches a diagnostic device (abstract; Fig. 4) for detecting a first member of a reporter-analyte pair or a first member of each of a plurality of reporter-analyte pairs (interpreted as an intended use, see MPEP 2114; abstract and paragraphs [0026]-[0027],[0036] teaches detection of SARS-CoV-2 to test COVID-19; [0027] and [0030] teaches anti-S1 protein of SARS-CoV-2 polyclonal antibodies, which is used to capture SARS-CoV-2, specifically the S1 protein, i.e. a first member of a reporter-analyte pair) comprising:
an inlet (Fig. 4, inlet 412) for receiving a liquid, biological sample (interpreted as an intended use, see MPEP 2114; Fig. 4; paragraph [0065]; note that “liquid, biological sample” is not positively recited structurally); and
a porous membrane element (Fig. 4, nitrocellulose membrane 408) comprising a detection portion (Fig. 4, test line areas 416, 418, 420), the detection portion being in liquid communication with the inlet (Fig. 4 and paragraph [0065] teaches test lines areas 416,418,420 are in fluid communication with inlet 412 since the sample flows from the inlet towards the test line areas) and a second member of the or each reporter-analyte pair being immobilisable on the detection portion (paragraphs [0027],[0030] teaches the a SARS-CoV-2 test line on the test strip is coated with anti-S1 protein of SARS-CoV-2 polyclonal antibodies, i.e. a second member of the reporter-analyte pair),
wherein one of the first or second member of the reporter-analyte pair or each of the plurality of reporter-analyte pairs comprises a biological antigen ([0030] teaches S1 protein of virus, i.e. first member of the reporter-analyte pair comprises biological antigen, is captured by anti-S1 protein antibodies coated on the test area) and the other of the first or second member of the reporter-analyte pair or each of the reporter-analyte pairs comprises an antibody specific for the biological antigen (paragraphs [0027],[0030] teaches the a SARS-CoV-2 test line on the test strip is coated with anti-S1 protein of SARS-CoV-2 polyclonal antibodies, i.e. a second member of the reporter-analyte pair comprises an antibody specific for the biological antigen, that captures S1 protein), and wherein
i) the biological antigen comprises:
(a) a COVID-19 S1 spike protein (paragraph [0030] teaches S1 protein of the SARS-CoV-2 virus, i.e. COVID-19 S1 spike protein; paragraph [0036] teaches detection of SARS-CoV-2 for testing for COVID-19; therefore, the S1 protein is a COVID-19 S1 spike protein); or
(b) a first biological antigen from a first reporter-analyte pair comprising a COVID-19 S1 spike protein (paragraph [0030] teaches S1 protein of the SARS-CoV-2 virus, i.e. COVID-19 S1 spike protein; paragraph [0036] teaches detection of SARS-CoV-2 for testing for COVID-19; therefore, the S1 protein is a COVID-19 S1 spike protein),
wherein the device is for independent detection of a spike protein, or a fragment thereof, or of an antibody specific for a spike protein, or a fragment thereof, in the biological sample (interpreted as an intended use, see MPEP 2114; abstract and paragraphs [0026]-[0027],[0036] teaches detection of SARS-CoV-2 to test COVID-19; [0027] and [0030] teaches anti-S1 protein of SARS-CoV-2 polyclonal antibodies, which is used to capture SARS-CoV-2, specifically the S1 protein, i.e. independent detection of spike protein in the biological sample; [0132] teaches testing biological samples) or
ii) the biological antigen comprises a COVID-19 S1 spike protein or a fragment thereof (paragraph [0030] teaches S1 protein of the SARS-CoV-2 virus, i.e. COVID-19 S1 spike protein; paragraph [0036] teaches detection of SARS-CoV-2 for testing for COVID-19; therefore, the S1 protein is a COVID-19 S1 spike protein).
Fan fails to teach:
i) the biological antigen comprises:
(a) the COVID-19 S1 spike protein comprising the sequence of SEQ ID NO: 4 or a sequence having at least 99% or 100% sequence identity to the sequence of SEQ ID NO: 4; or
(b) the first biological antigen from the first reporter-analyte pair comprising a COVID-19 S1 spike protein comprising the sequence of SEQ ID NO:4 or a sequence having at least 99% or 100% sequence identity to the sequence of SEQ ID NO:4, or a fragment thereof, and a second biological antigen from a second reporter-analyte pair comprising a COVID-19 S2 spike protein or a fragment thereof, or
ii) the biological antigen comprises the COVID-19 S1 spike protein or a fragment thereof comprising a sequence in which one or more amino acids are substituted in a sequence consisting of the N-terminal 100, 200, 300, 400, 500 or 600 amino acids of the sequence of SEQ ID NO: 4, and wherein the device is for independent detection of the COVID-19 S1 spike protein, or the fragment thereof, in which one or more amino acids has been substituted, or of an antibody specific for the COVID-19 S1 spike protein, or the fragment thereof, in which one or more amino acids has been substituted, in the biological sample.
Ji teaches a lateral flow device for detecting COVID-19 (abstract), such as detecting the presence of IgG anti-S1 spike antibodies, IgM anti-S1 antibodies, and neutralizing antibodies (e.g., both IgM and IgG) that block binding between ACE2 antigen and S1 spike protein (paragraph [0003]). Ji teaches the lateral flow device or kit, wherein the coronavirus S1 spike polypeptide in the plurality of detectably labeled coronavirus S1 spike polypeptide conjugates comprises S1 spike polypeptide from SARS-CoV-2 and having the amino acid sequence of SEQ ID NO: 3-4 (paragraph [0010] and Fig. 10 teaches SEQ ID NO: 2, which comprises the instant application’s SEQ ID NO: 3 and 4). Ji teaches in one embodiment, the immobilized ACE2 receptor capture polypeptide binds the receptor binding domain (RBD) on an S1 spike polypeptide from a SARS-CoV-2 virus, where the S1 spike polypeptide comprises the amino acid sequence of SEQ ID Nos: 3-4 (paragraph [0164] and Fig. 10 teaches SEQ ID NO: 2, which comprises the instant application’s SEQ ID NO: 3 and 4). Ji teaches S1 spike refers to an S1 subunit of spike protein from SARS-CoV-2 virus, and comprises the amino acid sequence of SEQ ID Nos: 3-4 (paragraph [0117] and Fig. 10 teaches SEQ ID NO: 2, which comprises the instant application’s SEQ ID NO: 3 and 4).
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 the first biological antigen of Fan to incorporate the teachings of known sequences of SARS-Cov-2 spike S1 subunit of Ji (Fig. 10; paragraphs [0010],[0117],[0164]) to provide: i) the biological antigen comprises: (a) the COVID-19 S1 spike protein comprising the sequence of SEQ ID NO: 4 or a sequence having at least 99% or 100% sequence identity to the sequence of SEQ ID NO: 4. Doing so would have a reasonable expectation of successfully improving specificity of antigen-antibody detection of a sequence of the desired biological antigen that includes COVID-19 S1 spike protein.
Furthermore, the claimed limitations are obvious because all of the claimed elements were known in the prior art and one skilled in the art could have combined the elements (i.e. the COVID-19 S1 spike protein comprising the claimed SEQ ID: 4) by known methods with no change in their respective functions (i.e. detection of COVID-19 S1 spike protein), and the combinations yielded nothing more than predictable results (i.e. providing the COVID-19 S1 spike protein comprising the claimed SEQ ID: 4 would yield nothing more than the obvious and predictable result of enabling improved detection of the COVID-19 S1 spike protein). See MPEP 2143(A).
Note that claim 1 recites the biological antigen in alternative form using the phrase “or”, therefore, the limitations of i)(b) and ii) and dependent claims further defining the limitations of i)(b) and ii) are interpreted as not required. Since i)(a) is taught in the combination of Fan and Ji above, the limitations of i)(b) and ii) and dependent claims further defining the limitations of i)(b) and ii) are interpreted as not required. Specifically, i)(b) and ii) includes:
i) the biological antigen comprises:
(b) the first biological antigen from the first reporter-analyte pair comprising a COVID-19 S1 spike protein comprising the sequence of SEQ ID NO:4 or a sequence having at least 99% or 100% sequence identity to the sequence of SEQ ID NO:4, or a fragment thereof, and a second biological antigen from a second reporter-analyte pair comprising a COVID-19 S2 spike protein or a fragment thereof, or
ii) the biological antigen comprises the COVID-19 S1 spike protein or a fragment thereof comprising a sequence in which one or more amino acids are substituted in a sequence consisting of the N-terminal 100, 200, 300, 400, 500 or 600 amino acids of the sequence of SEQ ID NO: 4, and wherein the device is for independent detection of the COVID-19 S1 spike protein, or the fragment thereof, in which one or more amino acids has been substituted, or of an antibody specific for the COVID-19 S1 spike protein, or the fragment thereof, in which one or more amino acids has been substituted, in the biological sample.
Regarding claim 2, modified Fan fails to teach: wherein the first biological antigen comprising the COVID-19 S1 spike protein or the fragment thereof is a polypeptide comprising a sequence of at least 8, 10, 12, 14, 16, 18, 20, 30, 100, 200 or 300 amino acids from an amino acid sequence having at least 99% or 100% sequence identity to the sequence of SEQ ID NO: 4, optionally wherein the COVID-19 S1 spike protein or the fragment thereof comprises the COVID-19 S1 spike protein receptor binding domain having the sequence of SEQ ID NO: 3.
Ji teaches a lateral flow device for detecting COVID-19 (abstract), such as detecting the presence of IgG anti-S1 spike antibodies, IgM anti-S1 antibodies, and neutralizing antibodies (e.g., both IgM and IgG) that block binding between ACE2 antigen and S1 spike protein (paragraph [0003]). Ji teaches the lateral flow device or kit, wherein the coronavirus S1 spike polypeptide in the plurality of detectably labeled coronavirus S1 spike polypeptide conjugates comprises S1 spike polypeptide from SARS-CoV-2 and having the amino acid sequence of SEQ ID NO: 3-4 (paragraph [0010] and Fig. 10 teaches SEQ ID NO: 2, which comprises the instant application’s SEQ ID NO: 3 and 4). Ji teaches in one embodiment, the immobilized ACE2 receptor capture polypeptide binds the receptor binding domain (RBD) on an S1 spike polypeptide from a SARS-CoV-2 virus, where the S1 spike polypeptide comprises the amino acid sequence of SEQ ID Nos: 3-4 (paragraph [0164] and Fig. 10 teaches SEQ ID NO: 2, which comprises the instant application’s SEQ ID NO: 3 and 4). Ji teaches S1 spike refers to an S1 subunit of spike protein from SARS-CoV-2 virus, and comprises the amino acid sequence of SEQ ID Nos: 3-4 (paragraph [0117] and Fig. 10 teaches SEQ ID NO: 2, which comprises the instant application’s SEQ ID NO: 3 and 4).
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 the first biological antigen of modified Fan to incorporate the teachings of known sequences of SARS-Cov-2 spike S1 subunit of Ji (Fig. 10; paragraphs [0010],[0117],[0164]) to provide: wherein the first biological antigen comprising the COVID-19 S1 spike protein or the fragment thereof is a polypeptide comprising a sequence of at least 8, 10, 12, 14, 16, 18, 20, 30, 100, 200 or 300 amino acids from an amino acid sequence having at least 99% or 100% sequence identity to the sequence of SEQ ID NO: 4, optionally wherein the COVID-19 S1 spike protein or the fragment thereof comprises the COVID-19 S1 spike protein receptor binding domain having the sequence of SEQ ID NO: 3. Doing so would have a reasonable expectation of successfully improving specificity of antigen-antibody detection of a sequence of the desired biological antigen that includes COVID-19 S1 spike protein.
Furthermore, the claimed limitations are obvious because all of the claimed elements were known in the prior art and one skilled in the art could have combined the elements (i.e. COVID-19 S1 spike protein comprising the claimed SEQ ID: 3 or 4) by known methods with no change in their respective functions (i.e. detection of COVID-19 S1 spike protein), and the combinations yielded nothing more than predictable results (i.e. providing COVID-19 S1 spike protein comprising the claimed SEQ ID: 3 or 4 would yield nothing more than the obvious and predictable result of enabling improved detection of COVID-19 S1 spike protein). See MPEP 2143(A).
Regarding claim 3, note that claim 1 recites the “the second biological antigen comprising the COVID-19 S2 spike protein or the fragment thereof” in alternative form using the phrase “or”, therefore, the limitations of “wherein the second biological antigen comprising the COVID-19 S2 spike protein or the fragment thereof is a polypeptide comprising a sequence of at least 8, 10, 12, 14, 16, 18, 20, 30, 100, 200 or 300 amino acids from an amino acid sequence having at least 70%, 80%, 90%, 95%, 99% or 100% sequence identity to the sequence of SEQ ID NO: 5 or SEQ ID NO: 6” of claim 3 is interpreted as not required, since it further limits an optional limitation. As discussed above in claim 1, modified Fan teaches the biological antigen of i)(a). Therefore, modified Fan teaches all the limitations of claim 3.
Regarding claim 4, note that claim 1 recites the “the COVID-19 S2 spike protein or the fragment thereof” in alternative form using the phrase “or”, therefore, the limitations of “wherein the COVID-19 S2 spike protein or the fragment thereof comprises a sequence in which the C-terminal six or 62 amino acids are deleted from the sequence of SEQ ID NO: 5 or SEQ ID NO: 6” of claim 4 is interpreted as not required, since it further limits an optional limitation. As discussed above in claim 1, modified Fan teaches the biological antigen of i)(a). Therefore, modified Fan teaches all the limitations of claim 4.
Regarding claim 5, modified Fan fails to teach: wherein the COVID-19 S1 spike protein or the fragment thereof, the single polypeptide chain being immobilisable on the detection portion.
Ji teaches a lateral flow device for detecting COVID-19 (abstract), such as detecting the presence of IgG anti-S1 spike antibodies, IgM anti-S1 antibodies, and neutralizing antibodies (e.g., both IgM and IgG) that block binding between ACE2 antigen and S1 spike protein (paragraph [0003]). Ji teaches the lateral flow device or kit, wherein the coronavirus S1 spike polypeptide in the plurality of detectably labeled coronavirus S1 spike polypeptide conjugates comprises S1 spike polypeptide from SARS-CoV-2 and having the amino acid sequence of SEQ ID NO: 3-4 (paragraph [0010], SEQ ID NO:2 also shown in Fig. 10 is equivalent to the instant application’s SEQ ID NO: 3 and 4). Ji teaches in one embodiment, the immobilized ACE2 receptor capture polypeptide binds the receptor binding domain (RBD) on an S1 spike polypeptide from a SARS-CoV-2 virus, where the S1 spike polypeptide comprises the amino acid sequence of SEQ ID Nos: 3-4 (paragraph [0164], SEQ ID NO:2 also shown in Fig. 10 is equivalent to the instant application’s SEQ ID NO: 3 and 4). Ji teaches a synthetic antigen binding protein can comprise antibody fragments, 1-6 or more polypeptide chains, asymmetrical assemblies of polypeptides, or other synthetic molecules (paragraph [0082]). Ji teaches single-chain antibodies and single chain fragments (paragraphs [0086]-[0087]).
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 the COVID- 19 S1 spike protein or the fragment thereof of modified Fan to incorporate the teachings of a lateral flow device for COVID-19 and single polypeptide chains or single chain antibodies or fragments of Ji (paragraphs [0082],[0086],[0087]) to provide: wherein the COVID-19 S1 spike protein or the fragment thereof, the single polypeptide chain being immobilisable on the detection portion. Doing so would have a reasonable expectation of successfully improving antigen-antibody detection of a sequence of the desired COVID-19 S1 spike protein.
Furthermore, the claimed limitations are obvious because all of the claimed elements were known in the prior art and one skilled in the art could have combined the elements (i.e. the S1 spike protein being a single polypeptide chain) by known methods with no change in their respective functions (i.e. detection of COVID-19 S1 spike proteins), and the combinations yielded nothing more than predictable results (i.e. providing the claimed S1 spike proteins as a single polypeptide chain would yield nothing more than the obvious and predictable result of enabling improved detection of COVID-19 proteins). See MPEP 2143(A).
Note that claim 1 recites the “COVID-19 S2 spike protein or the fragment thereof” in alternative form using the phrase “or”, therefore, the limitations of “COVID-19 S2 spike protein or the fragment thereof” is interpreted as not required. Therefore, “and the COVID-19 S2 spike protein or the fragment thereof are comprised within a single polypeptide chain, the single polypeptide chain being immobilisable on the detection portion” of claim 5 is interpreted as not required since it further limits an optional limitation.
Regarding claim 8, Fan further teaches wherein the second member of the reporter-analyte pair or each of the reporter-analyte pairs is immobilised on the detection portion (paragraphs [0027],[0030] teaches the a SARS-CoV-2 test line on the test strip is coated with anti-S1 protein of SARS-CoV-2 polyclonal antibodies, i.e. second member of the reporter-analyte pair is immobilised on the detection portion).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Fan in view of Ji as applied to claim 1 above, and further in view of Skraba et al. (US 20200241010 A1; filed 04/13/2020).
Regarding claim 6, Fan fails to teach: wherein the biological antigen further comprises a third biological antigen from a third reporter-analyte pair and wherein the third biological antigen comprises a COVID-19 nucleoprotein or a fragment thereof.
Fan teaches a plurality of test line areas for multiple rapid detection of different analytes (Fig. 4; paragraph [0066],[0125]).
Skraba teaches a cartridge may comprise a plurality (e.g., 3) of solid phase substrates, wherein each solid phase substrate holds one of the first bacterial-binding agent, the second bacterial-binding agent or the third bacterial-binding agent (paragraph [0018]). Skraba teaches testing for the presence of two types of viruses and three different types of bacteria in parallel (paragraph [0193]). Skraba teaches the assays can include any antigen binding agents that bind antigens specific to each type of bacteria and viruses (paragraph [0191]), and pairs or pools of antibodies may be chosen to have low cross-reactivity, while allowing comparable detection of the bacterium/bacteria and/or virus(es); and a pair or pool of antibodies specific to one or more antigen binding agents can be relatively specific or characteristic of a bacteria or virus (paragraph [0191]). Skraba teaches the binding agent includes a binding agent for SARS-CoV-2 that may bind with a nucleoprotein and/or Spike (S1, S2, or RBD subunits) antigen binding site of coronavirus (e.g. SARS-CoV, MERS-CoV, or SARS-CoV-2) (paragraph [0191]).
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 the biological antigen of modified Fan to incorporate the teachings of detecting multiple antigens, such as a nucleoprotein, S1, S2, or RBD subunits of SARS-CoV-2 of Skraba (paragraphs [0018],[0191],[0193]) to provide: wherein the biological antigen further comprises a third biological antigen from a third reporter-analyte pair and wherein the third biological antigen comprises a COVID-19 nucleoprotein or a fragment thereof. Doing so would have a reasonable expectation of successfully improving detection of components of desired viruses, such as the nucleoprotein, S2, or RBD subunits of SARS-CoV-2, and therefore improving detection of SARS-CoV-2.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Fan in view of Ji as applied to claim 1 above, and further in view of Kouvonen et al. (US 5965458 A).
Regarding claim 7, Fan further teaches wherein the porous membrane element (Fig. 4, nitrocellulose membrane 408) further comprises a reference element (control line area 414). Modified Fan fails to teach the reference element for indicating a level of the first member of the or each reporter-analyte pair in the liquid, biological sample.
Kouvonen teaches a test strip for rapid immunoassay containing specific reagent zones (abstract). Kouvonen teaches the strip comprises multiple membranes or zones, and the strip contains several different concentrations of the same reagent or label in order to determine different analyte concentrations semiquantitatively (column 4, lines 1-9). Kouvonen teaches the same membrane may contain several reagents for detecting different concentrations of the same analyte (column 5, lines 55-58).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have the reference element of modified Fan to incorporate the teachings of test strips with multiple zones with different concentrations of a reagent or label for determining analyte concentration of Kouvonen (column 4, lines 1-9; column 5, lines 55-58) to provide: the reference element for indicating a level of the first member of the or each reporter-analyte pair in the liquid, biological sample. Doing so would have a reasonable expectation of successfully improving semiquantitative analysis of a desired analyte as discussed by Kouvonen (column 4, lines 1-9; column 5, lines 55-58).
Response to Arguments
Applicant’s arguments, see pages 1-13, filed 04/16/2026, with respect to the rejections under 35 U.S.C. 103, specifically regarding amended claim 1, have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Fan (US 20230212589 A1; effectively filed 02/26/2020) in view of Ji (US 20230168245 A1; effectively filed 04/24/2020).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
McDevitt et al. (US 20210311055 A1; effectively filed 03/25/2020) teaches assays for diagnosing and assessing pathogen-mediated diseases and infections (abstract). McDevitt teaches in the context of SARS CoV-2, the first panel of biomarkers comprises a biomarker of SARS CoV-2, including any viral protein or viral nucleic acid, such as SARS CoV-2 spike protein (e.g., spike antigen), the S1 or S2 subunits of the SARS CoV-2 spike protein, or the SARS CoV-2 nucleocapsid protein (N-protein) (paragraph [0059]).
Laderman et al. (US 20230204581 A1; effectively filed 03/03/2020) teaches methods and devices for detection of SARS-CoV-2 (abstract). Laderman teaches in one embodiment, the SARS-CoV-2 antigen is selected from the group consisting of a spike protein (S), a receptor-binding (RBD) protein, a S1 protein, a S2 protein, a whole protein (S1+S2), and a nucleocapsid protein (NP); in a specific embodiment, the SARS-CoV-2 antigen is a nucleocapsid protein; and in another specific embodiment, the SARS-CoV-2 antigen is a spike protein (paragraph [0009]).
Loomis (US 20230145699 A1; effectively filed 04/03/2020) teaches lateral flow assay devices adapted to detect IgA specific for SARS-CoV-2 in biological samples from subjects suspected to have COVID-19 (abstract). Loomis teaches lateral Flow tests have been developed for the presence of mucosal IgA1 and IgA2 in nasal swabs obtained from the nasopharynx and from saliva which are directed against various SARS-CoV-2 components (Spike protein, receptor binding domain (RBD), nucleocapsid, S1 and S2) (paragraph [0002]). Loomis teaches lateral flow assays capable of detecting IgA antibodies specific for a component of SARS-CoV-2, such as for example, the Spike protein and/or RBD (paragraph [0014]).
Victor (US 20230176054 A1; effectively filed 03/20/2020) teaches detection of SARS-CoV-2 using a sandwich assay (abstract). Victor teaches a microfluidic device for detecting an anti-coronavirus spike protein antibody in a sample from a subject, the device comprising a microchannel comprising a first and a second binding moiety dried within, wherein the first binding moiety comprises an S1 or an S2 subunit of a coronavirus spike protein, or a fragment thereof, and is labeled with a detectable label or a capture agent, and wherein the second binding moiety is attached to a detectable label or a capture agent, and wherein the first and second binding moieties, when solubilized with the sample, form a complex comprising the first binding moiety, the anti-coronavirus spike protein antibody, and the second binding moiety (paragraph [0036]).
Howard (US 20210285943 A1; effectively filed 03/28/2020) teaches a virumeter for rapid detection of COVID-19 infection and assessment of immunity to the virus, for example detecting antibodies to a pathogen (abstract). Howard teaches an to be detected may comprise SARS-CoV-2 S1 protein (paragraph [0008]). Howard teaches embodiments may use a single primary antibody towards a conserved portion of any of the aforementioned proteins can be used, or embodiments may use a mixture of primary antibodies, which are specific to different mutations of the virus; and monoclonal antibodies towards a conserved portion of the S1 spike surface proteins of SARS-CoV-2 may be a primary target of embodiments; however S2, M, E, or N antibodies may be tested in embodiments (paragraph [0072]).
Tan et al. (Tan et al., “Rapid and quantitative detection of COVID-19 markers in micro-liter sized samples”, bioRxiv, April 22, 2020) teaches a microfluidic ELISA device for rapid, quantitative, and sensitive detection of SARS-CoV-2 biomarkers using SARS-CoV-2 specific IgG and viral antigen – S protein in serum for rapid and quantitative analysis of COVID-19 patients (abstract). Tan teaches a sandwich assay for S1 protein detection using a capture antibody immobilized on a surface, and a HRP-conjugated detection antibody (Fig. 3).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HENRY H NGUYEN whose telephone number is (571)272-2338. The examiner can normally be reached M-F 7:30A-5:00P.
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/HENRY H NGUYEN/Primary Examiner, Art Unit 1758
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