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 .
This action is in response to the amendment filed 08/28/2025, in which claims 1-3, 7-12, 28 and 29 were amended and claims 4-6 were canceled. Claims 1-3, 7-12, 28 and 29 are currently pending.
Any rejection of record in the previous office actions not addressed herein is withdrawn. New grounds of rejection are presented herein that were not necessitated by applicant’s amendment of the claims since the office action mailed 5/28/2025. Therefore, this action is not final.
Nucleotide and/or Amino Acid Sequence Disclosures
REQUIREMENTS FOR PATENT APPLICATIONS CONTAINING NUCLEOTIDE AND/OR AMINO ACID SEQUENCE DISCLOSURES
Items 1) and 2) provide general guidance related to requirements for sequence disclosures.
37 CFR 1.821(c) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.821(a) must contain a "Sequence Listing," as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.821 - 1.825. This "Sequence Listing" part of the disclosure may be submitted:
In accordance with 37 CFR 1.821(c)(1) via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/PatentLegalFramework), hereinafter "Legal Framework") as an ASCII text file, together with an incorporation-by-reference of the material in the ASCII text file in a separate paragraph of the specification as required by 37 CFR 1.823(b)(1) identifying:
the name of the ASCII text file;
ii) the date of creation; and
iii) the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(1) on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation-by-reference of the material in the ASCII text file according to 37 CFR 1.52(e)(8) and 37 CFR 1.823(b)(1) in a separate paragraph of the specification identifying:
the name of the ASCII text file;
the date of creation; and
the size of the ASCII text file in bytes;
In accordance with 37 CFR 1.821(c)(2) via the USPTO patent electronic filing system as a PDF file (not recommended); or
In accordance with 37 CFR 1.821(c)(3) on physical sheets of paper (not recommended).
When a “Sequence Listing” has been submitted as a PDF file as in 1(c) above (37 CFR 1.821(c)(2)) or on physical sheets of paper as in 1(d) above (37 CFR 1.821(c)(3)), 37 CFR 1.821(e)(1) requires a computer readable form (CRF) of the “Sequence Listing” in accordance with the requirements of 37 CFR 1.824.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed via the USPTO patent electronic filing system as a PDF, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the PDF copy and the CRF copy (the ASCII text file copy) are identical.
If the "Sequence Listing" required by 37 CFR 1.821(c) is filed on paper or read-only optical disc, then 37 CFR 1.821(e)(1)(ii) or 1.821(e)(2)(ii) requires submission of a statement that the "Sequence Listing" content of the paper or read-only optical disc copy and the CRF are identical.
Specific deficiencies and the required response to this Office Action are as follows:
Drawings filed on 04/29/2022, Fig. 2A: comprises a sequence without a sequence identifier within the figure or the brief drawing description.
Specific deficiency – Nucleotide and/or amino acid sequences appearing in the drawings are not identified by sequence identifiers in accordance with 37 CFR 1.821(d). Sequence identifiers for nucleotide and/or amino acid sequences must appear either in the drawings or in the Brief Description of the Drawings.
Required response – Applicant must provide:
Replacement and annotated drawings in accordance with 37 CFR 1.121(d) inserting the required sequence identifiers;
AND/OR
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required sequence identifiers into the Brief Description of the Drawings, consisting of:
A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter.
Response to Amendment - Specification
The previous objection to the specification for comprising embedded hyperlinks has been withdrawn in view of applicant’s submission of a substitute specification filed on 08/28/2025.
Claim Objections
Claims 1 and 28 are objected to because of the following informalities:
Claim 1 comprises language that renders the claim not succinct. It would be beneficial to amend the claim to recite: “wherein a biological sample capable of gravitational flow is introduced to the device through the matrix and absorbent pad, and wherein the formation of a complex between the detection reagent or molecule, the biological sample, the antigen-specific DCS and an antigen encoding sequence on the matrix within the cassette detects the presence of the antigen within the device.”
Claim 7 recites “wherein the assay comprises…”. It would be remedial to amend the claim to replace the term “assay” with the term “device”.
Claim 28 recites “an assay comprising…”. It would be remedial to amend the claim to replace the term “assay” with the term “device”.
Appropriate correction is required.
Response to Amendment - Claim Objections
The previous objection to claims 2-6 and 8-12 has been withdrawn in view of Applicant’s amendments to the claims filed on 08/28/2025.
Response to Amendments - Claim Rejections - 35 USC § 112
The previous rejection of claims 1-3 and 7-12 under 35 U.S.C. 112(b) has been withdrawn in view of the Applicant’s amendments filed on 08/28/2025.
The previous rejection of claims 4-6 under 35 U.S.C. 112(b) is moot in view of Applicant’s cancellation of the claims filed on 08/28/2025.
Claim Rejections - 35 USC § 103
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 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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1, 2, 8-10 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Chan (US 2003/0049857 Al) in view of Tang et al (Microchim Acta (2019) 186: 831, Pgs: 1-8) and Guo et al (WO 2021/007357 Al). This is a NEW rejection.
Regarding claim 1, Chan teaches a vertical flow-through diagnostic device (Page 4, Figure 4). Chan teaches a test unit comprising a reaction zone in vertical communication with an absorbent zone, wherein the reaction zone contains immobilized capture reagent capable of binding with a target analyte of interest to form a two-membered complex of a specific binding interaction; and a post-filter unit comprising a label zone containing a dried indicator reagent, wherein the indicator reagent is capable of binding to a member of the specific binding interaction to produce a visually detectable signal following resolubilization thereof by buffer reagent (Page 26, Claim 1; [0084]). Chan teaches the reaction zone is made up of nitrocellulose material (Page 27, claims 6 and 11; [0101]). Chan teaches the fluid test sample containing a DNA sequence as target analyte is deposited on the reaction zone and binds to a known complimentary DNA sequence immobilized as capture reagents [0079].
Chan does not teach the cellulose or polymer backing on the nitrocellulose membrane.
Tang teaches improving the adsorption capacity of biomolecules by modifying the nitrocellulose (NC) membrane with cellulose nanofibers (CNF) (Page 2, Column 1). Tang teaches the modification of the nitrocellulose membrane by integrating both the front and back of the nitrocellulose membrane with CNFs (Page 2, Column 2). Tang teaches the porosity of CNF- modified NC membrane is higher than that of unmodified NC membrane (Page 4, Column 2). Tang teaches the CNF has higher surface area resulting in the higher surface area of NC membrane which provides binding sites for adsorb biomolecules (Page 4, Column 2).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Chan to include the cellulose nanofiber backing as taught by Tang because Chan teaches it is within the ordinary skill in the art to use a method of gravitational flow through an assay for detecting an antigen in a sample where the cassette comprises an absorbent pad, a reaction matrix layer on top of the absorbent pad within the cassette, the reaction matrix is a nitrocellulose membrane and a detection agent and Tang teaches a nitrocellulose membrane with the cellulose backing for improved porosity and surface area.
One would have been motivated to make such a modification in order to receive the expected benefit of improved porosity and higher surface area for the detection assay as taught by Tang.
Chan and Tang do not teach wherein the detection reagent or molecule comprises a nanoparticle and is covalently linked to the antigen-specific DCS.
Guo teaches the immobilization oligonucleotide can be a nucleic acid (e.g. DNA) aptamer, and the marker oligonucleotide can be a nucleic acid (e.g. DNA) aptamer [0009]. Guo teaches the target molecule is a viral protein wherein the viral protein is a SARSCo
V-2 N protein or S protein [0011]. Guo teaches that biotin is attached to the end of the
aptamer which is capable of binding to streptavidin treated nitrocellulose membrane for
anchoring [0163]. Guo teaches a first probe that is a gold or fluorophore labeled aptamer (marker probe) to find and label the SARS-CoV-2 virus, and a second probe that is fixed on a
nitrocellulose membrane (fixing probe) to concentrate the labelled virus in a band [0161].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Chan and Tang to include the detection reagent or molecule comprises a nanoparticle and is covalently linked to the antigen-specific DCS as taught by Guo because Chan teaches it is within the ordinary skill in the art to use a method of gravitational flow through an assay for detecting an antigen in a sample where the cassette comprises an absorbent pad, a reaction matrix layer on top of the absorbent pad within the cassette, the reaction matrix is a nitrocellulose membrane and a detection agent, Tang teaches a nitrocellulose membrane with the cellulose backing for improved porosity and surface area and
Guo teaches that biotin is attached to the end of the aptamer (the immobilization oligonucleotide such as (e.g. DNA) aptamer) which is capable of binding to streptavidin treated nitrocellulose membrane for anchoring and a first probe that is a gold or fluorophore labeled aptamer (marker probe) to find and label the SARS-CoV-2 virus, and a second probe that is fixed on a nitrocellulose membrane (fixing probe) to concentrate the labelled virus in a band.
One would have been motivated to make such a modification in order to receive the
expected benefit of effective and successful detection within the assay as taught by Guo.
Regarding claim 2, Chan teaches the materials suitable for the capture zone membrane include microporous materials having a pore size from about 0.2um to 0.8um [0099].
Regarding claims 8 and 10, Chan and Tang do not teach the antigen-specific DNA capture sequence as well as the SARS-CoV-2 DNA capture sequence is to the nucleocapsid (N) protein or spike (S) protein.
Guo teaches the target molecule is a viral protein wherein the viral protein is a SARSCo
V-2 N protein or S protein [0011]. Guo teaches that biotin is attached to the end of the
aptamer which is capable of binding to streptavidin treated nitrocellulose membrane for
anchoring [0163]. Guo teaches a first probe that is a gold or fluorophore labeled aptamer (marker probe) to find and label the SARS-CoV-2 virus, and a second probe that is fixed on a
nitrocellulose membrane (fixing probe) to concentrate the labelled virus in a band [0161].
It would have been obvious to one of ordinary skill in the art before the effective filing
date of the claimed invention to modify the teachings of Chan and Tang to include specific
antigen proteins, such as the nucleocapsid protein and spike protein, as taught by Guo because
Chan teaches it is within the ordinary skill in the art to use a method of gravitational flow
through an assay for detecting an antigen in a sample where the cassette comprises an absorbent
pad, a reaction matrix layer on top of the absorbent pad within the cassette, the reaction matrix is
a nitrocellulose membrane and a detection agent, Tang teaches a nitrocellulose membrane with
the cellulose backing for improved porosity and surface area and Guo teaches the nucleocapsid and spike proteins are used for detection of the SARS-Co V-2 virus.
One would have been motivated to make such a modification in order to receive the
expected benefit of effective and successful detection within the assay as taught by Guo.
Regarding claim 9, Chan and Tang do not teach wherein the SARS-Cov-2 DCS is
an LNA-modified DCS.
Guo teaches the target molecule is a viral protein wherein the viral protein is a SARSCo
V-2 N protein or S protein [0011]. Guo teaches that biotin is attached to the end of the
aptamer which is capable of binding to streptavidin treated nitrocellulose membrane for
anchoring [0163]. Guo teaches a first probe that is a gold or fluorophore labeled aptamer (marker
probe) to find and label the SARS-CoV-2 virus, and a second probe that is fixed on a
nitrocellulose membrane (fixing probe) to concentrate the labelled virus in a band [0161]. Guo
teaches the disclosed nucleic acid aptamers comprise one or more locked nucleic acids [0010]. Guo teaches locked nucleic acids can increase complex stability approximately tenfold and can
alter the hybridization temperature of a nucleic acid to a probe [0064].
It would have been obvious to one of ordinary skill in the art before the effective filing
date of the claimed invention to modify the teachings of Chan and Tang to include specific
antigen proteins, such as the nucleocapsid protein and spike protein, as taught by Guo because
Chan teaches it is within the ordinary skill in the art to use a method of gravitational flow
through an assay for detecting an antigen in a sample where the cassette comprises an absorbent
pad, a reaction matrix layer on top of the absorbent pad within the cassette, the reaction matrix is
a nitrocellulose membrane and a detection agent, Tang teaches a nitrocellulose membrane with
the cellulose backing for improved porosity and surface area and Guo teaches the DCS sequence contains one or more locked nucleic acid.
One would have been motivated to make such a modification in order to receive the
expected benefit of increased complex stability approximately tenfold and alteration of the
hybridization temperature of a nucleic acid to a probe as taught by Guo.
Regarding claim 12, Chan teaches the use of multiple cassettes to test a plurality of samples at the same time [0111].
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Chan (US 2003/0049857 Al) in view of Tang et al (Microchim Acta (2019) 186: 831, Pgs: 1-
8) and Guo et al (WO 2021/007357 Al), as applied to claims 1, 2, 8-10 and 12 above, and in further view of NyBond et al (Analytical and Bioanalytical Chemistry (2019) 411:813–822). This is a NEW rejection.
The teachings of Chan, Tang and Guo are described above and applied as before.
Regarding claim 3, Chan, Tang and Guo do not teach the nanoparticle diameter.
Nybond teaches the AuNP used were 40 nm particles conjugated with monoclonal anti-biotin antibodies (Page 816, Column 1).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Chan, Tang and Guo to include the nanoparticle size as 40nm as taught by Nybond because Chan teaches it is within the ordinary skill in the art to use a method of gravitational flow through an assay for detecting an antigen in a sample where the cassette comprises an absorbent pad, a reaction matrix layer on top of the absorbent pad within the cassette, the reaction matrix is a nitrocellulose membrane and a detection agent, Tang teaches a nitrocellulose membrane with the cellulose backing for improved porosity and surface area, Guo teaches that biotin is attached to the end of the aptamer (the immobilization oligonucleotide such as (e.g. DNA) aptamer) which is capable of binding to streptavidin treated nitrocellulose membrane for anchoring and a first probe that is a gold or fluorophore labeled aptamer (marker probe) to find and label the SARS-CoV-2 virus, and a second probe that is fixed on a nitrocellulose membrane (fixing probe) to concentrate the labelled virus in a band and Nybond teaches it is within the ordinary skill in the art to use gold nanoparticles (AuNPs) for detection of red color in the visible region.
One would have been motivated to make such a modification in order to receive the expected benefit of effective and successful detection within the assay as taught by Nybond.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Chan (US 2003/0049857 Al) in view of Tang et al (Microchim Acta (2019) 186: 831, Pgs: 1-
8) and Guo et al (WO 2021/007357 Al), as applied to claims 1, 2, 8-10 and 12 above, and in further view of Kim et al (ACS Sensors, Vol. 6, Issue 5, pages 1891-1898, April 6th, 2021). This is a NEW rejection.
The teachings of Chan, Tang and Guo are described above and applied as before.
Chan, Tang and Guo do not teach wherein the device comprises at least two cassettes, wherein one cassette is a control.
Regarding claims 7, Kim teaches multiple flow through cassette devices where one is a negative control sample and one is a positive control sample where the control samples were prepared by spiking 0 and 40 nM SARS-Co V2 NP monoclonal rabbit antibody into human serum to simulate nonspecific binding signals (N) and specific binding signals (S) (Page 1893, Column 2).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Chan, Tang and Guo to include the negative and positive controls cassette as taught by Kim because Chan teaches it is within the ordinary skill in the art to use a method of gravitational flow through an assay for detecting an antigen in a sample where the cassette comprises an absorbent pad, a reaction matrix layer on top of the absorbent pad within the cassette, the reaction matrix is a nitrocellulose membrane and a detection agent, Tang teaches a nitrocellulose membrane with the cellulose backing for improved porosity and surface area, Guo teaches that biotin is attached to the end of the aptamer (the immobilization oligonucleotide such as (e.g. DNA) aptamer) which is capable of binding to streptavidin treated nitrocellulose membrane for anchoring and a first probe that is a gold or fluorophore labeled aptamer (marker probe) to find and label the SARS-CoV-2 virus, and a second probe that is fixed on a nitrocellulose membrane (fixing probe) to concentrate the labelled virus in a band and Kim teaches the negative and positive controls is used to provide validity of the test.
One would have been motivated to make such a modification in order to receive the expected benefit of effective and successful detection within the assay as taught by Kim.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Chan (US
2003/0049857 Al), Tang et al (Microchim Acta (2019) 186: 831, Pgs: 1-8) and Guo et al (WO 2021/007357 Al) as applied to claims 1-3, 7-10 and 12 above, and further in view of Takeuchi et al (US 2021/0333272 Al). This is a NEW rejection.
The teachings of Chan, Tang and Guo are described above and applied as before.
Regarding claim 11, Chan, Tang and Guo do not teach wherein the SARS-Cov-2
DCS is an LNA-modified DCS and wherein the DCS comprises a sequence selected from SEQ ID NO: 1-13.
Takeuchi teaches the affinity of the nucleic acid aptamer per detection target can be
remarkably improved, even if the nucleic acid aptamer has an innate affinity that is equal or
lower than the affinity of the antibody or lower than the affinity of the antibody, showing it is
possible to effectively obtain the effect of improving the affinity of the nucleic acid aptamer per
detection target [0092]. Takeuchi teaches that SEQ ID No: 6 is 100% identical to instant SEQ ID
NO: 5 and identified as a DNA specific sequence to SARS-CoV-2 [0286] (Sequence listed on
Page 17; See Appendix I).
It would have been obvious to one of ordinary skill in the art before the effective filing
date of the claimed invention to have substituted the biotin aptamer protein as taught by Guo for
the specific sequence as taught by Takeuchi because Chan teaches it is within the ordinary skill in the art to use a method of gravitational flow through an assay for detecting an antigen in a sample where the cassette comprises an absorbent pad, a reaction matrix layer on top of the absorbent pad within the cassette, the reaction matrix is a nitrocellulose membrane and a detection agent, Tang teaches a nitrocellulose membrane with the cellulose backing for improved porosity and surface area, Guo teaches nitrocellulose is widely used and the DNA aptamers are capable and effective at binding the virus in order for detection within the assay and Takeuchi teaches the specific sequence of the SARS-CoV-2 specific DNA sequence.
One of ordinary skill in the art would have had a reasonable expectation of success in
doing so because the SARS-CoV-2 specific DNA sequence would provide better affinity of the
nucleic acid aptamer to the detection target.
Claim 28 is rejected under 35 U.S.C. 103 as being unpatentable over Chan (US
2003/0049857 Al), Tang et al (Microchim Acta (2019) 186: 831, Pgs: 1-8) and Guo et al (WO 2021/007357 Al) in view of Ahern (The Scientist, 1995, 9(15):20). This is a NEW rejection.
The teachings of Chan, Tang and Guo are described above and applied as before.
Regarding claim 28, Chan and Tang do not teach a coronavirus-specific DCS.
Guo teaches the immobilization oligonucleotide can be a nucleic acid (e.g. DNA) aptamer and the marker oligonucleotide can be a nucleic acid (e.g. DNA) aptamer [0009]. Guo teaches the target molecule is a viral protein wherein the viral protein is a SARS-CoV-2 N protein or S protein [0011]. Guo teaches that biotin is attached to the end of the aptamer which is capable of binding to streptavidin treated nitrocellulose membrane for anchoring [0163]. Guo teaches a first probe that is a gold or fluorophore labeled aptamer (marker probe) to find and label the SARS-CoV-2 virus, and a second probe that is fixed on a nitrocellulose membrane (fixing probe) to concentrate the labelled virus in a band [0161]. Guo teaches that the method can provide a convenient, simple, efficient, and low-cost diagnosis method for COVI D-19 as well as the approach is the use of aptamers that bind to one virus or to one protein (to detect the protein as replication by-product) [0161].
A kit is a collection of items and therefore a reference that teaches the elements of the kit also teaches the kit. Guo does not teach instructions to use the elements within a kit.
Ahern teaches producing kits of premade biochemicals and reagents offers scientists the opportunity to better manage their time because putting these products all together in kits takes the convenience one step further (Page 5, Paragraph 2). Ahem teaches that there is a large selection of prepared biochemicals and kits for specific applications that save individuals time and money, particularly when the individuals do not have specific background in production of the biochemicals needed for an experiment (Page 6, Paragraphs 1-5).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Chan and Tang to include specific antigen proteins, such as the nucleocapsid protein and spike protein, as taught by Guo and the benefits of providing the steps and materials in a kit as taught by Ahem because Chan teaches it is within the ordinary skill in the art to use a method of gravitational flow through an assay for detecting an antigen in a sample where the cassette comprises an absorbent pad, a reaction matrix layer on top of the absorbent pad within the cassette, the reaction matrix is a nitrocellulose membrane and a detection agent, Tang teaches a nitrocellulose membrane with the cellulose backing for improved porosity and surf ace area, Guo teaches the nucleocapsid and spike proteins are used for detection of the SARS-CoV-2 virus and Ahem teaches that kits are important for saving scientists time and money while performing experiments.
One would have been motivated to make such a modification in order to receive the expected benefit of production of a kit with all the necessary materials as taught by Ahem.
Claim 29 is rejected under 35 U.S.C. 103 as being unpatentable over Chan (US
2003/0049857 Al), Tang et al (Microchim Acta (2019) 186: 831, Pgs: 1-8) and Guo et al (WO 2021/007357 Al) in view of Ahern (The Scientist, 1995, 9(15):20) as applied to claim 28 above, and further in view of Takeuchi et al (US 2021/0333272 Al). This is a NEW rejection.
The teachings of Chan, Tang, Guo and Ahern are described above and applied as
before.
Regarding claim 29, Chan, Tang, Guo and Ahern do not teach the DCS comprises a
sequence selected from SEQ ID NO: 1-13.
Takeuchi teaches the affinity of the nucleic acid aptamer per detection target can be remarkably improved, even if the nucleic acid aptamer has an innate affinity that is equal or lower than the affinity of the antibody or lower than the affinity of the antibody, showing it is possible to effectively obtain the effect of improving the affinity of the nucleic acid aptamer per detection target [0092]. Takeuchi teaches that SEQ ID No: 6 is 100% identical to instant SEQ ID NO: 5 and identified as a DNA specific sequence to SARS-CoV-2 [0286] (Sequence listed on Page 17; See Appendix I).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the teachings of Chan, Tang, and Guo to include the specific sequence of the aptamer as taught by Takeuchi Chan teaches it is within the ordinary skill in the art to use a method of gravitational flow through an assay for detecting an antigen in a sample where the cassette comprises an absorbent pad, a reaction matrix layer on top of the absorbent pad within the cassette, the reaction matrix is a nitrocellulose membrane and a detection agent, Tang teaches a nitrocellulose membrane with the cellulose backing for improved porosity and surf ace area, Guo teaches the nucleocapsid and spike proteins are used for detection of the SARS-Co V-2 virus, Ahern teaches that kits are important for saving scientists time and money while performing experiments and Takeuchi teaches the specific sequence of the SARSCoV-2 specific DNA sequence aptamer.
One of ordinary skill in the art would have had a reasonable expectation of success in doing so because the SARS-CoV-2 specific DNA sequence would provide better affinity of the nucleic acid aptamer to the detection target.
Response to Arguments - Claim Rejections - 35 USC § 103
The previous rejection of claims 1, 2 and 12 under 35 U.S.C. 103 over Chan (US 2003/0049857 Al) in view of Tang et al (Microchim Acta (2019) 186: 831, Pgs: 1-8) has been withdrawn in view of Applicant’s amendments.
The previous rejection of claims 4, 5 and 7-10 under 35 U.S.C. 103 over Chan (US 2003/0049857 Al) in view of Tang et al (Microchim Acta (2019) 186: 831, Pgs: 1-8) and further in view of Kim et al (ACS Sensors, Vol. 6, Issue 5, pages 1891-1898, April 6th, 2021) and Guo et al (WO 2021/007357 Al) has been withdrawn in view of Applicant’s amendments.
The previous rejection of claim 11 under 35 U.S.C. 103 over Chan (US 2003/0049857 Al) and Tang et al (Microchim Acta (2019) 186: 831, Pgs: 1-8) in view of Kim et al (ACS Sensors, Vol. 6, Issue 5, pages 1891-1898, April 6th, 2021) and Guo et al (WO 2021/007357 Al) and further in view of Takeuchi et al (US 2021/0333272 Al) has been withdrawn in view of Applicant’s amendments.
The previous rejection of claim 28 under 35 U.S.C. 103 over Chan (US 2003/0049857 Al) and Tang et al (Microchim Acta (2019) 186: 831, Pgs: 1-8) in view of Kim et al (ACS Sensors, Vol. 6, Issue 5, pages 1891-1898, April 6th, 2021) and Guo et al (WO 2021/007357 Al) and further in view of Ahern (The Scientist, 1995, 9(15):20) has been withdrawn in view of Applicant’s amendments.
The previous rejection of claim 29 under 35 U.S.C. 103 over Chan (US 2003/0049857 Al) and Tang et al (Microchim Acta (2019) 186: 831, Pgs: 1-8) in view of Kim et al (ACS Sensors, Vol. 6, Issue 5, pages 1891-1898, April 6th, 2021), Guo et al (WO 2021/007357 Al) and Ahern (The Scientist, 1995, 9(15):20) and further in view of Takeuchi et al (US 2021/0333272 Al) has been withdrawn in view of Applicant’s amendments.
Conclusion
No claims are allowed.
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/ALEXANDRA ROSE LIPPOLIS/ Examiner, Art Unit 1637
/Jennifer Dunston/ Supervisory Patent Examiner, Art Unit 1637