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 04/29/2026, in which claims 1, 7, 11, 12, 28 and 29 were amended, claims 2, 3 and 8-10 were previously presented and claims 13-27 were withdrawn in a previous office action due to a restriction requirement. Claims 1-3, 7-12, 28 and 29 are currently pending.
Applicant’s arguments have been thoroughly reviewed, but are not persuasive for the
reasons that follow. Any rejection and objections not reiterated in this action have been
withdrawn. This action is FINAL.
Nucleotide and/or Amino Acid Sequence Disclosures
The previous objection to the specification/drawings for sequences being provided within the drawings filed on 04/29/2022 has been withdrawn in view of Applicant’s substitute specification filed on 04/29/2026 comprising the SEQ ID NOs corresponding to the sequences shown in the drawings within the figure descriptions.
Claim Objections
The previous objections of claims 1, 7 and 28 is withdrawn in view of Applicant’s amendments to the claims filed on 04/29/2026.
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, 3 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Chan (US 2003/0049857 Al) in view of Bora et al (Journal of Biotechnology 126 (2006) 220–229). This is a NEW rejection necessitated by the amendment filed on 04/29/2026.
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 paper backed 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 teaches colloidal gold particle is selected for its unusual properties including the ability to intensify color to the naked eye when concentrated on solid surfaces, to minimally bind nonspecifically to solid surfaces and to be easily lyophilized and resolubilized and about 15nm to 20nm in size [0148-0151].
Chan does not teach wherein the DCS that is linked to the matrix is covalently bound to the nitrocellulose by a photoreaction induced by exposure to ultraviolet (UV) light having a wavelength in a range of about 250 nm to about 370nm.
Bora teaches a simple and mild procedure for the preparation of a photoreactive cellulose membrane capable of forming a covalent bond with a biomolecule in presence of 365nm UV light (Page 220, Abstract). Bora teaches immobilization of goat anti-rabbit IgG by 30 min UV irradiation on photoreactive cellulose membrane gave much higher ELISA readings than that obtained on untreated membrane (Page 227, 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 to include the attachment of the DCS to the nitrocellulose membrane using 365nm UV light as taught by Bora 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 Bora teaches a photoreactive cellulose membrane capable of forming a covalent bond with a biomolecule in presence of 365nm UV light.
One would have been motivated to make such a modification in order to receive the expected benefit of improved covalent linkage of DNA capture sequences to cellulose membranes as taught by Bora.
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 claim 3, Chan teaches colloidal gold particle is selected for its unusual properties including the ability to intensify color to the naked eye when concentrated on solid surfaces, to minimally bind nonspecifically to solid surfaces and to be easily lyophilized and resolubilized and about 15nm to 20nm in size [0148-0151].
Regarding claim 12, Chan teaches the use of multiple cassettes to test a plurality of samples at the same time [0111].
Claims 8-10 are rejected under 35 U.S.C. 103 as being unpatentable over Chan (US 2003/0049857 Al) in view of Bora et al (Journal of Biotechnology 126 (2006) 220–229) as applied to claims 1, 2, 3 and 12 above, and in further view Guo et al (WO 2021/007357 Al). This is a NEW rejection necessitated by the amendment filed on 04/29/2026.
The teachings of Chan and Bora as described and applied above.
Regarding claims 8 and 10, Chan and Bora 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 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 Bora 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, Bora teaches a photoreactive cellulose membrane capable of forming a covalent bond with a biomolecule in presence of 365nm UV light 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 Bora 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 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 Bora 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 as well as utilizing a gold nanoparticle, Bora teaches a photoreactive cellulose membrane capable of forming a covalent bond with a biomolecule in presence of 365nm UV light 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.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Chan (US 2003/0049857 Al) in view of Bora et al (Journal of Biotechnology 126 (2006) 220–229), as applied to claims 1, 2, 3 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 necessitated by the amendment filed on 04/29/2026.
The teachings of Chan and Bora are described above and applied as before.
Chan and Bora 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 and Bora 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, Bora teaches a photoreactive cellulose membrane capable of forming a covalent bond with a biomolecule in presence of 365nm UV light 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), Bora et al (Journal of Biotechnology 126 (2006) 220–229) 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 necessitated by the amendment filed on 04/29/2026.
The teachings of Chan, Bora and Guo are described above and applied as before.
Regarding claim 11, the claim is interpreted that “a sequence” means two or more consecutive nucleotides and not the entirety of the sequence.
Chan, Bora 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: 1-14.
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 Previously Submitted Appendix I). Takeuchi teaches that SEQ ID NO: is 100% identical to instant SEQ ID NOs: 1-4 and 6-14 identified as a DNA specific sequence SARS-CoV-2 [0286] (NEW Appendices II-XIV, respectively).
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, Bora teaches a photoreactive cellulose membrane capable of forming a covalent bond with a biomolecule in presence of 365nm UV light, 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), Bora et al (Journal of Biotechnology 126 (2006) 220–229) and Guo et al (WO 2021/007357 Al) in view of Ahern (The Scientist, 1995, 9(15):20). This is a NEW rejection necessitated by the amendment filed on 04/29/2026.
The teachings of Chan, Bora and Guo are described above and applied as before.
Regarding claim 28, Chan and Bora 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 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 Bora 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, Bora teaches a photoreactive cellulose membrane capable of forming a covalent bond with a biomolecule in presence of 365nm UV light, 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), Bora et al (Journal of Biotechnology 126 (2006) 220–229) 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 necessitated by the amendment filed on 04/29/2026.
The teachings of Chan, Bora, Guo and Ahern are described above and applied as
before.
Regarding claim 29, the claim is interpreted that “a sequence” means two or more consecutive nucleotides and not the entirety of the sequence.
Chan, Bora, Guo and Ahern do not teach the DCS comprises a sequence selected from SEQ ID NO: 1-14.
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 Previously Submitted Appendix I). Takeuchi teaches that SEQ ID NO: is 100% identical to instant SEQ ID NOs: 1-4 and 6-14 identified as a DNA specific sequence SARS-CoV-2 [0286] (NEW Appendices II-XIV, respectively).
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, Bora, and Guo to include the specific sequence of the aptamer 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, Bora teaches a photoreactive cellulose membrane capable of forming a covalent bond with a biomolecule in presence of 365nm UV light, 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 rejections of claims 1, 2, 8-10 and 12 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); Claim 3 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) and in further view of NyBond et al (Analytical and Bioanalytical Chemistry (2019) 411:813–822); Claim 7 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) and in further view of Kim et al (ACS Sensors, Vol. 6, Issue 5, pages 1891-1898, April 6th, 2021); Claim 11 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) and further in view of Takeuchi et al (US 2021/0333272 Al); Claim 28 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); and Claim 29 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) and further in view of Takeuchi et al (US 2021/0333272 Al), has been withdrawn in view of Applicant’s amendments to the claims filed on 04/29/2026.
In the interest of compact prosecution, the Applicant’s Arguments to address the cited references still utilized in the current rejections recited above, have been fully considered but have not been found persuasive.
Applicant argues the amendments to the current claim, specifically claim 1, overcomes the previous rejection due to the new limitations which are not taught by the previous references.
However, as stated above, claim 1 was amended to recite that the nitrocellulose membrane is a paper-backed nitrocellulose membrane which is taught by Chan as recited above stating, “Chan teaches the reaction zone is made up of paper backed nitrocellulose material (Page 27, claims 6 and 11; [0101]).”. Claim 1 was also amended to recite “wherein each DCS that is linked to the matrix is covalently bound to the nitrocellulose by a photoreaction induced by exposure to ultraviolet (UV) light having a wavelength in a range of about 250 nm to about 370 nm” which while not taught by Chan, is taught by Bora. Bora teaches a simple and mild procedure for the preparation of a photoreactive cellulose membrane capable of forming a covalent bond with a biomolecule in presence of 365nm UV light (Page 220, Abstract). Bora teaches immobilization of goat anti-rabbit IgG by 30 min UV irradiation on photoreactive cellulose membrane gave much higher ELISA readings than that obtained on untreated membrane (Page 227, 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 to include the attachment of the DCS to the nitrocellulose membrane using 365nm UV light as taught by Bora 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 Bora teaches a photoreactive cellulose membrane capable of forming a covalent bond with a biomolecule in presence of 365nm UV light. One would have been motivated to make such a modification in order to receive the expected benefit of improved covalent linkage of DNA capture sequences to cellulose membranes as taught by Bora.
Applicant argues Guo’s probe immobilization strategies are exclusively non-covalent (biotin-streptavidin binding or lipid hydrophobic anchoring). Applicant continues that Guo does not teach using UV irradiation as a mechanism for covalently attaching any probe to any membrane surface. Applicant argues that the biotin-streptavidin binding of Guo is not interchangeable with UV-induced covalent photo crosslinking. Applicant continues to argue that Guo’s entire two-probe system operates within a lateral flow strip architecture in which the sample is introduced at one end and migrates horizontally by capillary forces, which is the conventional immunochromatographic strip format.
However, Applicant’s arguments for Guo’s teachings pertaining to the biotin-streptavidin binding to the paper-backed nitrocellulose membrane is not applicable. This is because Guo is only relied on in the current rejection above for the antigen-specific DNA capture sequence, the SARS-CoV-2 DNA capture sequence is to the nucleocapsid (N) protein or spike (S) protein as well as the SARS-Cov-2 DCS is an LNA-modified DCS. In combination with Chan and Bora, 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 Bora 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 as well as utilizing a gold nanoparticle, Bora teaches a photoreactive cellulose membrane capable of forming a covalent bond with a biomolecule in presence of 365nm UV light 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.
Applicant argues Guo teaches the aptamer detect the SARS-CoV-2 N protein or S protein antigen through three-dimensional aptamer folding and shape-complementary, conformation-dependent protein-surface recognition and not through Watson-Crick base pairing to a nucleic acid sequence. Specifically, in regards to claim 9, Applicant argues Guo’s LNA modifications are employed in a functionally distinct context such as that claim 9 recites an LNA-modified DCS used as a hybridization probe that forms a Watson-Crick duplex with a complementary nucleic acid sequence from the sample.
However, the claim simply recites “wherein the SARS-Cov-2 DCS is an LNA-modified DCS”. The limitations argued by Applicant are not current limitations of the claim as currently recited. The claim is thus read with the broadest reasonable interpretation which includes any LNA-modified SARS-CoV-2 DCS.
Applicant argues, in regards to claim 7, Kim’s “control” is instead an experimental control sample, specifically a separately prepared sample with a known spiked-in analyte concentration that is run in a separate experimental cassette during assay validation.
However, the claim simply recites “wherein the device comprises at least two cassettes, wherein one cassette is a control”. The limitations argued by Applicant are not current limitations of the claim as currently recited. The claim is thus read with the broadest reasonable interpretation. Even with Applicant’s interpretation of the control cassette used in Kim, it is still acknowledged by Applicant that the cassette is a “experimental control sample”.
Applicant argues, with regard to claim 11, that the sequences listed in the claim as SEQ ID NOs: 1-14 are a Markush group and the Office’s response only addresses one sequence of the Markush group. Applicant continues to argue that simply stating that instant SEQ ID NO: 5 exists does not establish obviousness and Takeuchi does not teach any of the claimed limitations of the independent claims.
This argument is not found persuasive. A Markush-type claim provides a list of elements in the alternative. Claim 11 recites “a sequence selected from SEQ ID NO: 1-14,” which reads on the selection of any two or more consecutive nucleotides from a single sequence identifier of the list. Only one sequence is selected, and the prior art need only render obvious a single sequence. All of the independent limitations of claim 1 are taught by Chan, Bora and Guo, therefore, 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, Bora teaches a photoreactive cellulose membrane capable of forming a covalent bond with a biomolecule in presence of 365nm UV light, 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.
Applicant continues to argue, with regards to claims 28 and 29, previous arguments that have been stated prior and responded to above. In addition, Applicant argues that every structural component of the claimed kit must be present in the cited art.
However, every structural component of the claimed kit has been addressed in the above rejection as well as the Applicant’s arguments previously discussed above. Ahern is relied upon for the 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 and 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. Ahern is not relied on to teach all of the limitations of the current independent claim.
Conclusion
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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/ALEXANDRA ROSE LIPPOLIS/Examiner, Art Unit 1637
/Jennifer Dunston/Supervisory Patent Examiner, Art Unit 1637
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