DETAILED ACTION
In application filed on 02/24/2023, Claims 1-27 are pending. The claim set submitted on 02/24/2023 is considered because this is the most recent claim set. Claims 1-22 are considered in the current office 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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 08/15/2023 and 07/10/2024 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Election/Restrictions
Applicant’s election without traverse of Group I in the reply filed on 12/26/2025 is acknowledged. Claims 23-27 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Groups, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/26/2024.
Group I, Claims 1-22 are considered on the merits below.
Claim Rejections - 35 USC § 102
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 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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-9 and 15-20 are rejected under 35 U.S.C. 102 (a) (1) as being anticipated by Thomas et al. (US20150177152A1).
Regarding Claim 1, Thomas teaches a fiber array (See Para 0144-0146…embodiment of a PEG linker being linked to the SERS-active nanoparticles, thereby teaching “fiber array”) comprising a plurality of nanoparticles (‘SERS-active nanoparticles’) attached to one or more fibers (‘specific binding members’) (See Para 0146… a bifunctional PEG linker can be used to attach specific binding members to the SERS-active nanoparticles),
wherein each nanoparticle (See Para 0129… a SERS-active nanoparticle) of the plurality of the nanoparticles (See Para 0124… composite SERS-active nanoparticles) is attached to a fiber (See Para 0144… specific binding member comprises a polynucleotide (e.g., an oligonucleotide), the polynucleotide can be attached to the PEG molecule) of the one or more fibers (See Para 0146… a bifunctional PEG linker can be used to attach specific binding members to the SERS-active nanoparticles) at a different location (See Annotated Fig. 5, thereby teaching “different location” ) through a linker (See Para 0103…e.g., a monoclonal antibody, can be treated with linker, e.g., polyethylene glycol (PEG), and attached directly to the nanoparticle through the PEG linker) wherein at least one of either:
d) the linker is 20 Da to 500 KDa (See Para 0138… PEG linker can have a molecular weight of about 200 Da to about 100,000 Da).
Examiner further submits that the limitation “a) the linker is attached to the fiber through a silane coupling group; b) the nanoparticle further comprises an analyte capture molecule; c) the linker is covalently attached to the nanoparticle; and e) and/or the fiber array comprises at least two fibers” is interpreted as optional due the recitation of “wherein at least one of either” and therefore limitation is not required by the claim.
Regarding Claim 2, Thomas teaches 5 or more fibers (See Para 0109…Other binding members include specific binding members having an affinity for a target analyte, including antibodies for target analytes, such as prostate specific antigen (PSA), creatine kinase MB (CKMB) isoenzyme, cardiac troponin I (cTnI) protein, thyroid-stimulating hormone (TSH), influenza A (Flu A) antigen, influenza B (Flu B) antigen, and respiratory syncytial virus (RSV) antigen, thereby teaching “5 or more fibers”).
Regarding Claim 3, Thomas teaches that the fiber array (See Para 0144-0146…embodiment of a PEG linker being linked to the SERS-active nanoparticles, thereby teaching “fiber array”) is a three-dimensional fiber array (See Para 0035…60-nm spherical gold nanoparticles; Under BRI, a spherical object is 3-dimensional.)
Regarding Claim 4, Thomas teaches that the nanoparticle (See Para 0035…spherical gold nanoparticles) is a plasmonic nanoparticle (Para 0035… the Raman intensity observed with non-fluorescent Raman molecules and commercial dyes adsorbed on 60-nm spherical gold nanoparticles, thereby teaching “plasmonic nanoparticle”).
Regarding Claim 5, Thomas teaches that the plasmonic nanoparticle (Para 0035… the Raman intensity observed with non-fluorescent Raman molecules and commercial dyes adsorbed on 60-nm spherical gold nanoparticles, thereby teaching “plasmonic nanoparticle”) comprise a metal selected from rhenium, ruthenium, rhodium, palladium, silver, osmium, iridium, platinum, gold, and alumni; and/or a non-metal selected from graphene, silica, and carbon nanotube (Para 0035… 60-nm spherical gold nanoparticles…).
Regarding Claim 6, Thomas teaches that the plasmonic nanoparticle (Para 0035… the Raman intensity observed with non-fluorescent Raman molecules and commercial dyes adsorbed on 60-nm spherical gold nanoparticles, thereby teaching “plasmonic nanoparticle”) comprise gold (Para 0035… 60-nm spherical gold nanoparticles…).
Regarding Claim 7, Thomas teaches that the nanoparticle (See Para 0035…spherical gold nanoparticles) is polymeric nanoparticle, or polymeric vesicle (See Para 0119-0120… some embodiments, the encapsulating shell comprises a dielectric material, such as a polymer…); comprises either a liposome, micelle, peptide, or dendrimer; or comprises a quantum dot (See Para 0107…In some embodiments, the binding member conjugated with the presently disclosed SERS-active nanoparticle, either through the SERS-active reporter molecule or directly attached to an outer surface of the nanoparticle itself, comprises a polypeptide or protein, thereby teaching “peptide”.
Regarding Claim 8, Thomas teaches that the fiber (See Para 0144… specific binding member comprises a polynucleotide (e.g., an oligonucleotide), the polynucleotide can be attached to the PEG molecule) comprises cross-linked silicone oxide or a polymer (See Para 0144… specific binding member comprises a polynucleotide (e.g., an oligonucleotide), the polynucleotide can be attached to the PEG molecule; Under BRI, polynucleotide is a polymer).
Regarding Claim 9, Thomas teaches that the one or more fibers (See Para 0144… specific binding member comprises a polynucleotide (e.g., an oligonucleotide), the polynucleotide can be attached to the PEG molecule) provides a three-dimensional glass fiber array (See Para 0144-0146…embodiment of a PEG linker being linked to the SERS-active nanoparticles, thereby teaching “fiber array”; See Para 0117…a nanoparticle, can be coated or encapsulated, for example, in a shell, of a different material, including glass; See Para 0035…60-nm spherical gold nanoparticles; Under BRI, a spherical object is 3-dimensional).
Regarding Claim 15, Thomas teaches that the linker (See Para 0103… linker, e.g., polyethylene glycol (PEG)…) is attached (See Para 0144…polynucleotide can be attached to the PEG molecule) to the fiber (See Para 0144… specific binding member comprises a polynucleotide (e.g., an oligonucleotide) through a silane coupling group (See Para 0348… DNA oligonucleotides were attached to the surface of SERS-active nanoparticles (gold particles coated with SERS-active reporter molecules, e.g., various bipyridyl dyes, and encapsulated by a thiol-functionalized glass coating) through a polyethylene glycol (PEG) linker molecule; See Para 0124… For example, immersion of glass in a suitable base allows for the covalent attachment of alkyl trichlorosilanes or alkyl trialkoxysilanes, with additional functionality available on the end of the alkyl group of the alkyl trichlorosilane or alkyl trialkoxysilane group; Further See Para 0225 for methods are known in the art for attaching oligonucleotides to nanoparticles).
Regarding Claim 16, Thomas teaches that the linker comprises a polyethylene glycol (See Para 0103… treated with linker, e.g., polyethylene glycol (PEG), and attached directly to the nanoparticle through the PEG linker) having a molecular weight of about 20 Da to about 500 kDa (See Para 0138… PEG linker can have a molecular weight of about 200 Da to about 100,000 Da).
Regarding Claim 17, Thomas teaches that the linker comprises a polyethylene glycol (See Para 0103… treated with linker, e.g., polyethylene glycol (PEG), and attached directly to the nanoparticle through the PEG linker) is covalently bonded to the fiber (‘specific binding members’) (See Para 0146… a bifunctional PEG linker can be used to attach specific binding members to the SERS-active nanoparticles) through a sulfur (See Para 0145… thiol groups on the surface of a SERS-active nanoparticle are reacted with a thiol-reactive maleimide group on the PEG linker to form a carbon-sulfur bond, thereby teaching “through sulfur”).
Regarding Claim 18, Thomas teaches that the nanoparticle (See Para 0035…spherical gold nanoparticles; See Para 0103…nanoparticle) further comprises an analyte capture molecule (See Para 0103…such as a monoclonal antibody…).
Regarding Claim 19, Thomas teaches that the said analyte capture molecule (See Para 0103… a binding member of a specific binding pair, for example, an antibody, such as a monoclonal antibody) further comprises an energy transfer molecule (See Para 0196… See Para 0196… Different reporter molecules) attached to the analyte capture molecule (See Para 0103… a binding member of a specific binding pair, for example, an antibody, such as a monoclonal antibody; See Para 0196… Different reporter molecules can be attached to different specific binding members).
Regarding Claim 20, Thomas teaches that the analyte capture molecule (See Para 0103… a binding member of a specific binding pair, for example, an antibody, such as a monoclonal antibody) comprises either a single-stranded oligonucleotide, antibody or binding fragment thereof, or an aptamer (See Para 0103…an antibody, such as a monoclonal antibody); and the energy transfer molecule is a fluorophore or luciferase molecule (See Para 0196… See Para 0196… Different reporter molecules; See Para 0122… SERS-active reporter molecule of formula A-Y; See Para 0047…A “reporter molecule” also can be referred herein as a “label,” a “dye,”, thereby teaching “fluorophore”).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Thomas et al. (US20150177152A1) as applied to claim 4 above, and further in view of Glover et al. (US20170341054A1).
Regarding Claim 10, Thomas teaches that the fiber (See Para 0144… specific binding member…) comprises a polymer (See Para 0144… specific binding member comprises a polynucleotide (e.g., an oligonucleotide), the polynucleotide can be attached to the PEG molecule; Under BRI, polynucleotide is a polymer).
Thomas does not teach that the polymer comprises polyethersulfone, polydimethylsiloxane, nylon, polypropylene, polylactic acid, cellulose, polycarbonate, polyacrylamide, polyacylonitrile, polyvinyl alcohol, cellulose acetate, polyvinyl chloride, polyamine/polyurethane, polyvinylidene fluoride, polyethylene terephthalate, polymethyl methacrylate, polystyrene, epoxy resin, thermoplastic polyurethane, poly(lactic-co-glycolic acid), polyether amine, or polyvinylpyrrolidone.
In the analogous art of an invention generally to nanotechnological structures, Glover teaches that the polymer (referred to as nylon or cellulose [Para 0120]) comprises …, nylon, …, cellulose, … (See Para 0120… nylon or cellulose).
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 fiber array of Thomas to incorporate that the polymer comprises polyethersulfone, polydimethylsiloxane, nylon, polypropylene, polylactic acid, cellulose, polycarbonate, polyacrylamide, polyacylonitrile, polyvinyl alcohol, cellulose acetate, polyvinyl chloride, polyamine/polyurethane, polyvinylidene fluoride, polyethylene terephthalate, polymethyl methacrylate, polystyrene, epoxy resin, thermoplastic polyurethane, poly(lactic-co-glycolic acid), polyether amine, or polyvinylpyrrolidone, as taught by Glover for the benefit of modifying Nylon or Cellulose with Gold nanoparticles (Glover, Para 0120), where gold nanoparticles can be attached on either natural or synthetic fibers (Glover, Para 0093), allowing for the provision of a generic synthetic methods that utilize conditions commonly found in chemical production facilities, such as moderate temperature and pressure requirements, limited vacuum conditions, and methods amenable to roll-to-roll processing technology for a nanostructure is to be added to a fiber (Glover, Para 0006).
Claims 11-13 are rejected under 35 U.S.C. 103 as being unpatentable over Thomas et al. (US20150177152A1) as applied to claim 8 above, and further in view of Strickland et al. (US20120058697A1).
Regarding Claim 11, Thomas does not teach that the average fiber diameter of the one or more fibers is 0.1 µm to 50 µm.
In the analogous art of textile fibers and other fibrous substrates functionalized with particles are provided for use in the detection of targets of interest by spectroscopic methods, Strickland teaches that the average fiber diameter of the one or more fibers is 0.1 µm to 50 µm (See Para 0565… uniform and continuous nanofibers—with an average diameter of ˜100 nm).
Strickland further teaches that Metallic particles (e.g., Ag and Au particles) in the ˜10-50 nm size regime can be deposited onto the resulting nanofiber-substrate blends (Para 0566).
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 fiber array of Thomas to incorporate that the average fiber diameter of the one or more fibers is 0.1 µm to 50 µm, as taught by Strickland for the benefit of producing spectroscopically active coatings on base textile substrates (fibers) (Strickland, Para 0563-0565), allowing for the provision of functionalized textile fibers for use in the signature detection methods which are produced by performing layer-by-layer self-assembly of particles on natural and synthetic textile substrates (Strickland, Abstract).
Regarding Claim 12, Thomas does not teach that the plurality of the nanoparticles provides for about 4% to about 95% coverage over a length of at least 14 µm2 of the one or more fibers.
In the analogous art of textile fibers and other fibrous substrates functionalized with particles are provided for use in the detection of targets of interest by spectroscopic methods, Strickland teaches that the plurality of the nanoparticles (See Para 0285… Ag/Au/Pt particles) provides for about coverage over a length of an area of the one or more fibers (‘cotton fibers’) (See Para 0285… high surface coverage of Ag/Au/Pt particles over cotton fibers).
Strickland further teaches that such textile substrates will be robust, can be prepared through simple processing, and will give very high and uniform metal particle surface coverage of the fiber surfaces (Para 0492). High surface coverage of the nanofibers by the particles can be achieved at pH intervals from 3 to 6, whereas only low surface coverage is achieved when the pH is greater than 7(Para 0531).
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 fiber array of Thomas to incorporate that the plurality of the nanoparticles provides for about coverage over a length of an area of the one or more fibers as taught by Strickland for the benefit of producing very high and uniform metal particle surface coverage of the fiber surfaces (Strickland, Para 0492), allowing for the provision of functionalized textile fibers for use in the signature detection methods which are produced by performing layer-by-layer self-assembly of particles on natural and synthetic textile substrates (Strickland, Abstract).
The combination of Thomas and Strickland does not explicitly teach that the plurality of the nanoparticles provides for about 4% to about 95% coverage over a length of at least 14 µm2 of the one or more fibers.
However, MPEP § 2144.05, Part II, Subpart B holds that a particular parameter that is recognized as a result effective variable (“a variable that achieves a recognized result”) would be one, but not the only motivation for a person of ordinary skill in the art to experiment to reach another workable product or process.
In the fabrication of biosensors based on plasmonic nanoparticles, nanoparticle (NP) coverage on a substrate directly dictates analyte detection sensitivity by controlling the density of active binding sites and, in optical sensors, the concentration of Raman "hot spots" or plasmonic coupling. Optimal, often sub-monolayer coverage, maximizes signal enhancement; however, excessive density (crowding) decreases sensitivity, whereas too little coverage provides insufficient surface area. Thus, the nanoparticles coverage over a length of an area of the one or more fibers is a result effective variable.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to design and fabricate a fiber array wherein the plurality of the nanoparticles provides for about 4% to about 95% coverage over a length of at least 14 µm2 of the one or more fibers, as taught by Strickland for the benefit of producing very high and uniform metal particle surface coverage of the fiber surfaces (Strickland, Para 0492), allowing for the provision of functionalized textile fibers for use in the signature detection methods which are produced by performing layer-by-layer self-assembly of particles on natural and synthetic textile substrates (Strickland, Abstract).
Regarding Claim 13, Thomas does not teach that the plurality of the nanoparticles provides for about 50% to about 75% coverage over a length of at least 25 µm2 of the one or more fibers.
In the analogous art of textile fibers and other fibrous substrates functionalized with particles are provided for use in the detection of targets of interest by spectroscopic methods, Strickland teaches that the plurality of the nanoparticles (See Para 0285… Ag/Au/Pt particles) provides for about coverage over a length of an area of the one or more fibers (‘cotton fibers’) (See Para 0285… high surface coverage of Ag/Au/Pt particles over cotton fibers).
Strickland further teaches that such textile substrates will be robust, can be prepared through simple processing, and will give very high and uniform metal particle surface coverage of the fiber surfaces (Para 0492). High surface coverage of the nanofibers by the particles can be achieved at pH intervals from 3 to 6, whereas only low surface coverage is achieved when the pH is greater than 7(Para 0531).
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 fiber array of Thomas to incorporate that the plurality of the nanoparticles provides for about coverage over a length of an area of the one or more fibers as taught by Strickland for the benefit of producing very high and uniform metal particle surface coverage of the fiber surfaces (Strickland, Para 0492), allowing for the provision of functionalized textile fibers for use in the signature detection methods which are produced by performing layer-by-layer self-assembly of particles on natural and synthetic textile substrates (Strickland, Abstract).
The combination of Thomas and Strickland does not explicitly teach that the plurality of the nanoparticles provides for about 50% to about 75% coverage over a length of at least 25 µm2 of the one or more fibers.
However, MPEP § 2144.05, Part II, Subpart B holds that a particular parameter that is recognized as a result effective variable (“a variable that achieves a recognized result”) would be one, but not the only motivation for a person of ordinary skill in the art to experiment to reach another workable product or process.
In the fabrication of biosensors based on plasmonic nanoparticles, nanoparticle (NP) coverage on a substrate directly dictates analyte detection sensitivity by controlling the density of active binding sites and, in optical sensors, the concentration of Raman "hot spots" or plasmonic coupling. Optimal, often sub-monolayer coverage, maximizes signal enhancement; however, excessive density (crowding) decreases sensitivity, whereas too little coverage provides insufficient surface area. Thus, the nanoparticles coverage over a length of an area of the one or more fibers is a result effective variable.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to design and fabricate a fiber array wherein the plurality of the nanoparticles provides for about 50% to about 75% coverage over a length of at least 25 µm2 of the one or more fibers, as taught by Strickland for the benefit of producing very high and uniform metal particle surface coverage of the fiber surfaces (Strickland, Para 0492), allowing for the provision of functionalized textile fibers for use in the signature detection methods which are produced by performing layer-by-layer self-assembly of particles on natural and synthetic textile substrates (Strickland, Abstract).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Thomas et al. (US20150177152A1) as applied to claim 4 above.
Regarding Claim 14, Thomas teaches that the plurality of the nanoparticles (See Para 0146… SERS-active nanoparticles).
Thomas does not explicitly teach that the plurality of the nanoparticles comprises 1000 nanoparticles.
However, MPEP § 2144.05, Part II, Subpart B holds that a particular parameter that is recognized as a result effective variable (“a variable that achieves a recognized result”) would be one, but not the only motivation for a person of ordinary skill in the art to experiment to reach another workable product or process.
In the fabrication of biosensors based on plasmonic nanoparticles, the number (concentration/density) of nanoparticles significantly affects analyte detection, often directly influencing the sensitivity and limit of detection (LOD) of sensors. Increasing the concentration of metallic nanoparticles, for example, can enhance signal intensity, such as in surface-enhanced Raman scattering (SERS) or colorimetric assays, by orders of magnitude. Thus, the number of the nanoparticles is a result effective variable.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to design and fabricate a fiber array wherein the plurality of the nanoparticles comprises 1000 nanoparticles for the benefit of providing a method for detecting the presence or amount of one or more analytes in a biological sample (Thomas, Para 0028), allowing for the provision for SERS-active reporter molecules that give rise to an increased Raman signal when compared to SERS-active reporter molecules known in the art (Thomas, Para 0007).
Claims 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over Thomas et al. (US20150177152A1) as applied to claim 1 above, and further in view of Barcelo et al. (US20190022650A1) and further in view of Strickland et al. (US20120058697A1).
Regarding Claim 21, Thomas teaches the fiber array of claim 1 (see claim 1 rejection), wherein
a) the nanoparticle (See Para 0124… composite SERS-active nanoparticles) is attached to the fiber (See Para 0144… specific binding member comprises a polynucleotide (e.g., an oligonucleotide), the polynucleotide can be attached to the PEG molecule; wherein the polynucleotide teaches “fiber”) .
b) the fiber array (See Para 0144-0146…embodiment of a PEG linker being linked to the SERS-active nanoparticles, thereby teaching “fiber array”) comprises 5 or more fibers (See Para 0109…Other binding members include specific binding members having an affinity for a target analyte, including antibodies for target analytes, such as prostate specific antigen (PSA), creatine kinase MB (CKMB) isoenzyme, cardiac troponin I (cTnI) protein, thyroid-stimulating hormone (TSH), influenza A (Flu A) antigen, influenza B (Flu B) antigen, and respiratory syncytial virus (RSV) antigen, thereby teaching “5 or more fibers”);
c) the fiber array (See Para 0144-0146…embodiment of a PEG linker being linked to the SERS-active nanoparticles, thereby teaching “fiber array”) is a three-dimensional glass fiber array (See Para 0035…60-nm spherical gold nanoparticles; Under BRI, a spherical object is 3-dimensional.);
d) the nanoparticle (See Para 0079…gold nanoparticles are plasmonic nanoparticles) is a plasmonic nanoparticle (See Para 0079…gold nanoparticles are plasmonic nanoparticles);
e) the linker (See Para 0079… a polyethylene glycol (PEG) linker) comprises a polyethylene glycol (See Para 0079… a polyethylene glycol (PEG) linker) having a molecular weight of about 20 Da to about 500 kDa (See Para 0138… PEG linker can have a molecular weight of about 200 Da to about 100,000 Da); and
h) an analyte capture molecule (See Para 0103… a binding member of a specific binding pair, for example, an antibody, such as a monoclonal antibody).
Thomas does not teach:
a) the nanoparticle is attached to the fiber through a siloxane bond.
In the analogous art of a microfluidic chip which may include a substrate, chamber supported by the substrate, a sacrificial material in the chamber, a spectroscopically active nano particle assembly anchored within the chamber by the sacrificial material and a fluid supply port connected to the chamber, Barcelo teaches that the nanoparticle (referred to as metallic cap [Para 0053; Fig. 5, ref. 254]) is attached (See Fig. 5 for the post being connected to the metallic cap) to the fiber (referred to as posts [Fig. 5, ref. 250]) through a siloxane bond (See Para 0052… each post 250 may be formed of siloxane).
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 fiber array of Thomas to incorporate the nanoparticle is attached to the fiber through a siloxane bond, as taught by Barcelo for the benefit of providing a plasmonic surface that enhances the intensity of electromagnetic radiation emitted as a result of the reaction of the analyte and the light impinging the reporter or tag molecule (Barcelo, Para 0054), allowing for the provision of enhanced Raman Spectroscopy (SERS) may be used for tagging in biological systems, such as reacting with bacteria, proteins, DNA, and the like, to allow the determination of presence and concentration (Barcelo, Para 0002).
The combination of Thomas and Barcelo does not teach that
f) the plurality of the nanoparticles provides for about 4% to about 95% coverage over a length of at least 14 µm2 of the one or more fibers; and
g) the average fiber diameter of the one or more fibers is 0.1 µm to 50 µm.
Regarding the limitation “the plurality of the nanoparticles provides for about 4% to about 95% coverage over a length of at least 14 µm2 of the one or more fibers”:
In the analogous art of textile fibers and other fibrous substrates functionalized with particles are provided for use in the detection of targets of interest by spectroscopic methods, Strickland teaches that the plurality of the nanoparticles (See Para 0285… Ag/Au/Pt particles) provides for about coverage over a length of an area of the one or more fibers (‘cotton fibers’) (See Para 0285… high surface coverage of Ag/Au/Pt particles over cotton fibers).
Strickland further teaches that such textile substrates will be robust, can be prepared through simple processing, and will give very high and uniform metal particle surface coverage of the fiber surfaces (Para 0492). High surface coverage of the nanofibers by the particles can be achieved at pH intervals from 3 to 6, whereas only low surface coverage is achieved when the pH is greater than 7(Para 0531).
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 fiber array of Thomas to incorporate that the plurality of the nanoparticles provides for about coverage over a length of an area of the one or more fibers as taught by Strickland for the benefit of producing very high and uniform metal particle surface coverage of the fiber surfaces (Strickland, Para 0492), allowing for the provision of functionalized textile fibers for use in the signature detection methods which are produced by performing layer-by-layer self-assembly of particles on natural and synthetic textile substrates (Strickland, Abstract).
The combination of Thomas and Strickland does not explicitly teach that the plurality of the nanoparticles provides for about 4% to about 95% coverage over a length of at least 14 µm2 of the one or more fibers.
However, MPEP § 2144.05, Part II, Subpart B holds that a particular parameter that is recognized as a result effective variable (“a variable that achieves a recognized result”) would be one, but not the only motivation for a person of ordinary skill in the art to experiment to reach another workable product or process.
In the fabrication of biosensors based on plasmonic nanoparticles, nanoparticle (NP) coverage on a substrate directly dictates analyte detection sensitivity by controlling the density of active binding sites and, in optical sensors, the concentration of Raman "hot spots" or plasmonic coupling. Optimal, often sub-monolayer coverage, maximizes signal enhancement; however, excessive density (crowding) decreases sensitivity, whereas too little coverage provides insufficient surface area. Thus, the nanoparticles coverage over a length of an area of the one or more fibers is a result effective variable.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to design and fabricate a fiber array wherein the plurality of the nanoparticles provides for about 4% to about 95% coverage over a length of at least 14 µm2 of the one or more fibers, as taught by Strickland for the benefit of producing very high and uniform metal particle surface coverage of the fiber surfaces (Strickland, Para 0492), allowing for the provision of functionalized textile fibers for use in the signature detection methods which are produced by performing layer-by-layer self-assembly of particles on natural and synthetic textile substrates (Strickland, Abstract).
Regarding the limitation “the average fiber diameter of the one or more fibers is 0.1 µm to 50 µm”:
In the analogous art of textile fibers and other fibrous substrates functionalized with particles are provided for use in the detection of targets of interest by spectroscopic methods, Strickland teaches that the average fiber diameter of the one or more fibers is 0.1 µm to 50 µm (See Para 0565… uniform and continuous nanofibers—with an average diameter of ˜100 nm).
Strickland further teaches that Metallic particles (e.g., Ag and Au particles) in the ˜10-50 nm size regime can be deposited onto the resulting nanofiber-substrate blends (Para 0566).
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 fiber array of Thomas to incorporate that the average fiber diameter of the one or more fibers is 0.1 µm to 50 µm, as taught by Strickland for the benefit of producing spectroscopically active coatings on base textile substrates (fibers) (Strickland, Para 0563-0565), allowing for the provision of functionalized textile fibers for use in the signature detection methods which are produced by performing layer-by-layer self-assembly of particles on natural and synthetic textile substrates (Strickland, Abstract).
Regarding Claim 22, Thomas teaches that the analyte capture molecule (See Para 0103… a binding member of a specific binding pair, for example, an antibody, such as a monoclonal antibody) comprises either a single-stranded oligonucleotide, antibody or binding fragment thereof, or an aptamer (See Para 0103…an antibody, such as a monoclonal antibody); and the energy transfer molecule is a fluorophore or luciferase molecule (See Para 0196… See Para 0196… Different reporter molecules; See Para 0122… SERS-active reporter molecule of formula A-Y; See Para 0047…A “reporter molecule” also can be referred herein as a “label,” a “dye,”, thereby teaching “fluorophore”).
Conclusion
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/OYELEYE ALEXANDER ALABI/ Examiner, Art Unit 1797