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 .
Priority
The present application was filed on 10/19/2023 and claims the benefit U.S. Provisional Patent Application No. 63/418,112 filed on 10/21/2022. All the content in the pending claims are supported in the original disclosure of the U.S. Provisional Patent Application No. 63/418,112 filed on 10/21/2022, the pending claims of this instant application have an effective filing date of 10/21/2022.
Claim Status
Claims 1-21 are pending and examined herein below.
Information Disclosure Statement (IDS)
One Information Disclosure Statement (IDS), filed on 3/18/2024, is acknowledged and considered. One reference on the IDS is stricken for the reasons detailed herein. The original version of Foreign Patent cite No. 1, Kimoto Co., Ltd, is provided but the English translation is not provided.
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 (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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-6, 13-14, 16 and 20 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Gjerde et al., (US 2004/0224425 A1, provided in IDS filed 03/18/2024 as U.S. Patent Pub Cite No. 1).
Throughout the disclosure, Gjerde teaches multiple embodiments for methods of making and using an open tubular capture/extraction device (capillary) with an inner surface or channel functioning as a capture/extraction surface that binds target analytes or specific types of analytes. Gjerde teaches some embodiments with the open tubular analyte capture/extraction device having a helical or coiled, annular geometry with several turns. Gjerde teaches the capture or extraction agent can comprise a biomolecule, polymer, or functionalized polymer having binding affinity for target biomolecules or specific types of biomolecules. Gjerde teaches that such capture/extraction agents can include protein A, protein G, protein L, or their combination. Gjerde further teaches elution of captured/extracted analytes using a low pH mobile phase.
Regarding claim 1, Gjerde teaches a tubular protein capture device, comprising (i) a continuous tubular body having an inner surface and an outer surface, wherein the inner surface defines a fluid flow path and includes a protein attached to at least a portion of the inner surface (US 2004/0224425 A1: Abstract, and paras 0033-0034), the protein selected from protein A, protein G, protein L, or combination thereof (US 2004/0224425 A1: paras 0300-0301, eg. 14); and (ii) an inlet and an outlet for flowing a sample matrix, the inlet and outlet being in fluid communication with the fluid flow path (US 2004/0224425 A1: Abstract; paras 0029, 0033-0034), wherein the continuous tubular body has a helical shape that extends continuously from the inlet to the outlet of the continuous tubular body (US 2004/0224425 A1: paras 0033, 0036, and 0057; Fig. 21).
Regarding claim 2, Gjerde teaches the tubular protein capture device of claim 1, wherein the continuous tubular body has an annular geometry (US 2004/0224425 A1: Fig. 21 and paras 0270, 0273).
Regarding claim 3, Gjerde teaches the tubular protein capture device of claim 1, wherein the continuous tubular body has an open tubular geometry (US 2004/0224425 A1: paras 0029, 0033, 0036, 0072, 0153).
Regarding claim 4, Gjerde teaches the tubular protein capture device of claim 1, wherein the sample matrix comprises at least one type of protein (US 2004/0224425 A1: paras 0034 and 0300,eg. 14).
Regarding claim 5, Gjerde teaches wherein the sample matrix comprises a cell culture, a cellular material, a cell extract or combination thereof (US 2004/0224425 A1: para 0248).
Regarding claim 6, Gjerde teaches the tubular protein capture device of claim 1, wherein the continuous tubular body comprises a plurality of tubes aligned within a hollow enclosure, wherein the inlet and the outlet for flowing a sample matrix being in fluid communication with the plurality of tubes (US 2004/0224425 A1: paras 0029 and 0088).
Regarding claim 13, Gjerde teaches the tubular protein capture device of claim 1, wherein the continuous tubular body comprises more than one turns (US 2004/0224425 A1: para 0270), wherein the distance between consecutive coils is less than 10 mm (US 2004/0224425 A1: para 0265).
Regarding claim 14, Gjerde teaches the tubular protein capture device of claim 1, wherein the outer surface of continuous tubular body is made of a material selected from metal, glass, polymer or combination thereof (US 2004/0224425 A1: paras 0039 and 0254).
Regarding claim 16, Gjerde teaches the method of capturing at least one type of protein from a sample matrix wherein the sample matrix comprises a cell culture, a cellular material, a cell extract or combination thereof, comprising: a) providing the tubular device of any one of claims 1-3, having an inner surface with protein A, G, L, or their combination attached to the inner surface (US 2004/0224425 A1: paras 029; 0033-0034; 0248; 0300-0301, eg. 14; Fig. 21). Gjerde further teaches (b) wherein the protein selected from protein A, protein G, protein L or combination thereof is capable of binding to at least one type of protein within the sample matrix and (c) binding the at least one type of protein within the sample matrix to the protein selected from protein A, protein G, protein L or combination thereof, thereby capturing at least one type of protein from the sample matrix. (US 2004/0224425 A1: para 0331-0332, references eg. 14, same embodiment).
Regarding claim 20, Gjerde teaches the tubular protein capture device comprising (i) a continuous annular tubular body having an inner surface and an outer surface, wherein the inner surface defines a fluid flow path and includes a protein attached to at least a portion of the inner surface (US 2004/0224425 A1: paras 0033-0034), the protein selected from protein A, protein G, protein L, or combination thereof (US 2004/0224425 A1: paras 0300-0301, eg. 14); and (ii) an inlet and an outlet for flowing a sample matrix, the inlet and outlet being in fluid communication with the fluid flow path (US 2004/0224425 A1: paras 0033), wherein the continuous tubular body has a helical shape that extends continuously from the inlet to the outlet of the continuous annular tubular body (US 2004/0224425 A1: Fig. 21, paras 0033, 0036, 0057, 0088).
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 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.
Claim(s) 7-10 are rejected under 35 U.S.C. 103 as being unpatentable over Gjerde et al., (US 2004/0224425 A1, provided in IDS filed 03/18/2024 as U.S. Patent Pub Cite No. 1), as applied to claim 1, in view of Chegel et al., (Chegel et al., Deposition of functionalized polymer layers in surface plasmon resonance immunosensors by in-situ polymerization in the evanescent wave field, 2009, Biosensors and Bioelectronics, 24, 1270–1275), and as evidenced by Stevens et al., (Stevens et al., 2021, Self-assembly of protein-polymer conjugates for drug delivery, 174, 447-460).
Regarding claims 7-8, the teachings of Gjerde are discussed herein above. Gjerde teaches all the limitations of claim 1 and further teaches wherein at least a portion of the inner surface of the tubular body is coated with a polymer [claim 7] and wherein the polymer comprises polyethylene glycol, fluorinated ethylene propylene or ethylene tetrafluoroethylene [claim 8] (US 2004/0224425 A1: paras 0089, 0098-0099, 0268, 0293). In the same embodiment, Gjerde does not teach attaching the protein selected from protein A, protein G, protein L or combination thereof to the inner surface of the tubular protein capture device or to the polymer on the inner surface of the tubular device.
In a separate embodiment in the same reference, Gjerde teaches wherein the protein selected from protein A, protein G, protein L or combination thereof is attached to the inner surface/channel of the tubular protein capture device of claim 1 (US 2004/0224425 A1: paras 0300-0301). Gjerde does not teach attaching the protein selected from protein A, protein G, protein L or combination thereof to the polymer on the inner surface of the tubular device.
Throughout the article, Chegel teaches a method for in-situ formation of polymers on the surface of an SPR device. Chegel teaches varying polymer thickness between 20–200 nm. Standard coupling with 1-ethyl-3-(3-dimethylaminopropyl)carbodiimide (EDC) and N-hydroxysuccinimide (NHS) was used for the immobilization of protein G onto the polymer to capture/extract an IgG antibody.
Chegel teaches the limitation(s) of claim 7 reciting wherein the protein selected from protein A, protein G, protein L or combination thereof is attached to a polymer surface (pg. 1270, Abstract and pg.1272, section 2.5).
It would have been prima facie obvious, at the time of filing, to combine the embodiment disclosing coating the inner surface of the tubular device with a polymer comprising polyethylene glycol, fluorinated ethylene propylene or ethylene tetrafluoroethylene, as taught by Gjerde, with the embodiment of immobilizing protein A, protein G, protein L, or their combination to the inner surface of the tubular device, as taught by Gjerde in a separate embodiment in the same reference, with the method of attaching protein G to a polymer surface, as taught by Chegel. A skilled artisan would have been motivated to combine the two embodiments taught by Gjerde in the same reference with the method taught by Chegel because attaching protein A, protein G, protein L, or their combination on the polymer would create a sensing layer on the polymer surface that has specificity since the immobilized protein(s) would extract/capture a specific analyte type it/they has/have a natural specific affinity for (see Chegel et al., 2009, Biosensors and Bioelectronics, 24, pg. 1270, Abstract and pg.1272, section 2.5). At the time of filing, coating the inner surface of an open tubular protein capture device with a helical shape and annular geometry with a polymer or attaching a capture protein selected from protein A, protein G, protein L, or their combination to the inner surface of the same tubular device were taught as separate embodiments in the art. Further, at the time of filing the successful combination of these two embodiments was already taught and suggested in the prior art, specifically attaching protein G to a polymer layer (see Chegel et al., 2009, Biosensors and Bioelectronics, 24, pg. 1270, Abstract and pg.1272, section 2.5). Thus, a person having ordinary skill in the art would have a reasonable expectation of success because combining known elements according to known methods, already known to perform the same function separately as they do when combined and known to be successfully combined, would yield expected and predictable results.
Regarding claim 9, Gjerde teaches all the limitation(s) of claim 1 and, Gjerde, in a separate embodiment, and Chegel teach the limitation(s) of claim 7. Gjerde, in the embodiments that read on claims 1 and 7, does not teach wherein the protein A, protein G, protein L or combination thereof is attached to the polymer through a covalent bond.
However, in a separate embodiment taught in the same reference, Gjerde teaches attaching protein G to the inner surface/channel of the tubular protein capture device via a PDITC linker, forming covalent bond(s) with the amino group(s) of the lysine residue(s) of protein G (US 2004/0224425 A1: paras 0288-0291). Gjerde does not teach the protein is attached to the polymer.
Chegel teaches the limitation(s) of claim 9 reciting wherein the protein selected from protein A, protein G, protein L or combination thereof is attached to a polymer surface through a covalent bond (pg. 1270, Abstract and pg.1272, section 2.5, 1-ethyl-3-(3-dimethylaminopropyl) carbodiimide and N-hydroxysuccinimide coupled to protein G through a covalent bond to form amide bond).
It would have been prima facie obvious, at the time of filing, to combine the embodiment disclosing coating the inner surface of the tubular device as disclosed in claim 1 with a polymer, as taught by Gjerde, with the embodiments of immobilizing protein A, protein G, protein L, or their combination to the inner surface of the same tubular device through covalent bonding, as taught by Gjerde in a separate embodiment in the same reference, with the method of attaching protein G to a polymer surface through a covalent bond (between EDC-NHS and carboxylic acid groups in protein G to form amide bond), as taught by Chegel. A skilled artisan would have been motivated to combine the two separate embodiments taught by Gjerde with the teachings of their successful combination as taught and suggested by Chegel because covalent bonding of the capture protein(s) to the polymer layer would create a stable sensing/extraction/capture layer on the polymer surface that has specificity for a specific type of analyte. At the time of filing, the teachings for (1) coating the inner surface of a tubular protein capture device, as disclosed in claim 1, with a polymer; (2) the teachings for attaching a protein selected from protein A, protein G, protein L, or their combination to the inner surface of a tubular protein capture device, as disclosed in claim 1; and (3) the teachings of immobilizing protein A, protein G, protein L, or their combination via covalent bonding to the inner surface of a tubular protein capture device were all already taught as separate embodiments in the same reference by Gjerde. Further, at the time of filing, the successful combination of attaching the recited capture protein(s) to a polymer layer was already taught in the prior art (see Chegel et al., 2009, Biosensors and Bioelectronics, 24, pg. 1270, Abstract and pg.1272, section 2.5). Thus, a person having ordinary skill in the art would have a reasonable expectation of success because combining known elements according to known methods, already known to perform the same function separately as they do when combined and already known to be successfully combined, would yield expected and predictable results.
Regarding claim 10, Gjerde teaches all the limitation(s) of claim 1 and, Gjerde, in a separate embodiment, and Chegel teach the limitation(s) of claim 7. In the embodiment that reads on claim 1, Gjerde further teaches wherein the protein is attached to the polymer through a non-covalent interaction (US 2004/0224425 A1: para 300, residues in protein G interact with silica via noncovalent interactions including hydrogen-bonding, van der Waals, and electrostatics).
It would have been prima facie obvious, at the time of filing, to combine the embodiment disclosing coating the inner surface of the tubular device with a polymer, as taught by Gjerde, with the embodiments of immobilizing protein A, protein G, protein L, or their combination to the inner surface of the tubular device through non-covalent bonding, as taught by Gjerde in a separate embodiment in the same reference. A skilled artisan would have been motivated to combine these embodiments taught in the same reference because first, a sensing layer with specificity for a specific type of analyte would be created on the coated polymer. Second, a skilled artisan would have been further motivated to combine these embodiments taught in the same reference because the non-covalent binding of the capture protein(s) to the polymer coat would enable reversible binding between the immobilized capture protein(s) and the polymer layer, allowing for function modulation of the immobilized capture protein (see Stevens et al., 2021, Self-assembly of protein-polymer conjugates for drug delivery, 174, pgs. 451-452, section 2.3.2). A person having ordinary skill in the art would have a reasonable expectation of success because combining known elements according to known methods, already known to perform the same function separately as they do when combined, would yield expected and predictable results.
Claim(s) 11, 17, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Gjerde et al., (US 2004/0224425 A1, provided in IDS filed 03/18/2024 as U.S. Patent Pub Cite No. 1), as applied to claims 1-4, as evidenced by Way et al., (Way et al., Purification Strategies for Recombinant Therapeutic Proteins, Feb 2022, American Pharmaceutical Review, URL: https://www.americanpharmaceuticalreview.com/Featured-Articles/583965-Purification-Strategies-for-Recombinant-Therapeutic-Proteins/ ), and Thermo Scientific (Thermo Scientific, 2009, Tech Tip#27:Optimize elution conditions for immunoaffinity purification, 1-2).
The teaching of Gjerde are discussed herein above. Regarding claim 11, Gjerde teaches all the limitations of claims 1 and 4, and further teaches wherein the protein selected from protein A, protein G, protein L or combination thereof is capable of binding to at least one type of protein present within the sample matrix (US 2004/0224425 A1: para 0331-0332, references eg. 14), but in the same embodiment, Gjerde does not teach the wherein the tubular body has a helical shape (references eg. 21 with “figure 8” coil and eg. 23 with straight tubular configuration) as in the embodiments that read on the limitations of claim 1.
It would have been prima facie obvious, at the time of filing, to combine the tubular protein capture device as disclosed in claim 1 for a sample matrix comprising at least one analyte, as taught by Gjerde, with the same tubular device having a capture protein immobilized on the inner surface capable of binding the analyte, as taught by Gjerde in a different embodiment in the same reference. A skilled artisan would have been motivated to combine these separate teachings taught in the same reference because it would enable a skilled artisan to efficiently capture and isolate therapeutic antibodies that the recited capture proteins (protein A, protein G, and protein L) have natural affinity for (Way et al., Purification Strategies for Recombinant Therapeutic Proteins, Feb 2022, American Pharmaceutical Review). At the time of filing, an open tubular device with a helical shape and annular geometry having a capture protein, selected from protein A, protein G, protein L, or their combination, immobilized on the inner surface of the tubular device and said immobilized capture protein capable of binding and capturing at least one specific type of analyte contained in a sample matrix, and said sample matrix is a cell-based sample were all teachings already known in the art. Thus, a person having ordinary skill in the art would have a reasonable expectation of success because combining known elements according to known methods, already known to perform the same function separately as they do when combined, would yield expected and predictable results.
Regarding claim 17, Gjerde teaches the method of claim 16 (US 2004/0224425 A1: paras 0248 and 0331-0332), but in the same embodiment Gjerde does not teach a mobile phase having a pH less than 6.
However, Gjerde, in a separate embodiment in the same reference, teaches eluting at least one type of extracted protein from the tubular device with a mobile phase having a pH less than 6 (US 2004/0224425 A1: paras 0326).
It would have been prima facie obvious, at the time of filing, to combine the method of extracting at least one target protein from a cell-based sample matrix performing the method of claim 16, as taught by Gjerde, with the method of eluting the extracted target protein using a mobile phase with a pH lower than 6, as taught by Gjerde, in a separate embodiment in the same reference. A skilled artisan would have been motivated to use a mobile phase with a pH lower than 6 because it would desorb/elute the target analyte from the capture surface by disrupting the ionic and hydrogen bonds, or the binding interactions, that attach the target analyte to the immobilized capture protein (see Thermo Scientific, Tech Tip #27, 2009, pg. 1, full para 5). At the time of filing, a method of capturing target analyte with an open, tubular, helical device having immobilized capture protein(s), on the inner surface, that specifically bind(s) a specific type of analyte was already taught in the art. Further, using a low pH mobile phase to elute a target analyte, such as an IgG antibody, from a capture protein, such as protein G, was already well-known in the art. Thus, a person having ordinary skill in the art would have a reasonable expectation of success because combining known elements according to known methods, already known to perform the same function separately as they do when combined, would yield expected and predictable results.
Regarding claim 21, Gjerde teaches all the limitations of claim 20, but in the same embodiment, Gjerde does not teach at least one type of protein in the sample matrix capable of binding to at least one from protein A, protein G, and protein L.
However, in a different embodiment but in the same reference, Gjerde teaches wherein the sample matrix comprises at least one type of protein capable of binding to at least one type of protein selected from protein A, protein G and protein L (US 2004/0224425 A1: paras 0331-0332).
It would have been prima facie obvious, at the time of filing, to combine the open, helical, annular tubular protein capture device, as disclosed in claim 20, having an inner surface with protein A, protein G, protein L or their combination immobilized on the inner surface/channel portion, as taught by Gjerde, with the sample matrix comprising at least one analyte capable of binding the capture protein immobilized in the channel of the tubular device of claim 20, as taught by Gjerde in a separate embodiment in the same reference. A skilled artisan would have been motivated to combine these teachings because immobilizing protein A, protein G, protein L, or their combination to the inner surface of the capture device would create an extraction/capture surface that has specificity for specific analyte types. Likewise, a skilled artisan would have been motivated to combine these teachings because a sample matrix comprising at least one type of analyte with affinity to the capture surface of the tubular device disclosed in claim 20 would enable the isolation and/or purification of target analyte. A skilled artisan would have a reasonable expectation of success because combining known elements according to known methods, already known to perform the same function separately as they do when combined, would yield expected and predictable results.
Claim(s) 12 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Gjerde et al., (US 2004/0224425 A1, provided in IDS filed 03/18/2024 as U.S. Patent Pub Cite No. 1), as applied to claims 16 and 17, in view of Toner et al., (US20200139372A1, Pub. Date 05/07/2020).
Throughout the disclosure, Toner teaches several embodiments of systems, methods, and devices for focusing particles contained in a moving fluid within an open tubular device (microfluidic channel) and localizing particles contained in the fluid into one or more stream lines. Toner teaches some embodiments with the open tubular device or channel being curved in a sigmodal or spiral geometry. Toner teaches the system can include a device with one or more open tubular channels with each having an inlet and an outlet. A fluid can move along the open tubular channel in a laminar flow. Toner teaches a range of Reynolds number for laminar flow to localize the flux of particles in the channel. Toner teaches a pumping element may drive the laminar flow of the fluid within the channel. Toner further teaches the sample matrix may include but not limited to bacterial cells, blood cells, cancer cells, tumor cells, mammalian cells, plant cells, and fungal cells.
Regarding claims 12 and 19, Gjerde teaches all the limitations of claims 1-3 and 16-17, and further teaches wherein the sample matrix flows through the continuous tubular body (US 2004/0224425 A1: para 0248). Gjerde does not teach continuous tubular body is configured to sustain laminar flow at an apparent Reynolds Number between 3 and 60 and does not teach the sample matrix flows at an apparent Reynolds Number between 3 and 60.
Toner, in the same field of endeavor, teaches the Reynolds number for laminar flow can be between 1 and 250 ((US20200139372A1: para 0017).
It would have been prima facie obvious, at the time of filing, to combine the tubular device disclosed in either one of claims 1- 3 having immobilized protein A, protein G, protein L, or their combination on the inner surface to capture target analytes in a flowing cell-based sample matrix, as taught by Gjerde, with the teachings of the Reynolds number range for achieving and sustaining laminar flow for a cell-based sample matrix containing target analytes and flowing in a tubular curved device/body, as taught by Toner. A skilled artisan would have been motivated to combine these teachings and try Reynolds number range taught in the prior art in order to find the optimal Reynolds number or range for the claimed invention to achieve and sustain laminar flow of the sample matrix flowing in the disclosed capture device because it would increase capture/extraction efficiency since laminar flow within the ideal Reynolds number range would enable localization of the moving sample fluid flux enriched with target analyte (see Toner et al., Abstract, paras 0017, 0167). At the time of filing, the prior art had already taught a tubular device with helical and annular geometry having an inner surface/channel with immobilized capture protein having affinity for target analytes in a flowing cell-based sample matrix and had already taught a Reynolds number range for laminar flow. At the time of filing, a range for the Reynolds number to sustain laminar flow was already known in the prior art. Thus, a skilled artisan would have a further reasonable expectation of success with trying the Reynolds number range taught in the art to arrive at the optimal range for the claimed invention because a skilled artisan would be choosing from a finite number of identified, predictable solutions. Additionally, a skilled artisan would have a reasonable expectation of success when combining these teachings because combining known elements according to known methods, already known to perform the same function separately as they do when combined, would yield expected and predictable results.
Claim(s) 15 is rejected under 35 U.S.C. 103 as being unpatentable over Gjerde et al., (US 2004/0224425 A1, provided in IDS filed 03/18/2024 as U.S. Patent Pub Cite No. 1), as applied to claims 1 and 14, and in view of Barhoumi et al., (Barhoumi et al., Fluorinated Ethylene Propylene Coatings Deposited by a Spray Process: Mechanical Properties, Scratch and Wear Behavior, Jan 2022, Polymers, 14, 347, 1-13).
Regarding claim 15, Gjerde teaches all the limitations of claims 1 and 14, but Gjerde does not teach wherein the polymer [for the outer surface of the tubular device] is selected from a material comprising polyethylene glycol, fluorinated ethylene propylene or ethylene tetrafluoroethylene.
Throughout the article, Barhoumi teaches increasing the lifetime of metallic substrates and protecting the outer surfaces from wear and corrosion by coating their outer surfaces with a fluorinated ethylene propylene (FEP) polymer. Barhoumi teaches applying the FEP polymer outer coat using an air spray process followed by a heat treatment. Barhoumi teaches the FEP outer coating has a smooth and dense microstructure with optimal scratch resistance, a low friction coefficient (around 0.13), and a low wear coefficient for the metallic substrate. Barhoumi further teaches that the FEP polymer outer coating enhances corrosion resistance as no corrosion was observed on the substrate surface after 60 days of immersion in salt (NaCl) solution.
Barhoumi teaches wherein a polymer [coating for the outer surface of a substrate) is a material comprising fluorinated ethylene propylene (Barhoumi et al., 2022, Polymers, 14, 34, pg. 1, Abstract).
It would have been prima facie obvious, at the time of filing, to combine the tubular capture device disclosed in claim 1, as taught by Gjerde, with the method of coating a surface with a polymer material comprising fluorinated ethylene propylene, as taught by Barhoumi. A skilled artisan would have been motivated to combine these teachings because a polymer outer surface comprising one from the group recited in the instant claim would provide the outer surface of the disclosed tubular capture device wear protection and corrosion resistance, especially when immersed or in contact with solutions comprising salt (see Barhoumi et al., Jan 2022, Polymers, 14, 347, 1-13). Thus, a person having ordinary skill in the art would have a reasonable expectation of success because combining known elements according to known methods, already known to perform the same function separately as they do when combined, would yield expected and predictable results.
Claim(s) 18 is rejected under 35 U.S.C. 103 as being unpatentable over Gjerde et al., (US 2004/0224425 A1, provided in IDS filed 03/18/2024 as U.S. Patent Pub Cite No. 1), as applied to claims 16 and 17, and in view of Phillips et al., (Phillips et al., Analysis of intracellular regulatory proteins by immunoaffinity capillary electrophoresis coupled with laser-induced fluorescence detection, 2003, Biomed. Chromatogr., 17, 182-187).
Regarding claim 18, the teachings of Gjerde are discussed herein above. Gjerde teaches all the limitations of claims 16 and 17, but Gjerde does not teach the sample matrix comprises less than 100 µg of total protein.
Throughout the communication article, Phillips teaches an immunoaffinity capillary electrophoresis (ICE) method and device, comprising an open tubular device with the inner surface having an extraction/capture surface with immobilized antibodies specific for the analyte types (STAT proteins). Phillips teaches coupling the ICE method with laser-induced fluorescence (LIF) detection, which is capable of detecting femtogram concentrations of target analytes. Phillips further teaches applying this method to detect and quantify phosphorylated and non-phosphorylated forms of STAT proteins (target analytes) in cytosolic extracts (intracellular proteins in cultures) of IL-6-activated T cells. Phillips teaches detecting 0.5 pg of labeled target analytes.
Phillips teaches the limitation(s) of claim 18 reciting wherein the sample matrix comprises less than 100 µg of a total protein (Phillips et al., 2003, Biomed. Chromatogr., 17, pg. 182, Abstract and pg. 183, full para 1).
It would have been prima facie obvious, at the time of filing, to combine the method of capturing at least one target analyte from a cell-based sample matrix using the tubular device of claims 1-3 with protein A, protein G, or protein L immobilized on its the inner extraction/capture surface, as taught by Gjerde, with the teachings of applying a sample matrix containing less than 100 µg of total protein, as taught by Phillips. A skilled artisan would have been motivated to combine these teachings to arrive at the claimed invention because this combination would ensure the tubular capture device is highly efficient and can capture target analyte(s) present in low concentrations. Additionally, a skilled artisan would have been motivated to combine these teachings to arrive at the claimed invention because a protein capture device capable of extracting such low levels of analyte in a complex sample matrix would require smaller sample volumes. At the time of filing, capturing at least one target analyte from a cell-based sample using the tubular device of claims 1-3 with protein A, protein G, or protein L immobilized on the inner extraction/capture surface was already known in the art. Further, at the time of filing, an open tubular device with the inner channel having an extraction/capture surface with protein G immobilized and capable of extracting/capturing less than 100 µg of target analytes had already been taught in the art. Thus, a person having ordinary skill in the art would have a reasonable expectation of success because combining known elements according to known methods, already known to perform the same function separately as they do when combined, would yield expected and predictable results.
Conclusion
All examined claims (1-21) are rejected. No claims are allowed.
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/MELISSA LIZETTE LIRIANO/Examiner, Art Unit 1677
/BAO-THUY L NGUYEN/Supervisory Patent Examiner, Art Unit 1677 May 11, 2026
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