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 .
Drawings
The drawings were received on 6/15/2023. These drawings are accepted.
Claim Objections
Claim 7 is objected to because of the following informalities: The term “the” appears to be missing between “wherein” and “defined” in line 1. Appropriate correction is required.
Claim 12: The conjunction between “BaFexO” and “SrFexO” in line 2 should be “or” instead of “and” to put the claim in proper Markush format. See MPEP 2117 which sets forth: alternatives may be set forth as “a material selected from the group consisting of A, B, and C” or “wherein the material is A, B, or C”).
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) 1-10, 12, 14, 15, 17, 18, 20-22, 24, and 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gong et al (US 2003/0138941 A1) in view of Fu et al (US 2015/0031575 A1).
With respect to claim 1 Gong discloses a device for nucleic acid analysis (chip apparatus 100; See Figs. 1-2, Para. 0082, and Paras. 0003 and 0013 for discussion of how the apparatus is use for detecting amplified nucleic acid products), the device comprising:
(a) a sample introduction port (test sample inlet 2, See Figs. 1-2) configured to receive a biological sample (See Para. 0095);
(b) a compartment (sample preparation chamber 6; See Fig. 2 and Para. 0095) comprising a plurality of magnetic particles (See Figs. 2 and Paras. 0179), and,
(c) one or more polymerase chain reaction (PCR) compartments (assay stations 26), wherein the one or more PCR compartments are configured to conduct a PCR analysis (See Paras. 0086-0087).
Gong fails to disclose that the magnetic particles comprise a plurality of superparamagnetic beads, each superparamagnetic magnetic bead comprising a stabilizer and a defined core of aggregated magnetic nanoparticles, wherein the defined core of aggregated magnetic nanoparticles comprises a diameter between 100-400 nm and wherein each superparamagnetic magnetic bead comprises a liquid-glass coating comprising a silicate.
Fu teaches compositions comprising a porous nanostructure of a known characteristics and a fragment of nucleic acid having a known sequence (See Para. 0005), wherein the core nanoparticle includes, for example, a superparamagnetic iron oxide (SPIO) nanoparticle (See Para. 0008), and the nanostructure comprises at least one core nanoparticle embedded in or coated with a low density porous 3-D structure or coating (See Paras. 0006 and 0075). The SPIO nanoparticle is an iron oxide nanoparticle, either maghemite (γ-Fe. 2O3) or magnetite (Fe3O4), or nanoparticles composed of both phases (See Para. 0054). The low density, porous 3-D structure is made of silicon-containing molecules (e.g., silanes, organosilanes, alkoxysilanes, silicates and derivatives thereof), to include sodium silicate (See Paras. 0013 and 0075), and during synthesis, surfactants (stabilizers) may be added to inhibit agglomeration or control particle size (See Para. 0054). The core nanoparticle has a diameter ranging from about 1 nm to about 1000 nm (See Paras. 0013 and 0015). The thickness of the low density, porous 3-D structure is controllable, and so is the number of payloads that could be carried. As a result, the nanostructures when systematically applied as injectable agents into the blood stream of a living subjects can accumulate at a disease region, such as a tumor or inflammation site (See Para. 0015). An aspect of the present invention relates to a method of detecting the coding signals of a plurality of IDed nanostructures on a surface by assembling the IDed nanostructures from the solution onto the surface. The assemble can be based on magnetic interaction. For example, the IDed nanostructures can be associated with a magnetic particle which can be attracted in response to an applied magnetic field. The IDed nanostructure could also be assembled onto a surface in an ordered array format using the interactions between the magnetic content of the IDed nanostructure and a magnetizable or magnetic grid. The assembling of the IDed nanostructures from solution to a surface can greatly improve or facilitate the detection and/or quantification of the IDed nanostructures (See Paras. 0127 and 0135).
As set forth in MPEP 2144.05,in the case where the claimed range “overlap or lie inside ranges disclosed by the prior art”, a prima facie case of obviousness exists, In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the superparamagnetic iron oxide nanoparticle taught by Fu as the magnetic particles held in the compartment of Gong to facilitate improved detection and/or quantification of the identified nanostructures during PCR analysis (See Paras. 0127 and 0135 of Fu).
With respect to claim 2, it should be noted that the claim contains the product-by-process limitation “the superparamagnetic beads are produced under solvothermal conditions.” While Fu does discuss the claimed process (See Para. 0054), it should be noted that MPEP 2113 states “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted).
With respect to claim 3, as set forth in MPEP 2144.05, in the case where the claimed range “overlap or lie inside ranges disclosed by the prior art”, a prima facie case of obviousness exists, In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) (See Para. 0058 of Fu for discussion of the size of the core nanoparticles ranges from 1nm to 100nm in size).
With respect to claim 4, as set forth in MPEP 2144.05, in the case where the claimed range “overlap or lie inside ranges disclosed by the prior art”, a prima facie case of obviousness exists, In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) (See Paras. 0015 and 0093 of Fu and for discussion of the liquid-glass coating (3-D structure) comprising a thickness ranging from 1nm to 1000nm).
With respect to claim 5, as set forth in MPEP 2144.05, in the case where the claimed range “overlap or lie inside ranges disclosed by the prior art”, a prima facie case of obviousness exists, In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) (See Paras. 0015 and 0093 and for discussion of the liquid-glass coating (3-D structure) comprising a thickness ranging from 1nm to 1000nm).
With respect to claim 6, as set forth in MPEP 2144.05, in the case where the claimed range “overlap or lie inside ranges disclosed by the prior art”, a prima facie case of obviousness exists, In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) (See Para. 0008 of Fu and for discussion of the core nanoparticle having a diameter ranging from about 1nm to about 900 nm; Para. 0007 of Fu discusses how the core nanoparticle comprises a nanoparticle or a cluster of nanoparticles, and further wherein a s ingle core nanoparticle may comprise a plurality of a cluster of mini nanoparticles).
With respect to claim 7, as set forth in MPEP 2144.05, in the case where the claimed range “overlap or lie inside ranges disclosed by the prior art”, a prima facie case of obviousness exists, In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) (See Para. 0008 of Fu and for discussion of the core nanoparticle having a diameter ranging from about 1nm to about 900 nm; Para. 0007 of Fu discusses how the core nanoparticle comprises a nanoparticle or a cluster of nanoparticles, and further wherein a s ingle core nanoparticle may comprise a plurality of a cluster of mini nanoparticles).
With respect to claim 8, while the combination of Gong and Fu does not address each superparamagnetic bead comprising a saturation magnetization between 50-70 Am2/kg, it has been determined that where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In the current case, the superparamagnetic bead taught by Fu has the same composition as the current invention. Absent persuasive evidence that the composition of the superparamagnetic beads of Fu and the current application are different, the prior art is considered to have the same properties with respect to the saturation magnetization as that is claimed. MPEP § 2112.01 (I-IV).
With respect to claim 9, while the combination of Gong and Fu does not address each superparamagnetic bead comprises a magnetic remanence below 3 Am2/kg, it has been determined that where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In the current case, the superparamagnetic bead taught by Fu has the same composition as the current invention. Absent persuasive evidence that the composition of the superparamagnetic beads of Fu and the current application are different, the prior art is considered to have the same properties with respect to the magnetic remanence as that is claimed. MPEP § 2112.01 (I-IV).
With respect to claim 10 the combination of Gong and Fu teaches that the silicate can be a sodium silicate (See Para. 0013 of Fu).
With respect to claim 12 the combination of Gong and Fu teaches that the defined core comprises Fe3O4 (See Para. 0008 of Fu).
With respect to claim 14 the combination of Gong and Fu teaches that the one or more PCR compartments comprises a reagent preparation compartment, a target enrichment compartment, an inhibitor removal compartment, a nucleic acid extraction compartment, an amplification compartment, or a real- time detection compartment, or a combination thereof (See Paras. 0086-0087 of Gong).
With respect to claim 15 the combination of Gong and Fu teaches that the device is a cartridge, container, or a pouch (See Para. 0014 of Gong for discussion of the microchip apparatus on which numerous types of assays can be performed).
With respect to claim 17 the combination of Gong and Fu teaches that the cartridge is a self-contained nucleic acid analysis cartridge (See Para. 0067 of Gong for discussion of the device being a lab-on-a-chip) that comprises a waste chamber (waste reservoir 45, See Para. 0121).
With respect to claim 18 the combination of Gong and Fu teaches that the compartment comprising the superparamagnetic beads is in fluid communication with the waste chamber (See Figs. 5A-C and Paras. 0121 and 0126).
With respect to claim 20 Gong discloses a device for nucleic acid analysis (chip apparatus 100; See Figs. 1-2, Para. 0082, and Paras. 0003 and 0013 for discussion of how the apparatus is use for detecting amplified nucleic acid products), the device comprising:
(a) a sample introduction port (test sample inlet 2, See Figs. 1-2) configured to receive a biological sample (See Para. 0095);
(b) a compartment (sample preparation chamber 6; See Fig. 2 and Para. 0095) comprising a plurality of magnetic particles (See Figs. 2 and Paras. 0179), and,
(c) a polymerase chain reaction (PCR) analysis region (areas of substrate 36 that contain assay stations 26, See Paras. 0082-0084) comprising one or more additional compartments (assay stations 26), each configured to conduct one or more steps of the PCR analysis (See Paras. 0086-0087).
Gong fails to disclose that the magnetic particles comprise a plurality of superparamagnetic beads, each superparamagnetic magnetic bead comprising a stabilizer and a defined core of aggregated magnetic nanoparticles, wherein (i) the defined core of aggregated magnetic nanoparticles comprises a diameter between 100-400 nm, wherein (ii) the nanoparticles comprise a size of 3nm or less, and (iii) wherein each superparamagnetic magnetic bead comprises a liquid-glass coating, the liquid glass coating comprising a silicate and a thickness of 20 nm or less.
Fu teaches compositions comprising a porous nanostructure of a known characteristics and a fragment of nucleic acid having a known sequence (See Para. 0005), wherein the core nanoparticle includes, for example, a superparamagnetic iron oxide (SPIO) nanoparticle (See Para. 0008), and the nanostructure comprises at least one core nanoparticle embedded in or coated with a low density porous 3-D structure or coating (See Paras. 0006 and 0075). The SPIO nanoparticle is an iron oxide nanoparticle, either maghemite (γ-Fe. 2O3) or magnetite (Fe3O4), or nanoparticles composed of both phases (See Para. 0054). Para. 0058 discusses how the size of the core nanoparticles ranges from 1nm to 100nm. The low density, porous 3-D structure is made of silicon-containing molecules (e.g., silanes, organosilanes, alkoxysilanes, silicates and derivatives thereof), to include sodium silicate (See Paras. 0013 and 0075), and during synthesis, surfactants (stabilizers) may be added to inhibit agglomeration or control particle size (See Para. 0054). The core nanoparticle has a diameter ranging from about 1 nm to about 1000 nm (See Paras. 0013 and 0015). See Paras. 0015 and 0093 of Fu and for discussion of the liquid-glass coating (3-D structure) comprising a thickness ranging from 1nm to 1000nm, further wherein the thickness of the low density, porous 3-D structure is controllable, and so is the number of payloads that could be carried. As a result, the nanostructures when systematically applied as injectable agents into the blood stream of a living subjects can accumulate at a disease region, such as a tumor or inflammation site (See Para. 0015). An aspect of the present invention relates to a method of detecting the coding signals of a plurality of IDed nanostructures on a surface by assembling the IDed nanostructures from the solution onto the surface. The assemble can be based on magnetic interaction. For example, the IDed nanostructures can be associated with a magnetic particle which can be attracted in response to an applied magnetic field. The IDed nanostructure could also be assembled onto a surface in an ordered array format using the interactions between the magnetic content of the IDed nanostructure and a magnetizable or magnetic grid. The assembling of the IDed nanostructures from solution to a surface can greatly improve or facilitate the detection and/or quantification of the IDed nanostructures (See Paras. 0127 and 0135).
As set forth in MPEP 2144.05, in the case where the claimed range “overlap or lie inside ranges disclosed by the prior art”, a prima facie case of obviousness exists, In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the superparamagnetic iron oxide nanoparticle taught by Fu as the magnetic particles held in the compartment of Gong to facilitate improved detection and/or quantification of the identified nanostructures during PCR analysis (See Paras. 0127 and 0135 of Fu).
With respect to claim 21, as set forth in MPEP 2144.05, in the case where the claimed range “overlap or lie inside ranges disclosed by the prior art”, a prima facie case of obviousness exists, In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990) (See Para. 0008 of Fu and for discussion of the core nanoparticle having a diameter ranging from about 1nm to about 900 nm; Para. 0007 of Fu discusses how the core nanoparticle comprises a nanoparticle or a cluster of nanoparticles, and further wherein a s ingle core nanoparticle may comprise a plurality of a cluster of mini nanoparticles).
With respect to claim 22, while the combination of Gong and Fu does not address each superparamagnetic bead comprising a saturation magnetization between 50-70 Am2/kg and a magnetic remanence below 3Am2/kg, it has been determined that where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In the current case, the superparamagnetic bead taught by Fu has the same composition as the current invention. Absent persuasive evidence that the composition of the superparamagnetic beads of Fu and the current application are different, the prior art is considered to have the same properties with respect to the saturation magnetization and magnetic remanence as that is claimed. MPEP § 2112.01 (I-IV).
With respect to claim 24 the combination of Gong and Fu teaches that the defined core comprises Fe3O4 (See Para. 0008 of Fu).
With respect to claim 25 the combination of Gong and Fu teaches that the PCR analysis region comprises a reagent preparation compartment, a target enrichment compartment, an inhibitor removal compartment, a nucleic acid extraction compartment, an amplification compartment, or a real- time detection compartment, or a combination thereof (See Paras. 0086-0087 of Gong).
Claim(s) 11 and 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gong et al (US 2003/0138941 A1) and Fu et al (US 2015/0031575 A1) in view of Fabis (US 2015/0307870 A1).
Refer above for the combined teachings of Gong and Fu.
With respect to claim 11 the combination of Gong and Fu fails to teach that the stabilizer is selected from the group consisting of citrate, histidine, cetyltrimethylammonium bromide (CTAB), cetyltrimethylammonium chloride (CTAC), sodium oleate, and polyacrylic acid.
Fabis teaches the preparation of stabilized iron oxide particles that are used as magnetic core particles, wherein the iron oxide core particles are stabilized by a surfactant, a phospholipid or an organic acid or salt thereof. In one embodiment, the iron oxide core particles are stabilized by a carboxylic acid such as citric acid or a salt thereof. In a preferred embodiment, magnetite core particles stabilized by citrate are used. It is assumed that the presence of a respective stabilizer supports the separation of the iron oxide core particles and thereby reduces the unwanted aggregation of the iron oxide particles in the reaction composition. Additionally, other anions of carboxylic acids, in particular of dicarboxylic acids, tricarboxylic acids or polycarboxylic acids can be used as respective stabilizers, examples include but are not limited to polyacrylic acid, polymethacrylic acid and carboxymethyl dextrane (See para. 0040).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate citrate or polyacrylic acid as the stabilizer, as taught by Fabis, into the stabilizer of combined Gong and Fu in order to reduce the unwanted aggregation of the iron oxide particles in the reaction composition (See Para. 0040 of Fabis).
With respect to claim 23, while the combination of Gong and Fu teaches that the silicate can be a sodium silicate (See Para. 0013 of Fu), there is no teaching that the stabilizer is elected from the group consisting of citrate, histidine, cetyltrimethylammonium bromide (CTAB), cetyltrimethylammonium chloride (CTAC), sodium oleate, and polyacrylic acid.
Fabis teaches the preparation of stabilized iron oxide particles that are used as magnetic core particles, wherein the iron oxide core particles are stabilized by a surfactant, a phospholipid or an organic acid or salt thereof. In one embodiment, the iron oxide core particles are stabilized by a carboxylic acid such as citric acid or a salt thereof. In a preferred embodiment, magnetite core particles stabilized by citrate are used. It is assumed that the presence of a respective stabilizer supports the separation of the iron oxide core particles and thereby reduces the unwanted aggregation of the iron oxide particles in the reaction composition. Also, other anions of carboxylic acids, in particular of dicarboxylic acids, tricarboxylic acids or polycarboxylic acids can be used as respective stabilizers, examples include but are not limited to polyacrylic acid, polymethacrylic acid and carboxymethyl dextrane (See para. 0040).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate citrate or polyacrylic acid as the stabilizer, as taught by Fabis, into the stabilizer of combined Gong and Fu in order to reduce the unwanted aggregation of the iron oxide particles in the reaction composition (See Para. 0040 of Fabis).
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gong et al (US 2003/0138941 A1) and Fu et al (US 2015/0031575 A1) in view of Lowery, Jr. et al (US 2012/0100546 A1)
Refer above for the combined teachings of Gong and Fu.
With respect to claim 13 the combination of Gong and Fu fails to teach that the plurality of superparamagnetic beads is dispersed within a suspension.
Lowery teaches systems for the detection of analytes, wherein the system can use magnetic particles. The assay of the invention can be designed to change the direction of T.sub.2 in the presence of analyte (see FIGS. 5A-5C). For example, the assay can be an agglomerative sandwich immunoassay in which two populations of magnetic particles bind to different epitopes of an analyte (see FIG. 5A); a competitive assay in which analyte competes with a multivalent binding agents to inhibit the aggregation of magnetic particles (see FIG. 5B); or a hybridization-mediated agglomeration in which two populations of magnetic particles bind to a first and second portion of an oligonucleotide (see FIG. 5C) (See Para. 0107). The magnetic particles are generally in the form of conjugates, that is, a magnetic particle with one or more binding moieties (e.g., an oligonucleotide, nucleic acid, polypeptide, or polysaccharide) linked thereto (See Para. 0111). The conjugates have high relaxivity owing to the superparamagnetism of their iron, metal oxide, or other ferro or ferrimagnetic nanomaterials. Iron, cobalt, and nickel compounds and their alloys, rare earth elements such as gadolinium, and certain intermetallics such as gold and vanadium are ferromagnets can be used to produce superparamagnetic particles. The magnetic particles can be monodisperse (a single crystal of a magnetic material, e.g., metal oxide, such as superparamagnetic iron oxide, per magnetic particle) or polydisperse (e.g., a plurality of crystals per magnetic particle) (See Para. 0112). The magnetic particles can be formed from a ferrofluid (i.e., a stable colloidal suspension of magnetic particles). For example, the magnetic particle can be a composite of including multiple metal oxide crystals of the order of a few tens of nanometers in size and dispersed in a fluid containing a surfactant, which adsorbs onto the particles and stabilizes them, or by precipitation, in a basic medium, of a solution of metal ions (See Para. 0120).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to put the superparamagnetic particles of combined Gong and Fu into a suspension, such as a ferrofluid, as taught by Lowery, in order to stabilize them (See Para. 0120 of Lowery).
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gong et al (US 2003/0138941 A1) and Fu et al (US 2015/0031575 A1) in view of Ririe et al (US 2013/0137172 A1).
Refer above for the combined teachings of Gong and Fu.
With respect to claim 16 the combination of Gong and Fu fails to teach that the device is a pouch and is a self-contained nucleic acid analysis pouch that comprises a cell lysis zone, a nucleic acid preparation zone, a first-stage amplification zone, a second-stage amplification zone, or a combination thereof.
Ririe teaches devices for performing biological analysis in a closed environment, such as high density nucleic acid amplification and detection and immuno-PCR (See abstract), such as a self-contained nucleic acid analysis pouch 10. Pouch 10 has a cell lysis zone 20, a nucleic acid preparation zone 40, a first-stage amplification zone 60, and a second-stage amplification zone 80. A sample containing nucleic acid is introduced into the pouch 10 via sample injection port 12. Pouch 10 comprises a variety of channels and blisters of various sizes and is arranged such that the sample flows through the system. The sample passes through the various zones and is processed accordingly (See Fig. 1 and Para. 0039). Pouch 10 is designed to contain all reactions and manipulations within, to reduce contamination (See para. 0063).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to replace the chip of combined Gong and Fu with the pouch and various zones/blisters of Ririe such that the design is optimized to contains all reactions and manipulations within while reducing contamination (See Para. 0063 of Ririe).
Claim(s) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gong et al (US 2003/0138941 A1) and Fu et al (US 2015/0031575 A1) in view of Chen et al (US 2007/0292858 A1).
Refer above for the combined teachings of Gong and Fu.
With respect to claim 19 the combination of Gong and Fu fails to teach that the device comprises a flexible tubule configured into a plurality of segments, wherein at least one segment comprises the plurality of superparamagnetic beads and wherein one or more additional segments of the flexible tubule comprises the one or more PCR compartments.
Chen teaches a cartridge which may include an array of segments 10 (FIGS. 2A-B). One or more segments may be transparent to light of at least a selected wavelength, to several wavelengths, to visible light, to infrared radiation, and/or to ultraviolet radiation. One or more segments may be flexible, or at least one part of the wall may be flexible, as described in more detail below. Segments such as 111, 112, 113, 114, 121, 122, 123, and/or 160-179, may be substantially flattened by compression. In an embodiment, an array of segments may have at least two tracks. In an embodiment, a track may have at least two segments. (See Paras. 0023). In a preferred embodiment one or more individual segments may contain various reagents and buffers for processing a sample (See Para. 0021). A solid phase substrate can be contained within a segment of an array of segments and used to capture one or more selected components of a sample (if such component is present in a sample), such as a target microorganism, nucleic acids, proteins or cells (See Para. 0034). The substrate can be: beads, pads, filters, sheets, and/or a portion of segment wall surface or a collection tool. In embodiments where the substrate is a plurality of beads, said beads can be: silica beads, magnetic beads, silica magnetic beads, glass beads, nitrocellulose colloid beads, and magnetized nitrocellulose colloid beads. In some embodiments where the beads can be paramagnetic, the beads can be captured by a magnetic field (See Para. 0037). When these solid phase surfaces are paramagnetic microparticles, the magnetic beads, to which the target nucleic acid molecules have been adsorbed, can be washed under conditions that retain the nucleic acids but not other molecules. The nucleic acid molecules isolated through this process are suitable for: capillary electrophoresis, nucleotide sequencing, reverse transcription, cloning, transfection, transduction, microinjection of mammalian cells, gene therapy protocols, the in vitro synthesis of RNA probes, cDNA library construction, and the polymerase chain reaction (PCR) amplification (See Para. 0038). The tubule and segment configuration facilitate the preparation of samples and the performance of multiple assays through multiple processing steps (See Para. 0003).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to replace the chip design, as taught by Gong and Fu, with the tubule configuration taught by Chen, in order to facilitate the preparation of samples and performance of multiple assays through multiple processing steps (See Para. 0003 of Chen).
Conclusion
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/BRITTANY I FISHER/Examiner, Art Unit 1796 January 5, 2026