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 .
Election/Restrictions
Claim(s) 2-3, 19, and 39 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 02/24/2026.
Applicant’s election without traverse of Claim(s) 4-18 and 38 in the reply filed on 02/24/2026 is acknowledged.
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, 9, 14-15, and 38 are rejected under 35 U.S.C. 103 as being unpatentable over McDowell-Buchanan et al. (US20180163270A1) and McFall et al. (US20210292746A1).
Regarding Claim 38, McDowell-Buchanan et al. teaches a sample cartridge for isolation and detection of nucleic acid from a biological sample (See the Abstract, the GENEXPERRT® cartridge, and in Claim(s) 1-13 and 25-26 in [0007]-[0016], [0071]-[0525] in Fig. 1-12), comprising: a cartridge body having a plurality of chambers defined therein (See how the cartridge 200 has a plurality of reagent and/or buffer chambers 208 in [0380]-[0384] in Fig. 5A-12),
wherein the plurality of chambers are in in fluidic communication through a fluidic path of the cartridge, and wherein at least one chamber is configured to receive the biological sample (See in in [0380]-[0384], [0442]-[0525] in Fig. 5A-12),
a reaction vessel configured for amplification of the nucleic acid by thermal cycling (See in in [0105]-[0137], [0275]-[0289] in Fig. 5A-12 and in Claim(s) 13 and 25), and
a filter disposed in the fluidic path between the plurality of chambers and the reaction vessel (See how the chamber 3 has an optional pre-filter or fibrous plug inserted into a funnel allowing on cartridge sample filtering in [0008], [0447], [0441]-[0532] in Fig. 5B and in Claim 1),
wherein the filter comprises a separating material (See how the cartridge typically contains one or channels or cavities such as, the chambers 214 that can contain a matrix material as described herein that can function to immobilize an immuno-PCR immunocomplex and, optionally to bind and elute a nucleic acid. In various embodiments the cartridge further comprises one or more temperature controlled channels or chambers 216 that can, in certain embodiments, function as thermocycling chambers in [0068]-[0071], [0363], [0375]-[0380] in Fig. 5A-7),
wherein the plurality of chambers and the reaction vessel independently comprise reagents for releasing nucleic acid from the biological sample, and primers and probes for detection of the nucleic acid (See in [0441]-[0532] in Fig. 5A-7),
wherein the separating material (See in Fig. 5A-12) comprises:
a glass fiber solid support comprising a compound bonded to the glass fiber solid support (See the glass fiber filter in [0068],[0363], [0401], [0504] in Fig. 11-12 and in Claim(s) 1-13 and 25-26),
McDowell-Buchanan et al. fails to explicitly teach a sample cartridge for isolation and detection of nucleic acid from a biological sample, comprising: a glass fiber solid support comprising a compound bonded to the glass fiber solid support, the compound being derived from a structure represented by the formula: Y-(L)y -SiX3 wherein, Y is a DNA binding ligand selected from an alkylamine, a cycloalkylamine, an alkyloxy amine, a polyamine moiety, an arylamine, an intercalating agent, a DNA groove binder, a peptide, an amino acid, a protein, or a combination thereof, L is a linker selected from an alkyl group, a heteroalkyl group, an alkene group, a heteroalkene group, a polyacrylic acid, a Diels-Alder adduct, or a combination thereof, each X, independently for each occurrence, is selected from a hydrolyzable group, an alkyl group, a heteroalkyl group, an alkenyl group, or two or three Xs combine to form one or more cyclic groups, or one X combines with Y to form a cyclic azasilane, and y is 0 or 1.
However, in the analogous art of the enhanced capture of target nucleic acids, McFall et al. teaches a sample cartridge for isolation and detection of nucleic acid from a biological sample (See the Abstract and in Claim(s) 1-24 in [0004]-[0044] in Fig. 1-4), comprising: a glass fiber solid support comprising a compound bonded to the glass fiber solid support (See in [0019]-[0020], [0040]-[0041] and in Claim(s) 5-7),
the compound being derived from a structure represented by the formula: Y-(L)y -SiX3 wherein, Y is a DNA binding ligand selected from an alkylamine, a cycloalkylamine, an alkyloxy amine, a polyamine moiety, an arylamine, an intercalating agent, a DNA groove binder, a peptide, an amino acid, a protein, or a combination thereof, L is a linker selected from an alkyl group, a heteroalkyl group, an alkene group, a heteroalkene group, a polyacrylic acid, a Diels-Alder adduct, or a combination thereof, each X, independently for each occurrence, is selected from a hydrolyzable group, an alkyl group, a heteroalkyl group, an alkenyl group, or two or three Xs combine to form one or more cyclic groups, or one X combines with Y to form a cyclic azasilane, and y is 0 or 1 (See in [0019]-[0020], [0040]-[0041] and in Claim(s) 5-7).
Thus, it would be obvious to one with ordinary skills in the arts to modify the sample cartridge of McDowell-Buchanan et al. by incorporating a glass fiber solid support structure (as taught by McFall et al.) for the benefit of isolating and detecting nucleic acids.
Regarding Claim 7, The combination of McDowell-Buchanan et al. and McFall et al. teaches the cartridge limitations of instant claim 38.
McDowell-Buchanan et al. fails to explicitly teach a sample cartridge for isolation and detection of nucleic acid from a biological sample, wherein the Diels-Alder adduct is derived from a structure represented by the general Formula, their isomers, salts, tautomers, or combinations thereof, wherein Y' is the DNA binding ligand, L is a linker selected from an alkyl group, a heteroalkyl group, an alkene group, a heteroalkene group, a polyacrylic acid, a Diels-Alder adduct, or a combination thereof, each X, independently for each occurrence, is selected from a hydrolyzable group, an alkyl group, a heteroalkyl group, an alkenyl group, or two or three Xs combine to form one or more cyclic groups, or one X combines with Y to form a cyclic azasilane, and y is 0 or 1.
However, in the analogous art of the enhanced capture of target nucleic acids, McFall et al. teaches a sample cartridge for isolation and detection of nucleic acid from a biological sample (See the Abstract and in Claim(s) 1-24 in [0004]-[0044] in Fig. 1-4), wherein the Diels-Alder adduct is derived from a structure represented by the general Formula, their isomers, salts, tautomers, or combinations thereof, wherein Y' is the DNA binding ligand, L is a linker selected from an alkyl group, a heteroalkyl group, an alkene group, a heteroalkene group, a polyacrylic acid, a Diels-Alder adduct, or a combination thereof, each X, independently for each occurrence, is selected from a hydrolyzable group, an alkyl group, a heteroalkyl group, an alkenyl group, or two or three Xs combine to form one or more cyclic groups, or one X combines with Y to form a cyclic azasilane, and y is 0 or 1 (See in [0037]).
Thus, it would be obvious to one with ordinary skills in the arts to modify the combined sample cartridge of McDowell-Buchanan et al. and McFall et al. by incorporating a Diels-Alder adduct is derived from and alkyl group (as taught by McFall et al.) for the benefit of isolating and detecting nucleic acids.
Regarding Claim 9, The combination of McDowell-Buchanan et al. and McFall et al. teaches the cartridge limitations of instant claim 38.
McDowell-Buchanan et al. teaches a sample cartridge for isolation and detection of nucleic acid from a biological sample (See the Abstract, the GENEXPERRT® cartridge, and in Claim(s) 1-13 and 25-26 in [0007]-[0016], [0071]-[0525] in Fig. 1-12), wherein at least two Xs are independently selected from a halogen, an alkoxy, a dialkylamino, a trifluoromethanesulfonate, or combine together with the Si atom to which they are attached to form a silatrane, a cyclic siloxane, a polysilsesquioxane, or a silazane (See in [0315]).
Regarding Claim 14, The combination of McDowell-Buchanan et al. and McFall et al. teaches the cartridge limitations of instant claim 38.
McDowell-Buchanan et al. teaches a sample cartridge for isolation and detection of nucleic acid from a biological sample (See the Abstract, the GENEXPERRT® cartridge, and in Claim(s) 1-13 and 25-26 in [0007]-[0016], [0071]-[0525] in Fig. 1-12), wherein the glass fiber solid support has a pore size from 0.2 µm to µm, from 0.2 µm to 2 µm, from 0.5 µm to 1.0 µm, or from 0.6 µm to 0.8 µm (See how the glass fiber filter has a pore size of 0.7 μm in [0504] in Fig. 11-12).
Regarding Claim 15, The combination of McDowell-Buchanan et al. and McFall et al. teaches the cartridge limitations of instant claim 38.
McDowell-Buchanan et al. teaches a sample cartridge for isolation and detection of nucleic acid from a biological sample (See the Abstract, the GENEXPERRT® cartridge, and in Claim(s) 1-13 and 25-26 in [0007]-[0016], [0071]-[0525] in Fig. 1-12), wherein the glass fiber solid support comprises beads to facilitate mechanical lysis (See in [0232], [0332], [0340]),
wherein the beads are selected from glass beads, silica beads, or a combination thereof (See in [0018], [0053]-[0057], [0066], [0369, [0375]).
Claim(s) 4 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over McDowell-Buchanan et al. (US20180163270A1) and McFall et al. (US20210292746A1) as applied to claim 38 above, and further in view of Parthasarathy et al. (US20050142571A1).
Regarding Claim 4, The combination of McDowell-Buchanan et al. and McFall et al. teaches the cartridge limitations of instant claim 38.
The combination of McDowell-Buchanan et al. and McFall et al. fails to explicitly teach a sample cartridge for isolation and detection of nucleic acid from a biological sample, wherein the DNA binding ligand comprises an alkylamine group, an imidazole group, a bisbenzimide minor groove binder, or a combination thereof.
However, in the analogous art of methods for nucleic acid isolation and kits using a microfluidic device and concentration step, Parthasarathy et al. teaches a sample cartridge for isolation and detection of nucleic acid from a biological sample (See the Abstract, the microfluidic device, and in Claim(s) 1-37 in [0002]-[0036], [0155]-[0197] in Fig. 1), wherein the DNA binding ligand comprises an alkylamine group, an imidazole group, a bisbenzimide minor groove binder, or a combination thereof (See in [0107]).
Thus, it would be obvious to one with ordinary skills in the arts to modify the combined sample cartridge of McDowell-Buchanan et al. and McFall et al. by incorporating a DNA binding ligand comprising an alkylamine group, an imidazole group, a bisbenzimide minor groove binder, or a combination thereof (as taught by Parthasarathy et al. ) for the benefit of isolating and detecting nucleic acids.
Regarding Claim 8, The combination of McDowell-Buchanan et al. and McFall et al. teaches the cartridge limitations of instant claim 38.
The combination of McDowell-Buchanan et al. and McFall et al. fails to explicitly teach a sample cartridge for isolation and detection of nucleic acid from a biological sample, wherein the linker, when present, is selected from an alkyleneoxy group, an alkylene group, cyanuric chloride, an alkylamine, or a combination thereof.
However, in the analogous art of methods for nucleic acid isolation and kits using a microfluidic device and concentration step, Parthasarathy et al. teaches a sample cartridge for isolation and detection of nucleic acid from a biological sample (See the Abstract, the microfluidic device, and in Claim(s) 1-37 in [0002]-[0036], [0155]-[0197] in Fig. 1), wherein the linker, when present, is selected from an alkyleneoxy group, an alkylene group, cyanuric chloride, an alkylamine, or a combination thereof (See in [0107]).
Thus, it would be obvious to one with ordinary skills in the arts to modify the combined sample cartridge of McDowell-Buchanan et al. and McFall et al. by incorporating a linker, when present, is selected from an alkyleneoxy group, an alkylene group, cyanuric chloride, an alkylamine, or a combination thereof (as taught by Parthasarathy et al. ) for the benefit of isolating and detecting nucleic acids.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over McDowell-Buchanan et al. (US20180163270A1) and McFall et al. (US20210292746A1) as applied to claim 38 above, and further in view of Ismagilov et al. (US20130309679A1).
Regarding Claim 5, The combination of McDowell-Buchanan et al. and McFall et al. teaches the cartridge limitations of instant claim 38.
The combination of McDowell-Buchanan et al. and McFall et al. fails to explicitly teach a sample cartridge for isolation and detection of nucleic acid from a biological sample, wherein the DNA binding ligand is selected from spermine, methylamine, ethylamine, propylamine, ethylenediamine, diethylene triamine, 1,3-dimethyldipropylenediamine, 3-(2- aminoethyl)aminopropyl, (2-aminoethyl)trimethylammonium hydrochloride, tris(2- aminoethyl)amine, or a combination thereof.
However, in the analogous art of fluidic devices and systems for sample preparations or autonomous analysis, Ismagilov et al. teaches a sample cartridge for isolation and detection of nucleic acid from a biological sample (See the Abstract and in Claim(s) 1-37 in [0003]-[0349] in Fig. 1-43), wherein the DNA binding ligand is selected from spermine, methylamine, ethylamine, propylamine, ethylenediamine, diethylene triamine, 1,3-dimethyldipropylenediamine, 3-(2- aminoethyl)aminopropyl, (2-aminoethyl)trimethylammonium hydrochloride, tris(2- aminoethyl)amine, or a combination thereof (See in [0206]-[0207]).
Thus, it would be obvious to one with ordinary skills in the arts to modify the combined sample cartridge of McDowell-Buchanan et al. and McFall et al. by incorporating a DNA binding ligand is selected from spermine, methylamine, ethylamine, propylamine, ethylenediamine, diethylene triamine, 1,3-dimethyldipropylenediamine, 3-(2- aminoethyl)aminopropyl, (2-aminoethyl)trimethylammonium hydrochloride, tris(2- aminoethyl)amine, or a combination thereof (as taught by Ismagilov et al.) for the benefit of isolating and detecting nucleic acids.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over McDowell-Buchanan et al. (US20180163270A1) and McFall et al. (US20210292746A1) as applied to claim 38 above, and further in view of Brahmasandra et al. (US20230010710A1).
Regarding Claim 13, The combination of McDowell-Buchanan et al. and McFall et al. teaches the cartridge limitations of instant claim 38.
The combination of McDowell-Buchanan et al. and McFall et al. fails to explicitly teach a sample cartridge for isolation and detection of nucleic acid from a biological sample, wherein the glass fiber solid support has a DNA binding capacity of at least 10 µg/cm2, 20 µg/cm2 or greater, 35 µg/cm2 or greater, or from 30-100 µg/cm2.
However, in the analogous art of fluidic devices and systems for sample preparations or autonomous analysis, Brahmasandra et al. teaches a sample cartridge for isolation and detection of nucleic acid from a biological sample (See the Abstract and in Claim(s) 1-11 in [0003]-[0117] in Fig. 1-22C), wherein the glass fiber solid support has a DNA binding capacity of at least 10 µg/cm2, 20 µg/cm2 or greater, 35 µg/cm2 or greater, or from 30-100 µg/cm2 (See in [0030]).
Thus, it would be obvious to one with ordinary skills in the arts to modify the combined sample cartridge of McDowell-Buchanan et al. and McFall et al. by incorporating a glass fiber solid support has a DNA binding capacity of at least 10 µg/cm2, 20 µg/cm2 or greater, 35 µg/cm2 or greater, or from 30-100 µg/cm2 (as taught by Brahmasandra et al.) for the benefit of isolating and detecting nucleic acids.
Allowable Subject Matter
Claim(s) 6, 10-12, and 16-18 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
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/BRITNEY N. WASHINGTON/Examiner, Art Unit 1797
/JENNIFER WECKER/Primary Examiner, Art Unit 1797
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