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 instant application is a CON of 17/485,599 filed on 09/27/2021, now US Patent 12071615 B2, which is a CON of 16/094,070 filed on 10/16/2018, now US Patent 11162091 B2, which is a 371 of PCT/US2017/029671 filed on 04/26/2017 having priority to provisional application 62/328,358 filed on 04/27/2016.
Information Disclosure Statement
The information disclosure statement filed 07/12/2024 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. The deficiency is as follows:
Foreign patent documents 1, 2, and 14 and non-patent literature document 11 have not been provided.
An English abstract of foreign patent document 7, as specified on the information disclosure statement, has not been provided.
Foreign patent document 8 has not been provided. It appears that this document number may be inaccurate. If so, this document is likely a duplicate of foreign patent document 13.
The aforementioned documents have not been considered; however, all other references disclosed were considered by the Examiner. The reference disclosed on the information disclosure statement filed 04/15/2026 was also considered.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
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Claims 1-16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-6, 8-10, 12, 13, and 15-20 of U.S. Patent No. US 10093989 B2 in view of Heath [US 7670768 B1; IDS reference], Ekeze [US 5702884 A], and Weisburg [US 6110678 A].
Although the claims at issue are not identical, they are not patentably distinct from each other because of the following reasons: The claims of ‘989 recite many of the same limitations as the instant claims as detailed in Table 1 below. However, ‘989 does not specify a concentration of EDTA, the ratio at which the lysis buffer and whole blood are combined, combining the lysate with a capture reagent in a 1:1 ratio, or a step of separating the captured analyte from other lysate components.
Heath teaches a red blood cell lysing reagent which contains ammonium chloride, sodium bicarbonate, and EDTA, specifying use of an EDTA concentration which is about 0.5mM to 10mM [Heath, C10 L45-67]. Therefore, Heath demonstrates that the concentration of EDTA within said reagent is a results effective variable which a person having ordinary skill in the art would routinely optimize. As both Heath and ‘989 use EDTA for the same purpose, the skilled artisan would have had a reasonable expectation its optimization within the lysing reagent would be successful.
Ekeze discloses an ammonium chloride-based reagent used to lyse red blood cells in a whole blood sample which can also include a buffer (e.g., sodium bicarbonate) and a chelating agent (e.g., EDTA). This reagent is mixed with a whole blood sample at a ratio of about 1:1 to 10:1, with a ratio of 4:1 being a preferred embodiment [Ekeze, C5 L28-43]. Therefore, in addition to teaching the claimed ratio at which the lysing reagent and whole blood is mixed, Ekeze demonstrates that this ratio is a results effective variable which a person having ordinary skill in the art would routinely optimize. As both Ekeze and ‘989 disclose methods of lysing red blood cells, the skilled artisan would have understood that optimizing the ratio at which the lysing reagent and the sample are mixed would have a reasonable expectation of success.
Finally, Weisburg teaches a method for capturing a target polynucleotide from a clinical sample onto a solid support using a capture probe and an immobilized probe. In Example 3, the sample is first lysed and an aliquot of the lysate is mixed with an equal volume of a solution containing the capture probe and the immobilized probe attached to magnetic particles. The capture probe contains a region which is complementary to the nucleic acid target and a region which is complementary to the immobilized probe. Once the target is captured, the complex is washed, thus removing any non-target components present in the lysate [Weisburg, C22-C24]. The skilled artisan would recognize that this methodology used Weisburg to specifically isolate a nucleic acid of interest, including the support upon which a probe is immobilized and the volumes used, could be applied to the teachings of ‘989 with a reasonable expectation of success as they both isolate a nucleic acid from a sample using probe schemes which mirror each other.
Table 1
Instant
US 10093989 B2
Claim Number
Limitation
Claim Number
Limitation
1
A target capture reaction mixture comprising:
1, 17
(a) contacting red blood cells with a reagent
(a) a lysis reagent admixed with whole blood, wherein the reagent comprises
1, 17
contacting red blood cells with a reagent ...the reagent being effective to lyse the red blood cells and inhibit degradation of target RNA released from the red blood cells;
(i) sodium bicarbonate at a concentration of 14 mM,
10, 17
wherein the reagent further comprises sodium bicarbonate buffer; wherein the concentration of sodium bicarbonate is 10-20 mM; sodium bicarbonate buffer at a concentration of 10-20 mM
(ii) lithium lauryl sulfate (LLS) at a concentration of 8% (w/v),
1, 8, 17, 20
lithium lauryl sulfate (LLS) at a concentration of 4% to 15% (w/v); wherein the concentration of lithium lauryl sulfate (LLS) is 5% to 8% (w/v); lithium lauryl sulfate (LLS) at a concentration of 4% to 15% (w/v)
(iii) ammonium chloride at a concentration of 250 mM, and
1, 13, 17
ammonium chloride at a concentration of 200-300 mM; wherein the concentration of ammonium chloride is 250 mM; ammonium chloride at a concentration of 100-500 mM
(iv) EDTA at a concentration of 10 mM;
9, 12, 18
wherein the reagent further comprises an anti-coagulant; wherein the anti-coagulant is EDTA, heparin, or citrate (in view of Heath)
and wherein the ratio of the reagent to the whole blood is 4:1; and
16
wherein the reagent is admixed with whole blood at step (a) in a ratio of 3:1 (v/v) (in view of Ekeze)
(b) an immobilized probe for immobilizing a nucleic acid analyte released from blood cells in the whole blood, wherein the immobilized probe is attached to a solid support.
3, 19
contacting the released target RNA with a capture probe and an immobilized probe prior to performing the amplification reaction; wherein the target RNA binds to the capture probe, and wherein the bound capture probe binds to the immobilized probe.
2
a capture probe comprising a first segment complementary to the nucleic acid analyte and
3, 19
the capture probe having a first segment complementary to the target RNA
a second segment complementary to the immobilized probe.
3, 19
a second segment complementary to the immobilized probe,
4
wherein the solid support is a magnetic bead solid support
(in view of Weisburg)
5
wherein the nucleic acid analyte is an RNA.
2
the target RNA is a pathogen-derived target
6
wherein the RNA is a pathogen-derived RNA.
2
the target RNA is a pathogen-derived target
7
wherein the pathogen is a parasitic organism.
5, 6
wherein the target RNA is 18S rRNA from a pathogenic organism of the genus Babesia; wherein the pathogenic organism is of the species Babesia microti
8
wherein the parasitic organism is selected from the group consisting of parasites from the genus Babesia.
5, 6
wherein the target RNA is 18S rRNA from a pathogenic organism of the genus Babesia; wherein the pathogenic organism is of the species Babesia microti
9
A method of detecting a nucleic acid analyte in a whole blood sample, comprising the steps of:
1, 17
A method of analyzing a target RNA from red blood cells
(a) contacting a whole blood sample with a lysis reagent that is effective to lyse blood cells and release therefrom a nucleic acid analyte,
1, 16, 17
(a) contacting red blood cells with a reagent ...the reagent being effective to lyse the red blood cells and inhibit degradation of target RNA released from the red blood cells; wherein the reagent is admixed with whole blood at step (a) in a ratio of 3:1 (v/v).
wherein the ratio of reagent to whole blood is 4:1, and
16
wherein the reagent is admixed with whole blood at step (a) in a ratio of 3:1 (v/v) (in view of Ekeze)
wherein the lysis reagent comprises
1, 17
reagent comprising
(i) sodium bicarbonate at a concentration of 14 mM,
10, 15, 17
wherein the reagent further comprises sodium bicarbonate buffer; wherein the concentration of sodium bicarbonate is 10-20 mM
(ii) lithium lauryl sulfate (LLS) at a concentration of 8% (w/v)
1, 8, 17, 20
lithium lauryl sulfate (LLS) at a concentration of 4% to 15% (w/v); wherein the concentration of lithium lauryl sulfate (LLS) is 5% to 8% (w/v)
(iii) ammonium chloride at a concentration of 250 mM, and
1, 13, 17
ammonium chloride at a concentration of 200-300 mM; wherein the concentration of ammonium chloride is 250 mM; ammonium chloride at a concentration of 100-500 mM
(iv) EDTA at a concentration of 10 mM;
9, 12, 18
wherein the reagent further comprises an anti-coagulant; wherein the anti-coagulant is EDTA, heparin, or citrate (in view of Heath)
(b) providing conditions for lysing blood cells in the sample whereby at least a portion of the blood cells are lysed and the nucleic acid analyte released therefrom;
1, 17
the reagent being effective to lyse the red blood cells and inhibit degradation of target RNA released from the red blood cells;
(c) combining an equal volume of a lysate formed in step (b) and a target capture reagent,
(in view of Weisburg)
wherein the target capture reagent comprises a solid support configured to immobilize the nucleic acid analyte;
3, 19
wherein analyzing the target RNA further comprises contacting the released target RNA with a capture probe and an immobilized probe prior to performing the amplification reaction; wherein the target RNA binds to the capture probe, and wherein the bound capture probe binds to the immobilized probe.
(d) separating the immobilized nucleic acid analyte from other components of the lysate; and
(in view of Weisburg)
(e) performing a nucleic acid amplification and detection reaction to determine the presence or absence of the nucleic acid analyte.
1, 4, 17
wherein said analyzing comprises performing an amplification reaction to amplify the target RNA; wherein the amplification reaction is a transcription mediated amplification reaction and analyzing the target RNA further comprises detecting the resulting amplification product with a detection probe.
10
wherein the solid support comprises an immobilized probe and
3, 19
contacting the released target RNA with a capture probe and an immobilized probe prior to performing the amplification reaction,
the target capture reagent further comprises a capture probe comprising
3, 19
the capture probe having
a first segment complementary to the nucleic acid analyte and
3, 19
a first segment complementary to the target RNA,
a second segment complementary to the immobilized probe.
3, 19
a second segment complementary to the immobilized probe,
12
wherein the solid support is a magnetic bead solid support
(in view of Weisburg)
13
wherein the nucleic acid analyte is an RNA.
5
wherein the target RNA
14
wherein the RNA is a pathogen-derived RNA.
5, 6
wherein the target RNA is 18S rRNA from a pathogenic organism of the genus Babesia; wherein the pathogenic organism is of the species Babesia microti
15
wherein the pathogen is a parasitic organism.
5, 6
wherein the target RNA is 18S rRNA from a pathogenic organism of the genus Babesia; wherein the pathogenic organism is of the species Babesia microti
16
wherein the parasitic organism is selected from the group consisting of parasites from the genus Babesia.
5, 6
wherein the target RNA is 18S rRNA from a pathogenic organism of the genus Babesia; wherein the pathogenic organism is of the species Babesia microti
Claims 1-8 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 4-7, 9-11, and 13-19 of U.S. Patent No. US 10689713 B2 in view of Heath and Ekeze.
Although the claims at issue are not identical, they are not patentably distinct from each other because of the following reasons: The claims of ‘713 recite many of the same limitations as the instant claims as detailed in Table 2 below. However, ‘713 does not specify a concentration of EDTA or a ratio at which the reagent is mixed with whole blood.
Heath teaches a red blood cell lysing reagent which contains ammonium chloride, sodium bicarbonate, and EDTA, specifying use of an EDTA concentration which is about 0.5mM to 10mM [Heath, C10 L45-67]. Therefore, Heath demonstrates that the concentration of EDTA within said reagent is a results effective variable which a person having ordinary skill in the art would routinely optimize. As both Heath and ‘713 use EDTA for the same purpose, the skilled artisan would have had a reasonable expectation its optimization within the lysing reagent would be successful.
Ekeze discloses an ammonium chloride-based reagent used to lyse red blood cells in a whole blood sample which can also include a buffer (e.g., sodium bicarbonate) and a chelating agent (e.g., EDTA). This reagent is mixed with a whole blood sample at a ratio of about 1:1 to 10:1, with a ratio of 4:1 being a preferred embodiment [Ekeze, C5 L28-43]. Therefore, in addition to teaching the claimed ratio at which the lysing reagent and whole blood is mixed, Ekeze demonstrates that this ratio is a results effective variable which a person having ordinary skill in the art would routinely optimize. As both Ekeze and ‘713 are directed to reagents which are admixed with whole blood for the purpose of lysing red blood cells, the skilled artisan would have understood that optimizing the ratio at which the lysing reagent and the sample are mixed would have a reasonable expectation of success.
Table 2
Instant
US 10689713 B2
Claim Number
Limitation
Claim Number
Limitation
1
A target capture reaction mixture comprising:
9
wherein the reagent is admixed
(a) a lysis reagent admixed with whole blood, wherein the reagent comprises
9, 10
wherein the reagent is admixed with red blood cells or products derived from red blood cells; wherein the reagent is admixed with whole blood
(i) sodium bicarbonate at a concentration of 14 mM,
2, 11
further comprising sodium bicarbonate buffer; sodium bicarbonate buffer at a concentration of 10-20 mM
(ii) lithium lauryl sulfate (LLS) at a concentration of 8% (w/v),
1, 7
lithium lauryl sulfate (LLS) at a concentration of 4% to 15% (w/v); wherein the concentration of LLS is 5-8% (w/v)
(iii) ammonium chloride at a concentration of 250 mM, and
1, 6
ammonium chloride at a concentration of 200-300 mM; wherein the concentration of ammonium chloride is 250 mM
(iv) EDTA at a concentration of 10 mM;
4, 5, 13
further comprising an anti-coagulant; wherein the anti-coagulant is EDTA, heparin, or citrate (in view of Heath)
wherein the ratio of the reagent to the whole blood is 4:1
(in view of Ekeze)
(b) an immobilized probe for immobilizing a nucleic acid analyte released from blood cells in the whole blood, wherein the immobilized probe is attached to a solid support.
17
further comprising a capture probe and an immobilized probe
2
a capture probe comprising a first segment complementary to the nucleic acid analyte and
17
wherein the capture probe comprises a first segment complementary to the target RNA and
a second segment complementary to the immobilized probe.
17
a second segment complementary to the immobilized probe
5
wherein the nucleic acid analyte is an RNA.
18
wherein the target RNA is a pathogen-derived target
6
wherein the RNA is a pathogen-derived RNA.
18
wherein the target RNA is a pathogen-derived target
7
wherein the pathogen is a parasitic organism.
19
wherein the target RNA is 18S rRNA from a pathogenic organism of the genus Babesia
8
wherein the parasitic organism is selected from the group consisting of parasites from the genus Babesia.
19
wherein the target RNA is 18S rRNA from a pathogenic organism of the genus Babesia
Claims 1-16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8, 10-12, 16, 18, and 19 of U.S. Patent No. US 11162145 B2 in view of Heath, Ekeze, and Weisburg.
Although the claims at issue are not identical, they are not patentably distinct from each other because of the following reasons: The claims of ‘145 recite many of the same limitations as the instant claims as detailed in Table 3 below. However, ‘145 does not specify that the sample containing red blood cells is whole blood, a concentration of EDTA, a ratio at which the reagent is mixed with the sample, combining the lysate with a capture reagent in a 1:1 ratio, or a step of performing amplification and detection. Additionally, instant claims 1-8 are directed to a reaction mixture whereas the claims of ‘145 are directed towards methods. However, practicing the methods of ‘145 necessarily forms a mixture of the lysis reagent, the sample, and the immobilized probe, which is the reaction mixture of the instant claims. Therefore, a skilled artisan practicing the methods of ‘145 would have arrived at the reaction mixture of the instant claims.
Heath teaches a red blood cell lysing reagent which contains ammonium chloride, sodium bicarbonate, and EDTA, specifying use of an EDTA concentration which is about 0.5mM to 10mM [Heath, C10 L45-67]. Therefore, Heath demonstrates that the concentration of EDTA within said reagent is a results effective variable which a person having ordinary skill in the art would routinely optimize. As both Heath and ‘145 use EDTA for the same purpose, the skilled artisan would have had a reasonable expectation its optimization within the lysing reagent would be successful.
Ekeze discloses an ammonium chloride-based reagent used to lyse red blood cells in a whole blood sample which can also include a buffer (e.g., sodium bicarbonate) and a chelating agent (e.g., EDTA). This reagent is mixed with a whole blood sample at a ratio of about 1:1 to 10:1, with a ratio of 4:1 being a preferred embodiment [Ekeze, C5 L28-43]. Therefore, in addition to teaching the claimed ratio at which the lysing reagent and whole blood is mixed, Ekeze demonstrates that this ratio is a results effective variable which a person having ordinary skill in the art would routinely optimize. As both Ekeze and ‘145 disclose methods of lysing red blood cells, the skilled artisan would have understood that the addition of the lysing reagent to whole blood and optimizing the ratio at which they are mixed would have a reasonable expectation of success.
Finally, Weisburg teaches a method for capturing a target polynucleotide from a clinical sample onto a solid support using a capture probe and an immobilized probe. In Example 3, the sample is first lysed and an aliquot of the lysate is mixed with an equal volume of a solution containing the capture probe and the immobilized probe attached to magnetic particles. The capture probe contains a region which is complementary to the nucleic acid target and a region which is complementary to the immobilized probe. Once the target is captured, the complex is washed, removing any non-target components present in the lysate, to facilitate downstream analysis. Specifically, the beads are resuspended in an amplification reagent and the amplification product is detected using a labeled probe [Weisburg, C22-C24]. The skilled artisan would recognize that this methodology used Weisburg to specifically isolate, amplify, and detect a nucleic acid of interest, including the support upon which a probe is immobilized and the volumes used, could be applied to the teachings of ‘145 with a reasonable expectation of success as they both isolate a nucleic acid from a sample using probe schemes which mirror each other. Isolating nucleic acid is a known step preceding amplification and detection, so extending the methods of ‘145 to include amplification and detection, as taught by Weisburg, would have bee a predictable use of the isolated product.
Table 3
Instant
US 11162145 B2
Claim Number
Limitation
Claim Number
Limitation
1
A target capture reaction mixture comprising:
1, 18
(a) mixing
(a) a lysis reagent admixed with whole blood, wherein the reagent comprises
1, 18
(a) mixing a sample containing red blood cells with a reagent comprising
(i) sodium bicarbonate at a concentration of 14 mM,
5-8, 18
wherein the mixture further comprises a buffer; wherein the buffer is sodium bicarbonate; wherein the concentration of sodium bicarbonate is 5-30 mM; wherein the concentration of sodium bicarbonate is 10-20 mM; sodium bicarbonate buffer at a concentration of 5-30 mM
(ii) lithium lauryl sulfate (LLS) at a concentration of 8% (w/v),
1, 12, 18, 19
lithium lauryl sulfate (LLS) at a concentration of 4% to 15% (w/v); wherein the concentration of LLS in the reagent is 5% to 8% (w/v)
(iii) ammonium chloride at a concentration of 250 mM, and
1, 11, 18
ammonium chloride at a concentration of 200-300 mM; wherein the concentration of ammonium chloride in the reagent is 250 mM; ammonium chloride at a concentration of 100-500 mM
(iv) EDTA at a concentration of 10 mM;
1, 10, 18
and an anti-coagulant; wherein the anti-coagulant is EDTA or citrate (in view of Heath)
and wherein the ratio of the reagent to the whole blood is 4:1; and
(in view of Ekeze)
(b) an immobilized probe for immobilizing a nucleic acid analyte released from blood cells in the whole blood, wherein the immobilized probe is attached to a solid support.
1, 18
(c) adding a target capture oligomer and an immobilized probe to the mixture,; thereby forming a capture hybrid complex comprising the target capture oligomer and the target nucleic acid;
2
a capture probe comprising a first segment complementary to the nucleic acid analyte and
1
wherein the target capture oligomer comprises (i) a target hybridizing sequence that hybridizes with the target nucleic acid and
a second segment complementary to the immobilized probe.
1
(ii) a segment for attaching the target capture oligomer to the immobilized probe,
4
wherein the solid support is a magnetic bead solid support
(in view of Weisburg)
5
wherein the nucleic acid analyte is an RNA.
3
wherein the target nucleic acid is RNA
6
wherein the RNA is a pathogen-derived RNA.
2, 4
wherein the target nucleic acid is a pathogen-derived target; wherein the target nucleic acid is RNA
9
A method of detecting a nucleic acid analyte in a whole blood sample, comprising the steps of:
1
A method for isolating a target nucleic acid from red blood cells, the method comprising:
(a) contacting a whole blood sample with a lysis reagent that is effective to lyse blood cells and release therefrom a nucleic acid analyte,
1
(a) mixing a sample containing red blood cells with a reagent comprising
wherein the ratio of reagent to whole blood is 4:1, and
(in view of Ekeze)
wherein the lysis reagent comprises
1
with a reagent comprising
(i) sodium bicarbonate at a concentration of 14 mM,
5-8
wherein the mixture further comprises a buffer; wherein the buffer is sodium bicarbonate; wherein the concentration of sodium bicarbonate is 5-30 mM; wherein the concentration of sodium bicarbonate is 10-20 mM
(ii) lithium lauryl sulfate (LLS) at a concentration of 8% (w/v)
1, 12
lithium lauryl sulfate (LLS) at a concentration of 4% to 15% (w/v); wherein the concentration of LLS in the reagent is 5% to 8% (w/v)
(iii) ammonium chloride at a concentration of 250 mM, and
1, 11
ammonium chloride at a concentration of 200-300 mM; wherein the concentration of ammonium chloride in the reagent is 250 mM
(iv) EDTA at a concentration of 10 mM;
1, 10
and an anti-coagulant; wherein the anti-coagulant is EDTA or citrate (in view of Heath)
(b) providing conditions for lysing blood cells in the sample whereby at least a portion of the blood cells are lysed and the nucleic acid analyte released therefrom;
1
(b) incubating the mixture of step (a), wherein the red blood cells are lysed and a target nucleic acid in the red blood cells is released;
(c) combining an equal volume of a lysate formed in step (b) and a target capture reagent,
(in view of Weisburg)
wherein the target capture reagent comprises a solid support configured to immobilize the nucleic acid analyte;
1, 16
(c) adding a target capture oligomer and an immobilized probe to the mixture; wherein the immobilized probe is attached to a magnetic support
(d) separating the immobilized nucleic acid analyte from other components of the lysate; and
1
(d) separating the capture hybrid complex away from other components of the sample,
(e) performing a nucleic acid amplification and detection reaction to determine the presence or absence of the nucleic acid analyte.
(in view of Weisburg)
10
wherein the solid support comprises an immobilized probe and
1, 16
(c) adding a target capture oligomer and an immobilized probe to the mixture; wherein the immobilized probe is attached to a magnetic support
the target capture reagent further comprises a capture probe comprising
1
wherein the target capture oligomer comprises (i)
a first segment complementary to the nucleic acid analyte and
1
a target hybridizing sequence that hybridizes with the target nucleic acid and
a second segment complementary to the immobilized probe.
1
(ii) a segment for attaching the target capture oligomer to the immobilized probe,
12
wherein the solid support is a magnetic bead solid support
(in view of Weisburg)
13
wherein the nucleic acid analyte is an RNA.
3
wherein the target nucleic acid is RNA.
14
wherein the RNA is a pathogen-derived RNA.
2, 4
wherein the target nucleic acid is a pathogen-derived target; wherein the target nucleic acid is RNA.
Conclusion
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/K.N.K./Examiner, Art Unit 1681
/SAMUEL C WOOLWINE/Primary Examiner, Art Unit 1681
