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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 01/22/2026 has been entered.
Claims Status
Claims 1, 4, 6, 7, & 14-19 filed on 01/22/2026 are pending. All the amendments and arguments have been thoroughly reviewed but are deemed insufficient to place this application in condition for allowance. The following rejections are either newly applied, as necessitated by amendment, or are reiterated. They constitute the complete set being presently applied to the instant application. Response to Applicant’s argument follow. This action is Non-FINAL.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office Action.
Any rejection not reiterated is hereby withdrawn in view of the amendments to the claims.
Information Disclosure Statement
Only the abstracts of the references in the IDS submitted on 01/22/2026 that are lined through, under the foreign patent documents section, were considered because an English copy of the full documents were not provided.
Claim Rejections - 35 USC § 103
Claim(s) 1, 4, 6, 7, 14-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nazareth (WO 2020/025947 A1), as cited in the IDS dated 04/26/2022, in view of Khan (U.S. Patent Application Publication US 2010/0331534 A1) and Nyan (WO 2020/050852 A1), as cited in the IDS dated 04/26/2022.
Regarding amended claim 1, Nazareth teaches a method for processing and detecting viral particles in a biological sample by processing the sample with a non-ionic detergent of Tween® 20 (polysorbate 20), probes (one or more probes for the target nucleic acid), primers (one or more primers for specifically binding to the target nucleic acid), and polymerase (one or more polymerases) wherein the nucleic acid becomes amplifiable (virus is made accessible to PCR components such as primers and polymerases) (pg. 8 lines 29-35), the target nucleic acid is then amplified (generate an amplified target nucleic acid product), and detecting the amplified target nucleic acid (detecting the presence of the target nucleic acid in the biological sample) all in the same vessel (mixture is created in a container, amplified in the container, and detected in the container) (pg. 6 lines 21-33; pg. 7 lines 20-25; pg. 8 lines 24-29; pg. 9 lines 8-19 & 30-33; pg. 13 lines 22-26 & 28-35; pg. 14 lines 1-2; pg. 17 lines 20-22; pg. 20 lines 1-5). In addition, Nazareth teaches that the non-ionic detergent, Tween® 20 (polysorbate 20), can be at a concentration of at least 0.4% (0.4% and higher) (pg. 20 lines 7-13).
Nazareth does not teach that the Tween® 20 (polysorbate 20) is at a concentration from about 2% to about 5% or that the method of amplifying the viral target nucleic acid comprises isothermal amplification.
Khan teaches a method for separating nucleic acids of interest from other cellular components (detecting the presence of a target nucleic acid) through generating a solution (mixture) including a non-ionic detergent of Tween® 20 (polysorbate 20) at a concentration of about 0.5% to about 30% (polysorbate 20 at a concentration from about 2% to about 5%) (abstract lines 1-10; paragraph [0009] lines 1-11; pg. 5 column 2 claim 4 lines 1-2). In addition, Khan teaches that the inclusion of Tween® 20 (polysorbate 20) at high concentrations allows for isolation of nucleic acids of interest and simplifies the protocol of detecting a nucleic acid of interest by eliminating the pre-heating step while maintaining the yield and quality of isolated nucleic acids of interest (paragraph [0025] lines 1-11).
Nyan teaches a lysis-buffer reaction that can be used for viral nucleic acid detection that performs lysis of the viral cells and isothermal amplification of the released DNA or RNA (viral target nucleic acid) simultaneously in which the lysis-reaction buffer contains Triton®-X 100 (a non-ionic detergent) and the isothermal amplification method comprises a loop-mediated isothermal amplification method (LAMP) (pg. 24-25 paragraph A lines 1-25; pg. 25-26 paragraph V lines 1-11). In addition, Nyan teaches that the lysis-reaction buffer enhances priming specificity in differential real-time multiplex isothermal amplification reaction (pg. 25-26 paragraph V lines 11-14).
Nazareth, Khan, and Nyan are considered to be analogous to the claimed invention because they are all in the same field of detecting nucleic acids through treatment with a detergent and subsequent amplification. Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of amplifying the viral target nucleic acid with a non-ionic detergent, Tween® 20 (polysorbate 20), at a concentration of at least 0.4% in Nazareth to incorporate the use of a non-ionic detergent, Tween® 20 (polysorbate 20) at a concentration between 0.5% and 30% as taught in Khan because Khan teaches that doing so would simplify the protocol for detecting a nucleic acid of interest while maintaining the yield and quality of the isolated nucleic acids of interest and it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of amplifying the viral target nucleic acid in Nazareth to incorporate the use of loop-mediated isothermal amplification as taught in Nyan because Nyan teaches that doing so would provide enhanced priming specificity in the isothermal amplification reaction.
Regarding claim 4, Nazareth teaches that the biological sample is heated in the mixture to lyse the sample so that the target viral nucleic acid becomes amplifiable (becomes accessible to the polymerase and other amplification components) at a temperature of 70°C (pg. 20 lines 24-25; pg. 21 lines 22-24; pg. 22 lines 22-25).
Khan teaches incubating the biological samples with the cell lysis buffer (containing 2% of Tween® 20 (polysorbate 20)) at 56°C for 15 minutes followed by 70°C for 2 minutes (biological sample is lysed for a period of time from about 30 seconds to about 20 minutes at a temperature from about 35°C to about 75°C (paragraph [0034] lines 1-3; paragraph [0061] lines 1-2; paragraph [0063] lines 1-2).
Regarding claim 6, Nazareth teaches that the target viral nucleic acid is DNA (viral nucleic acid comprising DNA) (pg. 16 lines 9-10 & 16; pg. 25 line 16).
Regarding claim 7, Nazareth teaches that the target viral nucleic acid is RNA (viral nucleic acid comprising RNA) (pg. 16 lines 19-21 & 16; pg. 25 line 16).
Regarding claim 14, Nyan teaches the isothermal amplification method comprises a loop-mediated isothermal amplification method (LAMP) (pg. 24-25 paragraph A lines 1-25; pg. 25-26 paragraph V lines 1-11).
Regarding claim 15, Nazareth teaches that one or more polymerases may be present and that the polymerase is a RNA dependent or DNA dependent DNA polymerase (pg. 25 lines 16-20 & 27-30).
Regarding claims 16 & 17, Nazareth teaches that the viral target nucleic acid can be amplified through a real time quantitative PCR method (real-time PCR assay) which requires the use of fluorophores or other suitable nucleic acid intercalating or detecting dyes and probe chemistries (one or more probes) (pg. 8 lines 29-35; pg. 13 lines 22-26 & 28-35).
Regarding claim 18, Nazareth teaches that the viral target nucleic acid can be amplified through a real time quantitative PCR method (real-time PCR assay) which requires the use of fluorophores or other suitable nucleic acid intercalating or detecting dyes (a non-sequence specific DNA binding dye) to detect the amplified viral target nucleic acid (pg. 8 lines 29-35; pg. 13 lines 22-26 & 28-35).
Nyan teaches that quantitative isothermal LAMP assays detect viruses based on the use of non-specific fluorescence chemistries such as SYBR® green (quantitative PCR method employs a non-specific double-stranded DNA-binding dye to detect the amplified target nucleic acid wherein the non-sequence specific double-stranded DNA binding dye is N’N’-dimethyl-N-[4-[(E)-(3-methyl-1,3-benzothiazol-2-ylidene)methyl]-1-phenylquinolin-1-ium-2-yl]-N-propylpropane-1,3-diamine (SYBR® green)) (pg. 56 1st full paragraph lines 12-17).
Regarding amended claim 19, Nazareth teaches a method for processing and detecting viral particles in a biological sample by processing the sample with a non-ionic detergent of Tween® 20 (polysorbate 20), probes (one or more probes for the viral nucleic acid), primers (one or more primers for specifically binding to the viral nucleic acid), and polymerase (one or more polymerases) wherein the nucleic acid (viral nucleic acid) becomes amplifiable (virus is made accessible to PCR components such as primers and polymerases) (pg. 8 lines 29-35), the viral target nucleic acid is then amplified (generate an amplified viral nucleic acid product), and detecting the amplified viral target nucleic acid (detecting the presence of the virus in the biological sample) all in the same vessel (mixture is created in a container, amplified in the container, and detected in the container) (pg. 6 lines 21-33; pg. 7 lines 20-25; pg. 8 lines 24-29; pg. 9 lines 8-19 & 30-33; pg. 13 lines 22-26 & 28-35; pg. 14 lines 1-2; pg. 17 lines 20-22). In addition, Nazareth teaches that the non-ionic detergent, Tween® 20 (polysorbate 20), can be at a concentration of at least 0.4% (0.4% and higher) (pg. 20 lines 7-13).
Nazareth does not teach that the Tween® 20 (polysorbate 20) is at a concentration from about 2% to about 5% or that the method of amplifying the viral target nucleic acid comprises isothermal amplification.
Khan teaches a method for separating nucleic acids of interest from other cellular components (detecting the presence of a target nucleic acid) through generating a solution (mixture) including a non-ionic detergent of Tween® 20 (polysorbate 20) at a concentration of about 0.5% to about 30% (polysorbate 20 at a concentration from about 2% to about 5%) (abstract lines 1-10; paragraph [0009] lines 1-11; pg. 5 column 2 claim 4 lines 1-2). In addition, Khan teaches that the inclusion of Tween® 20 (polysorbate 20) at high concentrations allows for isolation of nucleic acids of interest and simplifies the protocol of detecting a nucleic acid of interest by eliminating the pre-heating step while maintaining the yield and quality of isolated nucleic acids of interest (paragraph [0025] lines 1-11).
Nyan teaches a lysis-buffer reaction that can be used for viral nucleic acid detection that performs lysis of the viral cells and isothermal amplification of the released DNA or RNA (viral target nucleic acid) simultaneously in which the lysis-reaction buffer contains Triton®-X 100 (a non-ionic detergent) and the isothermal amplification method comprises a loop-mediated isothermal amplification method (LAMP) (pg. 24-25 paragraph A lines 1-25; pg. 25-26 paragraph V lines 1-11). In addition, Nyan teaches that the lysis-reaction buffer enhances priming specificity in differential real-time multiplex isothermal amplification reaction (pg. 25-26 paragraph V lines 11-14).
Nazareth, Khan, and Nyan are considered to be analogous to the claimed invention because they are all in the same field of detecting nucleic acids through treatment with a detergent and subsequent amplification. Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of amplifying the viral target nucleic acid with a non-ionic detergent, Tween® 20 (polysorbate 20), at a concentration of at least 0.4% in Nazareth to incorporate the use of a non-ionic detergent, Tween® 20 (polysorbate 20) at a concentration between 0.5% and 30% as taught in Khan because Khan teaches that doing so would simplify the protocol for detecting a nucleic acid of interest while maintaining the yield and quality of the isolated nucleic acids of interest and it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of amplifying the viral target nucleic acid in Nazareth to incorporate the use of loop-mediated isothermal amplification as taught in Nyan because Nyan teaches that doing so would provide enhanced priming specificity in the isothermal amplification reaction.
Claim(s) 1, 4, 6, 7, 14-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Nazareth (WO 2020/025947 A1), as cited in the IDS dated 04/26/2022, in view of Wang (Wang et al.; Molecular Therapy: Methods & Clinical Development, Vol. 13, pages 526-531, May 2018) and Nyan (WO 2020/050852 A1), as cited in the IDS dated 04/26/2022.
Regarding amended claim 1, Nazareth teaches a method for processing and detecting viral particles in a biological sample by processing the sample with a non-ionic detergent of Tween® 20 (polysorbate 20), probes (one or more probes for the target nucleic acid), primers (one or more primers for specifically binding to the target nucleic acid), and polymerase (one or more polymerases) wherein the nucleic acid becomes amplifiable (virus is made accessible to PCR components such as primers and polymerases) (pg. 8 lines 29-35), the target nucleic acid is then amplified (generate an amplified target nucleic acid product), and detecting the amplified target nucleic acid (detecting the presence of the target nucleic acid in the biological sample) all in the same vessel (mixture is created in a container, amplified in the container, and detected in the container) (pg. 6 lines 21-33; pg. 7 lines 20-25; pg. 8 lines 24-29; pg. 9 lines 8-19 & 30-33; pg. 13 lines 22-26 & 28-35; pg. 14 lines 1-2; pg. 17 lines 20-22; pg. 20 lines 1-5). In addition, Nazareth teaches that the non-ionic detergent, Tween® 20 (polysorbate 20), can be at a concentration of at least 0.4% (0.4% and higher) (pg. 20 lines 7-13).
Nazareth does not teach that the Tween® 20 (polysorbate 20) is at a concentration from about 2% to about 5% or that the method of amplifying the viral target nucleic acid comprises isothermal amplification.
Wang teaches a method of quantifying DNA (detecting the presence of a target nucleic acid) through the addition of Tween® 20 (polysorbate 20) to the mixture and qPCR analysis in which Tween® 20 (polysorbate 20) was added to the samples at concentrations of 0%, 0.625%, 1.25%, 2.5%, 5%, and 10% (polysorbate concentration from about 2% to about 5%) (abstract lines 5-18; pg. 527-528 paragraph bridging pg. 527 & 528 lines 1-10; Figure 3). Wang also teaches that Tween® 20 (polysorbate 20) reached its peak efficiency in amplification at 5% (polysorbate concentration from about 2% to about 5%) and that the addition of Tween® 20 (polysorbate 20) significantly simplifies the assay and can easily be automated for high-throughput applications (abstract lines 16-22; pg. 527-528 paragraph bridging pg. 527 & 528 lines 1-10).
Nyan teaches a lysis-buffer reaction that can be used for viral nucleic acid detection that performs lysis of the viral cells and isothermal amplification of the released DNA or RNA (viral target nucleic acid) simultaneously in which the lysis-reaction buffer contains Triton®-X 100 (a non-ionic detergent) and the isothermal amplification method comprises a loop-mediated isothermal amplification method (LAMP) (pg. 24-25 paragraph A lines 1-25; pg. 25-26 paragraph V lines 1-11). In addition, Nyan teaches that the lysis-reaction buffer enhances priming specificity in differential real-time multiplex isothermal amplification reaction (pg. 25-26 paragraph V lines 11-14).
Nazareth, Wang, and Nyan are considered to be analogous to the claimed invention because they are all in the same field of detecting nucleic acids through treatment with a non-ionic detergent and subsequent amplification. Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of amplifying the viral target nucleic acid with a non-ionic detergent, Tween® 20 (polysorbate 20), at a concentration of at least 0.4% in Nazareth to incorporate the use of a non-ionic detergent, Tween® 20 (polysorbate 20) at a concentration between 2% and 5% as taught in Wang because Wang teaches that doing so would significantly simplifies the assay for detection of target nucleic acids and can easily be automated for high-throughput applications and it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of amplifying the viral target nucleic acid in Nazareth to incorporate the use of loop-mediated isothermal amplification as taught in Nyan because Nyan teaches that doing so would provide enhanced priming specificity in the isothermal amplification reaction.
Regarding claim 4, Nazareth teaches that the biological sample is heated in the mixture to lyse the sample so that the target viral nucleic acid becomes amplifiable (becomes accessible to the polymerase and other amplification components) at a temperature of 70°C (pg. 20 lines 24-25; pg. 21 lines 22-24; pg. 22 lines 22-25).
Khan teaches incubating the biological samples with the cell lysis buffer (containing 2% of Tween® 20 (polysorbate 20)) at 56°C for 15 minutes followed by 70°C for 2 minutes (biological sample is lysed for a period of time from about 30 seconds to about 20 minutes at a temperature from about 35°C to about 75°C (paragraph [0034] lines 1-3; paragraph [0061] lines 1-2; paragraph [0063] lines 1-2).
Regarding claim 6, Nazareth teaches that the target viral nucleic acid is DNA (viral nucleic acid comprising DNA) (pg. 16 lines 9-10 & 16; pg. 25 line 16).
Regarding claim 7, Nazareth teaches that the target viral nucleic acid is RNA (viral nucleic acid comprising RNA) (pg. 16 lines 19-21 & 16; pg. 25 line 16).
Regarding claim 14, Nyan teaches the isothermal amplification method comprises a loop-mediated isothermal amplification method (LAMP) (pg. 24-25 paragraph A lines 1-25; pg. 25-26 paragraph V lines 1-11).
Regarding claim 15, Nazareth teaches that one or more polymerases may be present and that the polymerase is a RNA dependent or DNA dependent DNA polymerase (pg. 25 lines 16-20 & 27-30).
Regarding claims 16 & 17, Nazareth teaches that the viral target nucleic acid can be amplified through a real time quantitative PCR method (real-time PCR assay) which requires the use of fluorophores or other suitable nucleic acid intercalating or detecting dyes and probe chemistries (one or more probes) (pg. 8 lines 29-35; pg. 13 lines 22-26 & 28-35).
Regarding claim 18, Nazareth teaches that the viral target nucleic acid can be amplified through a real time quantitative PCR method (real-time PCR assay) which requires the use of fluorophores or other suitable nucleic acid intercalating or detecting dyes (a non-sequence specific DNA binding dye) to detect the amplified viral target nucleic acid (pg. 8 lines 29-35; pg. 13 lines 22-26 & 28-35).
Nyan teaches that quantitative isothermal LAMP assays detect viruses based on the use of non-specific fluorescence chemistries such as SYBR® green (quantitative PCR method employs a non-specific double-stranded DNA-binding dye to detect the amplified target nucleic acid wherein the non-sequence specific double-stranded DNA binding dye is N’N’-dimethyl-N-[4-[(E)-(3-methyl-1,3-benzothiazol-2-ylidene)methyl]-1-phenylquinolin-1-ium-2-yl]-N-propylpropane-1,3-diamine (SYBR® green)) (pg. 56 1st full paragraph lines 12-17).
Regarding amended claim 19, Nazareth teaches a method for processing and detecting viral particles in a biological sample by processing the sample with a non-ionic detergent of Tween® 20 (polysorbate 20), probes (one or more probes for the viral nucleic acid), primers (one or more primers for specifically binding to the viral nucleic acid), and polymerase (one or more polymerases) wherein the nucleic acid (viral nucleic acid) becomes amplifiable (virus is made accessible to PCR components such as primers and polymerases) (pg. 8 lines 29-35), the viral target nucleic acid is then amplified (generate an amplified viral nucleic acid product), and detecting the amplified viral target nucleic acid (detecting the presence of the virus in the biological sample) all in the same vessel (mixture is created in a container, amplified in the container, and detected in the container) (pg. 6 lines 21-33; pg. 7 lines 20-25; pg. 8 lines 24-29; pg. 9 lines 8-19 & 30-33; pg. 13 lines 22-26 & 28-35; pg. 14 lines 1-2; pg. 17 lines 20-22). In addition, Nazareth teaches that the non-ionic detergent, Tween® 20 (polysorbate 20), can be at a concentration of at least 0.4% (0.4% and higher) (pg. 20 lines 7-13).
Nazareth does not teach that the Tween® 20 (polysorbate 20) is at a concentration from about 2% to about 5% or that the method of amplifying the viral target nucleic acid comprises isothermal amplification.
Wang teaches a method of quantifying DNA (detecting the presence of a target nucleic acid) through the addition of Tween® 20 (polysorbate 20) to the mixture and qPCR analysis in which Tween® 20 (polysorbate 20) was added to the samples at concentrations of 0%, 0.625%, 1.25%, 2.5%, 5%, and 10% (polysorbate concentration from about 2% to about 5%) (abstract lines 5-18; pg. 527-528 paragraph bridging pg. 527 & 528 lines 1-10; Figure 3). Wang also teaches that Tween® 20 (polysorbate 20) reached its peak efficiency in amplification at 5% (polysorbate concentration from about 2% to about 5%) and that the addition of Tween® 20 (polysorbate 20) significantly simplifies the assay and can easily be automated for high-throughput applications (abstract lines 16-22; pg. 527-528 paragraph bridging pg. 527 & 528 lines 1-10).
Nyan teaches a lysis-buffer reaction that can be used for viral nucleic acid detection that performs lysis of the viral cells and isothermal amplification of the released DNA or RNA (viral target nucleic acid) simultaneously in which the lysis-reaction buffer contains Triton®-X 100 (a non-ionic detergent) and the isothermal amplification method comprises a loop-mediated isothermal amplification method (LAMP) (pg. 24-25 paragraph A lines 1-25; pg. 25-26 paragraph V lines 1-11). In addition, Nyan teaches that the lysis-reaction buffer enhances priming specificity in differential real-time multiplex isothermal amplification reaction (pg. 25-26 paragraph V lines 11-14).
Nazareth, Wang, and Nyan are considered to be analogous to the claimed invention because they are all in the same field of detecting nucleic acids through treatment with a detergent and subsequent amplification. Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of amplifying the viral target nucleic acid with a non-ionic detergent, Tween® 20 (polysorbate 20), at a concentration of at least 0.4% in Nazareth to incorporate the use of a non-ionic detergent, Tween® 20 (polysorbate 20) at a concentration between 2% and 5% as taught in Wang because Wang teaches that doing so would significantly simplifies the assay for detection of target nucleic acids and can easily be automated for high-throughput applications and it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of amplifying the viral target nucleic acid in Nazareth to incorporate the use of loop-mediated isothermal amplification as taught in Nyan because Nyan teaches that doing so would provide enhanced priming specificity in the isothermal amplification reaction.
Response to Arguments
The response traverses the rejection. The response asserts that neither Nazareth nor Nyan (considered alone or in combination) teaches or suggests a method including at a minimum polysorbate 20 concentration from about 2% to about 5% as recited in the independent claims 1 and 19. Further, the response asserts that the disclosure of Nazareth regards the benefits of lower amounts of Tween 20 (less than 0.4% and preferably less than 0.2%) in maintaining amplification efficiency which such disclosure is further supported by even lower Tween 20 amounts disclosed n Nyan of 0.01%-0.05% and that one skilled in the art would not have a reasonable expectation of success of polysorbate 20 at a concentration from about 2% to about 5% (i.e., at least 5 times higher than the highest preferred reaction condition identified in Nazareth, and at least 200 to 500 times higher than Nyan) as recited in independent claims 1 and 19. Further, the response asserts that Nazareth alone, and in combination with Nyan, teaches away from increasing concentration of polysorbate 20 to ranges recited by independent claims 1 and 19. These arguments have been thoroughly reviewed but were not found persuasive. First, Nazareth teaches that the non-ionic detergent, Tween® 20 (polysorbate 20), can be at a concentration of at least 0.4%, indicating concentrations of 0.4% and higher for Tween® 20 (polysorbate 20). In addition, in regards to the teachings of a preferred set of reaction conditions of 0.2% Tween20 in Nazareth, it is not required that the limitations of a claim be taught in a preferred embodiment. Second, the prior art of Khan appreciates including a non-ionic detergent of Tween® 20 (polysorbate 20) at a concentration of about 0.5% to about 30% (polysorbate 20 at a concentration from about 2% to about 5%) to a detect a nucleic acid of interest.
The response also asserts that the reliance on Khan’s disclosure of 0.5% to about 30% of polysorbate 20 is misguided since there is no motivation to apply aspects of Khan’s purification method to the presently recited claims that are directed to a method for detecting the presence of target nucleic acid in a biological sample in the same container in which the biological sample is deposited as part of a mixture. Further, the response asserts that the specification describes methods for amplifying and detecting a target nucleic acid in a biological sample in a single solution or mixture in a single container and that, in contrast, Khan generally describes a method for lysing cells and isolating genomic DNA for further analysis including steps of purifying DNA and separating the DNA from its cellular components, thereby teaching away from the claims of the claims of the present application that are directed to forming a mixture comprising the biological sample and detecting the target nucleic acid all in the same container. Further, the response asserts that there is no motivation to utilize aspects of Khan’s genomic DNA purification methods for methods recited by the present claims directed to detecting presence of a target nucleic acid using a single container as fully recited by such claims. These arguments have been thoroughly reviewed but were not found persuasive. First, in response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Second, Nazareth teaches a method for processing and detecting viral particles in a biological sample by processing the sample with a non-ionic detergent of Tween® 20 (polysorbate 20), probes, primers, and polymerase, the viral target nucleic acid is then amplified, and detecting the amplified viral target nucleic acid (detecting the presence of the virus in the biological sample) all in the same vessel (mixture is created in a container, amplified in the container, and detected in the container) (pg. 6 lines 21-33; pg. 7 lines 20-25; pg. 8 lines 24-29; pg. 9 lines 8-19 & 30-33). Therefore, Nazareth appreciates a method wherein the mixture is created in the container and the target nucleic acid is amplified and detected in the same container as recited in claims 1 and 19 as currently amended. Further, Khan teaches a method for separating nucleic acids of interest from other cellular components (detecting the presence of a target nucleic acid) through generating a solution (mixture) including a non-ionic detergent of Tween® 20 (polysorbate 20) at a concentration of about 0.5% to about 30% (polysorbate 20 at a concentration from about 2% to about 5%) (abstract lines 1-10; paragraph [0009] lines 1-11; pg. 5 column 2 claim 4 lines 1-2). In addition, Khan teaches that the inclusion of Tween® 20 (polysorbate 20) at high concentrations allows for isolation of nucleic acids of interest and simplifies the protocol of detecting a nucleic acid of interest by eliminating the pre-heating step while maintaining the yield and quality of isolated nucleic acids of interest (paragraph [0025] lines 1-11). Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the method of amplifying the viral target nucleic acid with a non-ionic detergent, Tween® 20 (polysorbate 20), at a concentration of at least 0.4% in the same container in Nazareth to incorporate the use of a non-ionic detergent, Tween® 20 (polysorbate 20) at a concentration between 0.5% and 30% as taught in Khan because Khan teaches that doing so would simplify the protocol for detecting a nucleic acid of interest while maintaining the yield and quality of the isolated nucleic acids of interest.
The response further asserts that because claims 1 & 19 are allowable, due to the reasons above, that all remaining claims are allowable at least due to their dependence on an allowable independent claim. This argument has been thoroughly reviewed but was not found persuasive for the reasons set forth above.
For these reasons, and the reasons already made of record and modified to address the claims as currently amended, the rejections are maintained and applied to the newly amended claims.
Conclusion
Claims 1, 4, 6, 7, & 14-19 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BAILEY C BUCHANAN whose telephone number is (703)756-1315. The examiner can normally be reached Monday-Friday 8:00am-5:00pm ET.
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/BAILEY BUCHANAN/Examiner, Art Unit 1682
/JEHANNE S SITTON/Primary Examiner, Art Unit 1682
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