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 .
DETAILED ACTION
1. 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 January 12, 2026 has been entered.
Status of the Application
2. Claims 1-9, 11-13 and 15-20 are pending under examination. Claims 10 and 14 were canceled. The Applicant’s arguments and the amendment have been fully considered and found persuasive for the following reasons.
Claim Rejections - 35 USC § 102-Withdrawn
3. The rejection of claims under 35 USC 102(a)(1) as being anticipated by Cardy et al. has been withdrawn in view of the amendment.
4. The rejection of claims under 35 USC 102(a)(1) as being anticipated by Becker et al. has been withdrawn in view of the amendment.
Claim Rejections - 35 USC § 103
5. 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.
Claims 1-9, 11-13 and 15-20 are rejected under 35 U.S.C. 103 as being unpatentable over Mohammadi-Yeganeh et al. (Iranian Journal of Microbiology, Vol. 4(2), page 47-54, (2012) in view of Wilson et al. (US 2013/0029331).
Mohammadi-Yeganeh et al. teach a method of claim 1, for multiplexed amplification of target sequences within nucleic acids comprising: providing a sample comprising or containing nucleic acids that comprise two or more target sequences to be amplified (page 48, paragraph 1 under subheading ‘materials and methods’);
performing nucleic acid sequence-based amplification reaction on the sample to ratiometrically amplify the two or more target sequences in the sample by combining the sample with reaction components comprising a pair of target specific primers for each target sequence, nucleotides and a reverse transcriptase, a DNA polymerase and an RNA polymerase, wherein the nucleotides comprise NTPs and dNTPs (page 49-51, paragraphs under the subheading ‘multiplex NASBA real-time’); and incubating the sample and the reaction components (page 49-51, paragraphs under the subheading ‘multiplex NASBA real-time’).
With reference to claims 2-3, Mohammadi-Yeganeh et al. teach that the incubation step is performed with an initial heating and then incubated isothermally, wherein isothermal amplification (page 49-51, paragraphs under the subheading ‘multiplex NASBA real-time’).
With reference to claims 4-9, Mohammadi-Yeganeh et al. teach that the method further comprises analyzing an output of amplification reaction, wherein the analyzing comprises fluorescence assay, an output of the amplification reaction to identify one or more target sequences, analyzing comprises capillary electrophoresis capable of quantitatively analyzing the output components (page 49-52, paragraphs under the subheading ‘multiplex NASBA real-time’ and paragraphs under the subheading ‘Results’).
With reference to claims 11-12, Mohammadi-Yeganeh et al. teach that the analyzing step includes diagnosing an individual for a disease or disease state, wherein the disease state is HIV (page 49-51, paragraphs under the subheading ‘multiplex NASBA real-time’ and page 48, paragraph 1 on the left-hand column).
With reference to claims 13, 15-17, Mohammadi-Yeganeh et al. teach that the reaction components comprise a buffer, at least one primer comprising RNA polymerase transcription start site, RNA polymerase and reverse transcriptase and RNase (page 49-51, paragraphs under the subheading ‘multiplex NASBA real-time’. Table 1).
With reference to claim 20, Mohammadi-Yeganeh et al. teach that the sample is obtained from a blood, serum, urine or sweat sample (page 48, paragraph 1 under the subheading ‘materials and methods’).
However, Mohammadi-Yeganeh et al. did not specifically teach dNTPs are at a concentration that renders them a limiting reagent of the amplification reaction prior to the pairs of target specific primers becoming a limiting reagent.
Wilson et al. teach a method of claims 1, 18, for rapid detection and sensitive fluorescence-based assay to quantify dNTPs, the method comprises NTPs and dNTPs wherein the concentration of limiting dNTPs is directly proportional to the fluorescence generated and the concentration of dNTPs is no greater than 1/10x concentration of NTPs (abstract, para 0014, 0010, 0042).
It would have been prima facie obvious to one skilled in the art before the effective filing date of the invention to modify the method of Mohammadi-Yeganeh et al. with lower dNTP concentrations as taught by Wilson et al. to develop an improved method for detecting multiple target nucleic acids. The ordinary person skilled in the art would have motivated to combine the method of Mohammadi-Yeganeh et al. with lower dNTP concentrations as taught by Wilson et al. and have a reasonable expectation of success that the combination would improve the method because Wilson et al. explicitly taught 100 or 1000 fold lower dNTP concentrations or limiting dNTPs than that of NTPs is proportional to the fluorescence generated during primer extension which improves the sensitivity of fluorescence-based primer extension assays (para 0042, 0014) and such a modification of the method is considered obvious over the cited prior art.
Conclusion
No claims are allowable.
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/SURYAPRABHA CHUNDURU/Primary Examiner, Art Unit 1681