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. The Applicant’s response to the office action filed on June 18, 2026 is acknowledged.
Status of the Application
2. Claims 1-6 and 8-10 are pending under examination. Claim 7 is canceled. New claims 11-14 are added. The Applicant’s arguments have been fully considered and found persuasive for the following reasons. While incorporating the limitations from canceled claim 7 which recites (and/or), the amendment introduces new limitations (suramin and tRNA). The action is made Final necessitated by the amendment.
Response to Arguments:
3. The objection to the specification has been withdrawn in view of the amendment.
4. The rejection of claims under 35 USC 112(b) has been withdrawn in view of the amendment.
5. The rejection of claims under 35 USC 102(a)(1) as being anticipated by Teng et al. has been withdrawn in view of the amendment.
6. The rejection of claims under 35 USC 103 as being obvious over Li et al. in view of Nautiyal et al. and the rejection of claims under 35 USC 103 as being obvious over Li et al. in view of Kober et al. has been withdrawn in view of the amendment.
New Rejections necessitated by the Amendment
Claim Rejections - 35 USC § 103
7. 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 1-6 and 8-14 are rejected under 35 U.S.C. 103 as being unpatentable over Zhang et al. (WO 2019/126716) in view of Basu et al. (Biochem and Biophys Res Commun., Vol. 128 (3), 1985) and Trotta et al. (US 2010/0136710).
Zhang et al. teach a method of claim 1, for detecting an RNA target nucleic acid in a sample: comprising reacting the target RNA in the sample with a mixed reaction system consisting of a sgRNA-Cas system and isothermal amplification system and detecting a detectable signal generated by the reaction after the reaction is completed; wherein the sgRNA-Cas system comprises a Cas12b (c2cl) protein and sgRNA targeting the target nucleic acid and the isothermal amplification system comprises a primer and a single-stranded DNA reporter molecule (labeled probe) that generates a detectable signal after being cleaved (para 0118-0120, 0281-0286, 0503, 0255-0263).
With reference to claim 2-4, 11, Zhang et al. teach that the concentration of sgRNA is 2-80ng/ul; primer concentration is 300-1200 nM and the DNA reporter concentration is 200-2000 nM (para 0284-0286).
With reference to claim 5, 12, Zhang et al. teach that the reaction is performed at a first temperature and inactivated at a second temperature and the second temperature is greater than the first temperature, or greater than 470 C (para 0283, 0558).
With reference to claim 6, 13, Zhang et al. teach that the reaction system further comprises a divalent cation at a concentration of 8-25 mM, wherein the divalent cation is magnesium ion (para 0284-0286).
With reference to claim 10, Zhang et al. teach that the sample is selected from blood, plasma, serum, cerebrospinal fluid and a urine sample (para 0058).
However, Zhang et al. did not specifically teach Suramin and tRNA.
Basu et al teach a method for suramin-mediated inhibition of cellular and viral DNA polymerases, wherein the method comprises suramin incubation with reverse transcriptase and DNA polymerases, wherein the concentration of suramin is 3-30 ng/ul (page 1396-1400, paragraphs under subheading ‘Material and methods’ and paragraphs under subheading ‘Results’). Basu et al. teach that suramin inhibits DNA polymerase binding to binding of dNTP or template primer and exhibit anti-reverse transcriptase that blocks the reverse transcription of microbial target nucleic acids (page 1400-1402, paragraphs under subheading ‘discussion’ section).
Trotta et al. teach a method for processing RNA, wherein the method comprises yeast tRNA which is splicing endonuclease that removes introns from pre-tRNA, wherein the tRNA is 10 to 20ng/ul (para 0129-0131, 0116, 00715-0718, 0760, 0785).
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 Zhang et al. with suramin as taught by Basu et al. and tRNA as taught by Trotta et al. to develop a sensitive and improved method for detecting RNA target. The ordinary person skilled in the art would have motivated to combine the method of Zhang et al. with suramin and tRNA and have a reasonable expectation of success that the combination would improve the sensitivity of detecting RNA target because Basu et al. explicitly taught suramin activity with polymerases (page 1400-1402, paragraphs under subheading ‘discussion’ section) and Trotta et al teach tRNA to remove introns (para 0129-0131) and such a modification of the method with suramin and tRNA is considered obvious over the cited prior art.
Conclusion
No claims are allowable.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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Suryaprabha Chunduru
Primary Examiner
Art Unit 1681
/SURYAPRABHA CHUNDURU/Primary Examiner, Art Unit 1681
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