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
Applicant’s election of the invention of Group 2 (claims 55-57 and 60, directed to methods comprising the use of a catalytic nucleic acid) in the reply filed on 02/09/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 1, 3, 5-6, 8-9, 11-13, 18, 20, 26, 28, 30 and 32-33 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 02/09/2026.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 55 and 57 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Li et al (US PG Pub 20110294125 A1).
Li et al teaches methods of analysis (e.g.: para 0095) comprising the detection of a nucleic acid target including a sample in which a target nucleic acid (e.g.: the ‘Substrate’ in Fig. 1 A) is contacted with a recognition moiety that produces cleavage fragments from the target nucleic acid (e.g.: Fig. 1 A; para 0108) (relevant to step a) of claim 55) and subsequent treatment of the cleavage fragments with polynucleotide kinase (PNK) to remove the 2’3’-cyclic phosphate that is on the resulting cleavage fragment (e.g.: para 0109) (relevant to step b) of claim 55). Li et al teaches that the cleavage fragment is used as a primer for rolling circle amplification which creates very long single-stranded DNA (ssDNA) molecules with tandem repeats (e.g.: para 0106; Fig. 1 B; para 0004) (relevant to step c) of claim 55) which are detected (relevant to step d) of claim 55) by methods including detection of a colorimetric signal (relevant to claim 57) (e.g.: para 0107; Fig. 1 C).
Claim Rejections - 35 USC § 103
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.
Claim(s) 55-57 is/are rejected under 35 U.S.C. 103 as being unpatentable over Li et al (US PG Pub 20110294125 A1) in view of Carter et al (2013).
Li et al teaches methods comprising the colorimetric detection of a nucleic acid that is cleaved with a recognition moiety (DNAzyme) that produces cleavage fragments from the detected nucleic acid, relevant to claims 55 and 57 as detailed earlier in this Office Action.
Li et al does not teach the contacting of a sample comprising the nucleic acid that is to be cleaved with a lysis buffer.
However, the use of buffers comprising lysing agents to isolated nucleic acids that are subsequently detected by DNAzyme-based methods was known in the art and is taught by Carter et al.
Carter et al teaches methods comprising the cleavage of a target nucleic acid molecule using a DNAzyme to produce cleavage fragments (e.g.: Figure 2). Carter et al teaches that target nucleic acid was released from viral particle by lysis in a solution comprising SDS (e.g.: p.10).
It would have been prima facie obvious to someone with ordinary skill in the relevant art before the effective filing date of the rejected claims to obtained a cleaving fragment of a target nucleic acid that is isolated using a lysis buffer, as taught by Carter et al, for detection using the methods of Li et al. The skilled artisan would have been motivated to detect the samples of Carter et al based on the expressed teachings of Carter et al that detection of viral targets in samples is essential for treatment of disease symptoms in a timely fashion. The skilled artisan would have been motivated to use the detection methods of Li et al based on the expressed teachings of Li et al that the methods provide for the sensitive detection of targets using simple steps.
Claim(s) 55, 57 and 60 is/are rejected under 35 U.S.C. 103 as being unpatentable over Li et al (US PG Pub 20110294125 A1) in view of Mao et al (2009) and Ellington et al (US PG Pub 20160076083 A1).
Li et al teaches methods comprising the colorimetric detection of a nucleic acid that is cleaved with a recognition moiety (DNAzyme) that produces cleavage fragments from the detected nucleic acid, relevant to claims 55 and 57 as detailed earlier in this Office Action. Further relevant to the instantly rejected claims, Li et al teaches the detection of rolling circle amplification product by hybridization to a complementary nucleic acid (e.g.: para 0013).
Li et a does not specifically provide for detection that includes detection of oligonucleotides hybridized to reporter moieties captured on a lateral flow strip, where the oligonucleotides are partially hybridized to another oligonucleotide that can hybridize to the rolling circle amplification product, as set forth in instantly rejected claim 60. However, such methods of detection were known in the prior art.
With regard to steps d) and e) of rejected claims 60, Mao et al teaches that a nucleic acid oligonucleotide may be detected using a lateral flow strip where the process includes hybridizing a first domain of the oligonucleotide to a detection moiety at a first end of a strip(e.g.: Figure 1 – AU NP-DNA probe 2 conjugate), flowing the hybridized reporter towards a second end of the strip (e.g.: Figure 2 B), and hybridizing a second domain of the oligonucleotide to an immobilized capture probe in a visualization area of the strip for detection (e.g.: Figure 2 C).
With regard to steps a) and b) of rejected claim 60, Ellington et al teaches oligonucleotides for detection (termed “one-step toehold-based strand displacement”) that include partially hybridized nucleic acids which are separated when one strand is preferentially hybridized to a target nucleic acid (e.g.: Fig 16, left side), including via hybridization to a large concatemer nucleic acids (e.g.: Fig. 17, para 0117) such as those produced by rolling circle amplification (e.g.: paras 0106-0107). Further relevant to the rejected claims, Ellington et al teaches that lateral flow methods are suitable for the detection of oligonucleotides.
It would have been prima facie obvious to someone with ordinary skill in the relevant art before the effective filing date of the rejected claims to have performed the lateral flow methods of Mao et al to detect an oligonucleotide reporter taught by Ellington et al and generated by the one-step toehold-based strand displacement of Ellington et al. The skilled artisan would have been motivated to use lateral flow detection methods based on the expressed teachings of Mao et al that such methods are fast and allow for low-cost and sensitive detection of nucleic acid samples. The skilled artisan would have been motivated to use the oligonucleotides and methods of Ellington et al based on the expressed teachings of Ellington et al that such elements allow for the detecting of targets that is robust, sensitive and selective. Combining the methods of Mao et al and Ellington et al for the detection of the rolling circle amplification product of Li et al would be the simple substitution of known elements with predictable results.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to STEPHEN THOMAS KAPUSHOC whose telephone number is (571)272-3312. The examiner can normally be reached M-F, 8am-5pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Anne Gussow can be reached at 571-272-6047. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
Stephen Kapushoc
Primary Examiner
Art Unit 1683
/STEPHEN T KAPUSHOC/Primary Examiner, Art Unit 1683
Prosecution Insights