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. Applicant’s election of Group I in the reply filed on July 13, 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)).
Status of the Application
2. Claims 1-3, 5-9 and 11-13 are considered for examination. Claims 14-18 and 20-24 are withdrawn from further consideration as being drawn to nonelected group. Claims 4, 10 and 19 are canceled.
Priority
3. This application filed on March 21, 2024 is a 371 of PCT/US22/77175 filed on September 28, 2022 which claims priority benefit of US 63/392,562 filed on July 27, 2022 and US 63/250,438 filed on September 20, 2021.
Specification
4. The disclosure is objected to because of the following informalities:
(i) The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code (see at least para 0034, 00114). Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
(ii) this application contains disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.821. Nucleotide and/or amino acid sequences appearing in the drawings (Fig. 1B, 15D) are not identified by sequence identifiers in accordance with 37 CFR 1.821(d). Sequence identifiers for nucleotide and/or amino acid sequences must appear either in the drawings or in the Brief Description of the Drawings. Appropriate correction is required.
Claim Rejections - 35 USC § 102
5. 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.
A. Claims 1-3 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yang et al. (PLOS one, Vol. 9(12), e0115293, p. 1-13, (2014)).
Yang et al. teach a primer nucleic acid molecule of claim 1, 3, comprising a stem-loop structure and a degenerate nucleic acid sequence of 2-10 nucleotides at the 3' end, wherein the degenerate nucleic acid sequence hybridizes to the 3'-end of a ribonucleic acid (RNA) molecule, wherein the degenerate nucleic acid sequence comprises 2, 3, 4, or 6 nucleotides (page 4, Fig. 1 and universal stem-loop primer under the subheading ‘primers in detail and miR-155 standard’).
With reference to claim 2, Yang et al. teach that the RNA molecule is a mature microRNA (miRNA), a messenger RNA (mRNA), or a long noncoding RNA (IncRNA) molecule (page 4, Fig. 1 and universal stem-loop primer under the subheading ‘primers in detail and miR-155standard’).
B. Claims 1-3 and 5-9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chen et al. (US 2005/0266418).
Chen et al. teach a primer nucleic acid molecule (linker probe comprising primer sequence) of claim 1, 3, comprising a stem-loop structure and a degenerate nucleic acid sequence of 2-10 nucleotides at the 3' end, wherein the degenerate nucleic acid sequence hybridizes to the 3'-end of a ribonucleic acid (RNA) molecule, wherein the degenerate nucleic acid sequence comprises 2, 3, 4, or 6 nucleotides (universal bases or LNA) (para 0014, 0026-0030, 0008-0011, Fig. 4, 6).
With reference to claim 2, Chen et al. teach that the RNA molecule is a mature microRNA (miRNA), a messenger RNA (mRNA), or a long noncoding RNA (IncRNA) molecule (para 0014, 0026-0027, 0011).
With reference to claim 5, Chen et al. teach that the stem comprises 14 base pairs and the loop comprises 16 nucleotides (para 0030-0031).
With reference to claim 6, 8, Chen et al. teach a composition comprising a mixture of two or more primer nucleic acid molecules, wherein each primer nucleic acid molecule comprises a stem-loop structure and a degenerate nucleic acid sequence of 2-10 nucleotides at the 3' end, wherein the degenerate nucleic acid sequence (universal bases) hybridizes to the 3'-end of a ribonucleic acid (RNA) molecule , wherein the degenerate nucleic acid sequence comprises 2, 3, 4, or 6 nucleotides (para 0014, 0026-0030, 0008-0011, Fig. 4, 6).
With reference to claim 7, Chen et al. teach that the RNA molecule is a mature microRNA (miRNA), a messenger RNA (mRNA), or a long noncoding RNA (IncRNA) molecule (para 0014, 0026-0027, 0011).
With reference to claim 9, Lao et al. teach that the composition comprises (i) one or more primer nucleic acid sequences molecules having a degenerate nucleic acid sequence of 2 nucleotides, (ii) one or more primer nucleic acid molecules having a degenerate nucleic acid sequence of 4 nucleotides, or (iii) one or more primer nucleic acid molecules having a degenerate nucleic acid sequence of 6 nucleotides (para 0014, 0026-0030, 0008-0011). For all the above the claims are anticipated.
C. Claims 1-3, 5-9 and 11-13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lao et al. (US 2010/0112581).
Lao et al. teach a primer nucleic acid molecule of claim 1, 3, comprising a stem-loop structure and a degenerate nucleic acid sequence of 2-10 nucleotides at the 3' end, wherein the degenerate nucleic acid sequence hybridizes to the 3'-end of a ribonucleic acid (RNA) molecule, wherein the degenerate nucleic acid sequence comprises 2, 3, 4, or 6 nucleotides (nucleobases)(para 0062, Fig. 2, 0043-0046, 0056, 0026, 0038, 0047, 0004-0010).
With reference to claim 2, Lao et al. teach that the RNA molecule is a mature microRNA (miRNA), a messenger RNA (mRNA), or a long noncoding RNA (IncRNA) molecule (para 0046, 0056, 0026).
With reference to claim 5, Lao et al. teach that the stem comprises 14 base pairs and the loop comprises 16 nucleotides (para 0026).
With reference to claim 6, 8, Lao et al. teach a composition comprising a mixture of two or more primer nucleic acid molecules, wherein each primer nucleic acid molecule comprises a stem-loop structure and a degenerate nucleic acid sequence of 2-10 nucleotides at the 3' end, wherein the degenerate nucleic acid sequence hybridizes to the 3'-end of a ribonucleic acid (RNA) molecule (para 0047-0062, Fig. 2, 0043-0046, 0038).
With reference to claim 7, Lao et al. teach that the RNA molecule is a mature microRNA (miRNA), a messenger RNA (mRNA), or a long noncoding RNA (IncRNA) molecule (para 0046, 0056, 0026).
With reference to claim 9, 12, Lao et al. teach that the composition comprises (i) one or more primer nucleic acid sequences molecules having a degenerate nucleic acid sequence of 2 nucleotides, (ii) one or more primer nucleic acid molecules having a degenerate nucleic acid sequence of 3 nucleotides, (iii) one or more primer nucleic acid molecules having a degenerate nucleic acid sequence of 4 nucleotides and (iv) one or more primer nucleic acid molecules having a degenerate nucleic acid sequence of 6 nucleotides (para 0060-0061, 0004-0005).
With reference to claims 11, 13, Lao et al. teach that the RNA molecule is a mature miRNA molecule, wherein the composition comprises (i), (ii), and (iii), and wherein the ratio of (i), (ii), and (iii) in the composition is about 8:1:1 or about 1:1: 7:1 (para 0058-0061, 0018, 0024, 0037). For all the above the claims are anticipated.
Conclusion
No claims are allowable.
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Suryaprabha Chunduru
Primary Examiner
Art Unit 1681
/SURYAPRABHA CHUNDURU/Primary Examiner, Art Unit 1681
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