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 .
Applicant’s election of Group 2 in the reply filed on October 10, 2025 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)).
3. Claims 5-7 are currently pending and have been examined herein.
Claim Rejections - 35 USC § 112
4. The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 5-7 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 5-7 are rejected as being indefinite because the method of claim 5 requires performing a PCR using the primer composition of claim 1 however, claim 1 has been canceled.
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.
6. As discussed above in the 112(b) rejection, claim 5 requires performing a PCR using the primer composition of claim 1 however, claim 1 has been canceled. For the purposes of applying prior art and advancing prosecution, the primer composition has been interpreted as comprising a first primer that includes a nucleotide sequence complementary to a to-be-detected DNA fragment including a single nucleotide variant to be detected, and 2 to 6 nucleotide sequences that are not complementary to the to-be-detected DNA fragment at a 3' end of the primer, based on the claim set that was filed on June 20, 2022.
7. Claims 5-7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yaku (Electrophoresis 2008 Vol 29 pages 4130-4140).
As noted in MPEP 2111.02, “If the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction.” In the present situation, the process steps are able to stand alone and the preamble limitation is not accorded patentable weight. Accordingly, the claim language of “A method for detecting a trace amount of a rare single nucleotide variant” merely sets forth the purpose of the process, but does not limit the scope of the claims.
Yaku teaches a method of detecting a single base pair difference in the ABO gene using allele specific primers. Yaku teaches that they designed allele specific forward primers for the detection of a single base pair difference in the AB allele and the O allele shown below at position 22. Yaku discloses the allele specific forward primers that were used for PCR amplification (see Tables 2 and 3). Shown below is one of the primers aligned to the A/B allele and O allele. The variant allele is underlined. The bolded nucleotides are mismatched.
A/B allele: 1 TAGGAAGGAT GTCCTCGTGG TGACCCCTTG GCTGGCTCCC 40
ABO261’ ACG TAGGAAGGAT GTCCTCGTGA CG
O allele: 1 TAGGAAGGAT GTCCTCGTGG TACCCCTTGG CTGGCTCCCA 40
ABO261’ ACG TAGGAAGGAT GTCCTCGTGA CG
Yaku teaches that the PCR was performed with Taq polymerase that has no 3’→5’ exonucl3ease activity (page 4139, col 1). Yaku teaches that only the AB allele DNA was amplified efficiently by the primer of ABO261-ACG. Yaku teaches that the amplification product with O allele DNA using this primer was undetectable by the Agilent 2100 Bioanalyzer, which has a detection sensitivity of about 1.1 nM (see page 4138, col 1-2 and Figures 8 and 9). Thus Yaku teaches a method of performing a PCR reaction using a first primer that includes a nucleotide sequence complementary to a to-be-detected DNA fragment including a single nucleotide variant to be detected, and 2 nucleotide sequences that are not complementary to the to-be-detected DNA fragment at a 3' end of the primer, with a to be detected DNA fragment including a single nucleotide variant as a template (the A/B allele). Yaku teaches a method wherein the PCR is performed using a DNA polymerase without 3'->5' exonuclease activity. Yaku teaches a method wherein when there is a single-nucleotide variant in the to-be-detected DNA fragment (A/B allele), an amplification product by the polymerase chain reaction (PCR) is generated, and when there is no single-nucleotide variant in the to-be-detected DNA fragment (the O allele), the amplification product by PCR is not generated.
8. Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMANDA HANEY whose telephone number is (571)272-8668. The examiner can normally be reached Monday-Friday, 8:15am-4:45pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Wu-Cheng Shen can be reached at 571-272-3157. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/AMANDA HANEY/Primary Examiner, Art Unit 1682