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
Status of Claims
Claims 1-20 are pending. Claims 1-2, 6-7 and 18-19 are the subject of this NON-FINAL Office Action. This is the first office action on the merits.
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-19), and the species of claims 6-7 and claim 2 in the reply filed on 04/09/2026 is acknowledged. Claims 3-5, 8-17 and 20 are withdrawn.
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 –
(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.
Claims 1-2, 6-7 and 18-19 are rejected under 35 U.S.C. § 102(a)(1) as being anticipated by WANGH (US20170335383).
As to claim 1, WANGH teaches a method for amplifying a target nucleic acid in a sample to produce a target amplicon, the method comprising using a nucleic acid primer set comprising a high-Tm primer and a low-Tm primer, wherein:
the target nucleic acid comprises a first template strand and, optionally, a second template strand, wherein the second template strand is complementary to the first template strand (paras. 0005, 0052, 0059, for example);
the high-Tm primer is capable of annealing to the first template strand and priming an extension product from the high-Tm primer (“primers are used that have a relatively low melting temperature on the target nucleic acid sequence and a higher melting temperature on a perfectly complementary DNA sequence”; para. 0059);
the low-Tm primer is capable of annealing to the first extension product and priming an extension product from the low-Tm primer (id.);
wherein the high-Tm primer has a Tm that is a least 5° C. higher than that of the low-Tm primer (“the melting temperature for the reverse primer on the target nucleic acid sequence is at least 5° C. lower than the melting temperature for the forward primer on the target nucleic acid sequence”; claim 31, para. 0006, for example).
As to claim 2, WANGH teaches the high-Tm primer has a Tm that is at least 10° C. higher than that of the low-Tm primer (paras. 0006, 0108, claim 9).
As to claim 6, WANGH teaches the method comprises:
contacting the sample with a reaction mixture comprising the nucleic acid primer set (paras. 0053-55);
raising the reaction temperature to a denaturation temperature to denature nucleic acids in the sample (id.);
pulsing the reaction by lowering the reaction temperature to a high annealing and extension temperature suitable for producing an extension product from the high-Tm primer and then raising the reaction temperature to the denaturation temperature ((“In some embodiments, the LATE-PCR amplification cycles comprise an annealing temperature that is above the melting temperatures for the forward primer and the reverse primer on the target nucleic acid sequence and below the melting temperature for the forward primer and the reverse primer on perfectly complementary nucleic acid sequences”; para. 0009, for example; see also claim 1);
lowering the reaction temperature to a low annealing and extension temperature suitable for producing an extension product from the low-Tm primer, wherein the high-Tm primer also anneals and produces a further extension product (id.);
wherein said pulse enables the production of an additional amplicon beyond the number of amplicons produced in a single amplification cycle carried out on a double-stranded template without said pulse (any results would have to flow from the same steps performed in the prior art).
As to claim 7, WANGH teaches said pulse is performed at least once per amplification cycle (paras. 0009, 0053-55).
As to claim 18, WANGH teaches the method further comprises detection of the target amplicon using a detection probe (claim 13, for example).
As to claim 19, WANGH teaches the nucleic acid amplification is carried out in multiplex using at least two nucleic acid primer sets for amplifying at least two target nucleic acids, each comprising a high-Tm primer and a low-Tm primer, wherein, for each nucleic acid primer set, the high-Tm primer has a Tm that is a least 5° C. higher than that of the low-Tm primer (para. 0126, for example).
Prior Art
The following prior art is also pertinent: US 5578467 (claim 1); US 5582989 (claim 12); US 20220002792; US20120156728 (claim 11).
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Aaron Priest whose telephone number is (571)270-1095. The examiner can normally be reached 8am-6pm.
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/AARON A PRIEST/Primary Examiner, Art Unit 1681
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