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 .
Request for Continued Examination
Receipt is acknowledged of a request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e) and a submission, filed on April 9, 2026. Claims 1-21 are pending and under examination in this Office action.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on April 9, 2026 has been considered by the examiner.
New Rejection
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
Claims 1-21 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 1-20 are drawn to A set of oligonucleotides for recombinase-polymerase amplification and detection of SARS-CoV-2 in a sample, comprising: a first amplification oligonucleotide comprising a nucleic acid sequence with at least 70% similarity to SEQ ID NO: 17, a second amplification oligonucleotide comprising a nucleic acid sequence with at least 70% similarity to SEQ ID NO: 19, and a probe oligonucleotide comprising a nucleic acid sequence with at least 70% similarity to SEQ ID NO: 18; or a first amplification oligonucleotide comprising a nucleic acid sequence with at least 70% similarity to SEQ ID NO: 20 or 21, a second amplification oligonucleotide comprising a nucleic acid sequence with at least 70% similarity to SEQ ID NO: 25 or 26, and a probe oligonucleotide comprising a nucleic acid sequence with at least 70% similarity to any of SEQ ID NOs: 22-24; or a combination thereof, wherein each probe oligonucleotide comprises a detectable label.
Claims 12-21 are drawn to A group of oligonucleotides for amplifying and detecting SARS-CoV-2 in a sample, comprising :a first set of oligonucleotides comprising: a first amplification oligonucleotide comprising a nucleic acid sequence with at least 70% similarity to SEQ ID NO: 2, a second amplification oligonucleotide comprising a nucleic acid sequence with at least 70% similarity to SEQ ID NO: 4, and a probe oligonucleotide comprising a nucleic acid sequence with at least 70% similarity to SEQ ID NO: 6,wherein the probe oligonucleotide comprises a detectable label.
Claims are rejected because there is lack of written description support for the genus of amplification primers encompassed by the 70% similarity to SEQ ID NO: 2, 3, 4, 5, 6, 11, 15, 17, 18, 19, 20, 21, 22, 23, 24, 25 and 26. For example the primer of SEQ ID NO: 11 consists of 22 nucleotides, as follows: AAAGAAGAAGCCTGATGAAACT. 70% similarity allows for 7 times 4 (ACTG) changes of nucleotides within SEQ ID NO: 11.
There is lack of structure and function correlation between the function of amplification and the partial structure of the primers.
Campbell et al. (2021, New England Biolabs, p. 1-3) teach the importance of primer design in detection of SARS-CoV-2.
Applicant’s specification fails to provide written description support for the entire genus of primer sequences encompassed by the present claims. Thus, the present claims are rejected for lack of written description support.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AGNIESZKA BOESEN whose telephone number is (571)272-8035. The examiner can normally be reached on 8:30 - 5:00 PM.
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/AGNIESZKA BOESEN/Primary Examiner, Art Unit 1648
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