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 without traverse of group I in the reply filed on 7/2/25 is acknowledged.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chan et al. (J Clin Microbiol 2015. 53:2722–2726) in view of GenBank NC_045512, Wuhan seafood market pneumonia virus isolate Wuhan-Hu-1, complete genome (15 pages) and Sola et al. (Annu. Rev. Virol. 2015. 2:265–88).
Chan teaches that oligomers for detection of human pathogenic coronaviruses were developed based on sequencing data analysis. The reference teaches that the leader sequence is an abundantly expressed target (p. 2723, 1st column; Figure 1). Chan teaches oligomers for detection of the leader sequence to five different human coronaviruses, including probes that hybridize to amplified sequences (Table 1). The reference teaches that the approach may be applied to identify and design real-time RT-PCR assays for other emerging viruses, including novel coronaviruses that are likely to emerge in the future, once their genomic data become available (p. 2725).
Chan does not teach oligomers for amplifying instant SEQ ID NO: 10.
However, the GenBank record taught the genome of Severe acute respiratory syndrome coronavirus 2, which comprised a leader sequence having instant SEQ ID NO: 10, see nucleotides 1-72 of the GenBank record, which are identical to instant SEQ ID NO: 10. The reference taught that the genome was from “A novel coronavirus associated with a respiratory disease.”
Furthermore, Sola taught that that the length of the coronavirus leader sequence is typically 65-98 nucleotides and is present at the very 5’ end of the genome (p. 266)
Therefore, it would have been prima facie obvious to have selected oligomers for the amplification of the leader sequence present in the novel coronavirus taught by the GenBank record. Sola teaches that for coronavirus the leader sequence is present at the very 5’ end of the genome, and that it is typically 65-98 nucleotides in length, a finite number of possible oligomers for amplification and detection of the leader sequence were present, including molecules that comprise instant SEQ ID NO: 1, 2, and 3, which are fragments within the very 5’ sequence of the genome taught in the GenBank record. Following the teaching of Chan that the leader sequence is an abundantly expressed target, and that amplification and detection of the leader sequence should be applied to novel corona viruses, it would have been obvious to provide oligomers that were fragments of the Wuhan coronavirus in order to provide tools for detection of the virus in humans.
The intended use of the claims has been amended to recite that the composition is “for detecting a severe acute respiratory syndrome coronavirus 2” leader sequence. The compositions selected to hybridize to the leader sequence taught in the GenBank record, following the teachings of Chan and Sola would necessarily be able to be used in this way. Likewise, the final clause that defines “the detecting” is also a statement of intended use.
Response to Remarks
The 101 rejection was withdrawn because SEQ ID NO: 1 and SEQ ID NO: 2 are defined in the sequence listing as being “DNA.” As the naturally occurring SARS-CoV-2 virus is RNA, the instantly claimed composition comprises molecules that comprise “thymine” and are markedly different from the naturally occurring RNA virus.
The 102 rejections were overcome by amendment to require an oligomer consisting of the sequence of SEQ ID NO: 1 or SEQ ID NO: 2.
Applicant traverses the 103.
Applicant argues that using the primer pair comprising the forward and reverse primer of the present invention, no non-specific amplification was observed in remaining templates, and that the assay had excellent sensitivity and specificity.
However, the instant claims are drawn to composition claims, and require only one of SEQ ID NO: 1 or SEQ ID NO: 2, while the arguments are directed to how the pair might be used. Furthermore, Chan teaches that targeting the leader sequence of corona virus resulted in a highly sensitive test since the leader sequence is an abundantly expressed target. There is no evidence that the outcome achieved in the instant specification was unexpected since Chan successfully and specifically detected five different coronaviruses by selecting primers to amplify the leader sequence.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Kim et al. (2020, Cell 181, 914–921) teach genome organization of SARS-CoV-2 (Figure 1). The location of the leader sequence is noted. The reference teaches the common leader sequence on transcripts is 72 nucleotides (p. 917). Yin (Genomics 112 (2020) 3588–3596) teaches SNP discovery in the SARS-CoV-2 genome, throughout.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Juliet Switzer whose telephone number is (571)272-0753. The examiner can normally be reached Monday to Thursday, 8:00 AM-3:30 PM.
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Juliet Switzer
Primary Examiner
Art Unit 1682
/JULIET C SWITZER/ Primary Examiner, Art Unit 1682