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 .
Response to Amendment
The Amendment filed 01/20/2026 in which claims 3, 5, 7, 9, 13, 15, 17, 19 were amended , has been entered. Claims 21-22 were previously withdrawn.
Claims 3-10, 13-20, and 36 are under examination on the merits.
Drawings
(Previous objection, withdrawn) Applicant’s amendments to the Drawings submitted on 01/20/2026 have overcome the objection previously set forth in the Non-Final Office Action mailed 10/20/2025.
Specification
(Previous objection, withdrawn) Applicant’s amendments to the Specification submitted on 01/20/2026 have overcome the objection previously set forth in the Non-Final Office Action mailed on 10/20/2025.
Nucleotide and/or Amino Acid Sequence Disclosures
(Previous objection, withdrawn) Applicant’s amendments to the Specification concerning nucleotide and/or amino acid sequence disclosures submitted on 01/20/2026 have overcome the objection previously set forth in the Non-Final Office Action mailed on 10/20/2025.
Claim Objections
(Previous objections, withdrawn as to claims 3, 5, 7, 9, 13, 17 and 19). Applicant’s amendments to claims 3, 5, 7, 9, 13, 17 and 19 have overcome previous objections to claims 3, 5, 7, 9, 13, 17 and 19.
Claim Rejections - 35 USC § 112(b)
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.
(Previous rejection, withdrawn as to claims 3-10, 13-20 and 36) Claims 3-10, 13-20 and 36 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being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.
See claims 3-10, 13-20 and 36 as submitted on 01/20/2026.
Applicant’s amendment to the instant claims filed on 01/20/2026 has overcome previous rejection to claims 3-10, 13-20 and 36.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
(Previous rejection, withdrawn as to claims 3-10, 13-20 and 36) Claims 3-10, 13-20 and 36 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a product of nature without significantly more. This judicial exception is not integrated into a practical application and the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception for the reasons set forth below. See MPEP § 2106 for analysis framework.
See claims 3-10, 13-20 and 36 as submitted on 01/20/2026.
Applicant’s amendment to the instant claims filed on 01/20/2026 has overcome previous rejection to claims 3-10, 13-20 and 36. Specifically, it is noted that independent claims 3 and 13 now recite “1-7 nucleotide analogs.”
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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.
(Previous rejection, maintained and modified as necessitated by amendment as to claims 3-10, 13-20 and 36) Claims 3-10, 13-20 and 36 are rejected under 35 U.S.C. 103 as being unpatentable over Chan et al., in view of Poetter et al., and the following GenBank Accession NOs: KC703321 (influenza A), AB027489 (influenza B), MF104666 (RSV), MG652941 (human adenovirus), NC045512 (SARS-CoV-2), and M21374 (M. pneumoniae). Prior art of record.
See claims 3-10, 13-20 and 36 as submitted on 01/20/2026.
Regarding claims 3-10, 36, it is noted that the amendment to independent claim 3 submitted on 01/20/2026 recites the “a first coronavirus OC43-specific amplification oligomer and a second human coronavirus OC43-specific amplification oligomer” and “1-7 nucleotide analogs”. However the cited prior art already teaches these limitations. Specifically Chan et al. teach compositions and methods for detecting the presence or absence of multiple human coronaviruses via highly sensitive and accurate nucleic acid RT-PCR amplification including OC43, HKU1, NL63 and 229E coronaviruses (Abstract, ¶¶ [0018]-[0022], Figs. 1, 2). Chan et al. further teach multiple primer-probe sets directed to OC43, HKU1, NL63 and 229E coronaviruses wherein the sequences comprise one or more nucleic acid analogs that provide increased hybridization affinity (¶¶ [0024]-[0028], Tables 4, 5; Figs 1, 2).
Poetter et al. teach a method for designing primers and probes specifically for detection of respiratory pathogens based on known sequences of said pathogens such that sequence conservation is maximized and degeneracy at the 3’ ends is minimized in highly conserved genomic regions (Example 1, page 57; Fig. 6). Poetter et al. further teach the use of probes comprising a fluorescent markers, wherein the signals of the fluorescent markers do not interfere with each other (¶¶ [0081], [0094]).
While Chan et al. and Poetter et al. teach multiple primer-probe sets directed to the pathogens indicated above and including one or more nucleotide analogs, neither Poetter et al. nor Chan et al. explicitly teach the genomic sequences serving as templates for design of primer-probe sets directed to an OC43, HKU1, NL63 and 229E coronaviruses.
However, template sequences of OC43, HKU1, NL63 and 229E coronaviruses were publicly available before the effective filing date of instant application as follows:
GenBank Accession No: NC005147 for HCoV-OC43, available since 2003
GenBank Accession No: NC006577 for HCoV-HKU1, available since 2004
GenBank Accession No: NC005831 for HCoV-NL63, available since 2004
GenBank Accession No: NC002645 for HCoV-229E, available since 2000
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date to have combined the RT-PCR compositions of Chan et al with the method of primer-probe design of Poetter et al., and the template sequences from GenBank indicated above to formulate an improved composition for PCR amplification comprising primer-probe sets directed to OC43, HKU1, NL63 and 229E coronaviruses, given that Poetter et al. teach a method for designing primer-probe sets and all of the genomic sequences for the pathogens indicated above were publicly available from GenBank at the accession numbers indicated above. One of ordinary skill in the art would have been motivated to combine the teachings of Chan et al., Poetter et al., and the template sequences from GenBank for the benefit of formulating a composition for nucleic acid amplification with maximized sequence conservation and minimized degeneracy at the 3’ ends of highly conserved genomic regions for reliable laboratory confirmation. See MPEP 2144.07. The selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945).
One of ordinary skill in the art would have had reasonable expectation of success in combining the teachings of Chan et al. Poetter et al., and the template sequences from GenBank given that the methods of primer-probe design for PCR amplification and formulation of compositions for PCR amplification are well known, successfully demonstrated, and commonly used as evidenced by the applied prior art.
Regarding claims 13-20, it is noted that the amendment to independent claim 13 submitted on 01/20/2026 recites the “a first coronavirus OC43-specific amplification oligomer and a second human coronavirus OC43-specific amplification oligomer” and “1-7 nucleotide analogs”. However, as indicated above the cited prior art already teaches these limitations. As previously explained, the primer-probe compositions were rendered prima facie obvious by the teachings of Chan et al. Poetter et al., and the template sequences from GenBank. Chan et al. further teach a kit comprising all of the elements necessary for RT-PCR amplification of OC43, HKU1, NL63 and 229E coronaviruses (¶ [0020]).
Accordingly, claims 3-10, 13-20 and 36 were prima facie obvious to one of ordinary skill in the art before the effective filing date, especially in the absence of evidence to the contrary.
Response to Arguments
Applicant's arguments filed 01/20/2026 have been fully considered but they are not persuasive.
Applicant contends on page 15 of the Remarks submitted on 01/20/2026:
Chan specifically teaches the target sequence to be amplified is "a relatively short untranslated region located 5' upstream to a transcription regulatory sequence." (abstract and paragraph [0018]). Chan teaches these leader sequences are about 60 to 90 nucleotides in length and can be found at the 5'-UTR upstream from the transcription regulatory sequence in the genomes and at the subgenomic RNAs of all CoVs (paragraph [0021], see also FIG. 1). Chan further teaches "The inventors have found that the leader sequence are [sic] a valuable diagnostic target not only for MERS-CoV, and similar leader sequences can serve as diagnostic targets for other currently circulating HCoVs which similarly possess leader sequences." (paragraph [0023]). Finally, Chan teaches the amplification and detection of these leader sequences is preferred relative to amplification and detection of, e.g., the other sequences, e.g., ORFib. (see paragraph [0029]). Thus, Chan teaches away from amplifying or detecting a target sequence in the ORFla gene sequences of OC43 or HKU1, the spike protein gene sequence of NL63, and/or the ORFib gene sequence of 229E, which are the target regions of the primers as instantly claimed. (see paragraph [0304]).
In response:
The instant rejection is in view of instant claim language. Although the claims are interpreted in light of the Specification, limitations from the Specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). It is noted that the instant claims merely recite “a composition for determining the presence or absence of human coronavirus OC43 (OC43) in a sample” and do not require any limitations regarding the presence or absence of a “leader sequence”. The teachings of Chan et al. described above were neither cited in instant rejections nor are they relevant to the instant rejections because Chan et al. as explained above in detail, teach the limitations of a composition for detecting the presence or absence of multiple human coronaviruses via highly sensitive and accurate nucleic acid RT-PCR amplification including multiple primer-probe sets directed to OC43, HKU1, NL63 and 229E coronaviruses wherein the sequences include one or more nucleotide analogs (¶¶ [0024]-[0028], Tables 4, 5; Figs 1, 2), as required by instant claims. Further, it is noted that primer-probe design and optimization is a widely practiced routine activity in the art and thus, it is well within the purview of one of ordinary skill in the art to design and optimize primer-probe sets for RT-PCR of the known viruses recited by instant claims.
Conclusion
No claims are allowed.
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARLENE V BUCKMASTER whose telephone number is (703)756-5371. The examiner can normally be reached M-R 8:00 AM - 5:00 PM.
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/MARLENE V BUCKMASTER/Examiner, Art Unit 1672
/NICOLE KINSEY WHITE/Primary Examiner, Art Unit 1672
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