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/Disposition of Claims
Applicant’s Amendment filed on 19 May 2026 has been received and entered. Claims 18, 21, 24-25, 27-35, 37-38, and 40-41 were pending, with Claim 18 withdrawn from consideration per Applicant’s response to the Restriction and Election of Species Requirement filed on 01 February 2024. Claims 21, 24-25, 27-35, 37-38, and 40-41 were examined on their merits. Claims 21, 29, 33, 37, and 41 have been amended. Claims 1-17, 19-20, 22-23, 26, 36, and 39 have been cancelled. No new claims have been added. Claim 18 remains pending but withdrawn from consideration.
Accordingly, Claims 21, 24-25, 27-35, 37-38, and 40-41 will be examined on their merits.
Examiner’s Note
All paragraph numbers (¶) throughout this office action, unless otherwise noted, are from the US PGPub of this application US 2022/0042117 A1, Published 10 February 2022. Applicant’s amended Specifications as presented on 15 July 2024, 12 June 2024, and 22 October 2021 are acknowledged and entered.
Applicant is encouraged to utilize the new web-based Automated Interview Request (AIR) tool for submitting interview requests; more information can be found at https://www.uspto.gov/patent/laws-and-regulations/interview-practice.
Response to Arguments
Applicant's arguments filed 19 May 2026 regarding the previous Office action dated 19 February 2026 have been fully considered. If they have been found to be persuasive, the objection/rejection has been withdrawn below. Likewise, if a rejection/objection has not been recited, said rejection/objection has been withdrawn. If the arguments have not been found to be persuasive, or if there are arguments presented over art that has been utilized in withdrawn rejections but utilized in new rejections, the arguments will be addressed fully with the objection/rejection below.
Information Disclosure Statement
The information disclosure statements (IDSes) submitted on 09 February 2022, 15 July 2022, and 27 February 2026 have been considered by the examiner.
Drawings
(Objection Withdrawn) – The objection to the Drawings for containing figures which are blurry and difficult to read is withdrawn in light of the Replacement Drawings which were submitted for Figures 1-4.
Specification
(New Objection) – The disclosure is objected to because of the following informalities: In Paragraphs 0010, 0047, and 0095, sequences are described by reference to Genbank Accession Nos., which are subject to change, rather than to sequences set forth in the specification. This is an improper incorporation by reference, since the information required to describe and enable the required sequences is found in the NCBI database, extraneous to the application. Furthermore, since the NCBI sequences are not irrevocably fixed but are corrected and updated as additional sequence information becomes available, the NCBI accession numbers may refer to sequences which change after the application filing date. Thus, the disclosure is objected to for this improper incorporation by reference.
Furthermore, essential material such as that which provides written description or enablement, as here since the antigen is needed for functional antibody identification, should not come from NPLs. See 37 CFR 1.57d.
Appropriate correction is required.
Claim Objections
(Objection Withdrawn) – The objection to Claims 21, 29, 37, and 41 for containing minor informalities is withdrawn in light of the amendments to the claims.
Claim Rejections - 35 USC § 112(b); Second Paragraph
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.
(Rejection Withdrawn) – The rejection of Claims 28 and 33 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, is withdrawn in light of the amendments to the claims.
Claim Interpretation
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art.
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.
(Rejection Maintained) – The rejection of Claims 21, 24-25, 27-35, 37-38, and 40-41 under 35 U.S.C. 103 as being unpatentable over Lassaunière et al. (Lassaunière R, Kresfelder T, Venter M. A novel multiplex real-time RT-PCR assay with FRET hybridization probes for the detection and quantitation of respiratory viruses. J Virol Methods. 2010 May;165(2):254-60.), Young (US 2004/0229261 A1, Published 18 November 2004), Kornegay et al. (U.S. Patent No. 7,482,142 B1, Issued 27 January 2009) (cited in a previous Office Action), Mehta (US 2017/0356058 A1, Published 14 December 2017) (cited in a previous Office Action), Li et al. (US 2021/0292856 A1, earliest Priority Date 18 February 2020), An et al. (US 2003/0050470 A1, Published 13 March 2003) (cited in a previous Office Action), Gardner et al. (US 2013/0267429 A1, Published 10 October 2013) (cited in a previous Office Action), Kirschner et al. (US 2023/0265484 A1, earliest Priority Date 24 March 2020), Juang and Juang et al. (US 2005/0233314 A1, Published 20 October 2005), Hang et al. (CN 111440896 A, earliest Priority Date 25 February 2020), Metsky et al. (US 2018/0340215 A1, Published 29 November 2018), King et al. (King DP, Reid SM, Hutchings GH, Grierson SS, Wilkinson PJ, Dixon LK, Bastos AD, Drew TW. Development of a TaqMan PCR assay with internal amplification control for the detection of African swine fever virus. J Virol Methods. 2003 Jan;107(1):53-61.), Buck et al. (Buck GA, Fox JW, Gunthorpe M, Hager KM, Naeve CW, Pon RT, Adams PS, Rush J. Design strategies and performance of custom DNA sequencing primers. Biotechniques. 1999 Sep;27(3):528-36.), and Rychlik and Rhoads (Rychlik W, Rhoads RE. A computer program for choosing optimal oligonucleotides for filter hybridization, sequencing and in vitro amplification of DNA. Nucleic Acids Res. 1989 Nov 11;17(21):8543-51.) is maintained.
Response to Arguments
Applicant's arguments filed with respect to the rejection of Claims 21, 24-25, 27-35, 37-38, and 40-41 under 35 U.S.C. 103 have been fully considered but they are not persuasive.
As an initial matter, throughout prosecution, Applicant has repeatedly stated that they incorporate by reference the remarks set forth in their various responses to the Office Actions mailed out by the Office. In response to that, Examiner states that every argument has been rebutted, as applicable.
In their most recent response filed on 19 February 2026, Applicant argues “that the Examiner previously withdrew the 35 U.S.C. 103 rejection of substantively identical claims after finding Applicant’s arguments persuasive” and that the “present rejection does not introduce materially different teachings from different references” (see Page 2 of Remarks, Last Paragraph). Applicant also argues “that the Examiner previously withdrew Li et al., yet Li et al. is resurrected to fill admitted deficiencies in Lassaunière” (see Page 3, First Paragraph). Applicant then argues that the “35 U.S.C. 103 rejection fails based on Li et al.’s disqualification alone; however, Applicant furthermore submits that the 13 cited references fail to disclose, teach or suggest at least the following core aspects of independent claim 21, namely, the specific primer/probe combination (SEQ ID NOS: 3, 4, 18); a FRET-based detection system using SEQ ID NOS: 3, 4, and 18; or simultaneous multiplex detection of SARS-CoV-2, influenza A, and influenza B in a single reaction without interference” (see Page 4, Paragraph 2). Additionally, Applicant argues that “Lassaunière itself demonstrates the absence of predictable results” (see Page 5, Paragraph 3), “is more likely to lead one of ordinary skill in the art to conclude that the claimed multiplex system would not have had predictably resulted from the 13 reference combination”, and “teaches a design approach that avoids the claimed combination and is more likely to dissuade or discourage one of ordinary skill in the art from its pursuit” (see Page 5, Last Paragraph). Furthermore, Applicant argues that the teachings of Buck and Rychlik only provide generalized teachings regarding primer construction and thus “do not establish that the specific claimed multiplex system would predictably function as claimed” (see Page 6, Paragraph 2), “that several of the cited references constitute non-analogous art and therefore cannot properly support he present obviousness rejection” (see Page 6, Paragraph 3), and that “the 13 reference combination is improper because the Office Action relies on information gleaned solely from Applicant’s specification” (see Page 6, Last Paragraph).
Examiner does not find these arguments persuasive.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
In response to applicant's argument that Buck, King, Rychlik, Young, and An is nonanalogous art, it has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992). In this case, while these references do not teach detecting and distinguishing between SARS-CoV-2, Influenza A, and Influenza B in a single multiplex assay, the principles taught by each would be applicable to such an assay. As stated in the previous Office Action, Young teaches a method of detecting and distinguishing between different flaviviruses and different variants of the same virus using multiplex amplification reactions comprising primers and FRET probes with different detectable labels. An et al. teach that various primers and probes can be designed around known or disclosed nucleotide sequences as well as an algorithm for defining and designing any and all primers, given a specific nucleotide sequence. King et al. teach a TaqMan PCR assay for the detection of a virus. Rychlik and Rhoads teach that it is routine and predictable to make primers for DNA amplification wherein primers are designed to a known oligonucleotide sequence and teach criteria to design/choose suitable primers for DNA amplification. Buck et al. expressly provide evidence of the equivalence of primers and provide direct evidence that all primers would be expected to function, and, in particular, all primers selected according to the ordinary criteria. Their teachings clearly show that every primer would have had a reasonable expectation of success and each is obvious including those in the instant claims and the prior art above for use in amplifying/binding the known target. As such, the primers of the instant claims were known in the prior art and would have been viewed as functional in the assay types above because the primer pairs disclosed by the prior art are close enough to each other that they can be viewed as functional pairs in the prior art assays. As also noted in the previous Office Action, An et al. taught all possible subsequences of a known sequence could be considered as a primer for that sequence, and thus renders all of the instant primers and probes obvious, especially in light of the specific sequences taught by Li et al., Gardner et al., Kirschner et al., Juang and Juang, Metsky et al., and Hang et al. The combined teachings of Young and An et al., along with Kornegay et al. and Mehta, would allow for the use of multiple primer pairs and probes which can distinguish between the three target nucleic acids while allowing for the simultaneous and specific detection of any of the three target nucleic acids, even if they are all present in the same sample. The teachings of Buck et al. and Rychlik and Rhoads render all primers obvious and demonstrate that all properly designed primers would be expected to succeed.
With respect to the arguments presented against Lassaunière et al., Examiner rebuts them by stating, as done in the previous Office Action, that Lassaunière et al. teach a multiplex assay, which would provide the basis for detecting and quantifying different respiratory viruses, including Influenza A, Influenza B, and human coronaviruses, specifically the common cold coronaviruses. This assay would allow for the assessment of viral load at a given time point and detect possible co-infections in patients. Again, the principles taught by Lassaunière et al. would be transferrable to an assay similar to the instantly claimed assay.
With respect to the arguments regarding the ineligibility of Li et al., Examiner sincerely apologizes for not clearly stating why the previous rejection under 35 U.S.C. 103 utilizing the teachings of Li et al. was withdrawn. While Examiner agreed with Applicant’s arguments that Li et al. lacked support for the teachings cited, Examiner failed to explicitly state what exactly lacked support. Examiner also failed to explain this in the Office Action mailed out on 19 February 2026. Again, Examiner sincerely apologizes for the oversight. The specific teachings which lacked support in Li et al. were those of the donor fluorescent moieties, such as those recited in instant Claims 28 and 33. The Provisional Applications of Li et al. with filing dates before the instant Effective Filing Date of 06 August 2020 do not mention the donor fluorescent moieties. These teachings were relied upon in the previous rejection under 35 U.S.C. 103 and this is why it was withdrawn. The new rejection under 35 U.S.C. 103 raised in the Office Action mailed out on 19 February 2026 does not rely on the teachings of Li et al. with respect to the donor fluorescent moieties, which is why the reference was utilized once again. The earliest Provisional Application of Li et al. mentions a multiplex assay as well as SARS-CoV-2, Influenza A, and Influenza B. The same goes for the Provisional Application of Li et al. filed on 30 July 2020. In light of this, Applicant’s arguments against the renewed utilization of Li et al. are not persuasive. Li et al. is available as prior art for all that it teaches in the earlier priority dates which precede the instant Effective Filing Date. As such, the resurrection of Li et al. is proper, it is not cited for teachings which do not have an earlier Effective Filing Date than the instant EFD, and, therefore, its use does not constitute a reason to invalidate and thus withdraw the outstanding rejection under 35 U.S.C. 103. For at least these reasons, the rejection of Claims 21, 24-25, 27-35, 37-38, and 40-41 under 35 U.S.C. 103 is maintained.
Conclusion
No claims are allowed.
The prior art made of record, but not relied upon, and considered pertinent to applicant's disclosure is listed below:
Storch et al. (US 2017/0218465 A1, Published 03 August 2017)
Storch et al. teach a composition comprising a panel of probes for detecting one or more viruses in a sample. This reference has not been utilized, as rejection would have been redundant to those set forth above.
THIS ACTION IS MADE FINAL. 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 CAREY A STUART whose telephone number is (703)756-4668. The examiner can normally be reached Monday - Friday, 7:30 AM - 4:30 PM EST.
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/CAREY ALEXANDER STUART/Examiner, Art Unit 1671 /Michael Allen/Supervisory Patent Examiner, Art Unit 1671
Prosecution Insights