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 .
Status of the Application
The Amendment and Response filed June 23, 2026, and the Request for Continued Examination filed July 8, 2026, are each acknowledged.
Claims 1-5, 7, 9-12, 14 and 16-20 are pending and are being examined on the merits.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on June 23, 2026 has been entered.
Response to Arguments
Applicant’s arguments filed June 23, 2026 have been fully considered.
The following objections are WITHDRAWN in view of Applicant’s arguments and amendments to the claims:
Objections to claim 14
The following rejections are MAINTAINED:
Prior art rejections
Response to arguments regarding prior art rejections
Applicant argues that the prior art rejections should be withdrawn because the instantly claimed primers demonstrate unexpectedly superior sensitivity and speed as compared to the Kawai method (Remarks, pp. 6-7). In the Response filed December 29, 2025, Applicant specifically noted that the claimed primer set is capable of detecting a single copy of the target nucleic acid, and that it can do so in 18.54 minutes. In contrast, Kawai can detect only 10 elementary bodies in 25 minutes
The Examiner agrees in part and disagrees in part. The Examiner agrees that there appears to be a significant increase in sensitivity and decrease in time to positive between the instantly claimed method using the instantly claimed primers and the Kawai primers and methods. However, given the differences between the Kawai method and the method described in the instant specification, it is not clear if these differences are attributable to the different primer sequences, or some other factor. As noted in the Final Office Action mailed April 22, 2026, these differences include a different sample source (purified genomic DNA vs. elementary bodies isolated from a patient), different master mix (Warmstart Lamp master mix vs. Loopamp DNA amplification kit), (very) different primer concentrations (micromolar concentrations vs. picomolar concentrations) and a different temperature (65.5°C vs. 62°C), in addition to different primers. It is known in the art that differences in any of sample source, template concentration, choice of enzyme and master mix, primer concentrations and temperature, etc. can affect LAMP assay sensitivity and time to positive. For example, see Optigene (LAMP User Guide – Mastermixes & Assay Optimization, 2016; pp. 11-22). Thus, given the numerous differences between the Kawai primers and method steps and the instantly claimed primers and method steps, it is not possible to determine whether Applicant’s assertion that it is the instantly claimed primer set that achieves the superior performance or if it is some other variable or combination of variables. For at least these reasons, Applicant has not demonstrated a showing of unexpected results.
As to the rejections made with additional secondary references, Applicant argues that the secondary references do not cure the deficiencies as to the unexpected results (Remarks, pp. 7-8).
The Examiner disagrees with reasoning corresponding to that noted above.
These arguments are not persuasive. The prior art rejections are maintained.
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.
Claims 1-3, 7, 10 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Kawai1 (Development and evaluation of a loop-mediated isothermal amplification method for the rapid detection of Chlamydophila pneumoniae, Eur J Clin Microbiol Infect Dis, 28:801-805, 2009) in view of GenBank Accession No. AF131230.12 (Chlamydophila pneumoniae mutant major outer membrane protein (MOMP) gene, partial cds, 1999).
Claims 1, 2, 7 and 14 are directed to a set of primers for amplifying the nucleotide
sequence of the Chlamydophila pneumonia MOMP gene, and for corresponding kits comprising said primers and additional LAMP reagents, while claims 3 and 10 are directed to methods of detecting Chlamydophila pneumonia MOMP gene using the sets of primers using LAMP. The claims further recite seven different sequences for the primers, SEQ ID NOs: 1-7, with SEQ ID NOs. 3 and 4 linked at the 3’ end of SEQ ID NO: 3, and SEQ ID NOs. 5 and 6 linked at the 3’ end of SEQ ID NO: 5.
Kawai teaches LAMP amplification primers, kits and methods for detecting Chlamydophila pneumonia ompA (i.e., the MOMP gene) (p. 803, left col., paras. 3-4 through right col., para. 1; Fig. 1).
The Kawai primers do not correspond to instant SEQ ID NOs: 1-7, nor is this collection of primers known in the art. However, GenBank Accession No. AF131230.1 teaches the sequence of Chlamydophila pneumonia ompA, and each of instant SEQ ID NOs: 1-7 correspond with 100% homology to GenBank Accession No. AF131230.13. Further, Kawai teaches how to design primers for LAMP (p. 803, left col., para. 3). Thus, the ordinary artisan would have been able to arrive at this combination of primers through routine optimization.
Prior to the effective filing date of the instant invention, it would have been prima facie obvious to modify the Kawai method to optimize the primer sequences through routine optimization to customize the assay as needed. The ordinary artisan would have had an expectation of success as Kawai teaches how to design LAMP primer sets.
Claims 4-5 and 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Kawai (Development and evaluation of a loop-mediated isothermal amplification method for the rapid detection of Chlamydophila pneumoniae, Eur J Clin Microbiol Infect Dis, 28:801-805, 2009) in view of GenBank Accession No. AF131230.1 (Chlamydophila pneumoniae mutant major outer membrane protein (MOMP) gene, partial cds, 1999) as applied to claims 1-3 and 10 above, and further in view of Kamachi4 (Development and Evaluation of a Loop-Mediated Isothermal Amplification Method for Rapid Diagnosis of Bordetella pertussis Infection, Journal of Clinical Microbiology, 44(5): 1899-1902, 2006).
Regarding dependent claims 4-5 and 11-12, which recite that the amplification is carried
out at 65.5°C for 40 min, followed by 80°C for 5 min, Kamachi suggests these limitations. Specifically, Kamachi teaches incubating at 65°C for 40 min, followed by 80°C for 2 min to terminate the reaction (p. 1900, left col., para. 2).
Prior to the effective filing date of the instant invention, it would have been prima facie obvious to further modify the modified Kawai method, discussed above, to optimize the amplification temperature parameters through routine optimization to customize the assay as needed. The ordinary artisan would have had an expectation of success as the design and modification of nucleic acid amplification assays is well-known in the art.
Claims 9 and 16-20 are rejected under 35 U.S.C. 103 as being unpatentable over Kawai (Development and evaluation of a loop-mediated isothermal amplification method for the rapid detection of Chlamydophila pneumoniae, Eur J Clin Microbiol Infect Dis, 28:801-805, 2009) in view of GenBank Accession No. AF131230.1 (Chlamydophila pneumoniae mutant major outer membrane protein (MOMP) gene, partial cds, 1999) as applied to claims 1-3, 6-7, 10 and 13-14 above, and further in view of Tanner5 (US Patent No. 10,968,493 B1; filed July 2020).
Regarding claims 17-20, which recite that the kit comprises D-(+)-Trehalose dihydrate
and a fluorescent marker interacting with double-stranded DNA, Tanner teaches or suggests these limitations. Specifically, Tanner teaches trehalose (col. 39, ll. 3-4) and teaches a fluorescent marker that interacts with double-stranded DNA (col. 1, ll. 66-67 through col. 2, ll. 1-17; col. 35, ll. 49-54). The ordinary artisan would have been able to arrive at these particular reagents and values through routine optimization.
Regarding claims 9 and 16, Kawai does not teach these particular primer concentrations. Tanner teaches primer concentrations of 0.2 µM, 0.4 µM and 1.6 µM (col. 36, Table 2). However, the ordinary artisan would have been able to arrive at these primer concentrations through routine optimization.
Prior to the effective filing date of the instant invention, it would have been prima facie obvious to further modify the modified Kawai method, discussed above, to optimize the primer concentrations, and the selection of types and amounts of reagents through routine optimization to customize the assay as needed. The ordinary artisan would have had an expectation of success as the design and modification of nucleic acid amplification assays is well-known in the art.
Subject Matter Eligibility
The claims are patent eligible, at least, because the primer formed by linking SEQ ID NO: 3 and SEQ ID NO: 4, and the primer formed by linking SEQ ID NO: 5 and SEQ ID NO: 6, are not naturally occurring molecules.
Conclusion
Claims 1-5, 7, 9-12, 14 and 16-20 are being examined and are rejected. Claim 14 is objected to. No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CAROLYN GREENE whose telephone number is (571)272-3240. The examiner can normally be reached M-Th 7:30-5:30 EST.
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/CAROLYN L GREENE/Primary Examiner, Art Unit 1681
1 Kawai was cited in the Information Disclosure Statement submitted July 3, 2023.
2 GenBank Accession No. AF131230.1 was cited in the PTO-892 Notice of References Cited mailed October 2, 2025.
3 SEQ ID NO: 1 corresponds to nucleotides 191 to 212 of GenBank Accession No. AF131230.1 with 100% homology; SEQ ID NO: 2 corresponds to the reverse complement of nucleotides 348 to 372 of GenBank Accession No. AF131230.1 with 100% homology; SEQ ID NO: 3 corresponds to the reverse complement of nucleotides 253 to 274 of GenBank Accession No. AF131230.1 with 100% homology; SEQ ID NO: 4 corresponds to nucleotides 213 to 235 of GenBank Accession No. AF131230.1 with 100% homology; SEQ ID NO: 5 corresponds to nucleotides 281 to 300 of GenBank Accession No. AF131230.1 with 100% homology; SEQ ID NO: 6 corresponds to the reverse complement of nucleotides 321 to 340 of GenBank Accession No. AF131230.1 with 100% homology; SEQ ID NO: 7 corresponds to nucleotides 301 to 320 of GenBank Accession No. AF131230.1 with 100% homology.
4 Kamachi was cited in the PTO-892 Notice of References Cited mailed October 2, 2025.
5 Tanner was cited in the PTO-892 Notice of References Cited mailed October 2, 2025.
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