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 .
RCE
The request filed on 08/10/2026 for a request for continued examination (RCE) under 37 CFR 1.114 (d) is acceptable and a RCE has been established. An action on the RCE follows.
Response
Applicants’ response and claims amendment filed on August 18, 2026 are acknowledged. Claims 1-4 and 19-21 were canceled. Claims 5-13 were amended. Claims 5-18 are pending. Claims 5-12 are withdrawn from consideration. Claims 13-18 are considered.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 13-15 and 17-18 are still rejected under 35 U.S.C. 102 (a) (1) by June et al. (Analytica Chemical Acta, Volume 853, 1 January 2015, Pages 541-547).
In the response, Applicants traverse the rejection and submit that claim 13 has been amended, the prior art should not read on the rejected claims as claim 13 has been amended to wherein two primers of the plurality of primers, except a forward outer primer (F3) and a reverse outer primer (B3) are conjugated at their respective 5'-end with different kinds of tags, such that the two kinds of tags are contained in corresponding amplicons as the identifier which are specifically bound with said antibody in the concurrent immunochromatographic assay; the two different kinds of tags are two different hapten tags selected from any two of various hapten tags comprising biotin, 6-carboxyfluorescein (FAM), fluorescein isothiocyanate (FITC), digoxigenin (DIG), tetramethyl rhodamine (TAMRA), dinitrophenyl and sulforhodamine (Texas Red), wherein the two primers consisting of (i) a forward primer (FIP) or a reverse inner primer (BIP), and (ii). A loop backward (LB) primer. The cited prior art by June do not teach such feature as he disclosed using six primers and not different heptane tags
Applicants’ argument has been respectfully considered. However, it is not found persuasive with the following reason:
A broad scope of newly amended claim 13 is reasonable interpretation (BRI) as a molecular diagnostic assay on a target pathogen gene in an analyte, comprising multiples primers without any limitation, wherein two of the primers among them are labeled with two different heptane tags except a forward outer primer (F3) and a reverse outer primer (B3) that are not limited to be labeled with two different hapten tags, which can be the same. The two primers can be (i) forward primer (FIP) or a reverse inner primer (BIP), and (ii). A loop backward (LB) primer. The hapten labeling tags are selected from biotin, 6-carboxyfluorescein (FAM), fluorescein isothiocyanate (FITC), digoxigenin (DIG), tetramethyl rhodamine (TAMRA), dinitrophenyl and sulforhodamine (Texas Red). In contrast to Applicants’ assertion, the disclosure by June meets the limitaiton as claim 12 amended. For instance, Fig. 2 teaches three sets of primers including the primers of H1N1; (a) +(d) or H3N2 (b) + (D) or H5 gene (c) +(d), wherein LB primer of H is labeled with Texas Red, and a forward primer (LF) of M protein is labeled with Digoxigenin. Texas Red and Digoxin are two different Hapten tags, which are respectively labeled one in loop backward (LB) primer and other in forward primer (LF). Since BRI of claim 13 is reasonable interpretation as a molecular diagnostic assay on a target pathogen gene in an analyte, comprising multiples primers without any limitation. However, other primers are not limited to the different or same.
June e et al. also teach that they used multiple RT-LAMP reaction and colorimetric detection of the RT-LAMP amplicon on ICS. said assay of amplification of target nucleic acid in the reaction mixture directly comprises loop-mediated isothermal amplification (LAMP) reaction. An immunochromatographic strip (ICS) has been widely utilized and commercialized for pathogen diagnostic tools in this document.
The packaged ICS in a polystyrene case and the structure of an ICS are illustrated in Fig. 1. The ICS consists of four parts: a buffer loading pad, a conjugate pad, a detection region with test and control lines, and an absorbent pad. Streptavidin and mouse IgG coated gold nanoparticles (AuNPs) were concentrated in the conjugate pad to capture the biotin labeled RT-LAMP products. In the detection region, two test lines and one control line were patterned. The test line 1 and line 2 were coated with Digoxigenin monoclonal antibodies (Medisensor Inc., Korea), and Texas Red monoclonal antibodies (Medisensor Inc., Korea) respectively, and the control line was immobilized with goat anti-mouse IgG. Because it is the PCR and RT-PCT , the assay also disclosed inherently comprises a thermocycler, water bath or heat block. Moreover, it also teaches a lateral flow strip as a , which is considered as a lateral flow device. Therefore, the cited reference still meets the limitation of claims, rejection is maintained.
Fig. 2.
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Claim Rejections - 35 USC § 103
Primer design for multiplex RT-LAMP. (a) H1 gene of influenza A H1N1. (b) H3 gene of H3N2. (c) H5 gene of H5N1. LF and LB loop primers for targeting HA genes were labeled with Texas Red haptens. (d) Primer design for targeting conserved M gene of influenza A viruses (H1N1, H3N2, and H5N1). An LF loop primer for M gene was labeled with a Digoxigenin hapten.
The rejection of Claims 13-18 under 35 U.S.C. 103 (a) (1) by (202021100985U1. (985U1) had been removed necessitated by Applicants’ amendment.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 16 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Some of the dye cited in the claim 13 is either halochromic dye nor metallochromic dye. For instance, TAMRA (carboxytetramethylrhodamine) or Texas Red is fundamentally a fluorescent xanthene dye rather than a classical metachromatic or halochromic dye. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Conclusion
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BAO Q. LI
Examiner
Art Unit 1671
/BAO Q LI/Primary Examiner, Art Unit 1671
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