DETAILED CORRESPONDENCE
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 .
This action is in response to the papers filed December 29, 2025. Currently, claims 1-18 are pending. Claims 6-14 have been withdrawn as drawn to non-elected subject matter.
Election/Restrictions
Applicant's election of Group I and -13910C/T in the paper filed December 29, 2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.03(a)).
The requirement is still deemed proper and is therefore made FINAL.
Priority
This application is a 371 of PCT/EP2021/085058, filed September 13, 2021 and claims priority to EP 20195885.7, filed September 14, 2020.
Drawings
The drawings are acceptable.
Information Disclosure Statement
The listing of references in the PCT international search report is not considered to be an information disclosure statement (IDS) complying with 37 CFR 1.98. 37 CFR 1.98(a)(2) requires a legible copy of: (1) each foreign patent; (2) each publication or that portion which caused it to be listed; (3) for each cited pending U.S. application, the application specification including claims, and any drawing of the application, or that portion of the application which caused it to be listed including any claims directed to that portion, unless the cited pending U.S. application is stored in the Image File Wrapper (IFW) system; and (4) all other information, or that portion which caused it to be listed. In addition, each IDS must include a list of all patents, publications, applications, or other information submitted for consideration by the Office (see 37 CFR 1.98(a)(1) and (b)), and MPEP § 609.04(a), subsection I. states, “the list ... must be submitted on a separate paper.” Therefore, the references cited in the international search report have not been considered. Applicant is advised that the date of submission of any item of information in the international search report will be the date of submission of the IDS for purposes of determining compliance with the requirements for the IDS with 37 CFR 1.97, including all timing statement requirements of 37 CFR 1.97(e). See MPEP § 609.05(a).
It is noted that a listing of references has been provided but a copy of the references have not been provided. Therefore, the references on the IDS have not been considered.
Claim Rejections - 35 USC § 112- 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.
Claims 15-18 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 pre-AIA the applicant regards as the invention.
A) Regarding claims 15-18, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claims 15-18 are indefinite because it claims both product and methods steps for using the products. The claim requires “for labelling the resulting amplified DNA with biotin” and “wherein the resulting labeled amplified DNA can be detected”. As the limitations of the claim are drawn to a method step, and not to a further product limitation of the kit, there is confusion as to when direct infringement occurs. See MPEP 2173.05(p).
Claim 15-18 are also indefinite over the recitation “the detection reagent of a lateral flow assay” because “the detection reagent” lacks proper antecedent basis.
Claim 16 is directed to “the kit is included in a kit”. It is unclear how a kit is within another kit or whether the limitation is an artifact from a prior claim. Clarification is required.
Claim 17 is directed to “the assay results” however “the assay results” lack proper antecedent basis. The claim also requires “the LAMP reaction medium” that lacks proper antecedent basis. Correction is required.
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, 5 are rejected under 35 U.S.C. 103 as being unpatentable over Marton et al. (Ailment Pharmacol Ther Vol. 35, pages 429-440, 2012) in view of Nguyen et al. (WO2018068064, April 12, 2018).
Marton teaches analysis of lactose tolerance tests for predicting the North European lactase polymorphism C/T-13910.
Marton does not teach using a lateral flow immunoassay device.
However, Nguyen teaches a lateral flow rapid test strip (see Figure 1). Nguyen teaches these test strips have a sample pad, a conjugate pad, nitrocellulose membrane, backing card (i.e backing support), absorbent wick and cover tape (page 46, lines 26-30). Nguyen teaches the base substrate is a nitrocellulose member and onto which the capture antigens are immobilized (capture line or test line). Nguyen teaches rapid lateral flow assays are capable of detecting multiple analytes simultaneously on a single strip. Nguyen teaches peptides may be conjugated to a ligand (e.g. biotin) and complexed with labeled ligand receptor (e.g. streptavidin-colloidal gold)(page 28)(limitations of Claim 5). An antibody specific to the labeled antibody or a second labeled antibody can be used to product a control signal. Nguyen teaches the lateral flow devices are rapid diagnostic tests for detecting complexes (page 8).
With respect to Claim 3, Nguyen teaches multiple test lines (namely allows up to 10 antigens may be evaluated in a single assay). Figure 2B illustrates multiple capture test reagents (namely 5).
Therefore, it would have been prima facie obvious prior to the invention to have modified the detection method of the T allele (-13910 C/T) as taught by Marton to use a lateral flow rapid test strip of Nguyen. Nguyen teaches the lateral flow rapid test strip is rapid and allows for diagnostic testing. The ordinary artisan would have been motivated to use a lateral flow rapid test strip because it allows point of care analysis and does not require sophisticated machinery.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Marton et al. (Ailment Pharmacol Ther Vol. 35, pages 429-440, 2012) in view of Nguyen et al. (WO2018068064, April 12, 2018) as applied to Claim 1-3, and 5 above and further in view of Cho et al. (US 2016/0266118, September 15, 2016).
Neither Marton nor Nguyen teach using anti-DIG or anti-FAM or anti-FITC antibody in the capture test reagent array.
However, Cho teaches anti-FITC may be used for detecting on the paper strip device (para 42). Cho teaches the GNP-HRP-anti-FITC is conjugated to the FITC group on the probe on the conjugation pad (para 42)(see Figure 7). The probe also comprises a biotin moiety.
Therefore, it would have been prima facie obvious prior to the invention to have modified the lateral flow device of Marton in view of Nguyen to include anti-DIG or anti-FAM or anti-FITC for detecting the test reagent, as taught by Cho. The art teaches the FITC is a label for detection of the analytes that is equivalent to other labels. The ordinary artisan would be motivated to select any suitable label including anti-FITC.
Conclusion
No claims allowable.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Duong et al. teaches Evaluation of LAMP technique for the diagnosis of genetic predisposition to lactose intolerance Loop-Mediated isothermal amplification detection of lactose intolerance (Revue Francophone des Laboratories, Vol. 2018, No. 504, pages 20-26, July-August 2018). Duong teaches using LAMP to detect rs4988235 (13910C>T). Duong does not teach the sequence for the primers.
Abildgaard et al. (Clinica Chimica Acta, Vol. 482, pages 50-56, 2018) teaches lactase persistence genotyping on whole blood b LAMP and melting curve analysis. Abildgaard teaches LAMP amplification but does not provide the sequence for the primers.
Augustine et al. (Biology, Vol. 9, No. 8, 2020) teaches LAMP is a rapid, sensitive, specific and cost-effective point of care test for COVID. Augustine teaches LAMP analysis on a lateral flow device.
Becherer et al. (Anal. Methods, Vol. 12, pages 717-746, 2020) teaches LAMP analysis on lateral flow dipsticks (see 4.3.4.1. Figure 7).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JEANINE ANNE GOLDBERG whose telephone number is (571)272-0743. The examiner can normally be reached Monday-Friday 6am-3:30pm.
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/JEANINE A GOLDBERG/Primary Examiner, Art Unit 1682
January 29, 2026