DETAILED ACTION
Election/Restrictions
Applicant’s election of selected species in the reply filed April 8, 2026 is acknowledged and entered. Claims 1-6, 8-18, 28, 29 and 32 are under examination. Claim 7 is withdrawn from consideration being directed non-elected subject matter. Applicant’s traversal is persuasive with regard to the six primers (claim 9) and DNA/RNA (claim 13). However, the traversal is not persuasive with regard to the chaotropic agent and excipient. As seen below, the prior art (US Patent 10,968,493 B1) discloses a lyophilized composition for LAMP or RT-LAMP comprising a reaction buffer comprising a DNA polymerase, a reverse transcriptase, guanidine hydrochloride, and trehalose. Since the technical feature fails to make a contribution over the prior art, it is not a special technical feature. Thus, the species lack unity of invention.
Claims Summary
Claim 1 is directed to a composition for performing a loop-mediated isothermal amplification (LAMP) reaction, or a reverse transcription LAMP reaction. The claimed composition is lyophilized (i.e., is in a state of lyophilization). The composition comprises:
A reaction buffer comprising a DNA polymerase and optionally a reverse transcriptase;
A chaotropic agent, specifically guanidine hydrochloride (elected species, claims 2 and 3) present at a concentration prior to lyophilization sufficient to produce a reconstituted concentration ranging from about 20 mM to about 80 mM (claim 4); and,
At least one excipient, specifically trehalose (elected species, claim 5) present at a concentration prior to lyophilization sufficient to produce a reconstituted concentration ranging from about 5% w/v to about 20% w/v (claim 6)
In claim 8, the composition further comprises a visible pH indicator (claim 8) or a LAMP or RT-LAMP primer mix (claim 9) with other components such as dNTPs, etc. (claim 10); the primer mix comprises primers specific for genomic DNA for a pathogenic organism, double-stranded or single-stranded DNA pathogen (claim 16), or cDNA corresponding to RNA from a pathogenic organism (claim 13), an RNA virus (claim 14), SARS-CoV-2 (claim 15)
The LAMP reaction mixture or RT-LAMP reaction mixture is mixed with a biological sample from a subject (claim 11) obtained from the mouth and/or nasal cavity (claim 12). Also claimed is a method for detecting a pathogenic organism in a biological sample from a subject comprising incubating the sample for at least 5 mins at a temperature of at least 90°C (claim 18), combining the sample and the LAMP/RT-LAMP reaction mixture in a reaction vessel, incubating for at least 20 minutes at a substantially constant temperature, and performing a visual inspection of the vessel to determine if the sample is positive for the presence of a pathogenic organism (claim 17). Claim 28 is directed to a method for generating a LAMP or RT-LAMP reaction mixture comprising combining a reaction buffer comprising a DNA polymerase and optionally a reverse transcriptase with a chaotropic agent, guanidine hydrochloride (claim 29), and at least one excipient, trehalose (claim 32), into a container, and subjecting the container to a lyophilization process.
Claim Rejections - 35 USC § 112
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.
Claim 10 is 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.
Claim 10 contains the trademark/trade name Tween. Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade name is used to identify/describe a polysorbate, and, accordingly, the identification/description is indefinite.
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 1-5, 8-18, 28, 29 and 32 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tanner et al. (US Patent 10,968,493 B1, filed July 24, 2020, “Tanner”). The claims are summarized above and correlated with the teachings of the prior art below in bold font.
Tanner discloses rapid diagnostic tests using colorimetric LAMP (see abstract). Tanner’s master mix is in a container, either lyophilized or freeze dried, or in a weakly buffered solution, and comprises a DNA polymerase, a reverse transcriptase, dNTPs, at least one visually detectable dye that changes color or fluorescence (e.g., phenol red), six primers (loop forward, loop backward, forward internal, backward internal, forward and backward), and guanidine hydrochloride, among other components (see col. 1, line 49 through col. 2, line 67, col. 15 through col. 16, line 23, and col. 17, line 59 through col. 18, line 28, and (col. 25, line 67 to col. 26, line 2) (claims 1-3, 8-10, 28 and 29, aspects of LAMP, RT-LAMP, reaction buffer, reverse transcriptase, DNA polymerase, primers, dNTPs, chaotropic agent (guanidine HCl), and lyophilized). The guanidine hydrochloride is present in a concentration of between 20mM-40mM, or up to 60mM (see col. 2, lines 59-68) (claim 4). Example 5 provides for a lyophilized LAMP mix with 150mM trehalose (claims 1, 5 and 32, aspects of excipient, specifically, trehalose). Biological samples, such as nasal and oral samples, are tested for DNA or RNA viruses, e.g., SARS-CoV-2 (see col. 23, line 65 to col. 24, lines 18-37) (claims 11-16).
(claim 28). Tanner discloses heating a saliva sample in a buffer for about 5 minutes at about 95°C in order to store it prior to performing LAMP (see col. 20, lines 6-14) (claim 18). The LAMP process comprises mixing the sample with the master mix, or vice versa, incubating for 30-min, 45-min or 60-min during which amplification takes place, and detecting a chance in color or fluorescence indicating the presence of the target nucleic acid (see cols. 20-21, bridging paragraph) (claim 17).
Claim 6 is directed to an embodiment wherein the concentration of trehalose, when reconstituted, is from about 5% w/v to about 20% w/v. Tanner’s Example 5 provides for a lyophilized LAMP mix with 150mM trehalose, but the concentration of trehalose when reconstituted does not appear to be disclosed in terms of percent w/v. However, Tanner discloses reconstitution of master mix (including the 150mM trehalose) in a 12.5 µl of water and 12.5 µl of primer/template mix. Given the breadth of the claimed range, about 5% w/v to about 20% w/v, Tanner’s concentration of trehalose in 25 µl is expected to fall within the claimed range. Therefore, the claimed embodiments are anticipated by the prior 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.
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.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Tanner et al. (US Patent 10,968,493 B1, filed July 24, 2020, “Tanner”) as applied to claims 1 and 5 above. Claim 6 is directed to an embodiment wherein the concentration of trehalose, when reconstituted, is from about 5% w/v to about 20% w/v. Tanner’s Example 5 provides for a lyophilized LAMP mix with 150mM trehalose, but the concentration of trehalose when reconstituted does not appear to be disclosed in terms of percent w/v. However, Tanner discloses reconstitution of master mix (including the 150mM trehalose) in a 12.5 µl of water and 12.5 µl of primer/template mix. One would have been motivated to optimize the concentration of trehalose in the composition for purposes of preservation of reagents during lyophilization, with a reasonable expectation of success. The concentration of trehalose in the composition is a result-effective variable impacting the integrity of reagents during lyophilization as seen in Example 5 of Tanner. Therefore, the claimed embodiment would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
Conclusion
No claim is allowed.
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Any inquiry concerning this communication or earlier communications from the examiner should be directed to Stacy B. Chen whose telephone number is 571-272-0896. The examiner can normally be reached on M-F (7:00-4:30). If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Thomas Visone, can be reached on 571-270-0684. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
/STACY B CHEN/Primary Examiner, Art Unit 1672
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