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 .
DETAILED ACTION
Status of the Claims
Claims 1-9, 11-13 and 15 are pending and the subject of this NON-FINAL Office Action. This is the first action on the merits.
Allowable Subject Matter
The only allowable subject matter in the specification that the Examiner could identify was the LNA primer sets in Example 6.
Priority
Claims 9, 13 and 15 receive a priority date of 11/10/2021 because the priority document (PCT/EP2021/081230) filed on this date is the first priority document to disclose PAR.
Claim Rejections - 35 USC § 112- Indefiniteness
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 1-9, 11-13 and 15 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.
In claim 1, the last clause is confusing because it is unclear what it is modifying. Specifically, the last clause begins “at such a temperature,” but follows “nucleotides serving as substrates for said DNA polymerase.” It would be confusing, indeed, if this is modifying the nucleotides because nucleotides are not commonly understood as temperature-dependent, much less affecting FIP and BIP hybridization and polymerase activity.
In claim 4, there is a missing conjunction rendering the scope of claim 4 unclear. Specifically, a conjunction must be used between “(iii) wherein said DNA polymerase is a DNA-dependent DNA polymerase or an RNA-dependent DNA polymerase” and “(iv) wherein said DNA polymerase has reverse transcriptase activity.”
Claims 5-9, 13 and 15 contain exemplary confusing language of “preferably,” “e.g.” and “most preferably.” See MPEP § 2173.05(d).
In claim 5, the following phrase is plainly nonsensical: “The method of any claim 1.”
In claim 7, the following clause is also nonsensical: “guanidine thiocyanate or hydrochloride, preferably in a concentration between 20 mM and 80 mM, single-stranded binding protein (SSB), BSA preferably in a concentration between 0.02 mg/ml to 2 mg/ml.” In fact, claim 7 is a meandering run-on sentence that is ripe for a clear list.
In claim 8, “detector” is not defined in the specification, and has so many possible common meanings that no sensical metes and bounds can be provided without a clear definition in the claims. Thus, in claim 8, Applicants are strongly encouraged to require the only “detector” disclosed: metallochromic indicator.”
In claims 13 and 15, the claim scope is confusing due to “and/or optionally” conjunction. Specifically, the claims recite a list (a)-(f) with “(e) a metallochromic indicator, preferably 5-Br-PAPS, PAR or Zincon; and/or optionally (f) metal ions, preferably Zn2+ ions.” This renders the claim confusing because such a conjunction indicates all of (a)-(f) are optional. This would further render claims 13 and 15 confusing because the “synthesizing” steps found after this list (a)-(f) seems to require all of (a)-(f). Finally, the claims fails to recite a proper Markush transitional phrase. All of this renders claims 13 and 15 very confusing.
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 –
(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 1-6 are rejected under 35 U.S.C. § 102(a)(1) as being anticipated by LIU (US 2017/0362669).
As to claim 1, LIU teaches LAMP with F3 and B3 primers that have LNA at their last third of 5’-side (AceIN-B3a_L and AceIN-B3bL used in LAMP sets 31, 43 and 44; Tables 1-3). The LAMP reaction include nucleotides (Examples; para. 0007) and DNA polymerase (e.g. para. 0007).
As to claims 2-3, this only further describes the common LAMP primers F3, B3, BIP and FIP, which are taught in LIU (Table 1).
As to claim 4, LIU teaches RNA or DNA (HIV nucleic acids; Examples).
As to claims 5-6, LIU teaches 15-30 bases with 1-5 LNA (Table 1).
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.
Claim(s) 7-9, 11-13 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over LIU, in view of TANNER (US20210285065).
The prior art as a whole demonstrates that it would have been obvious to a skilled artisan at the time of filing to use familiar LAMP detection techniques to detect the LAMP amplification of LIU with familiar results with a reasonable expectation of success.
LIU does not explicitly teach more than one LNA on 5’-third of primer, to use metallochromic indicator such as PAR, or “regulator for melting temperature.”
As to another PNA, this was a known option, based on LIU, to further affect primer affinity (para. 0043). A skilled artisan would have been motivated to optimize the primer with another PNA, similar to AceIN-B3bL, in the 5’-third of the primer based on the specific application.
As to metallochromic indicator such as PAR, or “regulator for melting temperature,” these techniques were very familiar for LAMP detection. For example, TANNER teaches
Kits and methods are provided for performing multiplex Loop-Mediated Isothermal Amplification (LAMP) reactions. These kits and methods are directed to specific and sensitive methods of target nucleic acid detection and more specifically pathogen diagnostics such as detection of Coronavirus. The kits and methods utilize a plurality of sets of oligonucleotide primers for targeting the viral nucleic acid target
(Abstract). Metallochromic indicator dyes such as 4-(2-pyridylazo) resorcinol (PAR) are well-known option in LAMP to detect reactions without the need for expensive detection equipment (paras. 0002, 0007). Furthermore, using SSB, TCEP and guanidine hydrochloride in the LAMP reaction were very familiar options (paras. 0043, 0098-0103). A skilled artisan would have been motivated to include these familiar LAMP detection solutions in the LAMP reaction of LIU to achieve similar increase in efficiency with a reasonable expectation of success.
Thus, the claims are obvious.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Aaron Priest whose telephone number is (571)270-1095. The examiner can normally be reached 8am-6pm.
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/AARON A PRIEST/Primary Examiner, Art Unit 1681