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 .
Election/Restrictions
Applicant’s election of Group II, claim 19 in the reply filed on 11/26/2025 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 § 818.01(a)).
Claims 1-18, 20 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 11/26/2025
Priority
The instant application was filed 01/12/2023 and claims priority from provisional application 63298857, filed 01/12/2022.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 3/19/2024 is being considered by the examiner.
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 19 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 19 recites, “target sequence-specific portion.” Target sequence-specific portion suggests there is target sequence non-specific portion and thus is relative. The specification and claims fail to provide any standard or definition to differentiate target sequence-specific portion from target sequence non-specific portion
Claim 19 also recites, “second hemiduplex does not for a hairpin.” The metes and bounds are unclear what condition or design not forming a hairpin is relative to a specific temperature, salt concentration, number of nucleotides incorporated, etc.. Further it is unclear if the attempt to exclude a hairpin is only in step (2) or the whole method.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 19 is/are rejected under 35 U.S.C. 102(a)(1)/102(a)(2) as being anticipated by Wang (US 2019/0203271 A1).
With regards to claim 19, Wang teaches a method of producing dual labeled lateral flow assay detection products by a method comprising a target nucleic acid, specific detection probe and a universal detection probe (0007). Wang teaches a signal is generated by interaction between the specific detection probe a universal detection probe (producing dual labeled lateral flow products). Wang teaches the specific detection probe comprises an arbitrary sequence linked to a 5' target specific probe. The specific probe sequence hybridizes with a second oligonucleotide that is complementary to the specific probe sequence that may include a linker that blocks polymerase extension (0007) (mediator probe). Wang teaches a universal detection probe (FQ probe) comprises two oligonucleotide strands wherein the first strand comprises a quencher probe positions at 3' end and a fluorophore on the 5' end. Wang teaches the modified oligonucleotides must be capable of preferentially hybridizing to target nucleic acid and the 3' terminus can be blocked using a blocking moiety (0044). Wang teaches the specific probe sequence comprises labeled target primer sequence (0011) (5' labeled end). Wang teaches universal detection probe can a stem loop hairpin structure, thus Wang teaches detection probes without stem loop structures (0060). Wang teaches universal FQ probe are single stranded oligonucleotides that can have hairpin structure. The FQ probe will interact with a specific probe sequence (mediator compliment) (0272). Wang teaches the FQ probe can comprise a fluorophore and a quencher (0 275).
Wang thus anticipates claim 19.
Prosecution Insights