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 without traverse of group I, claims 1-8 in the reply filed on 08/31/2026 is acknowledged.
Claims 9-12 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 08/31/2026.
Claims 1-8 are under examination.
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.
Claims 1-8 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 states “Multiplex nucleic acid amplification reaction” and states what the reaction comprises and defines the amplicon, primer and probe with a wherein clause that characterizes the amplification reaction. The claims do not recite any active method steps. Therefore it is entirely unclear what steps are required to be practiced in order to meet the claimed invention. See MPEP 2173.05(q). Depends claims 2-8 further characterize the rat6io, amplicon, reaction, sample. While claim 5 recites detecting the labels of the oligonucleotides is performed electrophoresis, sequencing, or PCR or microarray analysis this step does not recite how this step is performed. The dependent claims do not add any further required steps but further states intended fields of use for the claimed method.
Claim 1 recites at least two separate amplicons with normalized signal strength. It is unclear what is encompassed by two separate amplicons with normalized signal strength as amplicons do not have normalized signal strength. Amplicons are the result of an amplification reaction and the signal strength is what is measured, it is unclear how amplicons have a normalized signal strength.
Claim 1 recites the limitation “the forward primer”, “the reverse primer” , “the optional detection probe”, "the subset amount of labeled primer/probe oligonucleotides to subset amount of unlabeled primer/probe oligonucleotides " in line 3-6 of the claim. There is insufficient antecedent basis for this limitation in the claim. The claims do not recite or require a forward primer, a reverse primer or an optional detection probe and only recite for at least one amplicon either the forward primer, reverse primer or the optional detection probe are only partially labeled. Furthermore, it is unclear what is the subset amount of labeled primer/probe and subset amount of unlabeled primer/probe. Does the subset encompass a primer, two different primers, forward primers, reverse primers, a primer pair, a primer and probe for one amplicon, primers for two amplicons or some other subset of the amplification reaction. Additionally the recitation of “primer/probe” is indefinite it is unclear if this is a relationship, subset or unstated relationship between the primer and probe.
Claim 2 recites the limitation "the ratio of the labeled subset to unlabeled subset" in line 2 of the claim. There is insufficient antecedent basis for this limitation in the claim. Claim 1 recites the subset amount of labeled primer/probe oligonucleotides to subset amount of unlabeled primer/probe oligonucleotides”. Claim 1 does not recite or define a ratio. None of the preceding claims or claim recites a ratio and therefore claim 2 lacks antecedent basis and it is unclear what is encompassed by the ratio of the labeled subset to unlabeled subset.
Regarding claim 2 and 3, the phrase "preferably ", “even more preferably” and “most preferably” renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d). It is unclear which ratio is required for the labeled subset to unlabeled subset. The recitation of preferably, even more preferably, and most preferably renders the claim indefinite. One of ordinary skill in the art would not know the metes and bounds of the claim as it is unclear if most preferably is required or is preferably required for the limitation of the claim.
Claims 2-8 depend from claim 1 and are indefinite for the reasons applied to claim 1. Claim 4 and 7 depend from claim 3 and are indefinite for the reasons applied to claim 3.
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 1-8 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kenefic (2008, cited on IDS).
With regard to claim 1 and 2, Kenefic teaches an amplification reaction comprising template DNA using primer concentrations of labeled forward and unlabeled reverse primers. Kenefic teaches final primer concentrations were .2µM HM1 labeled forward and unlabeled reverse primer, .2 µM HM2 labeled forward primer and unlabeled reverse primer, and .1 µM unlabeled forward primer for HM6 and .2 µM labeled forward primer for HM6, and .2 µM HM13 labeled and unlabeled primer. Kenefix teaches the mixture of unlabeled and dye labeled forward primers for HM6 reduced fluorescent signal strength that facilitates normalization of peak intensities across all loci. (see pg. 270, 2nd column). Kenefic therefore teaches an amplification reaction that results in normalized signal strength with a subset of primers that are labeled (forward primers) and a subset of primers that are unlabeled (reverse primers). Kenefic teaches that the primers are adjusted to have normalized (equal) signal strength. The recitation of subset has been interpreted as encompasses primers for each locus. Kenefic teaches the ratio of labeled primers to unlabeled primers is 1:1. Additionally Kenefic for locus HM6, the subset can be interpreted to be only the forward primer, in this case, the HM6 forward primer has a ratio of 1:1 as Kenefic teaches .1 uM unlabeled forward primer with .1uM labeled forward primer (claim 2).
With regard to claim 3-4, Kenefic teaches .1ng template DNA and does not teach dilution or quantification of template DNA prior to amplification (see pg. 270, 2nd column).
With regard to claim 5-6 and 8, Kenefic teaches isothermal multiplex PCR capillary electrophoresis system for genotyping (see abstract and pg. 270).
With regard to claim 7, Kenefic teaches the assay was screened across a panel of 89 B. anthracis isolates. The sample of Kenefic comprises bacteria, and is from a sample containing biological material form which nucleic acids can be extracted. It is noted that the recitation of a forensic is intended use and any sample that could be used in this way is a “forensic” sample. Kenefic teaches characterization of an event involving B. anthracis necessitates analysis of large number of isolates and teaches the genotyping system allows for analysis of B. anthracis associated with these events, thus demonstrating that the samples by Kenefic could be used as forensic samples.
Conclusion
No claims are allowable.
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/SARAE L BAUSCH/ Primary Examiner, Art Unit 1699
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