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 .
This action is in response to papers filed 11/07/2025.
Applicant’s election without traverse of Group I in the reply filed on 4/16/2024 is acknowledged.
Claims 1,5-14,16,18-20,113,150-151 are pending.
Claims 2-4,15,17,21-112,114-149 have been cancelled.
The following rejections are maintained or newly applied with response to arguments following.
This action is FINAL.
Newly Applied 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 1,5-14,16,18-20,113,150-151 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.
Claims 1,5-14,16,18-20,113,150-151 are indefinite over “is favored at an elevated temperature”. The phrase is not clear as it is not clear the metes and bounds of “favored”. It is not clear how the term alters the third oligonucleotide. Further, the claims are drawn to oligonucleotides “configured to hybridize”, however the elevated temperature is “annealing/extension” temperature. This phrase is not identical to hybridizing to a target and as such it is not clear if the structures are “configured to hybridize ” or are configured to be used in annealing/extension temperature reactions.
Maintained Claim Rejections - 35 USC § 103
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 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(s) 1,5-14,16,18-20,113,150-151 is/are rejected under 35 U.S.C. 103 as being unpatentable over Billard et al. (Applied and Environmental Microbiology 2012 cited on IDS) in view of Nolling et al. (US Patent Application Publication 2016/0130660 May 12, 2016)
With regard to claim 1, 16, Billard et al. teaches a mixture comprising a pair of primers and a probe wherein the probe and the reverse primer are both allele specific and at the 3’ end of the primer complementary to the variant to be detected (paragraph 1064-1065 table 1, figure 1, p. 1066 table 4 and p. 1067 last paragraph). Therefore Billard teaches a first and second oligonucleotide wherein the first oligonucleotide that has a residue at the 3’ end to the target variant and the second oligonucleotides that is 5’ upstream from the first. Billard et al teaches a third sequence that hybridizes to the target and includes a variant (table 1). Although Billard et al. does not particularly recite a plurality of oligonucleotide sets it would be prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to modify the structure of oligonucleotides of Billard et al. to combine multiple sets of oligonucleotides for multiplex mixtures. However, Billard et al. does not teach between about 20mM and about 80 mM potassium chloride.
With regard to claim 5, Billard et al. teaches a variant at least 2 nucleotides from the 3’ end (table 1).
With regard to claim 6-7, Billard et al. teaches a oligonucleotides with a fluorescent label (p. 1064 1st column last para).
With regard to claim 8-9, Billard et al. teaches a fluorescent on the terminal and a quencher on the oligonucleotide (p 1064 1st column last para).
With regard to claims 10 and 12-13, Billard teaches a 5’ and 3’ ended and therefore teaches a first and second terminal nucleotides. Billard et al. teaches that the quencher is on the 3’ end (second terminal) (p. 1604 1st column last paragraph).
With regard to claim 11, Billard et al. teaches a mixture that comprises a double stranded polynucleotide molecule that includes a first target polynucleotide strand and a first target complement polynucleotide strand (figures 1).
With regard to claim 14, Billard teaches that mixture comprises a single stranded polynucleotide (figure 1).
With regard to claim 18, Billard et al. teaches a mixture that comprise a double stranded polynucleotide molecule with a first target and a first target complement (figure 1). Billard et al. teaches a variant polynucleotide that is substantially complementary to the variant strand (figure 1 and table 1 and p. 1064).
With regard to claim 19-20, Billard et al. teaches that the tired oligonucleotides that can have an overlap of 3 nucleotides between the primer and probe (p 1065 1st column last paragraph).
With regard to claim 113, Billard et al. teaches that the mixture can comprises an additional analysis of a control (p. 1064 2nd column). As such Billard teaches the composition of the second container. Although Billard does not use the term “container” the fact that these components are used in an assay PCR, these mixtures would be placed in the same tube (container).
With regard to Claim 1, 150, Nolling et al. teaches 50 mM KCL and 10mM ammonium sulfate (para 82, 87, 89, 92) for use in multiplex PCR assays associated with the primers. Although Nolling et al. does not teach the amounts in combination, it would be obvious to one of ordinary skill in the art to optimize known reagents in a PCR buffer using known methods of optimization.
With regard to claim 151, Nolling et al suggests that different detectable labels can be attached to oligonucleotides (para 100-101).
Therefore it would be prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to modify the mixture of Billard et al. to include in multiplex PCR assays reagents such as KCL and ammonium sulfate that are known to be used with oligonucleotides for detection and hybridization assays.
Response to Arguments
The reply traverses the rejection. A summary of the argument is provided below with response to arguments following. The reply asserts that the references do not teach the newly amended wherein clause in claim 1.
This argument has been reviewed but have not been found persuasive.
The wherein clause appears to be drawn to the intended use of the mixture with particular temperatures for the hybridization. The temperature used in the hybridization does not alter the structure of the third oligonucleotide and the oligonucleotides of the art above would be capable of hybridization.
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE D SALMON whose telephone number is (571)272-3316. The examiner can normally be reached 9-530.
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/KATHERINE D SALMON/ Primary Examiner, Art Unit 1682