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 .
Claims 1-7 are pending and will be examined.
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.
(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) 1-7 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Barany et al. (US Patent 10344321 B2; July 2019).
With regard to claim 1, Barany teaches a method for counting circulating tumor cells expressing a tumor-specific gene or having a tumor-specific genomic sequence in a cell sample using a real-time dPCR device of the invention, comprising:
a) partitioning a mixture of RT-PCR reagents and a cell sample enriched with circulating tumor cells into many small individual reaction volumes in a PCR microchip of the real-time dPCR device such that more than 50% of the reaction volumes contain no more than one circulating tumor cell, wherein the mixture comprises tumor-specific primers for amplification of a plurality of tumor- specific sequences and a plurality of sequence-specific reporter probes for detection of the plurality of tumor-specific sequences (col. 32, lines 8-65 where multiplex RT-PCR is described as carried out alongside a distribution system as depicted in Fig 3, 4, 5, 7-9, 11-13, Fig 15-18, Fig 20-22; see also, discussion of pixel PCR/LDR as described);
b) performing multiplexed real-time quantitative RT-PCR to amplify the plurality of tumor-specific sequences in each reaction volume (col. 32, lines 8-65 where multiplex RT-PCR is described as carried out alongside a distribution system as depicted in Fig 3, 4, 5, 7-9, 11-13, Fig 15-18, Fig 20-22);
c) recording an amplification curve for each reaction volume during the PCR amplification (col. 129 and Fig 159-176, where presence of specific mutations are detected through real time curves as depicted);
d) counting the number of reaction volumes with positive fluorescent signals based on the amplification curve of the reaction volume (col. 129 and Fig 159-176, where presence of specific mutations are detected through real time curves as depicted); and
e) determining the fraction of circulating tumor cells based on the fraction of reaction volumes with positive fluorescent signals (col. 31, where fraction is described relating to CTC).
With regard to claim 2, Barany teaches a method of claim 1, wherein the plurality of sequence-specific probes are linked to the same fluorophore (col. 41, col. 45).
With regard to claim 3, Barany teaches a method of claim 1, wherein different sequence-specific probes are linked to different fluorophores (col. 41, col. 45).
With regard to claim 4, Barany teaches a method of claim 1, wherein concentrations of the tumor-specific primers and the sequence-specific reporter are different for each tumor-specific sequence which results in different plateau fluorescence intensity for each tumor-specific sequence after PCR amplification, and the detection of a circulating tumor cell having a particular tumor- specific sequence is based on the plateau fluorescence intensity (col. 129 and Fig 159-176, where presence of specific mutations are detected through real time curves as depicted).
With regard to claim 5, Barany teaches a method of claim 1, wherein the PCR amplification of different tumor-specific sequence has different Ct and the detection of a circulating tumor cell having a particular tumor-specific sequence is based on the Ct (col. 129 and Fig 159-176, where presence of specific mutations are detected through real time curves as depicted).
With regard to claim 6, Barany teaches a method of claim 1, wherein the detection of a circulating tumor cell having a particular tumor-specific sequence is based on the plateau fluorescence intensity and the Ct (col. 129 and Fig 159-176, where presence of specific mutations are detected through real time curves as depicted).
With regard to claim 7, Barany teaches a method of claim 1, wherein the mixture of PCR reagents and the cell sample is partitioned into many small individual reaction volumes such that more than 50% of the reaction volumes contain no more than one cell (col. 32, lines 8-65 where multiplex RT-PCR is described as carried out alongside a distribution system as depicted in Fig 3, 4, 5, 7-9, 11-13, Fig 15-18, Fig 20-22; see also, discussion of pixel PCR/LDR as described).
Citation of Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Collins US 9149806 B2; October 2015). Hindson US 20120252015 A1; October 2012).
Conclusion
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/STEPHANIE K MUMMERT/Primary Examiner, Art Unit 1681