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 .
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.
Claim(s) 1-20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chenna (US 2003/0092012).
Regarding claim 1, Chenna teaches a method for detecting a plurality of analytes by chromatography comprising electing at least one dye-tagged affinity molecule (DTAM) of the formula D₁-8-L₀-₈-M, wherein D represents an ultraviolet (UV) or a fluorescent dye molecule (detection group, [0025]); -L- represents an optionally substituted aliphatic, aromatic, heterocyclic, polyethylene glycol, carbohydrate, or peptide linker (linking group) and M is an affinity group (target binding moiety, [0036]); adding the at least one DTAM to a sample comprising at least one target analyte ([0061]); c) injecting the sample into a liquid chromatographic system comprising at least one detector (0090]); and d) measuring at least one attribute of the at least one target analyte with the at least one detector ([0010]).
Regarding claim 2, D is 1 and L is 1. ([0042])
Regarding claim 3, the detector is selected from the group consisting of: UV, fluorescence, multi-angle light scattering, asymmetric flow field-flow fractionation, evaporative light scattering, refractive index, conductivity, charged aerosol, mass spectrometry, or charge detection mass spectrometry detector. ([0018])
Regarding claim 4, the liquid chromatographic system comprises a size-exclusion column, reversed phase column, hydrophilic interaction column, hydrophobic interaction column, ion exchange column, chiral column, or combinations thereof. ([0079])
Regarding claim 5, the affinity group is selected from the group consisting of: a polyclonal antibody, a monoclonal antibody, a fusion protein, a bispecific antibody, a chimeric antibody, a monobody, a nanobody, a camelid, an affimer, an affibody, an aptamer, a cyclodextrin, a peptide, DNA, RNA, a lectin, a chelating agent, a molecular imprinted polymer, or combinations thereof. ([0036])
Regarding claim 6, the target analyte is a small molecule, a protein, a peptide, an antibody, a hormone, a pesticide, a toxin, and/or nucleic acids. ([0003])
Regarding claim 7, the target analyte in the sample and the DTAM are at equivalent concentrations. ([0099])
Regarding claim 8, the DTAM is at a higher concentration than the target analyte in the sample. ([0084])
Regarding claim 9, the attribute is quantity, size, charge, post-translational modification, glycan concentration, and/or aggregation. ([0027]) ([0064])
Regarding claim 10, more than one attribute is measured in parallel (simultaneously). ([0027]) ([0064])
Regarding claim 11, the attributes measured in parallel are quantity, glycan concentration, and size. ([0027]) ([0064])
Regarding claim 12, the attributes measured in parallel are quantity, glycan concentration, and charge. ([0027]) ([0064])
Regarding claim 13, the quantity is antibody quantity and the glycan concentration is mannose, fucose, and/or a sialylated glycan concentration. ([0146])
Regarding claim 14, wherein two to six DTAMs are selected, wherein each of the two to six DTAMs have different emission wavelengths. ([0053)]
Regarding claim 15, two DTAMs are selected, wherein the affinity groups of each of the two DTAMs are an antibody. ([0036)]
Regarding claim 16, the affinity groups of each of the three DTAMs are an antibody. ([0061])
Regarding claim 17, the attributes measured in parallel (simultaneously) are antibody quantity, mannose, fucose, and/or a sialylated glycan concentration, and size. ([0122)]
Regarding claim 18, the attributes measured in parallel are antibody quantity, mannose, fucose, and/or a sialylated glycan concentration, and charge. ([0122)]
Regarding claim 19, the DTAMs have affinity groups that bind to the same target analyte. ([0064])
Regarding claim 20, the DTAMs have affinity groups that bind to unique target analytes. ([0064])
Conclusion
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/JYOTI Mutreja/Primary Examiner, Art Unit 1798
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