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 .
DETAILED ACTION
Response to Election/Restrictions
Applicant’s election with traverse of “thioether bond” in response to election of species requirement is acknowledged. Applicant’s election is not complete because “thioether bond” is not a single species of a “non-disulfide crosslinker”. As argued in Applicant’s remark, a bis-maleimide-mediated bond is a species of thioether bond and there are several classes of sulfhydryl reactive cross-linker compounds forming stable thioether bond. Thus it is clear from Applicant’s argument that the elected “thioether bond” encompasses various non-disulfide crosslinkers and thus the election of “thioether bond” is incomplete as this is not a single species of a “non-disulfide crosslinker”. Moreover, thioether bond is not crosslinker but is a rection product of crosslinker with a moiety on the antibody.
In order to expedite the prosecution, Examiner considered prior art thioether crosslink but Applicant is required to elect a single disclosed species of a non-disulfide crosslinker to be fully responsive to the election of species requirement is the next reply.
Claims 1-19 are examined on merits in this office action.
Claim Rejections - 35 USC § 103
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.
Claims 1-19 are rejected under 35 U.S.C. 103 as being unpatentable over Knowles et al (US 4,658,022) in view of Tous et al. (US 7,786,273) and further in view of Maret et al (US 5,478,741).
In regards to claims 1-2 and 11-12, Knowles teaches immunoassay detection of a protein (i.e. analyzing a protein) comprising denaturation of the protein by chemical means and detecting denatured protein by biding with antibody reagent specifically binding the protein wherein the denaturation effectively exposes or enhances the exposure of the linear peptide epitope for binding by the antibody reagent (Abstract). Knowles teaches that highly specific immunobinding to a particular protein can be achieved by forming an antibody reagent against a linear peptide epitope in the protein and contacting such antibody reagent with the protein after denaturing the protein sufficiently to expose or increase the exposure of the linear peptide epitope therein (col 2. “Summary of the Invention”).
Knowles teaches utilizing antibody reagent but however, does not teach the antibody comprises one or more chemically-introduced non-disulfide cross-links.
Tous discloses an antibody comprising at least one thioether cross-link (col. 38, lines 53-55) wherein the thioether cross-link links a heavy chain and a light chain of the antibody (col. 14, ln 21-25; Col. 38, lines 66-67) wherein the antibody is specific for an antigen (col. 39, ln 4-17). Tous teaches that the antibody can be a monoclonal, synthetic, humanized, chimeric, single-chain Fvs (scFv), and Fab fragments (col. 2, ln 10-19; pages 25-26, and 28). Tours teaches contacting the composition with a reducing agent (col. 65, lines 23-30) and linking residues between residues of polypeptide with a thioether cross-link (bridge) (col.13). Tous teaches that the antibody may be conjugated to a therapeutic or a drug moiety (col. 31, ln 34-56) or the antibody may be attached to a solid support which are particularly useful for immunoassays or purification of target antigen (col. 32, ln 58-65). Tous teaches the antibody of the invention display enhanced stability, pharmaceutical properties and functional properties (Abstract; col.1, lines 10-20). Tous teaches macromolecules comprising thioether cross-links can be purified from macromolecules that do not comprise thioether cross-links under denaturing conditions. Useful techniques include gel electrophoresis, SDS-PAGE and capillary gel electrophoresis. The purified macromolecules comprising thioether cross-links can be renatured according to techniques known to those of skill in the art. Advantageously, the stability of the thioether cross-link can permit more vigorous denaturing and renaturing than what would be tolerated by macromolecules comprising disulfide bonds.
Therefore, from the description in mind of Tous, it would be obvious to one of ordinary skilled in the art to easily envisage utilizing antibody having thioether cross-linked in the method of Knowles for detection of denatured protein analyte with the expectation of providing more stabilized antibody for the denatured conditions utilized in the method of Knowles with a reasonable expectation of success. Since Tous teaches that antibody comprising thioether cross-links have added advantages of stability due to the thioether cross-link which permit more vigorous denaturing and renaturing than what would be tolerated by macromolecules comprising disulfide bonds, one of ordinary skilled in the art would obviously consider utilizing thioether cross-linked antibody in the method of Knowles because Knowles teaches denaturing conditions for denaturing sample proteins before contacting with antibody.
The references of Knowles in view of Tous teaches denaturing target protein in the sample and utilizing thioether cross-linked antibodies but the references do not teach the denaturing agent and the antibody supplied/provided in a kit.
Maret discloses immunoassays that teach that components for carrying out immunoassay methods can be packaged in the form of a kit for convenience and such a kit may include an appropriate assay device, antibody reagents, reagents for development of the assay such as buffers and, if needed, reagents for detection of the chosen label (column 6, lines 16-21).
Since Knowles in view of Tous teach immunoassay detection utilizing denaturing agent and thioether crosslinked antibody in the process of detection and since the packaging of components in a kit form is a well-known obvious expedient for ease and convenience in assay performance (Maret), one skilled in the art would clearly consider compiling the method components in a kit format and change/modify different components of the kit to best suit the assay.
In regards to claims 3 and 13, Tous teaches various thioether cross-link of antibody including thioether cross-link of 50% or 75% and thus various thioether cross-linked antibody would be obvious to one of ordinary skilled in the art.
In regards to claim 4, Knowles teaches denaturation effectively exposes or enhances the exposure of the linear peptide epitope for binding by the antibody reagent (Abstract) and also teaches examine internal epitopes by denaturation (col. 5, lines 66-67).
In regards to claims 5 and 14, Knowles teaches utilization of the antibody in an immobilized or mobilizable form (col. 10, lines 51-52) and immunoassay utilizing immobilized antibody (col. 15, lines 13 and 32) and Tous teaches antibodies attached to solid support (col. 32, line 60).
In regards to claims 6-8, 10, 15-17 and 19, Knowles teaches monoclonal antibody and binding fragments thereof and teaches blood sample (col. 3, lines 40-45 and col. 11, lines 19-36).
In regards to claims 9 and 18, Knowles teaches various immunoassays rarioimmunoassay, ELISA type assay and fluorescent immunoassays among others and compiling the various immunoassay component in a kit would be obvious to one of ordinary skilled in the art in view of Maret.
Conclusion
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/SHAFIQUL HAQ/Primary Examiner, Art Unit 1678
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