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 .
Applicant’s preliminary amendment, dated August 21, 2023, has been received. By way of this submission, Applicant has amended the specification.
Claims 1-6 are pending in the application and under examination before the Office.
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.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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.
Claims 1-6 are rejected under 35 U.S.C. 103 as being unpatentable over Huiquang (CN110716055A, machine translation attached) in view of Kim (Exp Mol Med. 2002 May 31;34(2):152-8) and Lee (Proteomics. 2003 Dec;3(12):2289-304).
Huiquang teaches a microtiter plate (i.e., a substrate), which is coated with recombinant human FcεRI (i.e., a capture protein) (page 2, last paragraph), which is pertinent to claims 1 and 6.
Huiquang further teaches adding a serum to be rested (i.e., a functional material candidate) to the above plate, followed by adding biotin-labeled IgE, then adding streptavidin labeled with a detection moiety (page 3, steps 1-6).
Huiquang further teaches treating the substrate with 2% bovine serum albumin (BSA) after applying the FcεRI (page 3, first paragraph), which is pertinent to claim 2.
Huiquang further teaches washing and drying steps after application of biotin-labeled IgE and streptavidin labeled with a detection moiety (page 3, step 3), which is pertinent to claims 3 and 4.
Huiquang further teaches analyzing the reaction with a microplate reader (page 3, step 9 and last paragraph), which is pertinent to claim 5.
Huiquang further teaches that this method is useful to screen allergen-specific immunoglobulin E antibody pathogenic activity (page 2, fifth paragraph).
However, Huiquang does not teach a linker material-coated substrate or fluorescently labeled streptavidin.
Kim teaches a method of analyzing IgE levels in a sample, comprising contacting protein chips with biotin-labeled IgE, followed by washing, then incubating with Cy3-conjugated streptavidin (i.e., fluorescently labeled streptavidin) (page 153: "Reaction and detection").
Kim teaches that such protein chip arrays are useful for the quantitation of multiple allergen-specific IgE (page 155, right column, last paragraph).
Lee teaches the use of ProLinker, a linker material that is useful to coat a protein chip substrate, and that ProLinker permits efficient immobilization of capture proteins on solid matrixes and makes high throughput analysis of protein-protein interactions possible (abstract and page 2291: "2.3 Preparation of ProteoChips").
It would have been prima facie obvious for a person of ordinary skill in the art as of the effective filing date to combine the teachings of Huiquang, Kim, and Lee to arrive at the claimed invention. An ordinary artisan would have been motivated to do so, and have a reasonable expectation of success, since Huiquang, Kim, and Lee are all concerned with methods of protein interaction analysis. Starting from the teachings of Huiquang, methods of analyzing allergen-specific IgE activity using FcεRI-coated substrates were known in the art. Kim and Lee teach further improvements to this method, such as the use of fluorescently-labeled streptavidin by Kim, and a linker material by Lee. One of ordinary skill could apply the improvements of Kim and Lee to the method of Huiquang to arrive at the claimed invention by following the guidance in the references, with each individual component of the combination performing its known, usual function, and the combination would have yielded nothing more than predictable results.
All the claimed elements were known in the prior art and one of ordinary skill in the art could have arrived at the claimed invention by using known methods with no change in their respective functions, and the combination would have yielded nothing more than predictable results. Therefore, the invention, as a whole, was prima facie obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention as evidenced by the references, especially in the absence of evidence to the contrary.
Conclusion
No claim is allowed.
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/PETER JOHANSEN/Examiner, Art Unit 1644