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 .
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or
under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. This application claims benefit of
Foreign Application JAPAN 2022-089389 filed 06/01/2022. Based on the filing receipt, the effective filing date of this application is June 1, 2022, which is the filing date of Foreign Application JAPAN 2022-089389 from which the benefit of priority is claimed.
Status of Claims
Claims 1-10 are pending and examined herein.
Information Disclosure Statements
The information disclosure statement filed 06/01/2023 has been considered by the examiner.
Claim Objections
Claim 2 is objected to because of the following informalities: claim 2 recites, “the antibody is an antibody whose immunogen is a hapten derivative in which an immunogenic substance is bound to the hapten via a linker,”. The claim as written is lacking clarity. The claim would be clearer if it recited, “the antibody is an antibody whose immunogen is bound to a hapten via a linker, resulting in a hapten derivative,”. Appropriate correction is required.
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.
Claim 2 recites the limitation "an antibody whose immunogen is a hapten derivative in which an immunogenic substance is bound to the hapten via a linker" in the body of the claim. There is insufficient antecedent basis for this limitation in the claim. It is unclear whether the immunogenic substance is the same as the immunogen. Appropriate correction is required.
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 1-10 are rejected under 35 U.S.C. 103 as being unpatentable over Morel and Delaage (“lmmunoanalysis of histamine through a novel chemical derivatization”, published 1988), Smith, et al. (“Fluorescence polarization immunoassays and related methods for simple, high-throughput screening of small molecules”, published 2008), and Zuk (US Patent Number 4,208,479, published 1980-06-17).
Morel and Delaage teach all the components of a kit, comprising: a derivatization reagent that derivatizes at least a portion of an antigen, an antibody that binds to the antigen, and the antigen modified with a label, as in claim 1 (see, e.g., p. 648-649, under “Antibody-binding measurements”, and p. 650, under “FIG. 2”). It is understood that the differing concentrations of histamine in “FIG. 2” of Morel and Delaage have different derivatization reagents.
Morel and Delaage teach wherein the antigen is a hapten, the antibody is an antibody whose immunogen is a hapten derivative in which an immunogenic substance is bound to the hapten via a linker, the derivatization reagent imparts, to the hapten in the specimen, a structure identical to at least a portion of the linker, and the label binds to the hapten via the structure identical to at least a portion of the linker, as in claim 2 (see, e.g., p. 647, under “FIG. 1”).
Morel and Delaage teach the hapten is histamine, as in claim 3 (see, e.g., p. 647, under “FIG. 1”).
Morel and Delaage teach a concentration estimation method, comprising: mixing a specimen including an antigen and a derivatization reagent that derivatizes at least a portion of the antigen included in the specimen, and obtaining a plurality of samples having different derivatization rates, the derivatization rate being a ratio of a derivatized antigen relative to the antigen included in the specimen; mixing each of the samples, an antibody that binds to the antigen, and the antigen modified with a label to obtain a plurality of solutions to be measured; and measuring the solutions, as in claim 6 (see, e.g., p. 648-649, under “Antibody-binding measurements” , and p. 650, under “FIG. 2”). It is understood that the differing concentrations of histamine in “FIG. 2” of Morel and Delaage have different derivatization reagents.
Morel and Delaage teach wherein the antigen is a hapten, the antibody is an antibody whose immunogen is a hapten derivative in which an immunogenic substance is bound to the hapten via a linker, the derivatization reagent imparts, to the hapten in the specimen, a structure identical to at least a portion of the linker, and the label binds to the hapten via the structure identical to at least a portion of the linker, as in claim 7 (see, e.g., p. 647, under “FIG. 1”).
Morel and Delaage teach wherein the hapten is a histamine, as in claim 8 (see, e.g., p. 647, under “FIG. 1”).
Morel and Delaage fail to teach the label is a dye used in fluorescence polarization immunoassay, as in claims 1 and 6.
However, Smith teaches a dye label. Smith teaches that “Fluorescence polarization immunoassay (FPIA) is a homogeneous (without separation) competitive immunoassay method based on the increase in fluorescence
polarization (FP) of fluorescent-labeled small antigens when bound by specific antibody”, as in claims 1 and 6 (see, p. 1499, under “Abstract”).
Morel and Delaage and Smith are analogous to the field of the claimed invention because they are both in the field of immunoassays. One of ordinary skill in the art before the effective filing date of the application would have found it obvious to substitute one immunoassay format for another. An artisan would have been motivated to do so because Morel and Delaage disclose, “The quantification of histamine, either in vivo or in vitro, is of major importance for the evaluation of the effect of drugs or environmental agents on histamine release” (see, p. 646, col. 1, para. 2). Furthermore, Smith discloses “Because of its simplicity and speed, FPIA is readily automated and therefore suitable for high throughput screening (HTS) in a variety of application areas” (see, p. 1499, under “Abstract”). An artisan would have recognized that the immunoassay format of Smith would be more effective for measuring histamine release because of its simplicity and speed. An artisan would have had a reasonable expectation of success based on the given disclosures.
With regards to claims 4-5 and 9-10, Morel and Delaage disclose a plurality of solutions with differing concentrations of derivatization reagents, which results in differing derivatization rates (see, e.g., p. 650, under “FIG. 2”). The different derivatization rates lead to a shift in the dynamic range of the concentration curves, which an artisan would recognize is useful for measuring histamine at through different dynamic ranges. Although Morel and Delaage do not explicitly teach a plurality of derivatization reagent solutions with the same concentration and different volumes or the same volume and different concentrations, as in claims 4-5 and 9-10, it would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to perform routine optimization of the components in the claimed invention to make and use the claimed invention. As noted in In re Aller, 105 USPQ 233 at 235, more particularly, where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. Routine optimization is not considered inventive and no evidence has been presented that arriving at the claimed inversion was anything other than routine, that the properties of the plurality of solutions from the optimization has any unexpected properties, or that the results should be considered unexpected in any way as compared to the closest prior art. Optimization of parameters is a routine practice that would be obvious for the artisan to employ. See MPEP § 2144.05. The artisan would have had a reasonable expectation of success based on the cumulative disclosure of Morel and Delaage and Smith.
Morel and Delaage and Smith fail to specifically teach a “kit”, as in claims 1-10.
However, Zuk teaches that in performing assays, it is convenient and to combine the necessary reagents together in a kit (see, e.g., col. 22, lines 20-68). Zuk further teaches that this may improve assay accuracy (see, e.g., col. 22, lines 20-68).
Morel and Delaage and Smith, and Zuk are analogous to the field of the claimed invention because they are all in the field of immunoassays. One of ordinary skill in the art before the effective filing date of the application would have found it obvious to provide the reagents of Morel and Delaage and Smith together in kit form for convenience and accuracy as taught by Zuk. An artisan would have had a reasonable expectation of success based on the given disclosures.
Conclusion
No claims are allowed.
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/MICHAEL CAMERON SVEIVEN/ Examiner, Art Unit 1678
/GREGORY S EMCH/ Supervisory Patent Examiner, Art Unit 1678