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 .
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-11 and species of a soluble GPC3 immunoassay method; DEAET as the reducing agent; and Tween 20 as the surfactant in the reply filed on 4/13/2023 is acknowledged. Upon further consideration the species requirement of a reducing agent and surfactant are withdrawn.
Claims 1-8 and 12-15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention and species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 4/13/2023.
Claims 9-11 are under consideration in the instant Office Action.
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
The information disclosure statements filed 7/12/2023 fail to fully comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609 because no copies for non-patent literature cited in the IDS were provided and the citations have therefore been lined through. Applicant is advised that the date of any re-submission of any item of information contained in this information disclosure statement or the submission of any missing element(s) will be the date of submission for purposes of determining compliance with the requirements based on the time of filing the statement, including all certification requirements for statements under 37 CFR 1.97(e). See MPEP § 609.05(a). All references listed in the IDS that are not provided are lined through and not considered.
Claim Objections
Claim 9 is objected to because of the following informalities: “GPC3” is an abbreviation and/or acronym of soluble glypican-3 which should be spelled out at their first usage followed by the abbreviation/acronym in parenthesis. 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.
Claims 9-11 are rejected under 35 U.S.C. 103 as being unpatentable over Nakano et al US 2007/0190599 (IDS, 1/125/2025) and Watanabe et al., 2005 (instant PTO-892).
Nakano teaches anti-GPC3 antibodies useful for multiple processes including diagnosis of cancer (see abstract and [0401]). Nakano teaches quantitative methods for GPC3 which includes determination of the concentration of GPC3 protein, determination of the amount of GPC3 protein (see [0399]) as required in instant claim 9. Nakano teaches a method of detecting GPC3 protein contained in a test performed by an immunological method with the use of an anti-GPC3 antibody with a preferred enzyme linked immunosorbent assay (ELISA) such as sandwich ELISA (see [0402]) as required in instant claims 9 and 11. Nakano teaches that the above-mentioned immunological method like the ELISA can be carried out by a method known to those skilled in the art (see [0402]). Nakano teaches a general detection method with the use of an anti-GPC3 antibody comprises immobilizing an anti-GPC3 antibody on a support, adding a test sample thereto, incubating the support to allow the anti-GPC3 antibody and GPC3 protein to bind to each other, washing the support, and detecting the GPC3 protein binding to the support via the anti-GPC3 antibody to detect GPC3 protein in a test sample (see [0403],[0408]) and meets the limitation of two GPC3 antibodies of instant claims 9 and 11. Nakano teaches using a surfactant such as Tween 20 in the buffer (see [0404]) as required in instant claim 10. While Nakano teaches using reducing conditions for SDS-PAGE and Western blots with GPC3 proteins (see [0426], [0436]) Nakano does not specifically teach using reducing conditions for ELISA.
Watanabe teaches a novel ELISA using an extraction buffer containing a reducing agent and a surfactant since ELISA are sensitive and provide quantitative results (see abstract). Watanabe teaches combining protein samples with buffer solutions containing SDS, a surfactant, and 2-mercaptoethanol, a reducing agent (see page 117, sections 2.3.3 and 2.5 ELISA) and using two different antibodies against the same protein (see section 2.5.3) as required in instant claims 9-11. Watanabe teaches that the amount of protein extracted from various raw food ingredients was increased markedly by the addition of SDS and 2-ME to the extracting solution and thus, SDS and 2-MEare effective for increasing the extraction of protein even from non-processed, raw food ingredients (see page 122, bottom of 1st column). Watanabe does not specifically teach using this novel ELISA with GPC3 protein samples as required in instant claims 9-11.
It would have been prima facie obvious to the person of ordinary skill in the art to arrive at the claimed invention from the disclosures of Nakano and Watanabe. The person of ordinary skill in the art would have been motivated to make and use the invention as claimed because Watanabe teaches using buffers with surfactants and reducing agents in an ELISA since it increases the extraction of a protein from a sample. Therefore, one of ordinary skill in the art would be motivated in using the buffers of Watanabe in the ELISA used by Nakano to increase the sensitivity in detecting and quantifying the GPC3 protein in samples of possible cancer patients. The person of ordinary skill in the art would have had a reasonable expectation of success based on the cumulative disclosures of these prior art references.
Conclusion
No claims are allowed.
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/AURORA M FONTAINHAS/Primary Examiner, Art Unit 1675
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