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
Claims 26-43 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected composition for immunoassays and a method for preparing a composition for immunoassays, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 08/10/2026.
Applicant's election with traverse of claim 44-46 in the reply filed on 08/10/2026 is acknowledged. The traversal is on the ground(s) that group 1 and 3 fall under 'product and process of use of said product' and have This is not found persuasive because the even though the invention of the Group 1, 2 and 3 require the technical feature of "a composition of a immunoassay comprising a buffer, a salt, a blocking agent, a block copolymer, and a chaotropic agent", this technical feature does not make a contribution over the prior art of Takahashi et al cited in the IDS See MPEP 1893.03(d).
The requirement is still deemed proper and is therefore made FINAL.
Information Disclosure Statement
The information disclosure statement filed on 08/10/2026 with three pages fails to comply with the provisions of 37 CFR 1.97, 1.98 and MPEP § 609 because the format is incorrect. It has been placed in the application file, but the information referred to therein has not been considered as to the merits.
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).
There are duplicate references in the two IDS filed on 08/10/2026. The IDS filed 08/10/2026 with two pages was considered.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
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.
Claims 44-46 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 44 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, because it is unclear. It is unclear because examiner is not sure how a method for detection is to occur because there is only a contacting step. The preamble recites ‘for detecting presence or an analyte of interest in a biological sample’, however, there is not step indicative of detection. Claim 45 depends upon claim 44, thus also rejected.
Claim 46 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, because it is unclear. It is unclear because examiner is not sure how a method for detection is to occur because there is only a conducting step. The preamble recites ‘for detecting presence or an analyte of interest in a biological sample’, however, there is not step indicative of detection.
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.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 44 and 46 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Takahashi et al (JP 2014206391 A) which is cited in the IDS received on 02/09/2024. The examiner has obtained a machine translation of the JP document above from J-Plat Pat. The rejection below is based off the machine translation cited in the previous office action filed on 06/12/2026.
Regarding claim 44, Takahashi teaches a method of contacting a biological sample (pg 7-8, para 0012) with a composition for immunoassays comprising of a buffer (pg 7, para 0012), a salt (pg 13, para 0029), a block agent (‘polyvinyl pyrrolidone’, pg 13, para 0029), block copolymer (pg 7, para 0012) and chaotropic agent (pg 13, para 0029) and using the composition as a diluent for biological sample (pg 11, para 0023).
Regarding claim 46, Takahashi teaches a method of carrying out an immunoassay for the detecting the presence of an analyte (pg 7-8, para 0012) with a composition for immunoassays comprising of a buffer (pg 7, para 0012), a salt (pg 13, para 0029), a block agent (‘polyvinyl pyrrolidone’, pg 13, para 0029), block copolymer (pg 7, para 0012) and chaotropic agent (pg 13, para 0029).
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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.
Claim 45 is rejected under 35 U.S.C. 103 as being unpatentable over Takahashi et al (JP 2014206391 A) as applied to claim 44 above, and further in view of Lowery et al. (US 20130260367 A1).
Regarding claim 45, Takahashi teaches the invention in claim 44. Takahashi further teaches obtaining optical measurements of the immunoassay sample (pg 13, para 0028).
Takahashi does not teach electrochemical measurement to detect an analyte of interest.
However, Lowery teaches a method for the detection fog analytes (Abstracts). Lowery further teaches assay reagents such as blocking agents (Table 4), block copolymer (para 0218), a salt (para 0221), and buffers (para 0221). Lowery further teaches a method for detecting the presence of a pathogen in whole blood sample which includes obtaining an electrochemical measurement (para 0013). Thus, it would be obvious to one of ordinary skill in the art before the effective filing date to modify Takahashi with obtaining electrochemical measurement to detect an analyte of interest as taught by Lowery for the benefit of greater sensitivity.
Conclusion
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Capozzi can be reached at (571) 270-3638. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/H.R.B./Examiner, Art Unit 1798
/CHARLES CAPOZZI/Supervisory Patent Examiner, Art Unit 1798
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