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 .
Election/Restrictions
Applicant’s election of Group II in the reply filed on 07/13/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claims 13 & 15-22 are being examined.
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 13, 15-17, 19, 20 & 22 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Budelier (Budelier et al. US 2022/0120765 A1).
Regarding claim 13, Budelier teaches: A measurement method comprising the steps of: a start QC step of performing a measurement of a QC standard sample that comprises a blood sample comprising a peptide, and a peptide labeled with a stable isotope that is spiked into said blood sample; a sample measurement step of performing a measurement of one or more blood samples to be measured; an intermediate QC step of performing a measurement of the QC standard sample; a repeating step of repeating the sample measurement step and the intermediate QC step predetermined number of times; a sample measurement step of performing a measurement of one or more blood samples to be measured; and a final QC step of performing a measurement of the QC standard sample (see ¶ 0089-0092+ for example).
Regarding claim 15, the claim recites optional steps and resulting statements without including required method steps.
Regarding claims 16, 17, 19, 20 & 22, Budelier appears to teach the claimed methods in ¶ 0004-0010+, 0051, Example 2 ¶ 0084+ for example.
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.
Claim(s) 18 & 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Budelier (Budelier et al. US 2022/0120765 A1).
Regarding claims 18 & 21, Budelier does not explicitly teach: 18. The measurement method of a peptide according to claim 13, wherein the target peptide to be measured includes at least one selected from the group consisting of Aβ1-42 (SEQ ID NO.: 9), Aβ1-38 (SEQ ID NO.: 11), Aβ1-40 (SEQ ID NO.: 7), and APP669-711 (SEQ ID NO.: 10). 21. The measurement method of a peptide according to claim 20, wherein as to a ratio of abundance of the peptide labeled with a stable isotope in the QC standard sample, a ratio of SIL-Aβ1-40/SIL-Aβ1-42 is within a reference range from 25.0 to 32.5; and/or a ratio of SIL-APP669-711/SIL-Aβ1-42 is within a reference range from 0.7 to 1.3. However, it would have been obvious to one of ordinary skill in the art at the time the invention was made to use various target peptides, and a ratio of peptides labeled with a stable isotope in the QC standard sample to understand the relationships between different factors and their effects on biological processes (see Budelier Example 3 ¶ 0147-0150, Examples 4-5 ¶ 0151-0161+ for example).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DEAN KWAK whose telephone number is (571)270-7072. The examiner can normally be reached M-TH, 4:30 am - 2:30 pm EST.
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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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/DEAN KWAK/Primary Examiner, Art Unit 1798
DEAN KWAK
Primary Examiner
Art Unit 1798
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