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 .
Claim Rejections - 35 USC § 102
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) 1,3,4, and 5 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Ueno et al. (U.S. Patent Application Publication Number 2016/0266074; hereinafter referred to as Ueno).
With respect to claim 1, Ueno discloses and illustrates a multi-correction analysis method for correcting a result of analyzing a large number of object substances contained in a sample using a chromatograph (see at least paragraph [0001]), the method comprising: grouping at least a part of a large number of object substances which are possibly contained in a sample to be analyzed into a plurality of groups based on changes in measured values of the part of object substances obtained by performing chromatographic analysis of the sample a plurality of times under different analysis conditions (see at least paragraph[0013]), and determining a surrogate substance for each of the plurality of groups (see at least paragraphs [0013] and [0014]); and adding the surrogate substance to the sample as an internal standard substance common to object substances contained in each group (see at least paragraph[0014]), and correcting a measured value of each of the large number of object substance obtained from a result of chromatographic analysis of the sample with a measured value of an internal standard substance corresponding to a group to which the object substance belongs (see at least paragraphs [0008] and [0040]).
With respect to claim 3, the multi-correction analysis method using the chromatograph according to claim 1, wherein the surrogate substance is a compound in which one of object substances contained in a group to which the surrogate substance is assigned is labeled with a stable isotope is disclosed in at least paragraph [0008].
With respect to claim 4, the multi-correction analysis method using the chromatograph according to claim 1, wherein the performing chromatographic analysis of the sample a plurality of times under different analysis conditions is performing the chromatographic analysis of the sample by each of a plurality of different types of devices is disclosed in at least paragraph [0007].
With respect to claim 5, the multi-correction analysis method using the chromatograph according to claim 1, wherein the chromatographic analysis is gas chromatography mass spectrometry is disclosed in at least paragraph [0005].
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.
Claim(s) 2 and 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ueno as applied to claim 1 above, and further in view of Heindl et al. (U.S. Patent Application Publication Number 2019/0293615; hereinafter referred to as Heindl.)
With respect to claim 2, while Ueno discloses the multi-correction analysis method using the chromatograph according to claim 1, Ueno fails to disclose wherein the analysis condition is any one of pH of the sample, an amount of lipid in the sample, an amount of a chemical reaction reagent for promoting ionization, a chemical reaction time for promoting ionization, a number of uses of a sample injection container of a chromatograph analyzer, and a number of uses of a separation column used for chromatographic analysis is different. However, Heindl discloses that “an analysis system may comprise units assisting with the pipetting, dosing, and mixing of samples and/or reagents. The analysis system may comprise a reagent holding unit for holding reagents to perform the assays. Reagents may be arranged for example in the form of containers or cassettes containing individual reagents or group of reagents, placed in appropriate receptacles or positions within a storage compartment or conveyor.” (see at least paragraph [0025] of Heindl). Therefore, it would have been obvious to one skilled in the art at the time the invention was filed to utilize the specific reagents of Heindl with the system of Ueno as a “reagent” is a substance used for treatment of a sample in order, e.g., to prepare a sample for analysis, to enable a reaction to occur, or to enable detection of a physical parameter of the sample or analyte contained in the sample, thus use of a reagent would be helpful in order to ensure accurate and specific results with the system of Ueno.
With respect to claim 6, while Ueno discloses the multi-correction analysis method using the chromatograph according to claim 1, Ueno fails to disclose, wherein the sample is a sample containing plasma. However, Heindl discloses a sample can be plasma in at least paragraph [0028]. Therefore, it would have been obvious to one skilled in the art at the time the invention was filed to utilize plasma as a possible sample with the system of Ueno in order to more effectively and accurately analyze a sample that is possibly related to a specific medical condition.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RODNEY T FRANK whose telephone number is (571)272-2193. The examiner can normally be reached M-F 9am-5:30pm.
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/RODNEY T FRANK/Examiner, Art Unit 2855
March 5, 2026