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 with traverse of Species A in the reply filed on 07 April 2026 is acknowledged. The traversal is on the ground(s) that no serious burden exists for the search and/or examination of Species A and B because “all of the claims include common subject matter relating to a mass spectrometry system and method”. This is not found persuasive because Species A and B are mutually exclusive. By definition, “each of the species claims must require all the limitations of the generic claim” (MPEP § 806.04(d)); however, “a requirement for restriction to a single species may be proper if the species are mutually exclusive. Claims to different species are mutually exclusive if one claim recites limitations disclosed for a first species but not a second, while a second claim recites limitations disclosed only for the second species and not the first” (MPEP § 806.04(f)).
In the case at hand, claim 4, directed to Species A, recites the limitation “the information comprises an object indicating the first allowable range and the second allowable range.” This limitation is not disclosed by Species B, i.e., the limitation is mutually exclusive between Species A and B. Furthermore, claim 5, directed to Species B, recites the limitation “the information comprises the display format of the elements.” This limitation is not disclosed by Species A, i.e., the limitation is mutually exclusive between Species A and B.
Still further, a serious search burden is established because the species require a different field of search employing different search queries (MPEP § 808.02). Species A requires search queries relating to an allowable range, i.e., numerical values. In contrast, Species B requires search queries relating to a particular display format, e.g., colors, shapes, etc. Search queries regarding quantitative information are unlikely to yield relevant results for qualitative information and vice versa.
The requirement is still deemed proper and is therefore made FINAL.
Claims 5-6 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 07 April 2026.
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)(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.
(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.
Claims 10-11 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Yamashita (U.S. Patent Application Publication No. 2008/0237457 A1), hereinafter Yamashita.
Regarding claim 10, Yamashita discloses a peak evaluation method, comprising:
a step of identifying, based on quantification ion peaks and identification ion peaks derived from a plurality of compounds (FIG. 5A, peaks in chromatogram 504), measured retention times (paragraph 0060) and measured peak ratios corresponding to the compounds (paragraph 0064);
a step of calculating retention time errors (paragraph 0061) by comparing the measured retention times (paragraph 0060, retention times associated with chromatogram 504 and map 505) with standard retention times of the compounds (paragraph 0059, retention times associated with chromatogram 502 and map 501), and calculating peak ratio errors (paragraph 0061) by comparing the measured peak ratios (paragraph 0060, peaks associated with chromatogram 504) with standard peak ratios of the compounds (paragraph 0059, peaks associated with chromatogram 502); and
a step of plotting (FIG. 5A, plot 506), in a coordinate system with a retention time error axis (paragraph 0059, ordinate) and a peak ratio error axis (FIG. 5A, plot 506, gray level/color axis), a plurality of elements representing error sets composed of the retention time errors and the peak ratio errors (paragraph 0061), and thereby creating a chart for evaluating the quantification ion peaks and the identification ion peaks (paragraph 0061).
Regarding claim 11, Yamashita discloses a non-transitory storage medium having stored therein a program to be executed in an information processing device (paragraph 0014), wherein
through execution of the program, the information processing device
identifies, based on quantification ion peaks and identification ion peaks derived from a plurality of compounds (FIG. 5A, peaks in chromatogram 504), measured retention times (paragraph 0060) and measured peak ratios corresponding to the compounds (paragraph 0064);
calculates retention time errors (paragraph 0061) by comparing the measured retention times (paragraph 0060, retention times associated with chromatogram 504 and map 505) with standard retention times of the compounds (paragraph 0059, retention times associated with chromatogram 502 and map 501), and calculates peak ratio errors (paragraph 0061) by comparing the measured peak ratios (paragraph 0060, peaks associated with chromatogram 504) with standard peak ratios of the compounds (paragraph 0059, peaks associated with chromatogram 502); and
plots (FIG. 5A, plot 506), in a coordinate system with a retention time error axis (paragraph 0059, ordinate) and a peak ratio error axis (FIG. 5A, plot 506, gray level/color axis), a plurality of elements representing error sets composed of the retention time errors and the peak ratio errors (paragraph 0061), and thereby creates a chart for evaluating the quantification ion peaks and the identification ion peaks (paragraph 0061).
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 1-4 and 7-9 are rejected under 35 U.S.C. 103 as being unpatentable over Yamashita in view of DePalma et al. (U.S. Patent Application Publication No. 2018/0100847 A1), hereinafter DePalma.
Regarding claim 1, Yamashita discloses a mass spectrometry system, comprising:
a mass spectrometry device which has a mass analyzer configured to perform mass spectrometry on a plurality of compounds sequentially separated from a sample (paragraph 0009), and which is configured to generate quantification ion peaks and identification ion peaks derived from the compounds (FIG. 5A, peaks in chromatogram 504);
a processor (paragraph 0014) configured to identify, based on the quantification ion peaks and the identification ion peaks (FIG. 5A, peaks in chromatogram 504), measured retention times (paragraph 0060) and measured peak ratios corresponding to the compounds (paragraph 0064);
a processor (paragraph 0014) configured to calculate retention time errors (paragraph 0061) by comparing the measured retention times (paragraph 0060, retention times associated with chromatogram 504 and map 505) with standard retention times of the compounds (paragraph 0059, retention times associated with chromatogram 502 and map 501), and calculate peak ratio errors (paragraph 0061) by comparing the measured peak ratios (paragraph 0060, peaks associated with chromatogram 504) with standard peak ratios of the compounds (paragraph 0059, peaks associated with chromatogram 502); and
a processor (paragraph 0014) configured to plot (FIG. 5A, plot 506), in a coordinate system with a retention time error axis (paragraph 0059, ordinate) and a peak ratio error axis (FIG. 5A, plot 506, gray level/color axis), a plurality of elements representing error sets composed of the retention time errors and the peak ratio errors (paragraph 0061), and thereby create a chart for evaluating the quantification ion peaks and the identification ion peaks (paragraph 0061).
Yamashita fails to disclose that the system comprises a first processor, a second processor, and a third processor.
However, DePalma discloses a spectrometry system comprising multiple processors (paragraph 0023).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Yamashita to include that the system comprises a first processor, a second processor, and a third processor, based on the teachings of DePalma that the use of multiple processors improves system flexibility by enabling a variety of configurations and divisions of tasks between processors (DePalma, paragraph 0061).
Regarding claim 2, Yamashita in view of DePalma as applied to claim 1 discloses the mass spectrometry system according to claim 1.
In addition, Yamashita discloses an evaluator configured to evaluate the retention time errors (paragraph 0060) and the peak ratio errors (paragraph 0061), wherein
the chart contains information indicating a result of evaluation by the evaluator (FIG. 5A, line segments 503).
Regarding claim 3, Yamashita in view of DePalma as applied to claim 2 discloses the mass spectrometry system according to claim 2.
In addition, Yamashita discloses that the evaluator determines whether each of the retention time errors is within a first allowable range (paragraph 0052), and determines whether each of the peak ratio errors is within a second allowable range (paragraph 0057), and
the result of evaluation by the evaluator contains a determination result as to whether each of the retention time errors is within the first allowable range (paragraph 0053), and a determination result as to whether each of the peak ratio errors is within the second allowable range (paragraph 0053).
Regarding claim 4, Yamashita in view of DePalma as applied to claim 3 discloses the mass spectrometry system according to claim 3.
In addition, DePalma discloses that the information comprises an object indicating the first allowable range (FIG. 3, range
I
1
-
I
2
) and the second allowable range (FIG. 3, range
I
2
-
I
3
).
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Yamashita in view of DePalma to include that the information comprises an object indicating the first allowable range and the second allowable range, based on the additional teachings of DePalma that this information is valuable for determining additional characteristics of the sample (DePalma, paragraphs 0036-0038).
Regarding claim 7, Yamashita in view of DePalma as applied to claim 1 discloses the mass spectrometry system according to claim 1.
In addition, Yamashita discloses that each of the identification ion peaks comprises a first identification ion peak and a second identification ion peak (FIG. 5A, peaks in chromatogram 504),
each of the measured peak ratios comprises a first measured peak ratio and a second measured peak ratio (paragraph 0064),
each of the peak ratio errors comprises a first peak ratio error and a second peak ratio error (FIG. 5A: each bar in plot 506 is a separate error set), and
the elements comprise first elements representing error sets composed of the retention time errors and the first peak ratio errors, and second elements representing error sets composed of the retention time errors and the second peak ratio errors (FIG. 5A: each bar in plot 506 is a separate error set).
Regarding claim 8, Yamashita in view of DePalma as applied to claim 7 discloses the mass spectrometry system according to claim 7.
Features of an apparatus may be recited either structurally or functionally (In re Schreiber, 128 F.3d 1473, 1478, 44 USPQ2d 1429, 1432 (Fed. Cir. 1997)), but “apparatus claims cover what a device is, not what a device does” (Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990)(emphasis in original)). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim (Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987)), i.e., a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. See MPEP 2114. In the case at hand, Yamashita teaches the structural limitations of the mass spectrometry system, i.e., a processor which is capable of producing a plot with information regarding the retention time errors and peak ratio errors. Therefore, the limitations of the claim are met.
Regarding claim 9, Yamashita in view of DePalma as applied to claim 8 discloses the mass spectrometry system according to claim 8.
Features of an apparatus may be recited either structurally or functionally (In re Schreiber, 128 F.3d 1473, 1478, 44 USPQ2d 1429, 1432 (Fed. Cir. 1997)), but “apparatus claims cover what a device is, not what a device does” (Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990)(emphasis in original)). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim (Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987)), i.e., a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. See MPEP 2114. In the case at hand, Yamashita teaches the structural limitations of the mass spectrometry system, i.e., a processor which is capable of producing a plot with information regarding the retention time errors and peak ratio errors. Therefore, the limitations of the claim are met.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Fukuda et al. (U.S. Patent Application Publication No. 2024/0210366 A1), hereinafter Fukuda, teaches a mass spectrometry system, comprising: a mass spectrometry device which has a mass analyzer configured to perform mass spectrometry on a plurality of compounds sequentially separated from a sample, and which is configured to generate quantification ion peaks and identification ion peaks derived from the compounds; a first processor configured to identify, based on the quantification ion peaks and the identification ion peaks, measured retention times and measured peak ratios corresponding to the compounds; and a second processor configured to calculate retention time errors by comparing the measured retention times with standard retention times of the compounds, and calculate peak ratio errors by comparing the measured peak ratios with standard peak ratios of the compounds.
Maekawa et al. (U.S. Patent Application Publication No. 2020/0103380 A1), hereinafter Maekawa, teaches a mass spectrometry device which is configured to generate a first identification ion peak, a second identification ion peak, a first measured peak ratio, and a second measured peak ratio.
Du et al. (U.S. Patent Application Publication No. 2011/0049349 A1), hereinafter Du, teaches a processor configured to create a plot having a retention time error axis.
Tanaka (JP Patent No. 2018040655 A), hereinafter Tanaka (English machine translation provided), teaches a processor configured to create a plot having a peak ratio error axis.
Ran et al. (CN Patent No. 109061001 A), hereinafter Ran (English machine translation provided), teaches a processor configured to calculate peak ratio errors by comparing the measured peak ratios with standard peak ratios of the compounds.
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/A.K./Examiner, Art Unit 2881
/DAVID E SMITH/Examiner, Art Unit 2881
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