Prosecution Insights
Last updated: October 02, 2026
Application No. 18/481,469

DATA PROCESSING DEVICE FOR METABOLITE ANALYSIS

Non-Final OA §101§103§112
Filed
Oct 05, 2023
Priority
Jan 31, 2023 — JP 2023-013492
Examiner
SANFORD, DIANA PATRICIA
Art Unit
Tech Center
Assignee
SHIMADZU Corporation
OA Round
1 (Non-Final)
50%
Grant Probability
Moderate
1-2
OA Rounds
1y 6m
Est. Remaining
83%
With Interview

Examiner Intelligence

Grants 50% of resolved cases
50%
Career Allowance Rate
8 granted / 16 resolved
-10.0% vs TC avg
Strong +33% interview lift
Without
With
+33.3%
Interview Lift
resolved cases with interview
Typical timeline
4y 6m
Avg Prosecution
32 currently pending
Career history
46
Total Applications
across all art units

Statute-Specific Performance

§101
29.2%
-10.8% vs TC avg
§103
32.7%
-7.3% vs TC avg
§102
10.1%
-29.9% vs TC avg
§112
22.9%
-17.1% vs TC avg
Black line = Tech Center average estimate • Based on career data from 16 resolved cases

Office Action

§101 §103 §112
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 . Status of the Claims Claims 1-6 are pending and under consideration in this action. Priority This application claims foreign priority from Japanese Application 2023-013492, filed 01/31/2023, as reflected in the filing receipt mailed 11/22/2023. Acknowledgment is made of Applicant's claim for foreign priority based on an application filed in Japan on 01/31/2023. It is noted, however, that Applicant has not filed a certified copy of Application 2023-013492 as required by 37 CFR 1.55. Information Disclosure Statement The information disclosure statement (IDS) submitted on 10/05/2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the IDS’s has been considered by the examiner. A signed copy is included with this Office action. It is noted that certain references lack appropriate page numbers (NPL #2). The Examiner has annotated those references herein. Applicant is kindly reminded to provide proper citations in compliance with 37 CFR 1.97 in all future submissions to the office. Drawings The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character not mentioned in the description: S8 (or “Step 8” in Fig. 2). The drawings are also objected to as failing to comply with 37 CFR 1.84(p)(4) because reference characters "200" (Specification Para. [0021]) and "20" (Fig. 1) have both been used to designate the “metabolism-map-data storage section”. Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance. Claim Objections Claim 1 is objected to because of the following informalities: Claim 1 recites “a metabolite-measurement-result storage section in which a metabolite identified based on analysis data acquired by analyzing a test sample with one or more analyzers and a quantitative measurement result of the metabolite are stored”, which should be corrected to “a metabolite-measurement-result storage section in which a metabolite is identified based on analysis acquired by analyzing a test sample with one or more analyzers and a quantitative measurement result of the metabolite is stored” to correct the grammar for storing a quantitative measurement . Appropriate correction is required. Claim Rejections - 35 USC § 112(b) 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 1-6 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 1 recites the limitation “a metabolite-measurement-result storage section in which a metabolite identified based on analysis data acquired by analyzing a test sample with one or more analyzers and a quantitative measurement result of the metabolite are stored”. The metes and bounds of the claim are rendered indefinite due to the lack of clarity. It is unclear if the storage section is storing both the metabolite and a quantitative measurement, or if only the quantitative measurement for a metabolite is stored. If both the metabolite and the quantitative measurement are stored, Examiner suggests amendment of claim 1 to recite “a metabolite-measurement-result storage section in which both a metabolite and a quantitative measurement result of the metabolite are stored, wherein the metabolite is identified based on analysis data acquired by analyzing a test sample with one or more analyzers”. Note that this amendment includes the claim objection noted above. Claims 2-5 are also rejected due to their dependency on claim 1. Claims 1, 4, and 6 recite the phrase “when the metabolism-map display data stored in the metabolism-map-data storage section is read to display the (predetermined) metabolism map on the display screen”. The metes and bounds of the claim are rendered indefinite due to the lack of clarity. It is unclear what the phrase “is read to display” means. The Specification (see Para. [0005]) discloses that the device reads the metabolism-map display data from the storage section, creates a metabolism map in which the quantitative values (or similar data) of the metabolites are inserted, and displays the map on the display screen. Therefore, it appears that “display processor … is read to display” equates to the “display processor … is programmed/configured to display”; however, it is unclear if this is the intended interpretation. Clarification through clearer claim language is respectfully requested. Claims 2-3 and 5 are also rejected due to their dependency on claim 1. Claim 2 recites the limitation “wherein the one or more analyzers are a gas chromatograph mass spectrometer and a liquid chromatograph mass spectrometer”. The metes and bounds of the claim are rendered indefinite due to the lack of clarity. Claim 2 requires both a gas chromatograph mass spectrometer and a liquid chromatograph mass spectrometer to limit the one or more analyzers. It is therefore unclear if there is only one analyzer, which of the gas chromatograph mass spectrometer or liquid chromatograph mass spectrometer is required in the claimed device. Clarification through clearer claim language is respectfully requested. Claims 4-5 are also rejected due to their dependency on claim 2. Claim 4 recites the phrase “the metabolite-measurement-result storage section is configured so that…a quantitative measurement result obtained for a derivatization product formed by the derivatization process is stored and related to the metabolite” in lines 3-7 of the claim. The metes and bounds of the claim are rendered indefinite due to the lack of clarity. It is unclear what parameters the phrase “related to the metabolite” is associated with. For example, the phrase “related to the metabolite” could be interpreted as the quantitative measurement result is related to the metabolite, or that the storage is related to the metabolite (i.e., by some hardware component). Therefore, it is unclear what parameters or components are required to determine “related to the metabolite”. This rejection can be overcome by amendment of claim 4 to clarify what parameters or components are related to the metabolite. Claim 5 is also rejected due to its dependency on claim 4. Claim 6 recites the phrase “a metabolite-measurement-result storage section in which, for a metabolite identified based on analysis data acquired by analyzing a test sample with one or more analyzers, quantitative measurement results obtained for a plurality of derivatization products of the metabolite are stored and related to the metabolite”. The metes and bounds of the claim are rendered indefinite due to the lack of clarity. Analogous to claim 4 above, it is unclear what the phrase “related to the metabolite” is referring to (e.g., the quantitative measurement result is related to the metabolite, or that the storage is related to the metabolite). This rejection can be overcome by amendment of claim 6 to clarify what parameters or components are related to the metabolite. Claim Interpretation The following is a quotation of 35 U.S.C. 112(f): (f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof. The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph: An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof. The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked. As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph: (A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function; (B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and (C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function. Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function. Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function. Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: Claim 1: “a metabolite-measurement-result storage section in which a metabolite … and a quantitative measurement result of the metabolite are stored”. Claim 1: “a metabolism-map-data storage section in which metabolism-map display data for displaying, on a display screen, a metabolism map is stored for one or more metabolism maps…”. Claim 1: “a display processor configured to retrieve, for each metabolite on a predetermined metabolism map, a quantitative measurement result … and to display the quantitative measurement result…”. Claim 4: “the metabolite-measurement-result storage section is configured so that…a quantitative measurement result obtained for a derivatization product...is stored…”. Claim 4: “the display processor is configured to retrieve, from the metabolite-measurement-result storage section, the quantitative measurement result obtained for a derivatization product…and to insert and display the quantitative measurement result in the showing area for the metabolite on the metabolism map…”. Claim 5: “the display processor is configured so that…the display processor retrieves from the metabolite-measurement-result storage section, the quantitative measurement result obtained for a derivatization product…and inserts and displays the quantitative measurement result in the showing area for the metabolite on the metabolism map”. Claim 6: “a metabolite-measurement-result storage section in which, for a metabolite identified based on analysis data…quantitative measurement results obtained for a plurality of derivatization products of the metabolite are stored…”. Claim 6: “a metabolism-map-data storage section in which metabolism-map display data for displaying, on a display screen, a metabolism map showing a plurality of metabolites is stored…”. Claim 6: “a display processor configured to retrieve, for each metabolite on the metabolism map, a quantitative measurement result obtained for a derivatization product…from the metabolite-measurement-result storage section, and to insert and display the quantitative measurement result in the metabolism map…”. Because these claim limitations are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, they are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof. The instant Specification (see Para. [0015] and [0017]) discloses that the data processing device for metabolite analysis realized by the control-and-processing PC 2 includes, as its functional blocks, a metabolism-map-data storage section 20, 20 metabolite-information storage section 21, test-sample-analysis-result storage section 22, storage controller 23, data processor 24, analysis controller 25, method creation processor 26, display processor 27, information registration section 28, and metabolite selector 41 which is included in the input unit 4. The storage sections 20, 21, and 22 may be provided in different storage areas in one memory device (e.g., HDD or SSD), or they may be provided in separate memory devices. If applicant does not intend to have these limitations interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitations to avoid them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitations recite sufficient structure to perform the claimed function so as to avoid them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. Claim Rejections - 35 USC § 101 Claims 1-6 were analyzed under 35 U.S.C. 101 and it was found that independent claims 1 and 6 do not recite abstract ideas. In claims 1 and 6, the limitations reciting a metabolite-measurement-result storage section equate to gathering and storing data from an analyzer; the limitations reciting a metabolism-map-data storage section equate to displaying data received from the analyzer with specific features; and the limitations reciting a display processor configured to receive quantitative measurements and display a metabolism map equate to extra-solution steps of displaying the data map with specific features on a display screen. Therefore, claims 1-6 do not recite abstract ideas and are patent eligible under 35 U.S.C. 101. Claim Rejections - 35 USC § 103 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 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. 1. Claims 1-3 are rejected under 35 U.S.C. 103 as being unpatentable over Matsuda et al. (WIPO 2020230704 A1; published 11/19/2020; English Translation provided) in view of Wieder et al. (Pathway analysis in metabolomics: Recommendations for the use of over-representation analysis. PLoS Comput Biol. 17(9): e1009105 (23 pages) (2021); published 9/7/2021). Regarding claim 1, Matsuda et al. teaches an analysis device with an information acquisition means, an extraction means, and a presentation means, to identify various metabolites contained in biological samples (i.e., a data processing device for metabolite analysis) (Abstract, and Para. [0002], [0022]). Matsuda et al. further teaches that the analysis device comprises an auxiliary storage device that stores analysis results (Para. [0022]). When the analyzer is a chromatograph-mass spectrometer, graphs such as chromatograms and mass spectra are acquired as analytical data. Coordinate data representing each point on the graph (for example, numerical data such as pairs of retention time and signal intensity, or pairs of mass-to-charge ratio (m/z) value and signal intensity) may be obtained as analysis data (i.e., a metabolite-measurement-result storage section in which a metabolite identified based on analysis data acquired by analyzing a test sample with one or more analyzers and a quantitative measurement result of the metabolite are stored) (Para. [0020]). Matsuda et al. further teaches the use of a mapping tool that creates a metabolic map illustrating metabolic pathways. By using the mapping tool, a metabolic map can be created by incorporating quantitative values of metabolites contained in cell extracts of wild-type (WT), mutant (Δ1) and mutant (Δ2), making it possible to visualize quantitative changes in each metabolite caused by knocking out a specific gene (Para. [0029]). An example of the metabolic map display is shown in Fig. 3. This example shows the names of the metabolites produced in each reaction of the TCA cycle (Tricarboxyl Acid cycle), along with bar graphs representing the quantitative values of each metabolite in the wild-type (WT), mutant (Δ1), and mutant (Δ2) strains (i.e., a metabolism-map-data storage section in which metabolism-map display data for displaying, on a display screen, a metabolism map is stored for one or more metabolism maps, with each metabolism map showing a plurality of metabolites along with respective quantitative results) (Para. [0030]). Matsuda et al. further teaches that in the example in Fig. 3, the bar graphs, arranged from left to right on the page, show the quantitative values for the wild-type strain (WT), mutant strain (Δ1), and mutant strain (Δ2). Due to the nature of the LC column, metabolites that could not be detected are left blank in the graph. In this example, the quantitative changes in each metabolite resulting from the difference between the wild-type and mutant strains are shown in a graph. Therefore, by looking at the graph on the TCA circuit, users can manually select, for example, metabolites whose amounts are clearly reduced in the mutant strain (Δ2) compared to the wild-type strain (WT) (i.e., for each metabolite on a predetermined metabolism map, a quantitative measurement result corresponding to the metabolite from the metabolite-measurement-result storage section and to display the quantitative measurement result by inserting the quantitative measurement result into the showing area for the metabolite on the metabolism map, when the metabolism-map display data stored in the metabolism-map data storage section is read to display the predetermined metabolism map on the display screen) (Para. [0030]). Matsuda et al. further teaches that the analysis device is a personal computer, and that the software that constitutes each functional block of the analysis device is stored on an application server connected to the analysis device via a communication line (i.e., a display processor configured to receive a quantitative measurement result) (Para. [0049]). Regarding claim 2, Matsuda et al. teaches that the analytical instrument can include chromatographs such as LC (liquid chromatography) and GC (gas chromatography), and chromatograph-mass spectrometers such as LC/MS and GC/MS, which combine a chromatograph with a mass spectrometer (i.e., wherein the one or more analyzers are a gas chromatograph mass spectrometer and a liquid chromatograph mass spectrometer) (Para. [0020]). Matsuda et al. does not teach each metabolite having a showing area to which analyzer information representing a type of analyzer capable of detecting the metabolite is to be added (claim 1); and wherein the analyzer information added to the showing area for each metabolite on the metabolism map is color information for displaying at least a portion of the showing area in a color corresponding to the type of analyzer (claim 3). Regarding claim 1, Wieder et al. teaches a method for functional interpretation of metabolomics datasets using pathway analysis (Abstract). Wieder et al. further teaches the visualization of a pathway network, including the effects of assay type on the network. In the visualized network, the compounds are colored by assay type, as indicated in the legend. For example, orange compound circles correspond to RP/UPLC-MS/MS (hydrophilic) (ESI+) and yellow compound circles correspond to RP/UPLC-MS/MS (ESI-) (i.e., each metabolite having a showing area to which analyzer information representing a type of analyzer capable of detecting the metabolite is to be added) (Pg. 12, Para. 2-3 and Pg. 14, Fig. 6). Regarding claim 3, Wieder et al. teaches that on the pathway network, the compounds are shown in colored circles, colored by assay type, according to the assay type legend. For example, green compound circles correspond to RP/UPLC-MS/MS (hydrophobic) (ESI+) and blue compound circles correspond to HILIC UPLC-MS/MS (ESI-) (i.e., wherein the analyzer information added to the showing area for each metabolite on the metabolism map is color information for displaying at least a portion of the showing area in a color corresponding to the type of analyzer) (Pg. 14, Fig. 6). Therefore, regarding claims 1-3, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the analysis device for processing metabolic maps of Matsuda et al. with the coloring to indicate assay type of Wieder et al. because the method of Wieder et al. enables the visualization of accessible metabolic pathways using different types of assays as well as the degree of overlap between the pathways using the different assays, thereby eliminating bias introduced with a single assay type (Wieder et al., Pg. 12, Para. 2-3 and Pg. 14, Fig. 6). One of ordinary skill in the art would be able to combine the teachings of Matsuda et al. with Wieder et al. with reasonable expectation of success due to the same nature of the problem to be solved, since both are drawn towards a method for visualizing metabolic networks. Therefore, regarding claims 1-3, the instant invention is prima facie obvious (MPEP § 2142). 2. Claims 4-5 are rejected under 35 U.S.C. 103 as being unpatentable over Matsuda et al. in view of Wieder et al., as applied to claims 1-3 above, and further in view of Yang et al. (Establishment of GC–MS method for the determination of Pseudomonas aeruginosa biofilm and its application in metabolite enrichment analysis. J Chromatogr B Analyt Technol Biomed Life Sci. 1179: 122839 (7 pages) (2021); published 8/1/2021). Regarding claim 4, Matsuda et al. teaches the limitations of the metabolite-measurement-result storage section for storing a quantitative measurement related to the metabolite; and the display processor is configured to retrieve, from the metabolite-measurement-result storage section, the quantitative measurement result obtained and to insert and display the quantitative measurement result in the showing area for the metabolite on the metabolism map, when the metabolism-map display data stored in the metabolism-map-data storage section is read to display the metabolism map on the display screen as described for claim 1 above. Regarding claim 5, Matsuda et al. teaches the limitation of the display processor is configured so that, when quantitative measurement results obtained for a plurality of derivatization products are related to a metabolite and stored in the metabolite-measurement-result storage section, the display processor retrieves, from the metabolite-measurement-result storage section, the quantitative measurement result obtained and inserts and displays the quantitative measurement result in the showing area for the metabolite on the metabolism map as described for claim 1 above. Matsuda et al. further teaches the selection of metabolites that meet specific conditions (i.e., for a product that satisfies a predetermined condition among the plurality of products) (Para. [0026]). Matsuda et al. in view of Wieder et al., as applied to claims 1-3 above, does not teach a predetermined derivatization process is performed before the test sample is analyzed with an analyzer (claim 4); a derivatization product of a metabolite on the metabolism map (claim 4); and a derivatization product among the plurality of derivatization products (claim 5). Regarding claim 4, Yang et al. teaches a GC/MS method for quantification of metabolites in a biofilm and subsequent analysis in metabolic pathways (Abstract). Yang et al. further teaches that derivatization was performed by introducing silyl groups into the molecules before chromatographic analysis (i.e., a predetermined derivatization process is performed before the test sample is analyzed with an analyzer) (Pg. 5, Col. 2, Para. 2 and Pg. 3, Fig. 2). Yang et al. further teaches that the metabolite / metabolite derivatization products are visualized in a pathway network (i.e., a derivatization product of a metabolite on the metabolism map) (Pg. 6, Fig. 4). Regarding claim 5, Yang et al. teaches that derivatization was performed by introducing silyl groups into the molecules to generate palmitic and stearic acid, and the ion chromatogram for each compound was measured (i.e., a measurement of a derivatization product amount the plurality of derivatization products) (Pg. 5, Col. 2, Para. 2 and Pg. 3, Fig. 2). Therefore, regarding claims 4-5, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the analysis device for processing metabolic maps of Matsuda et al. in view of Wieder et al. with the derivatization process of Yang et al. because the method of Yang et al. enables the establishment of the relationship between the metabolic components in the metabolic pathway as well as provides a theoretical basis and the experimental and clinical inhibition of biofilms (Yang et al., Pg. 2, Col. 1, Para. 2). One of ordinary skill in the art would be able to combine the teachings of Matsuda et al. in view of Wieder et al. with Yang et al. with reasonable expectation of success due to the same nature of the problem to be solved, since both are drawn towards a method for analyzing metabolite analysis pathways. Therefore, regarding claims 4-5, the instant invention is prima facie obvious (MPEP § 2142). 3. Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Matsuda et al. (WIPO 2020230704 A1; published 11/19/2020; English Translation provided) in view of Yang et al. (Establishment of GC–MS method for the determination of Pseudomonas aeruginosa biofilm and its application in metabolite enrichment analysis. J Chromatogr B Analyt Technol Biomed Life Sci. 1179: 122839 (7 pages) (2021); published 8/1/2021). Regarding claim 6, Matsuda et al. teaches the limitations of a metabolite-measurement-result storage section in which, for a metabolite identified based on analysis data acquired by analyzing a test sample with one or more analyzers, quantitative measurement results of the metabolite are stored; and a metabolism-map-data storage section in which metabolism-map display data for displaying, on a display screen, a metabolism map showing a plurality of metabolites is stored for one or more metabolism maps as described for claim 1 above. Matsuda et al. further teaches a display processor configured to retrieve, for each metabolite on the metabolism map, a quantitative measurement result that satisfies a predetermined condition of the metabolite, from the metabolite-measurement-result storage section, and to insert and display the quantitative measurement result in the metabolism map, when the metabolism-map display data stored in the metabolism-map-data-storage section is read to display the metabolism map on the display screen as described for claims 1 and 5 above. Matsuda et al. does not teach that the quantitative results are obtained for a plurality of derivatization products. Regarding claim 6, Yang et al. teaches the limitation of quantitative results for a plurality of derivatization products for the metabolite as described for claims 4 and 5 above. Therefore, regarding claim 6, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the analysis device for processing metabolic maps of Matsuda et al. with the derivatization process of Yang et al. because the method of Yang et al. enables the establishment of the relationship between the metabolic components in the metabolic pathway as well as provides a theoretical basis and the experimental and clinical inhibition of biofilms (Yang et al., Pg. 2, Col. 1, Para. 2). One of ordinary skill in the art would be able to combine the teachings of Matsuda et al. with Yang et al. with reasonable expectation of success due to the same nature of the problem to be solved, since both are drawn towards a method for analyzing metabolite analysis pathways. Therefore, regarding claim 6, the instant invention is prima facie obvious (MPEP § 2142). Conclusion No claims allowed. Inquiries Any inquiry concerning this communication or earlier communications from the examiner should be directed to DIANA P SANFORD whose telephone number is (571)272-6504. The examiner can normally be reached Mon-Fri 8am-5pm EST. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Karlheinz Skowronek can be reached at (571)272-9047. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /D.P.S./Examiner, Art Unit 1687 /Lori A. Clow/Primary Examiner, Art Unit 1687
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Prosecution Timeline

Oct 05, 2023
Application Filed
Sep 22, 2026
Non-Final Rejection mailed — §101, §103, §112 (current)

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Prosecution Projections

1-2
Expected OA Rounds
50%
Grant Probability
83%
With Interview (+33.3%)
4y 6m (~1y 6m remaining)
Median Time to Grant
Low
PTA Risk
Based on 16 resolved cases by this examiner. Grant probability derived from career allowance rate.

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