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 § 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 1-4, 6-8 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over WO2015063886, hereinafter WO in view of Pascoe (U.S. Patent No. 5,813,015, hereinafter Pascoe).
With respect to Claim 1, WO discloses a chromatographic control device [see fig 1] that controls a chromatograph for performing an analysis of a sample by using any of a plurality of columns [31a-31e] and any of a plurality of mobile phases [10a-d], comprising:
a pH range registrar [75b] that registers a range of pH having a pH value of a mobile phase that is usable for an analysis with use of each column in association with identification information of each column; [See pages 3 and 5]
a pH registrar [75c] that registers a pH of each mobile phase; a column selector that selects a column to be used for an analysis; and [See page 3]
an analysis controller [7] controlling the chromatograph such that a mobile phase, having a pH that is registered in the pH registrar and out of a range of pH that is registered in the pH range registrar in association with a column selected by the column selector, is not supplied to the selected column, and controlling the chromatograph such that an analysis is performed while a mobile phase, having a pH that is registered in the pH range registrar and in a range of pH that is registered in the pH range registrar in association with the selected column, is supplied to the selected column [page 5]; and
a creator [70] that creates a batch file [page 5, method file] including combinations of each column and each mobile phase wherein the analysis controller controls the chromatograph such that an analysis is performed in accordance with the combinations of a column and a mobile phase included in the batch file.
WO does not explicitly disclose that the creator creates the batch file such that a combination of a column and a mobile phase having a pH that is registered in the pH register and out of a range of pH that is registered in the pH range registrar is not included in the batch file and does not disclose the creator removes from the batch file the combination of the column and the mobile phase having the pH that is registered in the pH registrar and is out of the range of the pH registered in the pH range registrar.
However, in light of Katsuyama's description of how "[t]he column attribute information
includes pH correspondence information indicating whether the column is compatible with a high pH mobile phase or a low pH mobile phase" (Katsuyama page 4 ), it would have been obvious to one of ordinary skill to create batch files with only combinations that were compatible, to avoid problems that might arise from the use of incompatible combinations. It thus would have been obvious to one of ordinary skill in the art to create a batch file such that "a combination of a column and a mobile phase having a pH that is registered in the pH register and out of a range of pH that is registered in the pH range registrar is not included in the batch file."
With a batch file having no incompatible combinations, one of ordinary skill would have understood that the analysis controller would control the chromatograph such that a mobile phase having a pH out of a
range of the pH registered in association with a column would not be supplied to the column, and a mobile phase having a pH in a range of pH registered in the pH range registrar in association with the selected column would be supplied to the column.
Second, to the extent the claims require a device the creates the method file, or otherwise recite creation of the method file, we find that taught in Katsuyama's description of how the method file is created "using the analysis condition setting processing unit 70" or "automatically." See Katsuyama page 4.
Moreover, Pascoe shows an example of specifically removing unwanted files, according to preselected criteria, to ensure they are not included. [column 4, lines 40-45].
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention that one way to ensure that certain combinations aren’t included in the batch file is to delete the unwanted combinations.
With respect to Claim 2, WO discloses further comprising a pH range receiver to which a range of pH of a mobile phase that is usable for an analysis with use of each column is input based on a user operation, wherein the pH range registrar registers a range of pH that is received by the pH range receiver in association with each column. See page 5, 2nd para.
With respect to Claim 3, WO discloses further comprising a pH receiver to which a pH of each mobile phase is input based on a user operation, wherein the pH registrar registers a pH received by the pH receiver in regard to each mobile phase. See page 5, first 2 paragraphs, user generates a method file with pH values of mobile phases
With respect to Claim 4, WO discloses further comprising: a mobile phase selector [steps 2 and 3] that automatically and sequentially selects the plurality of mobile phases as mobile phases to be used for an analysis; and an evaluator [5], wherein the column selector is configured to automatically and sequentially select the plurality of columns as columns to be used for an analysis, and the analysis controller controls the chromatograph such that a mobile phase, having a pH that is registered in the pH registrar and out of a range of pH that is registered in the pH range registrar in association with a column selected by the column selector, is not supplied to the selected column and a mobile phase, having a pH that is registered in the pH registrar and in a range of pH that is registered in the pH range registrar in association with the selected column is supplied to the selected column, and the evaluator evaluates a result of an analysis performed by the analysis controller.
With respect to Claim 6, WO discloses a chromatographic system comprising: a chromatograph [See page 2, 2nd para]; and the chromatographic control device according to claim 1, wherein the chromatograph includes a plurality of columns [31s-31e], a mobile phase supplier [18] that supplies any mobile phase out of a plurality of mobile phases to any column out of the plurality of columns, a sample supplier [2; see page 3] that supplies a sample to the column, and a detector [4] that detects a sample that has passed through the column.
With respect to Claim 7, WO discloses a chromatographic control method for controlling a chromatograph that performs an analysis of a sample by using any of a plurality of columns and any of a plurality of mobile phases, including the steps of: registering a range of pH having a pH value of a mobile phase that is usable for an analysis with use of each column in association with identification information of each column [page 5, 2nd para]; registering a pH of each mobile phase [page 5, 2nd para]; selecting a column to be used for an analysis [page 5, step 3]; and controlling the chromatograph such that a mobile phase, having a registered pH that is out of a range of pH that is registered in association with a selected column is not supplied to the selected column. See page 5, 3rd and 4th paragraphs.
WO does not disclose controlling the chromatograph such that an analysis is performed while a mobile phase, having a registered pH that is in a range of pH that is registered in association with the selected column, is supplied to the selected column removes from the batch file the combination of the column and the mobile phase having the pH that is registered in the pH registrar and is out of the range of the pH registered in the pH range registrar.
It would have been obvious to one of ordinary skill to create batch files with only combinations that were compatible, to avoid problems that might arise from the use of incompatible combinations. It thus would have been obvious to one of ordinary skill in the art to create a batch file such that "a combination of a column and a mobile phase having a pH that is registered in the pH register and out of a range of pH that is registered in the pH range registrar is not included in the batch file the creator removes from the batch file the combination of the column and the mobile phase having the pH that is registered in the pH registrar and is out of the range of the pH registered in the pH range registrar".
With a batch file having no incompatible combinations, one of ordinary skill would have understood that the analysis controller would control the chromatograph such that a mobile phase having a pH out of a range of the pH registered in association with a column would not be supplied to the column, and a mobile phase having a pH in a range of pH registered in the pH range registrar in association with the selected column would be supplied to the column.
With respect to Claim 8, WO discloses a non-transitory computer readable medium [wherever the method file in page 5, 2nd para is stored] storing a chromatographic control program that controls a chromatograph for performing an analysis of a sample by using any of a plurality of columns [31a-31e] and any of a plurality of mobile phases [10a-d; 11a-d], the chromatographic control program causing a processing device to execute the processes of: registering register a range of pH having a pH value of a mobile phase that is usable for an analysis with use of each column in association with identification information of each column [page 5, 2nd para]; registering register a pH of each mobile phase [page 5, second para]; selecting select a column to be used for an analysis; and controlling control the chromatograph such that a mobile phase, having a registered pH that is out of a range of pH that is registered in association with a selected column, is not supplied to the selected column, and controlling the chromatograph such that an analysis is performed while a mobile phase, having a registered pH that is in a range of pH that is registered in association with the selected column, is supplied to the selected column; and creating a batch file including combinations of each column and each mobile phase, wherein the process of controlling the chromatograph includes controlling the chromatograph such that an analysis is performed in accordance with the combinations of a column and a mobile phase included in the batch file. Page 5 describes how each column and mobile phase has corresponding pH values and are matched accordingly.
WO does not disclose that the process of creating a batch file includes creating the batch file such that a combination of a column and a mobile phase having a registered pH that is out of a range of pH that is registered is not included in the batch file, and removing from the batch file the combination of the column and the mobile phase having the pH that is registered in the pH registrar and is out of range of the pH registered in the pH range registrar.
It would have been obvious to one of ordinary skill to create batch files with only combinations that were compatible, to avoid problems that might arise from the use of incompatible combinations. It thus would have been obvious to one of ordinary skill in the art to create a batch file such that " the process of creating a batch file includes creating the batch file such that a combination of a column and a mobile phase having a registered pH that is out of a range of pH that is registered is not included in the batch file, and removing from the batch file the combination of the column and the mobile phase having the pH that is registered in the pH registrar and is out of range of the pH registered in the pH range registrar ".
With a batch file having no incompatible combinations, one of ordinary skill would have understood that the analysis controller would control the chromatograph such that a mobile phase having a pH out of a range of the pH registered in association with a column would not be supplied to the column, and a mobile phase having a pH in a range of pH registered in the pH range registrar in association with the selected column would be supplied to the column.
Response to Arguments
Applicant's arguments filed 20 October 2025 have been fully considered but they are not persuasive.
On page 11, the applicant argues that the board erred because Katsuyama doesn’t use pH compatibility data during the creation of the batch file. The applicant continues on page 12 that Katsuyama’s correction is reactive, not preventative, and that proactive exclusion eliminations the risk of erroneous or unsafe analyses. Katsuyama is already concerned with unsafe analysis and prevents an incompatible combination from being analyzed. There is not a functional difference between deleting the incompatible matches during creation of the batch file and removing them before executing the instructions given in the batch file.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.U.S. Patent No. 4,841,456 shows removing unwanted data from a file [column 9, lines 20-25]
U.S. Publication No. 2003/0167259 shows purging erroneous data from a file [para 60]
U.S. Publication No. 2002/0054383 shows deleting incompatible data from a file [para 113]
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALEX T DEVITO whose telephone number is (571)270-7551. The examiner can normally be reached 12pm- 8 pm EST M-S.
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/ALEX T DEVITO/Examiner, Art Unit 2855
/JOHN E BREENE/Supervisory Patent Examiner, Art Unit 2855