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 .
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 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.
Response to Amendment
The amendments to the claims, specification, and drawings filed 03/26/2026 have been considered and entered.
Terminal Disclaimer
The terminal disclaimer filed 06/03/2026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of USPN 12292420 has been reviewed and is accepted. The terminal disclaimer has been recorded.
The Examiner helpfully suggests that in the future, Applicant may wish to consider using an (electronic) eTerminal Disclaimer. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/ patents/apply/applying-online/eterminal-disclaimer.
Response to Arguments
Applicant's arguments filed 03/26/2026 have been fully considered.
Regarding the objection(s) to the Title, Applicant argued that the amendment overcame said objection(s); the Examiner is in agreement, therefore said objection(s) has/have been withdrawn.
Regarding the double patenting rejection(s) over U.S. Patent No. 12292420, Applicant provided a terminal disclaimer, therefore said rejection(s) have been withdrawn.
Regarding the provisional double patenting rejection(s) over copending application 18/371,405, Applicant improperly provided no argument; however, Applicant did amend the independent claim(s), which the Examiner has construed as at least an attempt to address said rejection(s). The Examiner has reviewed the amendments in (one-way) comparison to the copending application; the provisional double patenting rejection(s) over copending application 18/371,405 has/have been withdrawn.
Regarding the 103 prior art rejection(s) of previous claim(s) 5 (which had in the alternative different limitations) and now amended independent claim 1 & amended independent claim 10, Applicant traversed the Examiner’s Official Notice pertaining to flowrate being related to time and volume and the Examiner’s analysis pertaining to waiting on the operation of the pump for a sufficient period of time passing for proper measurements as being at least implicitly involving consideration of flowrate (at least to some accuracy). In response thereto (as well as the amendment), and in accordance with MPEP § 2144.03(C), the Examiner has relied upon Applicant newly cited JP 2002277451 A “Okada” as factual evidence of the aforementioned knowledge, the Examiner emphasizing that Okada teaches wherein determining the volume reduction behavior is under consideration of a flow rate and a conveyance time according to which the mobile phase (mobile phase) is driven (via pump) from the at least one mobile phase container (fig. 1, mobile phase containers 1 & 2) through the sample separation apparatus (fig. 1, Liquid Chromatograph) ([0010] “The mobile phase is sent to a column 5 at a predetermined flow rate by a liquid sending pump unit 3”; about middle of page 4 “Prior to the start of the analysis, the mobile phase required amount calculation unit 13 obtains information g on the mobile phase flow rate and the analysis time from the program control section 11 and obtains the required mobile phase amount d in the next analysis”; second paragraph of page 5 “the rotation speed of the liquid sending pump unit 3 is proportional to the liquid sending amount, the number of rotations of the liquid sending pump unit 3 is counted and moved”; third paragraph of page 4 “The management of the mobile phase during the continuous analysis is performed as follows. The mobile phase consumption calculating unit 14 obtains the liquid feeding amount information f of the liquid feeding pump unit 3 from the program control unit 11, calculates the mobile phase consumption e by integrating the obtained information with time, and converts the value into the mobile phase consumption value. It is sent to the remaining amount calculating section 15, where the mobile phase remaining amount c is calculated by subtracting the mobile phase consumption amount e from the capacity value h of the mobile phase container 1”). The Examiner emphasizes that Okada is factual evidence supporting the Examiner’s notice as well as the Examiner’s position that an ordinary artisan would be expected to know (at least to some degree sufficient for waiting a period of time to pass for measurement of the decreases in liquids in the container) a flowrate & conveyance time associated with use of a mobile phase pump. It therefore remains the Examiner’s position that either one of ordinary skill in the art at the time the invention was effectively filed would at once envisaged that Isoi’s sufficient amount of time for liquid volume change implicitly or inherently involves knowledge about flowrate (at least to some accuracy), or nevertheless, or in the alternative, it would have been trivially obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the conventional knowledge of the relationship between flowrate, time, & volume with Isoi’s requirement for measurement sufficiency to determine based on flowrate & time if a sufficient volume change for reliable measurements has occurred and thus decreasing possibility of analysis occurring too soon to be reliable or unnecessarily too late to interrupt to prevent wastage. See present rejections for further details. See also Conclusion which includes additional prior art that likewise provide factual evidence of the Examiner’s assertion.
Furthermore, MPEP § 2111 requires that during patent examination, the pending claims must be given their broadest reasonable interpretation consistent with the specification, and an Examiner must construe claim terms in the broadest reasonable manner during prosecution as is reasonably allowed in an effort to establish a clear record of what applicant intends to claim. The Examiner verified the meaning of ‘under consideration” in the specification (e.g., see [0044]) to see if a special definition precluded the plain meaning. No such special definition was found. The Examiner identifies that the plain meaning of “under consideration”, and more specifically “under consideration of a flow rate” includes the broad and reasonable interpretation of waiting a sufficiently long time on the pump based on (at least rough) knowledge of estimated flow rate.
Regarding new claim 17, Applicant provided no argument. However, it is the Examiner’s position that including a flow rate sensor to merely measure flow rate for a sample separation apparatus is conventional in the art, and the Examiner relied upon Applicant previously cited EP 2244091 A1 “Witt” to teach measuring flow rate by a flow rate sensor (flow rate sensors 112 with 114; exemplary positions shown in fig. 1). See present rejections for details.
Regarding new claim 16, the Examiner has indicated allowable subject matter.
Information Disclosure Statement
The information disclosure statement(s)
(IDS) submitted on 03/05/2026 & 07/09/2026 is/are in compliance
with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement(s) is/are being considered by the Examiner.
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) 1-3, 5-7, and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Applicant previously cited Isoi (US 20190257731 A1; hereafter “Isoi”) in view of previously cited factual evidence Poole (NPL Encyclopedia of Separation Science; hereafter “Poole’s Encyclopedia”) and in further view of Applicant cited Okada* (JP 2002277451 A; hereafter “Okada”) utilized as factual evidence.
*machine translation provided by Examiner with foreign document and utilized for English citations
Regarding independent claim 1,
Isoi teaches in a sample separation apparatus (liquid chromatography analysis system) for separating (at once so envisaged that a chromatography system utilizing mobile phase inherently/implicitly includes separating; additional obviousness analysis provided) a fluidic sample (liquid sample) using a mobile phase (mobile-phase) provided from at least one mobile phase container (fig. 1, container 6) (Title “ANALYTICAL LIQUID MONITORING DEVICE”; Abstract “a liquid-for-analysis determining part configured to obtain a variation ΔM between a weight of the container weighed by the weighing scale before a decreasing operation that decreases the liquid for analysis and a weight of the container weighed by the weighing scale after the decreasing operation, and determine whether the liquid for analysis has been normally used in the decreasing operation or not, based on the obtained variation ΔM, a volume V of the decrease in the liquid in the container in the decreasing operation”; [0011] “if a liquid for analysis is not normally used, a liquid different from the liquid for analysis that needs to be used is actually used in a decreasing operation that decreases the liquid for analysis, or an analyzer does not operate normally. Because a user disposes a wrong liquid for analysis or connects a liquid for analysis to a wrong pipe, a liquid different from the liquid for analysis that needs to be used is actually used”), a method of determining a density of the mobile phase (mobile-phase), the method comprising:
determining a weight (via weighing scales 8) and volume reduction (volume V of the decrease in the liquid in the container) behavior according to which weight and volume the mobile phase (mobile-phase) in the at least one mobile phase container (fig. 1, container 6) are reduced during conveying (fed through an analysis path) the mobile phase (mobile-phase) from the at least one mobile phase container (fig. 1, container 6) into the sample separation apparatus (liquid chromatography analysis system) ([0025] “mobile phases fed through an analysis flow path in a liquid chromatograph”; [0014] “calculates an amount of feeding of a liquid for analysis based on an amount of an operation of a feed pump, a volume V of consumption of a liquid for analysis in a decreasing operation is calculated using the function of the analyzer”; [0026] “the liquid-for-analysis monitor 4 includes weighing scales 8a to 8d and the system controller 10. The weighing scales 8a to 8d weigh the containers 6a to 6d, respectively, and are electronic scales, for example”);
determining the weight and volume reduction (volume V of the decrease in the liquid in the container) behavior is under consideration of (the Examiner emphasizes this is a broad and reasonable interpretation for consideration) a flow rate (implicit to the time being sufficient and to amount of an operation of a feed pump; additional obviousness analysis provided) and a conveyance time (time is explicit) according to which the mobile phase (mobile-phase) is driven from the at least one mobile phase container (fig. 1, container 6) through the sample separation apparatus (liquid chromatography analysis system) ([0029] “When a decreasing operation has decreased some liquids for analysis (e.g. feeding of a mobile phase or cleaning with a cleaning liquid), the liquid-for-analysis determining part 14 determines whether the decreasing operation has used correct liquids for analysis as scheduled or not, based on differences ΔM between weights M1 of containers that correspond to the liquids for analysis at a time and a weights M2 of the containers after a period of time passes that is sufficiently long for measurement of the decreases in liquids in the container, densities ρ of liquids for analysis that need to be used in the decreasing operation, and volumes V of consumption of the liquids for analysis in the decreasing operation (or a proportion between volumes V)”; [0036], [0040] “After a period of time passes that is sufficiently long for measurement”; [0014] “analysis based on an amount of an operation of a feed pump”);
determining the density (ρ’) of the mobile phase (mobile-phase) based on the determined weight (ΔM of weighed container) and volume reduction (volume V of the decrease in the liquid in the container) behavior ([0012] “the liquid-for-analysis determining part is configured to obtain a density ρ′ of the liquid contained in the container by dividing the variation ΔM between a weight of the container before the decreasing operation and a weight of the container after the decreasing operation by the volume V of the decrease in the liquid in the container in the decreasing operation”).
Isoi doesn’t explicitly state items: 1) that the chromatography apparatus is a separation apparatus for separating; and 2) wherein the determination is under consideration of a flow rate.
Regarding item 1):
The Examiner previously took Official Notice that chromatography conventionally uses separation techniques. As the Applicant had not adequately traversed this assertion, this is considered admitted prior art in accordance with MPEP § 2144.03(C).
Furthermore, and as supporting factual evidence of the aforementioned assertion, Poole’s Encyclopedia teaches “Chromatography is the most widely used separation technique” (Chapter Chromatography, first sentence of Introduction).
In view of the above, either one of ordinary skill in the art at the time the invention was effectively filed would at once envisaged that Isoi’s chromatography is utilized for separating, or nevertheless, or in the alternative, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize well-known and widely used separation techniques—as factually supported by Pool’s Encyclopedia—for the self-definitional motivation and/or for the expected purpose of analysis, isolation, purification, and/or for distinguishing individual compounds.
Regarding item 2):
The Examiner previously took Official Notice that flowrate (Q) multiplied by time (t) is volume (V): Q*t=V (or put another way t=V/Q). Applicant appears to be traversing this notice.
In view of Applicant’s amendment, clarifying remarks, and traversal, the Examiner notes as supporting factual evidence from the same field of endeavor (sample separation apparatus) and pertaining directly to the aforementioned understanding of the above formulaic relationship between time and flowrate and volume for mobile phase pumps, Okada teaches in a sample separation apparatus (fig. 1, Liquid Chromatograph) for separating a fluidic sample using a mobile phase (mobile phase) provided from at least one mobile phase container (fig. 1, mobile phase containers 1 & 2) (Title “LIQUID CHROMATOGRAPH”; Abstract) a method comprising: determining a volume reduction behavior according to which volume the mobile phase (mobile phase) in the at least one mobile phase container (fig. 1, mobile phase containers 1 & 2) are reduced during conveying the mobile phase (mobile phase) from the at least one mobile phase container (fig. 1, mobile phase containers 1 & 2) into the sample separation apparatus (fig. 1, Liquid Chromatograph), wherein determining the volume reduction behavior is under consideration of a flow rate and a conveyance time according to which the mobile phase (mobile phase) is driven from the at least one mobile phase container (fig. 1, mobile phase containers 1 & 2) through the sample separation apparatus (fig. 1, Liquid Chromatograph) ([0010] “The mobile phase is sent to a column 5 at a predetermined flow rate by a liquid sending pump unit 3”; about middle of page 4 “Prior to the start of the analysis, the mobile phase required amount calculation unit 13 obtains information g on the mobile phase flow rate and the analysis time from the program control section 11 and obtains the required mobile phase amount d in the next analysis”; second paragraph of page 5 “the rotation speed of the liquid sending pump unit 3 is proportional to the liquid sending amount, the number of rotations of the liquid sending pump unit 3 is counted and moved”; third paragraph of page 4 “The management of the mobile phase during the continuous analysis is performed as follows. The mobile phase consumption calculating unit 14 obtains the liquid feeding amount information f of the liquid feeding pump unit 3 from the program control unit 11, calculates the mobile phase consumption e by integrating the obtained information with time, and converts the value into the mobile phase consumption value. It is sent to the remaining amount calculating section 15, where the mobile phase remaining amount c is calculated by subtracting the mobile phase consumption amount e from the capacity value h of the mobile phase container 1”). The Examiner emphasizes that Okada is factual evidence supporting the Examiner’s notice as well as the Examiner’s position that an ordinary artisan would be expected to know (at least to some degree sufficient for waiting a period of time to pass for measurement of the decreases in liquids in the container) a flowrate & conveyance time associated with a mobile phase pump.
Therefore, in view of the above, it remains the Examiner’s position that either one of ordinary skill in the art at the time the invention was effectively filed would at once envisaged that Isoi’s sufficient amount of time for liquid volume change implicitly or inherently involves knowledge about flowrate (at least to some accuracy), or nevertheless, or in the alternative, it would have been trivially obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the conventional knowledge of the relationship between flowrate, time, & volume with Isoi’s requirement for measurement sufficiency to determine based on flowrate & time if a sufficient volume change for reliable measurements has occurred and thus decreasing possibility of analysis occurring too soon to be reliable or unnecessarily too late to interrupt to prevent wastage. The Examiner emphasizes that at the least this is a broad and reasonable interpretation for the under consideration limitation which includes merely knowing that period of time is sufficient long for (at least a very rough understanding/boundary) of the flowrate for a proper measurement, and furthermore, even under a more narrow interpretation, factual evidence Okada shows the expectation of knowledge of an ordinary artisan of consideration of a more precise/accurate mobile phase pump flow rate and conveyance time according to which the mobile phase is driven from the at least one mobile phase container through the sample separation apparatus.
Regarding independent claim 10,
Isoi teaches a method of controlling a sample separation apparatus (liquid chromatography analysis system) for separating (at once so envisaged that a chromatography system utilizing mobile phase inherently/implicitly includes separating; additional obviousness analysis provided) a fluidic sample (liquid sample) using a mobile phase (mobile-phase) provided from at least one mobile phase container (fig. 1, container 6) (Title “ANALYTICAL LIQUID MONITORING DEVICE”; Abstract “a liquid-for-analysis determining part configured to obtain a variation ΔM between a weight of the container weighed by the weighing scale before a decreasing operation that decreases the liquid for analysis and a weight of the container weighed by the weighing scale after the decreasing operation, and determine whether the liquid for analysis has been normally used in the decreasing operation or not, based on the obtained variation ΔM, a volume V of the decrease in the liquid in the container in the decreasing operation”; [0011] “if a liquid for analysis is not normally used, a liquid different from the liquid for analysis that needs to be used is actually used in a decreasing operation that decreases the liquid for analysis, or an analyzer does not operate normally. Because a user disposes a wrong liquid for analysis or connects a liquid for analysis to a wrong pipe, a liquid different from the liquid for analysis that needs to be used is actually used”), the method comprising:
determining a weight and volume reduction (volume V of the decrease in the liquid in the container) behavior according to which weight and volume of the mobile phase (mobile-phase) in the at least one mobile phase container (fig. 1, container 6) are reduced during conveying (fed through an analysis path) the mobile phase (mobile-phase) from the at least one mobile phase container (fig. 1, container 6) into the sample separation apparatus (liquid chromatography analysis system) ([0025] “mobile phases fed through an analysis flow path in a liquid chromatograph”; [0014] “calculates an amount of feeding of a liquid for analysis based on an amount of an operation of a feed pump, a volume V of consumption of a liquid for analysis in a decreasing operation is calculated using the function of the analyzer”; [0026] “the liquid-for-analysis monitor 4 includes weighing scales 8a to 8d and the system controller 10. The weighing scales 8a to 8d weigh the containers 6a to 6d, respectively, and are electronic scales, for example”);
wherein the determining the weight and volume reduction (volume V of the decrease in the liquid in the container) behavior is under consideration of (the Examiner emphasizes this is a broad and reasonable interpretation for consideration) a flow rate (implicit to the time being sufficient and to amount of an operation of a feed pump; additional obviousness analysis provided) and a conveyance time (time is explicit) according to which the mobile phase (mobile-phase) is driven from the at least one mobile phase container (fig. 1, container 6) through the sample separation apparatus (liquid chromatography analysis system) ([0029] “When a decreasing operation has decreased some liquids for analysis (e.g. feeding of a mobile phase or cleaning with a cleaning liquid), the liquid-for-analysis determining part 14 determines whether the decreasing operation has used correct liquids for analysis as scheduled or not, based on differences ΔM between weights M1 of containers that correspond to the liquids for analysis at a time and a weights M2 of the containers after a period of time passes that is sufficiently long for measurement of the decreases in liquids in the container, densities ρ of liquids for analysis that need to be used in the decreasing operation, and volumes V of consumption of the liquids for analysis in the decreasing operation (or a proportion between volumes V)”; [0036], [0040] “After a period of time passes that is sufficiently long for measurement”; [0014] “analysis based on an amount of an operation of a feed pump”);
determining a density (ρ’) of the mobile phase (mobile-phase) based on the determined weight (ΔM of weighed container) and volume reduction (volume V of the decrease in the liquid in the container) behavior ([0012] “the liquid-for-analysis determining part is configured to obtain a density ρ′ of the liquid contained in the container by dividing the variation ΔM between a weight of the container before the decreasing operation and a weight of the container after the decreasing operation by the volume V of the decrease in the liquid in the container in the decreasing operation”); and
controlling (e.g., interrupting operation and/or displaying/sounding warning to user) the sample separation apparatus (liquid chromatography analysis system) based on a result of the determining the density (ρ’) of the mobile phase (mobile-phase) ([0017] “a warning part that gives warning to a user when the liquid-for-analysis determining part determines that the liquid(s) for analysis has/have not been normally used in the decreasing operation. As a result, a user easily notices and quickly deals with disposition of a wrong liquid for analysis, a liquid for analysis connected to a wrong pipe, or an analyzer not normally operating”; [0032]; [0033] “When the liquid-for-analysis determining part 14 determines “abnormal use,” the warning part 16 gives warning to a user. For example, the warning may be displayed on a monitor connected to the system controller 10 and inform of abnormal use. Alternatively, the warning may be warning sound”; [0034] “Further, when the liquid-for-analysis determining part 14 determines “abnormal use,” the system controller 10 may transmit an instruction to the analyzer 2 so that the analyzer 2 interrupts a current operation, in addition to or instead of the warning”; [0038]; [0042]; [0043] “Consequently, if a user does not correctly dispose the liquids A to D for analysis or connects the liquids A to D for analysis to wrong tubes, for example, the liquid-for-analysis monitor 4 detects the error as abnormal use when an operation that consumes the liquids for analysis starts”).
Isoi doesn’t explicitly state items: 1) that the chromatography apparatus is a separation apparatus for separating; and 2) wherein the determination is under consideration of a flow rate.
Regarding item 1):
The Examiner previously took Official Notice that chromatography conventionally uses separation techniques. As the Applicant had not adequately traversed this assertion, this is considered admitted prior art in accordance with MPEP § 2144.03(C).
Furthermore, and as supporting factual evidence of the aforementioned assertion, Poole’s Encyclopedia teaches “Chromatography is the most widely used separation technique” (Chapter Chromatography, first sentence of Introduction).
In view of the above, either one of ordinary skill in the art at the time the invention was effectively filed would at once envisaged that Isoi’s chromatography is utilized for separating, or nevertheless, or in the alternative, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize well-known and widely used separation techniques—as factually supported by Pool’s Encyclopedia—for the self-definitional motivation and/or for the expected purpose of analysis, isolation, purification, and/or for distinguishing individual compounds.
Regarding item 2):
The Examiner previously took Official Notice that flowrate (Q) multiplied by time (t) is volume (V): Q*t=V (or put another way t=V/Q). Applicant appears to be traversing this notice.
In view of Applicant’s amendment, clarifying remarks, and traversal, the Examiner notes as supporting factual evidence that Okada teaches in a sample separation apparatus (fig. 1, Liquid Chromatograph) for separating a fluidic sample using a mobile phase (mobile phase) provided from at least one mobile phase container (fig. 1, mobile phase containers 1 & 2) (Title “LIQUID CHROMATOGRAPH”; Abstract) a method comprising: determining a volume reduction behavior according to which volume the mobile phase (mobile phase) in the at least one mobile phase container (fig. 1, mobile phase containers 1 & 2) are reduced during conveying the mobile phase (mobile phase) from the at least one mobile phase container (fig. 1, mobile phase containers 1 & 2) into the sample separation apparatus (fig. 1, Liquid Chromatograph), wherein determining the volume reduction behavior is under consideration of a flow rate and a conveyance time according to which the mobile phase (mobile phase) is driven from the at least one mobile phase container (fig. 1, mobile phase containers 1 & 2) through the sample separation apparatus (fig. 1, Liquid Chromatograph) ([0010] “The mobile phase is sent to a column 5 at a predetermined flow rate by a liquid sending pump unit 3”; about middle of page 4 “Prior to the start of the analysis, the mobile phase required amount calculation unit 13 obtains information g on the mobile phase flow rate and the analysis time from the program control section 11 and obtains the required mobile phase amount d in the next analysis”; second paragraph of page 5 “the rotation speed of the liquid sending pump unit 3 is proportional to the liquid sending amount, the number of rotations of the liquid sending pump unit 3 is counted and moved”; third paragraph of page 4 “The management of the mobile phase during the continuous analysis is performed as follows. The mobile phase consumption calculating unit 14 obtains the liquid feeding amount information f of the liquid feeding pump unit 3 from the program control unit 11, calculates the mobile phase consumption e by integrating the obtained information with time, and converts the value into the mobile phase consumption value. It is sent to the remaining amount calculating section 15, where the mobile phase remaining amount c is calculated by subtracting the mobile phase consumption amount e from the capacity value h of the mobile phase container 1”). The Examiner emphasizes that Okada is factual evidence supporting the Examiner’s notice as well as the Examiner’s position that an ordinary artisan would be expected to know (at least to some degree sufficient for waiting a period of time to pass for measurement of the decreases in liquids in the container) a flowrate & conveyance time associated with a mobile phase pump.
Therefore, in view of the above, it remains the Examiner’s position that either one of ordinary skill in the art at the time the invention was effectively filed would at once envisaged that Isoi’s sufficient amount of time for liquid volume change implicitly or inherently involves knowledge about flowrate (at least to some accuracy), or nevertheless, or in the alternative, it would have been trivially obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the conventional knowledge of the relationship between flowrate, time, & volume with Isoi’s requirement for measurement sufficiency to determine based on flowrate & time if a sufficient volume change for reliable measurements has occurred and thus decreasing possibility of analysis occurring too soon to be reliable or unnecessarily too late to interrupt to prevent wastage. The Examiner emphasizes that at the least this is a broad and reasonable interpretation for the under consideration limitation which includes merely knowing that period of time is sufficient long for (at least a very rough understanding/boundary) of the flowrate for a proper measurement, and furthermore, even under a more narrow interpretation, factual evidence Okada shows the expectation of knowledge of an ordinary artisan of consideration of a more precise/accurate mobile phase pump flow rate and conveyance time according to which the mobile phase is driven from the at least one mobile phase container through the sample separation apparatus.
Regarding claim 2, which depends on claim 1,
Isoi teaches comprising determining the density of the mobile phase (mobile-phase) using a gradient of the determined weight (ΔM of weighed container) and volume reduction (volume V of the decrease in the liquid in the container) behavior (Abstract “obtain a variation ΔM” and “a volume V of the decrease in the liquid in the container in the decreasing operation”; [0015] “analysis consumed in gradient liquid feeding, for example, is calculated using analysis program”; [0030] “analysis are used to perform gradient liquid feeding in an analysis” and “gradient liquid feeding and stores the measurement values in a memory element, for example. After a fixed period of time passes from the start of the gradient liquid feeding”).
Regarding claim 3, which depends on claim 1,
Isoi teaches comprising at least one of the following features:
wherein the method comprises measuring a gross weight information and/or the weight reduction behavior (Abstract “liquid-for-analysis determining part configured to obtain a variation ΔM between a weight of the container weighed by the weighing scale before a decreasing operation that decreases the liquid for analysis and a weight of the container weighed by the weighing scale after the decreasing operation”);
(silent) wherein the method comprises receiving a gross weight information from a user input;
wherein the method comprises determining a gross weight information based on at least one of an assumption, an experience, and a previous measurement (Abstract “weighed by the weighing scale before a decreasing operation”).
Regarding claim 5, which depends on claim 1,
Isoi teaches comprising:
determining a weight and volume characteristic of the at least one mobile phase container (fig. 1, container 6) (Abstract “A liquid-for-analysis monitor includes: a weighing scale that weighs a container that contains a liquid as a liquid for analysis that needs to be used in analysis”; [0014] “calculates an amount of feeding of a liquid for analysis based on an amount of an operation of a feed pump, a volume V of consumption of a liquid for analysis in a decreasing operation is calculated using the function of the analyzer”; [0037] “obtained amount of consumption of the liquid corresponds to a volume V.sub.A of a decrease in a liquid in the container 6a in the decreasing operation”); and
identifying the at least one mobile phase container (fig. 1, container 6) (e.g., identify container 6a having liquid A) based on a comparison of the determined weight (ΔM of weighed container) and volume characteristic of the at least one mobile phase container (fig. 1, container 6) with a pre-known reference weight and volume characteristic of one or more reference mobile phase containers (fig. 1, containers 6) with a pre-known identity (A is in container 6a, B is in container 6b, and so forth) ([0024] “Containers 6a to 6d that contain liquids as liquids A to D for analysis that are used for analysis are disposed in the analyzer 2” and “Disposing the containers 6a to 6d includes disposing the containers 6a to 6d at specific positions, or connecting the containers 6a to 6d to specific pipes”; [0031] “the liquid-for-analysis determining part 14 determines that the container(s) the densities of which do not correspond with each other contain(s) a liquid that is not a liquid for analysis that needs to be contained. In this case, the liquid-for-analysis determining part 14 determines “abnormal use””; [0036] “container 6a that corresponds to the liquid A”; [0043] “liquid-for-analysis monitor 4 described above determines whether liquids for analysis that need to be used are used as scheduled in an operation or not, based on variations ΔM between weights of the containers 6a to 6d before the decrease and weights of the containers 6a to 6d after the decrease, densities ρ of corresponding liquids for analysis, and amounts of consumption of liquids in the containers 6a to 6d or a consumption proportion between liquids in the containers 6a to 6d in a decreasing operation. Consequently, if a user does not correctly dispose the liquids A to D for analysis or connects the liquids A to D for analysis to wrong tubes, for example, the liquid-for-analysis monitor 4 detects the error as abnormal use when an operation that consumes the liquids for analysis start”; SUMMARY OF THE INVENTION [0004] “A user needs to dispose a plurality of containers that contain liquids for analysis in specific positions, respectively, and needs to connect the plurality of containers with specific pipes, respectively. If a wrong kind of liquid for analysis is disposed or a liquid for analysis is connected to a wrong pipe, composition of a mobile phase becomes different from an intended composition, or a liquid different from a liquid for analysis that needs to be used is used. Consequently, analysis is not normally performed”; the Examiner still emphasizes that the liquid-for-analysis monitoring identifies by the weight & volume characteristics whether the mobile phase containers have been swapped—in other words user placed say container “a” with “A” not in the proper specific position but instead say placed container “b” with “B” in said specific position and vice versa—or are the appropriately identified mobile phase containers as intended and therefore not abnormal. Put another way, for Isoi, disposing the wrong container is disposing the wrong liquid and disposing the wrong liquid is disposing the wrong container, likewise disposing right container is disposing the right liquid and disposing the right liquid is disposing the right container, as liquid “A” is inherently in container denoted “a” per the defined nomenclature, and so forth).
Regarding claim 6, which depends on claim 5,
Isoi teaches comprising one of the following features:
providing an information about the identified at least one mobile phase container (fig. 1, container 6) to a user of the sample separation apparatus (liquid chromatography analysis system) ([0017] “a warning part that gives warning to a user when the liquid-for-analysis determining part determines that the liquid(s) for analysis has/have not been normally used in the decreasing operation. As a result, a user easily notices and quickly deals with disposition of a wrong liquid for analysis, a liquid for analysis connected to a wrong pipe, or an analyzer not normally operating”; [0032]; [0033] “When the liquid-for-analysis determining part 14 determines “abnormal use,” the warning part 16 gives warning to a user. For example, the warning may be displayed on a monitor connected to the system controller 10 and inform of abnormal use. Alternatively, the warning may be warning sound”; [0034] “Further, when the liquid-for-analysis determining part 14 determines “abnormal use,” the system controller 10 may transmit an instruction to the analyzer 2 so that the analyzer 2 interrupts a current operation, in addition to or instead of the warning”; [0038]; [0042]; [0043] “Consequently, if a user does not correctly dispose the liquids A to D for analysis or connects the liquids A to D for analysis to wrong tubes, for example, the liquid-for-analysis monitor 4 detects the error as abnormal use when an operation that consumes the liquids for analysis starts”);
(silent to request) providing an information about the identified at least one mobile phase container (fig. 1, container 6) to a user of the sample separation apparatus (liquid chromatography analysis system), and requesting the user to confirm that the identified at least one mobile phase container matches or not with the actual at least one mobile phase container.
Regarding claim 7, which depends on claim 1,
Isoi teaches comprising:
identifying the mobile phase (mobile-phase) (determining if correct kinds of liquids) based on a comparison of the determined weight (ΔM of weighed container) and volume reduction (volume V of the decrease in the liquid in the container) behavior with a pre-known reference weight and volume reduction behavior of one or more reference mobile phase (mobile-phase) materials with a pre-known identity ([0043] “the liquid-for-analysis monitor 4 described above determines whether liquids for analysis that need to be used are used as scheduled in an operation or not, based on variations ΔM between weights of the containers 6a to 6d before the decrease and weights of the containers 6a to 6d after the decrease, densities ρ of corresponding liquids for analysis, and amounts of consumption of liquids in the containers 6a to 6d or a consumption proportion between liquids in the containers 6a to 6d in a decreasing operation. Consequently, if a user does not correctly dispose the liquids A to D for analysis or connects the liquids A to D for analysis to wrong tubes, for example, the liquid-for-analysis monitor 4 detects the error as abnormal use when an operation that consumes the liquids for analysis starts”; [0008] “Using this knowledge allows determining whether correct amounts of correct kinds of liquids for analysis have been used or not. The present invention is made based on the findings and is characterized by determining whether liquids for analysis are normally used or not based on information on weights of containers that contain liquids as liquids for analysis and information on densities ρ of the liquids for analysis”; [0026] “liquid-for-analysis monitor 4 that monitors whether operations that decrease liquids for analysis, such as feeding of a mobile phase, use correct liquids for analysis as scheduled or not”; [0029] “the liquid-for-analysis determining part 14 determines whether the decreasing operation has used correct liquids for analysis”; [0031] “If the containers 6a and 6b contain correct liquids A and B for analysis, respectively, ρ′.sub.A=ρ.sub.A and ρ′.sub.B=ρ.sub.B” and “On the other hand, if ρ′.sub.A≠ρ.sub.A and/or ρ′.sub.B≠ρ.sub.B, the liquid-for-analysis determining part 14 determines that the container(s) the densities of which do not correspond with each other contain(s) a liquid that is not a liquid for analysis that needs to be contained”; [0043] “determines whether liquids for analysis that need to be used are used”).
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Applicant previously cited Isoi in view of previously cited factual evidence Poole’s Encyclopedia, Applicant cited Okada utilized as factual evidence, and in further view of Applicant previously cited Witt et al (EP 2244091 A1; hereafter “Witt”).
Regarding claim 17, which depends on claim 1,
Isoi does not teach comprising measuring the flow rate by a flow rate sensor.
Witt measures flow rate by a flow rate sensor (flow rate sensors 112 with 114; exemplary positions shown in fig. 1) (Title “Leak Detection Upstream Of A Mixing Point”; Abstract “sample separation device”; [0015] “at least one sensor configured for measuring the flow at one or multiple positions of the fluidic system. Such one or more sensors may be flow sensors, pressure sensors, etc. The flow may be measured directly. It is also possible that the flow is derived indirectly for instance by inspecting a pump behaviour”; [0024] “one or more flowmeters (for instance for quantifying fluid movements in terms of volumetric or mass flow rates) may be provided and adapted for measuring a flow rate of a part of the fluid. A leak in a conduit may result in a characteristic change of the flow rate in the corresponding channel”; [0027] “also possible that pressure sensors and flow rate sensors are combined, for instance to implement a pressure sensor and a flow rate sensor in at least one of the fluidic conduits”; [0030] “quantifying a leak rate based on the detected flow rate”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine Witt’s explicit use of a flowrate sensor with Isoi’s pump based flow rating, thereby providing a more accurate/precise measurement of flowrate independent of pump type and/or condition of the pump, and thus providing even more reliable control over the delivery of mobile phase, as well as further providing Witt’s leak detection—which could otherwise be mis-conflated with determining improper mobile phase connections.
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Applicant previously cited Isoi in view of previously cited factual evidence Poole’s Encyclopedia, Applicant cited Okada utilized as factual evidence, and in further view of previously cited Kamata* et al (WO 2020170320 A1; hereafter “Kamata”).
*machine translation previously provided by Examiner
Regarding claim 4, which depends on claim 1,
Isoi is silent to wherein the method comprises receiving an initial mobile phase (mobile-phase) volume from a user input.
However:
The Examiner previously took Official Notice that a user inputting the initial volume of a mobile phase is a well-known & routine activity. As the Applicant had not adequately traversed this assertion, this is considered admitted prior art in accordance with MPEP § 2144.03(C).
Furthermore, and as supporting factual evidence of the aforementioned assertion, Kamata teaches wherein the method comprises receiving an initial mobile phase (mobile-phase) volume from a user input (Title “LIQUID CHROMATOGRAPH”; Abstract “the operator to perform, when refilling the mobile phase containers with the mobile phases, visual measurement of the liquid volumes of the mobile phases and manual input of values of the liquid volumes to a control device”).
In view of the above, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the conventional activity of the user inputting the initial volume of a mobile phase thereby providing a simple and low-tech solution to determining the volume of liquid which is easy for a user to perform and which provides an initial value for Isoi’s volume reduction calculations.
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Applicant previously cited Isoi in view of previously cited factual evidence Poole’s Encyclopedia, Applicant cited Okada utilized as factual evidence, and in further view of previously cited factual evidence Bell (NPL A Beginner's Guide to Uncertainty of Measurement; hereafter “Bell’s Beginner’s Guide”) with previously cited Shoykhet* (DE 102018100779 A1; hereafter “Shoykhet”).
*machine translation previously provided by Examiner
Regarding claim 8, which depends on claim 1,
Isoi teaches comprising determining the weight and volume reduction (volume V of the decrease in the liquid in the container) behavior under consideration of a measurement of a gross weight information and/or the weight reduction behavior for threshold conclusions based thereon that are within a margin of error (silent to repeating) (Abstract; [0031] “within a range of a margin of error”).
Isoi doesn’t explicitly state repeated measurement of a gross weight information and/or the weight reduction behavior.
However:
The Examiner previously took Official Notice that repeating measurements (statistically) decreases error. As the Applicant had not adequately traversed this assertion, this is considered admitted prior art in accordance with MPEP § 2144.03(C).
As supporting factual evidence of the aforementioned assertion, Bell’s Beginner’s Guide teaches to repeat measurements (Title Page “Measurement Good Practice Guide” and “A Beginner's Guide”; Abstract “Every measurement is subject to some uncertainty” and “Such uncertainties can be estimated using statistical analysis of a set of measurements”; section 3.1 ‘Measure thrice, cut once’ ... operator error “good reasons for repeating measurements many times”).
Moreover, and especially pertinent to solving a similar problem and in a same/analogous field of endeavor, Shoykhet teaches repeating measurements (Title “dentification And Correction Of A Fluid Composition In The Sample Separator”; Abstract “A control device (70) for controlling a sample separation device (10) for separating a fluidic sample using a mobile phase to be supplied according to a target composition, wherein the control device (70) comprises a determination device (152) for determining one for a Is set of mobile phase indicative information is set up, and a correction means (154), which is adapted to at least partially correct an influence of a deviation between the target composition and the actual composition”; page 6 about middle of page “the determining means for determining the information indicative of the actual composition by means of a measurement of at least one parameter from the group consisting of a density, a sound wave velocity in, and a viscosity of the mobile phase to be established” and “It is also possible for two or more of the measurements mentioned to be cumulative, simultaneous, supplementary, parallel and / or complementary to determine the actual composition or indicative information. Thereby, the precision of the determination of the actual composition can be further increased”).
In view of the above, it would have been trivially obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to commonsensically utilize repeat measurements to provide better results with less error—as factually supported by the good measurement practices in Bell’s Beginner’s Guide and as further shown by Shoykhet that cumulative measurements are known to increase precision of determinations in the art—and thus leading to better determinations of abnormalities (e.g., wrongly disposing liquids) being present or absent.
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Applicant previously cited Isoi in view of previously cited factual evidence Poole’s Encyclopedia, Applicant cited Okada utilized as factual evidence, and in further view of previously cited Li (US 20100057377 A1; hereafter “Li”).
Regarding claim 9, which depends on claim 1,
Isoi teaches the mobile phase (mobile-phase) from the at least one mobile phase container (fig. 1, container 6) used for chromatography ([0001], [0024], [0025] “chromatograph”).
Isoi does not explicitly state using the mobile phase as carrier fluid for carrying the fluidic sample during sample separation.
However:
It is still (see analysis of independent claim) the Examiner’s position that Isoi’s chromatography apparatus is for separating (at once so envisaged that a chromatography system utilizing mobile phase inherently/implicitly includes separating). It is further the Examiner's position that utilizing the mobile phase as carrier fluid for carrying the fluidic sample during sample separation is likewise at once so envisaged for a chromatography system utilizing mobile phase, noting that an ordinary artisan would be knowledgeable that the jargon mobile phase implicitly, inherently, and/or definitionally is a carrier fluid.
Furthermore, Li teaches using the mobile phase as carrier fluid for carrying the fluidic sample during sample separation (Title; Abstract “chromatographic systems”; BACKGROUND [0001] “Chromatography is a process that provides for the physical separation, quantification and identification of various analytes in a sample in a single analysis. A chromatography system comprises a number of components, including a separation column that separates the sample into its individual components as the components are passed through the column by a mobile phase. The separation column includes an inlet portion that acts as the interface for input of the sample into a separation column. The mobile phase provides a carrier fluid and driving force to move the components of the sample from the inlet portion of the column to the outlet portion, with the separation of the components dependent on their interactions with an immobilized liquid or solid material within the column (stationary phase) and the mobile phase”).
In view of the above, either one of ordinary skill in the art at the time the invention was effectively filed would at once envisaged that Isoi’s chromatography system having mobile phase would use said mobile phase as a carrier fluid for carrying the fluidic sample during sample separation, or nevertheless, or in the alternative, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to perform the routine use—as factually supported by Li—of mobile phase as a carrier fluid for carrying the fluidic sample during sample separation in chromatography thereby providing the expected conventional facilitation of moving the sample in a chromatographic apparatus.
Claim(s) 11-12 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Applicant previously cited Isoi in view of previously cited factual evidence Poole’s Encyclopedia, Applicant cited Okada utilized as factual evidence, and in further view of previously cited Shoykhet.
Regarding claim 11 and claim 15, where claim 11 depends on claim 1 and where claim 15 depends on claim 10,
Isoi teaches a sample separation apparatus (liquid chromatography analysis system) for separating a fluidic sample (liquid sample), the sample separation apparatus (liquid chromatography analysis system) comprising:
a control device (fig. 1, system controller 10) configured to carry out or controlling the respective method according to claim 1 (see analysis of independent claim 1) and method according to claim 10 (see analysis of independent claim 10) ([0027] “The system controller 10 includes a density storing part 12, a liquid-for-analysis determining part 14, and a warning part 16”; [0034] “the system controller 10 may transmit an instruction to the analyzer 2 so that the analyzer 2 interrupts a current operation, in addition to or instead of the warning”);
a fluid drive (not show; means for feeding/pumping/sampling from containers 6; additional obviousness analysis provided) configured to drive the mobile phase (mobile-phase) and the fluidic sample (liquid sample) when introduced (silent to injector) into the mobile phase (mobile-phase) ([0024] “If the containers 6a to 6d that contain the liquids A to D for analysis are correctly disposed, the analyzer 2 sucks liquids for analysis that are necessary for an analysis operation from the containers 6a to 6d with a feed pump or a sampling needle and uses the sucked liquids. Disposing the containers 6a to 6d includes disposing the containers 6a to 6d at specific positions, or connecting the containers 6a to 6d to specific pipes”); and
a sample separation unit (not shown; sample separation unit at once envisaged as part of liquid chromatography analysis system; additional obviousness analysis provided) configured to separate the fluidic sample (liquid sample) in the mobile phase (mobile-phase).
Isoi does not explicitly state item 1) that the chromatography apparatus is a separation apparatus comprising a fluid drive and sample separation unit configured to separate the fluidic sample in the mobile phase. Isoi is silent to item 2) an injector for injecting the fluidic sample into the mobile phase.
Regarding items 1) and 2):
The Examiner (again; see independent claim) previously took Official Notice that chromatography conventionally uses separation techniques, and the Examiner further previous took Official Notice that sample separation units (e.g., chromatography column) are conventional and (definitionally) expected component of chromatography. As the Applicant had not adequately traversed this assertion, this is considered admitted prior art in accordance with MPEP § 2144.03(C).
Furthermore, and as supporting factual evidence of the aforementioned assertion, Poole’s Encyclopedia teaches “Chromatography is the most widely used separation technique” (Chapter Chromatography, first sentence of Introduction), and further teaches a fluid drive (pump) configured to drive the mobile phase and a sample separation unit (column) configured to separate the fluidic sample in the mobile phase (Introduction second paragraph “Chromatography is essentially a physical method of separation in which the components of a mixture are separated by their distribution between two phases; one of these phases in the form of a porous bed, bulk liquid, layer or film is generally immobile (stationary phase), while the other is a fluid (mobile phase) that percolates through or over the stationary phase. A separation results from repeated sorption/desorption events during the movement of the sample components along the stationary phase in the general direction of mobile-phase migration”; Section Liquid Chromatography “Modern LC employs columns with small particle sizes and high packing density requiring high pressures for operation at useful mobile-phase velocities. Syringe-type or single- or multiple-head reciprocating piston pumps are commonly used to provide the operating pressures needed in configurations that depend on the design of the solvent-delivery system. A single pump is sufficient for isocratic operation. A single pump and electronically operated proportioning valves can be used for continuous variation of the mobile-phase composition (gradient elution) or, alternatively, independent pumps in parallel (commonly two) are used to pump different solvents into a mixing chamber. Between the pump and sample inlet may be a series of devices (check valves, pulse dampers, mixing chambers, flow controllers, pressure transducers, etc.) that correct or monitor pump output to ensure that a homogeneous, pulseless liquid flow is delivered to the column at a known pressure and volumetric flow rate” and “Loop-injection valves situated close to the head of the column are universally used for sample introduction”).
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Moreover, Shoykhet explicitly (substantially/exact same nomenclature) teaches a sample separation apparatus (fig. 1, sample separation apparatus 10) for separating a fluidic sample (fluidic sample) (Title “Identification And Correction Of A Fluid Composition In The Sample Separator”; Abstract “A control device (70) for controlling a sample separation device (10) for separating a fluidic sample using a mobile phase to be supplied according to a target composition, wherein the control device (70) comprises a determination device (152) for determining one for a Is set of mobile phase indicative information is set up, and a correction means (154), which is adapted to at least partially correct an influence of a deviation between the target composition and the actual composition”; page 2 section EPIPHANY first paragraph “object of the invention to operate a sample separation apparatus”), the sample separation apparatus (fig. 1, sample separation apparatus 10) comprising: a control device (fig. 1, control device 70) configured to carry out or control the sample separation apparatus (fig. 1, sample separation apparatus 10), a fluid drive (fig. 1, fluid drive 20) configured to drive the mobile phase (mobile phase) and the fluidic sample (fluidic sample) when injected (via fig. 1, sample application unit / injector device 40) into the mobile phase (mobile phase); and a sample separation unit (fig. 1, sample separator 30) configured to separate the fluidic sample (fluidic sample) in the mobile phase (mobile phase), wherein controlling the sample separation apparatus (fig. 1, sample separation apparatus 10) is based on a result of the determining the density of the mobile phase (mobile phase) (page 8 after middle of page “the fluid drive or fluid pump may be configured to convey the mobile phase through the system”; page 10 last paragraph “fluid pump as a fluid drive 20 containing solvents from a supply unit 25 supplied drives a mobile phase through a sample separator 30 (such as a chromatographic column)”; page 8 after middle of page “The sample separator may include a sample injector for introducing the sample into the fluidic separation path. Such a sample injector may comprise a syringe-dockable injection needle in a corresponding fluid path, which needle may be withdrawn from that seat to receive sample, wherein upon reintroduction of the needle into the seat, the sample is in a fluid path which, for Example, by switching a valve, can be switched into the separation path of the system, which leads to the introduction of the sample in the fluidic separation path”; page 6 about middle of page “the determining means for determining the information indicative of the actual composition by means of a measurement of at least one parameter from the group consisting of a density, a sound wave velocity in, and a viscosity of the mobile phase to be established. If the density, the speed of sound or the viscosity of the individual constituents are known (an empirical calibration curve can preferably be used), the respective proportion of a particular constituent can also be determined from a corresponding measurement of the respective parameter of the mobile phase composed thereof. It is also possible for two or more of the measurements mentioned to be cumulative, simultaneous, supplementary, parallel and / or complementary to determine the actual composition or indicative information. Thereby, the precision of the determination of the actual composition can be further increased”).
In view of the above, either one of ordinary skill in the art at the time the invention was effectively filed would at once envisaged that Isoi’s chromatography is (definitionally) utilized for separating and has the conventional and routine fluid drive, injector, & sample separating unit (see preceding citations in Isoi which suggest to an ordinary artisan that these elements are present or universally expected), or nevertheless, or in the alternative, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to include such conventional components—as factually supported by Poole’s Encyclopedia and as further explicitly (nomenclaturally substantially the same as claimed) exemplified by Shoykhet—with Isoi’s chromatography apparatus, and therefore providing the expected results of utilizing well-known & widely used separation techniques with a mobile drive, injector, and sample separation unit for the self-definitional motivation and/or for the expected purpose of analysis, isolation, purification, and/or for distinguishing individual compounds wherein the fluid drive commonsensically is configured to drive the mobile phase and the fluidic sample when injected via injector device into the mobile phase as is well-known in the art. Complementarily, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine Isoi’s mobile phase analysis & associated interruption/warning for improper disposition of mobile phases with Shoykhet’s sample separation apparatus for the expected purpose of likewise assisting with preventing improper disposition of mobile phases and associated waste of material and/or improper chromatographic techniques.
Regarding claim 12, which depends on claim 11,
Isoi teaches comprising at least one of the following features:
the sample separation apparatus (liquid chromatography analysis system) is configured as an apparatus selected from the group consisting of:
a chromatography sample separation apparatus (liquid chromatography analysis system);
a liquid chromatography sample separation apparatus (liquid chromatography analysis system);
(silent) a gas chromatography sample separation apparatus; and
(silent) a supercritical fluid chromatography sample separation apparatus;
Isoi is silent to: the sample separation apparatus comprises each of an injector configured to inject the fluidic sample into the mobile phase, a detector configured to detect the separated fluidic sample, and a fractionating unit configured to collect separated fractions of the fluidic sample.
Shoykhet teaches: comprising at least one of the following features: the sample separation apparatus (fig. 1, sample separation apparatus 10) is configured as an apparatus selected from the group consisting of: a chromatography sample separation apparatus (fig. 1, sample separation apparatus 10); a liquid chromatography sample separation apparatus (fig. 1, sample separation apparatus 10); a gas chromatography sample separation apparatus (fig. 1, sample separation apparatus 10); and a supercritical fluid chromatography sample separation apparatus (fig. 1, sample separation apparatus 10) (bottom paragraph of page 2 through second paragraph of page 3 “In this context, a fluid is understood as meaning a liquid, a gas, a mixture of a liquid and a gas, a substance in the supercritical state” and “chromatographic sample separation”); the sample separation apparatus (fig. 1, sample separation apparatus 10) comprises each of an injector (fig. 1, sample application unit / injector device 40) configured to inject the fluidic sample (fluidic sample) into the mobile phase (mobile phase); the sample separation apparatus (fig. 1, sample separation apparatus 10) comprises a detector (fig. 1, detector 50) configured to detect the separated fluidic sample (fluidic sample); and the sample separation apparatus (fig. 1, sample separation apparatus 10) comprises a fractionating unit (fig. 1, fractionator 60) configured to collect separated fractions of the fluidic sample (fluidic sample) (page 8 after middle of page “The sample separator may include a sample injector for introducing the sample into the fluidic separation path”; top of page 11 “a detector 50 a flow cell detects separated components of the sample, and a fractionator may be provided to dispense separated components of the sample into dedicated containers; reference claim on top of page 16 “the sample separator ( 10 ) has an injector device ( 40 ) for introducing the fluidic sample into a fluidic path between the fluid drive ( 20 ) and the sample separation device ( 30 )” and “the sample separator ( 10 ) has a detector ( 50 )” and “the sample separator ( 10 ) has a sample fractionator ( 60 ) for fractionating the separated fluidic sample”.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine Shoykhet’s sample separation apparatus having injector, detector, & fractionator with Isoi’s chromatography apparatus therefore providing conventional components having the expected results of utilizing well-known & widely used components in chromatography including for usefully introducing the sample, analyzing the separated sample, and collecting separated components of the sample for further use and/or additional analysis, and thus commonsensically increasing the versatility and marketability of Isoi’s chromatography apparatus. See also preceding combination and motivation analysis provided for preceding claim. It further would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine in the alternative each of gas, liquid, and supercritical versions/applications of chromatography sample separation—as taught by Shoykhet—with Isoi’s method for the increased versatility and marketability within these respective fluid applications.
Allowable Subject Matter
Claim(s) 16 is/are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
When this application is finally acted upon and allowed (i.e., the Notice of Allowance), the Examiner will determine, at the same time, whether the reasons why the application is being allowed are sufficiently evident from the record; see MPEP § 1302.14(I).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Applicant is invited to review PTO form 892 accompanying this Office Action listing Prior Art relevant to the instant invention cited by the Examiner. The Examiner notes in particular (the first two being pertinent evidence factually supporting an Official Notice):
Encyclopedia of Separation Science, Chapter Theory of Liquid Chromatography, page 780 section Mobile phase pertaining to relating volume, flow rate, & time.
Modern HPLC Pumps: Perspectives, Principles, and Practices “Constant flow rate pumps have been the standard approach since the debut of the first commercial HPLC system in the 1960s. This is important” and “Since V is equal to retention time (t) multiplied by flow rate (F)”
Pertinent to teaching a method of identifying a container, the method comprising: determining a weight and volume characteristic of the container; and identifying the container based on a comparison of the determined weight and volume characteristic of the container with a pre-known reference weight and volume characteristic of one or more reference containers with pre-known identity:
US 20170089236 A1 Apparatus And Method, Andersen et al, Abstract “An apparatus comprising: an identity determiner configured to determine an identity of a removable fluid container; a characteristic determiner configured to obtain a first characteristic based on testing the fluid of the fluid container; a data obtainer configured to obtain a second characteristic based on the identity; and a processor configured to control a fluid provider to provide fluid from the removable fluid container based on the comparison of the first characteristic and the second characteristic”; [0057] “a measurement of the weight of the fluid, and/or volume of the fluid”; [0060] “first characteristic is determined based on testing the fluid of the fluid container and the second characteristic is determined based on the identity of the fluid container. The apparatus may also obtain a first characteristic based on data stored on the data store of the fluid container and obtain a second characteristic from a remote memory based on the identity of the fluid container”
US 20140135732 A1 MONITORING SYSTEM FOR A MEDICAL LIQUID DISPENSING DEVICE, Spronken et al, Abstract “combination of an identification unit (2), which identifies a medical liquid container and optionally the patient to be treated, a weight monitoring unit, which measures the weight of the medical liquid container when liquid is dispensed therefrom, and a processing unit (3), which processes and/or stores data that are acquired from the identification unit and the weight monitoring unit”; [0076] “information concerning the identity of the medical liquid container at least includes information concerning the weight and/or volume of the medical liquid container (and/or the liquid to be dispensed therefrom), i.e. information concerning the initial weight or volume of a full medical liquid container prior to use”; [0133] “obtaining information concerning the weight of the medical liquid container (e.g. information concerning the initial weight or volume of a full medical liquid container prior to use and/or information on the emptied medical liquid container after use, or information on the weight of the liquid to be administered) and optionally concerning the content of the medical liquid container”
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to DAVID L SINGER whose telephone number is (303) 297-4317. The Examiner can normally be reached on Monday - Friday 8:00 am - 6:00pm CT, EXCEPT alternating Friday.
If attempts to reach the Examiner by telephone are unsuccessful, the Examiner’s supervisor, John Breene can be reached on 571-272-4107. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DAVID L SINGER/Primary Examiner, Art Unit 2855 30JUL2026
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