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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 06 MARCH 2026 has been entered.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Claim Status
Rejected Claims: 1-10
Response to Amendment
The amendment filed on 06 MARCH 2026 has been entered.
In view of the amendment to the claims, the amendment of claim 1 has been acknowledged.
In view of the amendment to claim 1, the rejections under 35 U.S.C. 102 have been withdrawn and rejections under 35 U.S.C. 103 have been made/modified to account for the amendments.
Response to Arguments
Applicant’s arguments filed on 06 MARCH 2026 have been fully considered.
Applicant argues, regarding newly amended instant claim 1, that Ziegler does not teach each feature of instant claim 1 and Jones does not cure the deficiencies of Ziegler. Specifically, Jones teaches that the mobile phase being cooled by the Peltier element contains sample and therefore cannot teach “the mobile phase adjusted to the second temperature, which does not include the sample, is fed to the separation column being in a state heated to a temperature higher than the initial temperature thereof before a next sample is injected after separation of the sample components by the separation column ends” and therefore instant claim 1 is allowable (Arguments filed 06 MARCH 2026, Page 6, Paragraphs 1-5).
Regarding Applicant’s argument, Applicant is arguing a method of using the apparatus and not the apparatus itself. All mobile phases and samples go through the heating elements, as taught by both Ziegler and Jones. Furthermore, after a sample is introduced into a separation column, mobile phases, which do not contain sample, are then introduced into the column to actually perform the chromatographic separation by selectively reversing the sample binding to the chromatographic matrix inside the column, which is the elution step of the chromatographic process. The device made obvious by Ziegler in view of Jones contains all of the elements of the instant claim 1 and is capable of performing the intended control schemes because the control systems are linked to the flows of samples and the heating/cooling elements. Therefore, instant claim 1 is not allowable.
Applicant argues that the feature of precooling the mobile phase “after the separation process and before injection of the sample” and “supplying the cooled mobile phase to the separation column so as to rapidly lower the temperature of the separation column” of instant claim 1 would not be derived from the combination of Ziegler in view of Jones because cooling a mobile phase before a heated column would decrease the resolution of the sample and therefore instant claim 1 is allowable (Arguments filed 06 MARCH 2026, Page 6, Paragraph 6 to Page 7, Paragraph 2).
Regarding Applicant’s argument, Applicant is further arguing a method of using the apparatus. the limitation “wherein the control device controls at least one of the liquid feeding portion and the second temperature adjustment device such that the mobile phase adjusted to the second temperature, which does not include the sample, is fed to the separation column being in a state heated to a temperature higher than the initial temperature thereof before a next sample is injected after separation of the sample components by the separation column ends” is directed toward an expected result from the practice or use of the claimed invention and is therefore not subject to patentability. Where the prior art product structure is capable of performing the intended use as recited, a prima facie case of either anticipation or obviousness has been established because the devices meets the limitations of the claim (In re Schreiber, 128 F.3d 1473, 1477, 44 USPQ2d 1429, 1431 (Fed. Cir. 1997); MPEP §2111.02 II). The structure of the device of Ziegler is the same as the instant claim 1, excluding the second temperature adjustment device being a Peltier element, which is taught by Jones. Jones teaches that a cooler can be used for increasing resolution or speed (Paragraph 0003) and thus teaches motivation to utilize a pre-cooler. As both Ziegler and Jones teach controlling temperature, it is clear that the apparatus made obvious by Ziegler in view of Jones is capable of performing the control scheme described above in the limitation of instant claim 1. Therefore, instant claim 1 is not allowable.
Applicant argues that instant claims 2-10 are allowable because they depend upon instant claim 1, which is allowable (Arguments filed 06 MARCH 2026, Page 7, Paragraphs 3-4).
Regarding Applicant’s argument, instant claims 2-10 are not allowable because instant claim 1 is not allowable.
Claim Interpretation
Claim 8 of the instant application includes the limitation “an adjustment liquid”, which is described in the specification as “Regarding the adjustment liquid, any of liquids generally used for liquid chromatography can be used” (Paragraph 0029).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1, 4, and 6-8 are rejected under 35 U.S.C. 103 as being unpatentable over Ziegler US Patent Application No. 20070181702 A1 (hereinafter Ziegler) in view of Jones et al US Patent Application No. 20060054558 A1 (hereinafter Jones).
Regarding Claim 1, Ziegler teaches a heating system (Abstract) for a liquid chromatography system (i.e., a liquid chromatograph comprising; Paragraph 0028)
in which a fluid delivery system (i.e., a liquid feeding portion; Fig. 1, #1) supplies a flow of effluent (i.e., which feeds a mobile phase; Fig. 1, #2) to the flow path (i.e., to a flow channel)
of the heating system which flows to a sample injection unit (i.e., a sample injection portion which is provided downstream of the liquid feeding portion in the flow channel; Fig. 1, #3) into which a volume of sample (Fig. 1, #4) is injected (i.e., injects a sample into the mobile phase),
the heated effluent and sample are supplied to a separation column (i.e., a separation column which is provided downstream of the sample injection portion in the flow channel; Fig. 1, #6) that contains a stationary phase which causes the components of the sample to appear at the column outlet at different time points (i.e., separates sample components in the sample)
that comprises a thermostatted column compartment (i.e., a first temperature adjustment device; Fig. 1, #7) which keeps the separation column at a predefined temperature, for example 80°C (i.e., which raises temperature of the separation column to a first temperature during separation of the sample components by the separation column),
the outlet of the separation column is fluidically coupled with a detection unit (i.e., a detector which is provided downstream of the separation column in the flow channel and detects sample components separated by the separation column; Fig. 1, #8; Paragraph 0045),
both the eluent and sample flow to a heating system (i.e., wherein the liquid chromatograph further comprises a second temperature adjustment device which is provided upstream of the separation column in the flow channel and lowers the temperature of the mobile phase which is equal to an initial temperature of the separation column before being adjusted by the first temperature device; Fig. 1, #5) wherein the fluid is supplied to the column at a temperature, which is lower than the separation column temperature, and the fluid’s temperature increases as it passes through the separation column (Paragraph 0050),
the separation system further comprises a control unit (i.e., a control device; Fig. 1, #11) controlling the operation of the fluid delivery unit and the heating system (i.e., which controls at least one of the liquid feeding portion and the second temperature adjustment device; Paragraph 0047),
and the control unit for the separation system can operate in gradient mode with at least two different eluents and the solvent composition of the eluent is varied over time and where the second eluent is composed of two different solvents for the purpose of washing out the sample compounds consecutively (i.e., wherein the control device controls at least one of the liquid feeding portion and the second temperature adjustment device such that the mobile phase adjusted to the second temperature, which does not include the sample, is fed to the separation column being in a state heated to a temperature higher than the initial temperature thereof before a next sample is injected after separation of the sample components by the separation column ends; Paragraph 0047).
Ziegler does not explicitly teach (1) wherein the liquid chromatograph further comprises a second temperature adjustment device which lowers the temperature of the mobile phase to a second temperature which is equal to or lower than an initial temperature of the separation column before being adjusted by the first temperature adjustment device and (2) wherein the second temperature adjustment device is any one of a Peltier refrigerator, a Peltier element, a compressor refrigerator, a low-temperature thermostatic water circulation device, and a liquified carbon dioxide cylinder utilizing cooler.
However, Jones teaches a precooling apparatus (Abstract) that can allow for cooling of samples to about -10°C using a Peltier cooler (i.e., the liquid chromatograph further comprises a second temperature adjustment device which lowers the temperature of the mobile phase to a second temperature which is equal to or lower than an initial temperature of the separation column before being adjusted by the first temperature adjustment device; and wherein the second temperature adjustment device is any one of a Peltier element; Paragraph 0038) for the purpose of separating components such as enantiomers during chromatographic procedures so that the resolution of the analytes can be maximized (Paragraph 0036).
Jones is analogous to the claimed invention because it pertains to mobile phases and their use in chromatography, and specifically heating and or cooling of fluids used as mobile phases (Paragraph 0002). It would have been obvious to one of ordinary skill in the art at the time of filing the instant claimed invention to modify the heating system for the liquid chromatograph as taught by Ziegler to be able to precool the mobile phase as taught by Jones because the chromatography system would be able to maximize the resolution during the separation of enantiomers.
Furthermore, the limitations “separates sample components in the sample”, “which raises temperature of the separation column to a first temperature during separation of the sample components by the separation column”, “detects sample components separated by the separation column”, “lowers temperature of the mobile phase to a second temperature which is equal to or lower than an initial temperature of the separation column before being adjusted by the first temperature adjustment device”, and “wherein the control device controls at least one of the liquid feeding portion and the second temperature adjustment device such that the mobile phase adjusted to the second temperature, which does not include the sample, is fed to the separation column being in a state heated to a temperature higher than the initial temperature thereof before a next sample is injected after separation of the sample components by the separation column ends” are directed toward an expected result from the practice or use of the claimed invention and is therefore not subject to patentability. Where the prior art product structure is capable of performing the intended use as recited, a prima facie case of either anticipation or obviousness has been established because the devices meets the limitations of the claim (In re Schreiber, 128 F.3d 1473, 1477, 44 USPQ2d 1429, 1431 (Fed. Cir. 1997); MPEP §2111.02 II).
Regarding Claim 4, Ziegler further teaches a second embodiment where there is a heat exchanger (i.e., the second temperature adjustment device; Fig. 5, #31) located between the fluid delivery unit (Fig. 5, #29) and the injection unit (i.e., wherein the second temperature adjustment device is installed on the flow channel between the liquid feeding portion and the sample injection portion; Fig. 5, #33; Paragraph 0062).
Regarding Claim 6, Ziegler further teaches a second embodiment where there is an auxiliary heat exchanger (i.e., the second temperature adjustment device; Fig. 5, #37) located between the injection unit (Fig. 5, #33) and fluidically connected to the inlet of the separation column (i.e., wherein the second temperature adjustment device is installed on the flow channel between the sample injection portion and the separation column; Fig. 5, #39; Paragraphs 0062-0064).
Regarding Claim 7, Ziegler further teaches that the control unit for the separation system can operate in gradient mode with at least two different eluents (i.e., wherein the mobile phase includes two or more kinds of eluents) and the solvent composition of the eluent is varied over time (i.e., including a first eluent and a second eluent which starts to be fed for separation of a sample later than the first eluent; Paragraph 0047). As seen in the rejection for claim 1, Ziegler disclosed that the heating element heats the first effluent and sample combined (i.e., wherein the second temperature adjustment device adjusts temperature of the first eluent; Paragraph 0045).
Furthermore, the limitation “wherein the mobile phase includes two or more kinds of eluents including a first eluent and a second eluent” is directed toward materials or articles worked upon by the claimed invention and is therefore not subject to patentability. The inclusion of material or article worked upon by a structure being claimed does not impart patentability to the claims (In re Young, 75 F.2d 996, 25 USPQ 69 (CCPA 1935) and thus holds no patentable weight. See MPEP §2115.
Furthermore, the limitation “which starts to be fed for separation of a sample later than the first eluent, and wherein the second temperature adjustment device adjusts temperature of the first eluent” is directed toward an expected result from the practice or use of the claimed invention and is therefore not subject to patentability. Where the prior art product structure is capable of performing the intended use as recited, a prima facie case of either anticipation or obviousness has been established because the devices meets the limitations of the claim (In re Schreiber, 128 F.3d 1473, 1477, 44 USPQ2d 1429, 1431 (Fed. Cir. 1997); MPEP §2111.02 II).
Regarding Claim 8, Ziegler further teaches the use of water as a second eluent (i.e., wherein the mobile phase includes an adjustment liquid which is not used for separation of the sample; Paragraph 0047). As seen in the rejection for claim 1, Ziegler disclosed that the heating element heats the first effluent and sample combined (i.e., wherein the second temperature adjustment device adjusts temperature of the adjustment liquid; Paragraph 0045).
Furthermore, the limitation “wherein the mobile phase includes an adjustment liquid” is directed toward materials or articles worked upon by the claimed invention and is therefore not subject to patentability. The inclusion of material or article worked upon by a structure being claimed does not impart patentability to the claims (In re Young, 75 F.2d 996, 25 USPQ 69 (CCPA 1935) and thus holds no patentable weight. See MPEP §2115.
Furthermore, the limitation “which is not used for separation of the sample, and wherein the second temperature adjustment device adjusts temperature of the adjustment liquid” is directed toward an expected result from the practice or use of the claimed invention and is therefore not subject to patentability. Where the prior art product structure is capable of performing the intended use as recited, a prima facie case of either anticipation or obviousness has been established because the devices meets the limitations of the claim (In re Schreiber, 128 F.3d 1473, 1477, 44 USPQ2d 1429, 1431 (Fed. Cir. 1997); MPEP §2111.02 II).
Claims 2 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Ziegler in view of Jones as applied to claim 1 above, and further in view of Juvet, Jr. et al US Patent No. 3902848 A (hereinafter Juvet).
Regarding Claim 2, Ziegler in view of Jones does not teach wherein the liquid feeding portion includes a container storing the mobile phase, and wherein the second temperature adjustment device is installed on the container.
However, Juvet teaches a mobile phase reservoir (i.e., the liquid feeding portion includes a container storing the mobile phase; Fig. 1, #22) that is heated (i.e., and wherein the second temperature adjustment device is installed on the container) for the purpose of degassing the mobile phase and reducing noise (Col. 4, Lines 25-60).
Juvet is analogous to the claimed invention because it pertains to the field of liquid chromatography (Col. 1, Lines 5-8). It would have been obvious to one of ordinary skill in the art at the time of filing the instant claimed invention to modify the heating system made obvious by Ziegler in view of Jones to comprise a heated mobile phase reservoir as taught by Juvet because the heated reservoir would remove the gas from the mobile phase and reduce noise.
Regarding Claim 10, Ziegler in view of Jones does not teach wherein the liquid chromatograph is an amino acid analyzer for analyzing amino acids.
However, Juvet teaches that materials such as amino acids are detectable with the liquid chromatography system (i.e., wherein the liquid chromatograph is an amino acid analyzer for analyzing amino acids; Col. 10, Lines 42-51) for the purpose of detecting minute quantities of solutes (Col. 3, Lines 1-3).
It would have been obvious to one of ordinary skill in the art at the time of filing the instant claimed invention to modify the separation system and detector made obvious by Ziegler in view of Jones to be the liquid chromatography system taught by Juvet because the liquid chromatography system would be capable of detecting minute quantities of amino acids.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Ziegler in view of Jones as applied to claim 1 above, and further in view of Ieuji US Patent Application No. 20200061494 A1 (hereinafter Ieuji).
Regarding Claim 3, Ziegler further teaches a pump (i.e., a pump) as part of the fluid delivery system (i.e., feeding the mobile phase in the container to the flow channel; Paragraph 0045).
Ziegler in view of Jones does not teach wherein the liquid feeding portion includes a container storing the mobile phase wherein the second temperature adjustment device is installed on the flow channel between the container and the pump.
However, Ieuji teaches a mobile phase supply device (i.e., wherein the liquid feeding portion; Fig. 1, #10) which includes storages that contain an aqueous solution (i.e., a container storing the mobile phase; Fig. 1, #11) and an organic solvent (i.e., a container storing the mobile phase; Fig. 1, #12) that are supplied through a heater (i.e., wherein the second temperature adjustment device; Fig. 1, #30) before being mixed and sent to an injector by a liquid sender (Fig. 1, #15) that is a pump (i.e., is installed on the flow channel between the container and the pump; Paragraphs 0028-0033) with the purpose of providing stable supply of the mobile phase to a liquid chromatography device (Paragraph 0006).
Ieuji is analogous to the claimed invention because it pertains to liquid chromatography (Paragraph 0001). It would have been obvious to one of ordinary skill in the art at the time of filing the instant claimed invention to modify the fluid delivery device made obvious by Ziegler in view of Jones with the mobile phase supply device as taught by Ieuji because the mobile phase supply device would improve the stability of the mobile phase supplied to the liquid chromatography device.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Ziegler in view of Jones as applied to claim 1 above, and further in view of Gjerde et al US Patent Application No. 20030165941 A1 (hereinafter Gjerde), in view of Fujii et al US Patent No. 5827426 A (hereinafter Fujii).
Regarding Claim 5, Ziegler in view of Jones does not teach an ammonia filter column which is disposed on the flow channel between the liquid feeding portion and the sample injection portion.
However, Fujii teaches an ammonia filter (Fig. 3, #8) located between a set of buffers (Fig. 3, #1-4) and an autosampler (i.e., on the flow channel between the liquid feeding portion and the sample injection portion; Fig. 3, #9; Col. 6, Lines 55-63), which is known to have the purpose of removing ammonia ions due to their interference with amino acid performance in ion exchange chromatography.
Fujii is analogous to the claimed invention because it pertains to liquid chromatography (Abstract). It would have been obvious to one of ordinary skill in the art at the time of filing the instant claimed invention to modify the separation system made obvious by Ziegler in view of Jones with the ammonia filter as taught by Fujii because the ammonia filter would remove ions that can interfere with ion exchange chromatography.
Ziegler in view of Jones in view of Fujii does not teach wherein the second temperature adjustment device is installed on the ammonia filter column.
However, Gjerde teaches a prefilter (Fig. 9, #208) which removes contaminants from incoming liquids prior to a high pressure liquid chromatography DNA analyzer column that has an elongated coil (Fig. 9, #210) for heating liquid on the outlet (i.e., wherein the second temperature adjustment device is installed on the ammonia filter column; Paragraph 0199) because optimum temperature control and pre-selection is important for accurate and reproducible high pressure liquid chromatography DNA separations (Paragraphs 0029-0030).
Gjerde is analogous to the claimed invention because it pertains to liquid chromatography (Abstract). It would have been obvious to one of ordinary skill in the art at the time of filing the instant claimed invention to modify the liquid chromatography system made obvious by Ziegler in view of Jones in view of Fujii with heating coil on the ammonia filter as taught by Gjerde because optimum temperature control would make the high pressure liquid chromatography DNA separations accurate and reproducible.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Ziegler in view of Jones as applied to claim 1 above, and further in view of Fujii.
Regarding Claim 9, Ziegler in view of Jones does not teach wherein the liquid chromatograph is an ion exchange chromatograph.
However, Fujii teaches that the separation column is filled with an ion exchange resin (i.e., wherein the liquid chromatograph is an ion exchange chromatograph; Abstract) for the purpose of high speed analysis (Col. 1, Lines 5-9).
It would have been obvious to one of ordinary skill in the art at the time of filing the instant claimed invention to modify the separation column made obvious by Ziegler in view of Jones with the ion exchange resin as taught by Fujii because the ion exchange resin would improve the speed of the analysis.
Conclusion
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/A.A.G./ Examiner, Art Unit 1777
/Bobby Ramdhanie/ Supervisory Patent Examiner, Art Unit 1779
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