DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
This is a response to Applicant's amendment filed on September 26, 2025.
Status of Claims
Claims 2 and 4 have been amended. No new claim has been added. Claims 1-13 are pending. Claims 1-13 are examined herein.
Response to Amendments
The Amendments to the Claims filed 09/26/2025 have been entered. The minor informalities have been addressed by amendments and objections to claims 2 and 4 thereto are withdrawn accordingly.
Response to Arguments
Applicant's Remarks/Arguments and Amendments to the Claims both filed 09/26/2025 have been fully considered.
Applicant argues that the claim 1 and its dependent claims, are not anticipated or prima facie obvious over cited prior art(s), Hughes et al. (US 2009/0054261 A1) and/or secondary references.
(a) Applicant argues that: the cited reference(s) does not disclose the feature of “acquiring a reference value from a chromatogram obtained from a result of analysis by the analyzer;”. Hughes sets the temperature, the reaction time, or the range of concentration, NOT a reference value from a chromatogram. That is, Hughes sets the range of a variable that is different from claim 1 's reference value acquired from a chromatogram. Hughes does not describe acquiring any value from a chromatogram. That is, Hughes's paragraph [0044] explains that Hughes's sensor detects a property of the reaction product such as purity, molecular weight, or yield. Hughes's measurement is a direct sensor measurement, not a chromatographic analysis. See Remarks, pages 6-10.
In response, the examiner respectfully disagrees.
As discussions presented in the Office action dated 07/01/2025 (see pages 3-4), Hughes discloses a chromatograph system (20, Fig. 2 that comprises a microfluidic chip reactor 1, Fig. 2 in conjunction with a computer 21, Fig. 2) comprising (Fig. 2 and its description in paragraphs [0031]-[0071]): (i) an analyzer (a liquid chromatograph (LC) column (32, Fig. 2) that is connected to a reaction device (1, Fig. 2 which is a microfluidic chip shown in Fig. 1) that includes a reactor (a Y-shaped microfluidic channel structure 3, Fig. 1) that produces a reaction product (an output from 1, Fig. 1) by reacting a first liquid raw material (A, Fig. 1) with a second liquid raw material (B, Fig. 1), and analyzes the reaction product produced by the reaction device; and (ii) a controller (21, Fig. 2) that controls an operation of the reaction device, wherein the controller (21, Fig. 2) is connected to the liquid chromatograph (LC) column (32, Fig. 2) wherein the resultant raw of the reaction product (detected data) is then analyzed (paragraph [0044]).
Hughes discloses the sensor (27, Fig. 2) produces a sensor signal (29, Fig. 2) which is representative of a predetermined property of the reaction product(s) and feeds this back to the computer (21, Fig. 1) for processing thereof. The predetermined property may be purity and/or molecular weight or identity and/or yield of the reaction product(s) (paragraph [0044]). The sensor (27, Fig. 2) taught by Hughes meets the recited “a reference values acquirer”. Since claim 1 recites “a reference values”, it is the examiner’s interpretation that the reference value can be any variable(s)/analytes for sensing, monitoring and/or controlling the chromatograph system. It is noted herein that per MPEP, during patent examination, the pending claims must be “given their broadest reasonable interpretation consistent with the specification.” The broadest reasonable interpretation of the claims must also be consistent with the interpretation that those skilled in the art would reach (See MPEP 2111).
In addition, Hughes discloses the liquid chromatograph (LC) column (32, Fig. 2), the sensor (27, Fig. 2) produces a sensor signal (29, Fig. 2), wherein the sensor is in connection with the liquid chromatograph (LC) column, and representative of a predetermined property of the reaction product(s) and feeds this back to the computer (21, Fig. 1) for processing thereof.
In light of teachings from Hughes, it is still the examiner’s interpretation that the sensor (27, Fig. 2) that receives analysis results from the liquid chromatograph (LC) column (32, Fig. 2) anticipates the recitation “a reference value acquirer that acquires a reference value from a chromatogram obtained from a result of analysis by the analyzer” this is because the analysis results from the liquid chromatograph (LC) column comprises chromatogram (i.e., results of the separation of components in a mixture achieved through chromatography).
(b) Applicant argues that: Hughes does not disclose the recitation “set an upper limit value and a lower limit value with respect to the reference value acquired from the chromatogram” as recited in claim 1. Hughes only describes controlling reaction conditions "within set ranges" for process variables such as temperature, reaction time, or reagent concentration. (See, e.g., Hughes, Abstract; paragraph [0009]; claim 1). These are preset bounds for input variables, not upper and lower limit values tied to an output "reference value" derived from a chromatogram. See Remarks, pages 10-11.
In response, the examiner respectfully disagrees.
As discussions presented in the Office action dated 07/01/2025 (see pages 3-4), Hughes discloses: a sensor signal (29, Fig. 2) is fed to the computer (21, Fig. 2) for processing and a demand signal (31, Fig. 2) is generated by the computer (21, Fig. 2) in response to the sensor signal (29, Fig. 2) in order to optimize/control flow rate, temperature, pressure,…etc. (paragraph [0051]) of the chip channel structure (3, Fig. 1). This implies the feature of “an allowable range setter that sets an upper limit value and a lower limit value with respect to the reference value” in the computer (21, Fig. 2).
Since the demand signal (31, Fig. 2) is generated by the computer (21, Fig. 2) in response to the sensor signal (29, Fig. 2) in order to optimize/control flow rate, temperature, pressure,…etc. (paragraph [0051]) of the chip channel structure (3, Fig. 1), one skilled in the art would have reasonably expected that the function of setting of an upper limit value and a lower limit value with respect to the reference value is encompassed/embedded in the computer (21, Fig. 2).
Moreover, it has long been held that “apparatus claims cover what a device is, not what a device does.” Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1468 (Fed. Cir. 1990); see also Boehringer Ingelheim Vetmedica, Inc. v. Schering-Plough Corp., 320 F.3d 1339, 1345 (Fed. Cir. 2003) (“An intended use or purpose usually will not limit the scope of the claim because such statements usually do no more than define a context in which the invention operates.”); In re Michlin, 256 F.2d 317, 320 (CCPA 1958) (“It is well settled that patentability of apparatus claims must depend upon structural limitations and not upon statements of function.”). The prior art merely needs to teach the same structural limitations that would be capable of performing the recited function. In this instance the chromatograph system of Hughes comprising “a sensor signal (29, Fig. 2) is fed to the computer (21, Fig. 2) for processing and a demand signal (31, Fig. 2) is generated by the computer (21, Fig. 2) in response to the sensor signal (29, Fig. 2) in order to optimize/control flow rate, temperature, pressure,…etc. (paragraph [0051]) of the chip channel structure (3, Fig. 1)” capable of “sets an upper limit value and a lower limit value with respect to the reference value” in the computer (21, Fig. 2).
It is the examiner’s position that applicants’ arguments are not persuasive to overcome the rejection. Therefore, the previous rejections to claims 1, 6, 7 and 9 under 35 U.S.C. 102 and rejections to claims 2-5, 8 and 10-13 under 35 U.S.C. 103(a) are maintained.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 6, 7 and 9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hughes et al. (US 2009/0054261 A1, hereinafter “Hughes”).
In regard to claim 1, Hughes discloses a chromatograph system (20, Fig. 2 that comprises a microfluidic chip reactor 1, Fig. 2 in conjunction with a computer 21, Fig. 2) comprising (Fig. 2 and its description in paragraphs [0031]-[0071]):
(i) an analyzer (a liquid chromatograph (LC) column (32, Fig. 2) that is connected to a reaction device (1, Fig. 2 which is a microfluidic chip shown in Fig. 1) that includes a reactor (a Y-shaped microfluidic channel structure 3, Fig. 1) that produces a reaction product (an output from 1, Fig. 1) by reacting a first liquid raw material (A, Fig. 1) with a second liquid raw material (B, Fig. 1), and analyzes the reaction product produced by the reaction device; and
(ii) a controller (21, Fig. 2) that controls an operation of the reaction device,
wherein the controller (21, Fig. 2) is connected to the liquid chromatograph (LC) column (32, Fig. 2) wherein the resultant raw of the reaction product (detected data) is then analyzed (paragraph [0044]).
Hughes discloses the sensor (27, Fig. 2) produces a sensor signal (29, Fig. 2) which is representative of a predetermined property of the reaction product(s) and feeds this back to the computer (21, Fig. 1) for processing thereof. The predetermined property may be purity and/or molecular weight or identity and/or yield of the reaction product(s) (paragraph [0044]). The sensor (27, Fig. 2) taught by Hughes meets the recited “a reference values acquirer”.
A sensor signal (29, Fig. 2) is fed to the computer (21, Fig. 2) for processing and a demand signal (31, Fig. 2) is generated by the computer (21, Fig. 2) in response to the sensor signal (29, Fig. 2) in order to optimize/control flow rate, temperature, pressure,…etc. (paragraph [0051]) of the chip channel structure (3, Fig. 1). This implies the feature of “an allowable range setter that sets an upper limit value and a lower limit value with respect to the reference value” in the computer (21, Fig. 2).
In addition, the teachings of Hughes, set forth above, and additional teachings in paragraphs [0058]-[0069] that describe how to operate the computer controlled system (20, Fig. 2) especially optimizing/controlling flow rate, temperature, pressure,…etc. (paragraph [0051]) of the chip channel structure (3, Fig. 1), meets the feature of “a reaction controller that dynamically changes at least one of a residence time of the first liquid raw material, a residence time of the second liquid raw material, a reaction temperature, and a reaction pressure in the reactor as a control target such that the reference value acquired by the reference value acquirer falls between the upper limit value and the lower limit value set by the allowable range setter” as recited in claim 1.
In regard to claims 6, 7 and 9, Hughes discloses a sensor signal (29, Fig. 2) is fed to the computer (21, Fig. 2) for processing and a demand signal (31, Fig. 2) is generated by the computer (21, Fig. 2) in response to the sensor signal (29, Fig. 2) in order to optimize/control flow rate, temperature, pressure,…etc. (paragraph [0051]) of the chip channel structure (3, Fig. 1). This implies the feature of “an allowable range setter that sets an upper limit value and a lower limit value with respect to the reference value” in the computer (21, Fig. 2) and the operation results in “the reference value acquired by the reference value acquirer falls between the upper limit value and the lower limit value set by the allowable range setter” as recited in claim 6 of claimed invention.
In addition, it is known in the art that the results of the liquid chromatograph (LC) is produced in peaks for different compounds as evidenced by Kawahara et al. (US 4,724,081), therefore, the recitations “wherein the reference value is a magnitude of any of peaks in the chromatogram” (claim 7) or “the reference value is an average molecular weight of the reaction product calculated from the chromatogram” (claim 9) are considered anticipated by Hughes reference.
Hughes discloses every limitation recited in claims 1, 6, 7 and 9 of claimed invention.
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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103(a) 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 2, 3 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Hughes, as applied to claim 1 above, and further in view of Sato et al. (US 2019/0171194 A1, hereinafter “Sato”).
In regard to claims 2, 3 and 5, Hughes does not explicitly disclose the features recited in claims 2, 3 and 5.
Sato discloses a method to be performed in a production support system configured to process a raw material and to produce a product (Abstract). Sato discloses a production support system that processes a raw material and produces a product , the production support system comprising: (i) a memory; and (ii) a processor coupled to the memory and that: acquires a plurality of element values determines whether the element values are within allowable ranges in which a quality of the product meets a predetermined allowed quality; resets the allowable ranges of one or a plurality of other element values to the allowable ranges in which the quality of the product meets the predetermined allowed quality, upon determining that at least one element value exceeds the allowable range; and outputs information about the reset allowable ranges, wherein the outputting of information includes generating display data for displaying the allowable ranges of the one or the plurality of other element values, and wherein the display data is data indicative of a radar chart showing the one or the plurality of other element values and the allowable range (Fig. 1; paragraph [0012]; page 18, claims 1-3).
Sato also discloses the features of: (1) an item of which an element value exceeds the allowable range and notification information indicative of a countermeasure to ensure that the quality of the product meets the predetermined allowed quality are stored in the memory in association with each other, and the outputting of information includes outputting the notification information associated with the item of the element value determined to exceed the allowable range; and (2) an item of an element value exceeding the allowable range and operation information indicative of execution of a countermeasure to ensure that the quality of the product meets the predetermined quality are stored in the memory in association with each other, and the outputting of information includes outputting the operation information that is stored in the memory and is associated with the item of an element value determined to exceed the allowable range (page 18, claims 4-5).
It is noted that both the Hughes and Sato references direct a production support system configured to process a raw material and to produce a product and a controller associated with the production support system.
Therefore, before the effective filing date of the claimed invention, it would have been prima facie obvious to one of ordinary skill in the art to modify the chromatograph system of Hughes, in view of Sato, to provide the features recited in claims 2, 3 and 5 of claimed invention, this is because the features recited in claims 2, 3 and 5 of claimed invention is a known, effective control features in a production support system configured to process a raw material and to produce a product and a controller associated with the production support system as taught by Sato ((page 18, claims 1-5).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Hughes, as applied to claim 1 above, and further in view of Murase (The practice of “Quality by Design” in original pharmacy manufacturing process, 2017, Pharmacia, Vol. 53, No. 5, pp.420-424).
In regard to claim 4, Hughes does not explicitly disclose the features recited in claim 4 which is the controller includes a searcher and a second determiner including the functional features as recited.
Murase discloses a practice of “Quality by Design” in original pharmacy manufacturing process (Title). Murase discloses the features of: (1) the design space can be efficiently set by avoiding unnecessary experiments by choosing the perfect execution factor plan with small number of experiments when it is not necessary to consider the secondary effect, and choosing the central composite plan when it is necessary to consider it (page 2, 1st paragraph); (ii) a specific method is shown in FIG. 10. First, an experiment with a fully implemented factorial design is conducted, and a model including interaction is created. Then, in order to verify the necessity of considering the quadratic effect, the experiment is carried out at the center point where all factors are set to the center value. Here, when the experimental result of the center point is well fitted to the model including the interaction, it is judged that this model is appropriate, that is, it is not necessary to consider the secondary effect, and the design space is set by the model including only the interaction (page 2, 2nd paragraph); and (iii) as a preparation for the experimental design, the following were set in the experimental result (response) to be evaluated: "by-product quantity of impurity D" which affects the raw material quality, and "yield" which is important in stable supply and cost. As factors, "reagent E consumption", "reagent F consumption" and "reaction temperature" were set by scientific consideration of the obtained data. The examination range was set so that the current manufacturing condition becomes the center value. On the basis of these, the model was verified by carrying out the experiment of 3 factors perfect execution factorial programming + center point (page 2, 3rd paragraph; also refer to corresponding Figures 9-12 in the original Japanese document).
It is noted that both the Hughes and Murase references direct a production support system configured to process a raw material and to produce a product and a controller associated with the production support system.
Therefore, before the effective filing date of the claimed invention, it would have been prima facie obvious to one of ordinary skill in the art to modify the chromatograph system of Hughes, in view of Murase, to provide the features recited in claim 4 of claimed invention, this is because the features recited in claim 4 of claimed invention is a known, effective control features in a production support system configured to process a raw material and to produce a product and a controller associated with the production support system as taught by Sato (page 2 and corresponding Figures 9-12 in the original Japanese document).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Hughes, as applied to claim 1 above, and further in view of Naoto (JP2014-178135A, see the attached English translation).
In regard to claim 8, Hughes does not explicitly disclose the feature of the reference value is a ratio between a magnitude of any of peaks and a magnitude of another peak in the chromatogram.
Naoto discloses a deterioration test method of a sealant that can accurately measure a deterioration state while quickly deteriorating the sealant (page 1, Abstract). Naoto discloses an embodiment that as a result of the analysis by the pyrolysis gas chromatography mass spectrometer 1, a pyrogram shown in FIG. 5 (of the original Japanese document) is obtained as an example. In this pyrogram, a peak is detected for each substance. The content of each substance is represented by the peak area. In this embodiment, paying attention to the thermal decomposition product derived from a polyether part among these peaks, the area of the peak which shows the thermal decomposition product derived from a polyether part is calculated/required. Moreover, the area of all the peaks of the thermal decomposition product in a sample is calculated/required. The area of the peak of the pyrolysis product derived from the polyether part and the area of all the peaks of the pyrolysis product in the sample are obtained for each of the plurality of sealing materials 30 having different accelerated degradation test times (page 3, 6th and 7th paragraphs from the top). The teachings of Naoto direct the relative magnitude of peaks can be used a reference value in operating chromatograph system.
It is noted that both the Hughes and Naoto references direct a system configured to analyze a product and a controller associated with the product analyzer system.
Therefore, before the effective filing date of the claimed invention, it would have been prima facie obvious to one of ordinary skill in the art to modify the chromatograph system of Hughes, in view of Naoto, to provide the feature of the reference value is a ratio between a magnitude of any of peaks and a magnitude of another peak in the chromatogram, this the feature of using the reference value is a ratio between a magnitude of any of peaks and a magnitude of another peak in the chromatogram is a known, effective in light of teachings from Naoto (page 3, 6th and 7th paragraphs from the top).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Hughes, as applied to claim 1 above, and further in view of Tomono et al. (WO 2019/038924A1, see the attached English translation, hereinafter “Tomono”).
In regard to claim 10, Hughes does not explicitly disclose the feature of the analyzer includes: a flow vial in which a part of the reaction product produced by the reaction device flows as a sample to be analyzed, a sample extractor that extracts the sample flowing in the flow vial, a separation column that separates a component of the sample extracted by the sample extractor, and a detector that detects the sample that passes the separation column.
Tomono discloses an autosampler comprises: a cooling block, a liquid-for-analysis vial rack for holding a plurality of a liquids-for-analysis within the same plane while cooling the liquids for analysis using the cold from the cooling block, a sampling needle, and a flow vial rack for holding at least one flow vial-which has an internal space for accommodating sample liquid, an inlet that is in communication with the space, and an outlet that is in communication with the space at a position higher than the inlet - within the movement range of the sampling needle while thermally separating the flow vial from the cooling block (page 1, Abstract).
Tomono discloses the autosampler 10 has a flow vial 38 (see FIG. 2 of the original Japanese document) for containing a sample supplied from the sample processing device 2 and a sampling needle 20 (see FIG. 2 of the original Japanese document) for collecting sample water from the flow vial 38. And a multiport valve (not shown) for switching whether or not the sample collected by the sampling needle 20 is introduced into the flow path through which the mobile phase from the liquid transfer device 8 flows. An analysis column (not shown) for separating the sample into components is housed in the column oven 12. The analytical column in the column oven 12 is connected to the outlet of the autosampler 10 via a pipe so that the sample injected by the autosampler 10 is introduced to the analytical column together with the mobile phase from the liquid transfer device 8 It is configured. The downstream end of the analysis column in the column oven 12 is connected to the detector 14 via piping. The detector 14 is for detecting a sample component separated by the analysis column, and is, for example, an ultraviolet absorbance detector. The detector signal obtained by the detector 14 is taken into the arithmetic processing unit 6 and used for quantifying the concentration of the sample component. As shown in FIG. 2 of the original Japanese document, in the autosampler 10, there is used, for example, an analysis solution for holding a plurality of analysis solution vials 24 containing analysis solutions such as standard samples and reaction reagents used for analysis. A vial rack 22 and a flow vial rack 36 for holding a flow vial 38 are installed. Although only one flow vial 38 is shown in the figure, a plurality of flow vials 38 are actually arranged in a line in a direction perpendicular to the paper surface of the figure. The number of flow vials 38 is not limited (page 3, description of Fig. 2).
It is noted that both the Hughes and Tomono references direct a system configured to analyze a product and a controller associated with the product analyzer system.
Therefore, before the effective filing date of the claimed invention, it would have been prima facie obvious to one of ordinary skill in the art to modify the chromatograph system of Hughes, in view of Tomono, to provide the feature of the analyzer includes: a flow vial in which a part of the reaction product produced by the reaction device flows as a sample to be analyzed, a sample extractor that extracts the sample flowing in the flow vial, a separation column that separates a component of the sample extracted by the sample extractor, and a detector that detects the sample that passes the separation column, this the recited feature is a known, effective feature in the context of a system configured to analyze a product and a controller associated with the product analyzer system as taught by Tomono (page 3, 6th and 7th paragraphs from the top).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Hughes, in view of Tomono, as applied to claim 10 above, and further in view of Minerva Biotechnologies Corp (JP2004531688A, see the attached English translation).
In regard to claim 11, Hughes, in view of Tomono, does not explicitly disclose the feature of a first flow path through which the first liquid raw material, the second liquid raw material or the reaction product flows at a position farther upstream than the flow vial; and a second flow path through which an eluent for eluting the reaction product flows, wherein a cross-sectional area of the second flow path is smaller than a cross-sectional area of the first flow path.
Minerva Biotechnologies Corp discloses a new detection method based on interruption of flow, related to diagnosis, therapy, environmental sampling and food monitoring, and to redirect the flow through the complex circuitry of the flow channel for detection (page 2, Section Field). Minerva Biotechnologies Corp discloses a channel capable of containing a flowing fluid; and a porous member connecting the channel at least in part and comprising colloidal particles: The channel has a cross-sectional dimension of less than about 500 microns. The channel has a cross-sectional dimension of less than about 300 microns. The channel has a cross-sectional dimension of less than about 100 microns. The channel has a cross-sectional dimension of less than about 50 microns, wherein the porous member completely connects the channel and any fluid flowing in the channel must pass through the porous member (page 1).
Therefore, before the effective filing date of the claimed invention, it would have been prima facie obvious to one of ordinary skill in the art to modify the chromatograph system of Hughes, in view of Tomono, and further in view of Minerva Biotechnologies Corp, to provide the feature of a first flow path through which the first liquid raw material, the second liquid raw material or the reaction product flows at a position farther upstream than the flow vial; and a second flow path through which an eluent for eluting the reaction product flows, wherein a cross-sectional area of the second flow path is smaller than a cross-sectional area of the first flow path, because the recited feature is a known, effective feature in the context of constructing a porous channel associated with the product analyzer system as taught by Minerva Biotechnologies Corp (page 1).
Claims 12 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Hughes, in view of Tomono and Minerva Biotechnologies Corp, as applied to claim 11 above, and further in view of Petersen et al. (US 2002/0042125 A1, hereinafter “Petersen”).
In regard to claims 12 and 13, Hughes, in view of Tomono and Minerva Biotechnologies Corp, does not explicitly disclose the feature of a filter that is provided at the flow path between the reactor and the flow vial and removes an unnecessary component contained in the reaction product, and a cleaner that cleans the filter.
Petersen discloses a method for separating an analyte from a sample (paragraph [0002]). Petersen discloses a device for separating a desired analyte from a fluid sample and for concentrating the analyte into a volume of elution fluid smaller than the original sample volume. The desired analyte may comprise, e.g., organisms, cells, proteins, nucleic acid, carbohydrates, virus particles, bacterias, chemicals, or biochemicals. In a preferred use, the desired analyte comprises nucleic acid (paragraph [0011]). Petersen discloses a use of filter that serves to remove debris from the fluid sample in the channels (paragraph [0068]) and a use of washing reagents for cleaning (paragraphs [0070]-[0072]).
Therefore, before the effective filing date of the claimed invention, it would have been prima facie obvious to one of ordinary skill in the art to modify the chromatograph system of Hughes, in view of Tomono, and Minerva Biotechnologies Corp, and further in view of Petersen, to provide the feature of a filter that is provided at the flow path between the reactor and the flow vial and removes an unnecessary component contained in the reaction product, and a cleaner that cleans the filter, because the recited feature is a known, effective feature in the context of constructing a porous channel associated with the product analyzer system as taught by Petersen (paragraphs [0068]; [0070]-[0072]).
Conclusion
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to YOUNGSUL JEONG whose telephone number is (571)270-1494. The examiner can normally be reached on Monday-Friday 9AM-5PM.
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/YOUNGSUL JEONG/Primary Examiner, Art Unit 1772