CTNF 18/570,131 CTNF 98854 DETAILED ACTION Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. Claim Objections 07-29-01 AIA Claim 3 is objected to because of the following informalities: Regarding claim 3, l. 4 recites “an amount of the organic solvent contained in the liquid“. Applicant may amend the claim to recite “ an the amount of the organic solvent contained in the liquid“ . Appropriate correction is required. Claim Rejections - 35 USC § 102 07-07-aia AIA 07-07 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 – 07-12-aia AIA (a)(1) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention. 07-15 AIA Claim s 1, 4 ,6, and 9 are rejected under 35 U.S.C. 102( a)(1 ) as being anticipated by Sawada (JPH10260118 A; 1998, see attached English translation) . Regarding claim 1, Sawada teaches a control method for controlling an automatic analyzer that analyzes a sample (Automatic extraction device and automatic concentration-measuring apparatus for component substance in liquid sample; Title), the control method comprising: a step of acquiring information about whether or not an amount of an organic solvent contained in a liquid added to a reaction container storing the sample (“in the centrifuge tube 14…the sample separation liquid in which the target component substance is dissolved in the organic solvent forms the upper layer part A… the sample separation liquid in the upper layer A is sucked; [0044]; Fig. 3) is a reference value or more (“two sets of liquid level detection photoelectric sensors 254a, 254b; 256a, 256b for detecting the upper end of the sample separation liquid sucked into the disposable tip 222,” wherein the reference value is the amount of light incident on the light receiving unit 254b when the light emitted from the light projecting unit 254a is not blocked by the sample separation liquid 264 in the disposable chip 222, which necessary corresponds to an amount of sample separation liquid present in the centrifuge tube 14; [0078])(Under broadest reasonable interpretation a reference value can be any value including 0); a step of determining, according to the information, whether or not the amount of the organic solvent contained in the reaction container is the reference value or more (The light emitted from the light projecting unit 254a is blocked by the sample separation liquid 264 in the disposable chip 222, the amount of light incident on the light receiving unit 254b is reduced , and the output from the light receiving unit 254b of the photoelectric sensor is changed; [00788]; Fig. 19D)(Emphasis added). a step of sucking a residual liquid remaining in the reaction container from the reaction container when it is determined that the amount of the organic solvent contained in the reaction container is the reference value or more, and not sucking the residual liquid from the reaction container when it is determined that the amount of the organic solvent contained in the reaction container is not the reference value or more (the amount of light incident on the light receiving unit 254b is reduced, and the output from the light receiving unit 254b of the photoelectric sensor is changed…The liquid inhalation operation stops…the suction operation is stopped; [0078]); and a step of moving the reaction container to a disposal container holding unit configured to hold a reaction container that is disposed of (the used centrifuge tube 14 is discarded into the disposal pot 73, wherein the separation liquid dispensing unit 62 is operated; [0099]; Fig. 15). Regarding claim 4, Sawada teaches the control method according to claim 1, further comprising: a step of dispensing a sample liquid containing the sample into a first reaction container (sample liquid is discharged into the centrifuge tube 14; [0044]); and a step of transferring the liquid in the first reaction container to a second reaction container (the sucked sample separation liquid is discharged into the test tube 24; [0044]), wherein in the determining step, it is determined whether or not the amount of the organic solvent contained in the first reaction container is the reference value or more (separation liquid 264 in the centrifuge tube 14 is sucked into the disposable chip 222 from its lower end…The light emitted from the light projecting unit 254a is blocked by the sample separation liquid 264 in the disposable chip 222, the amount of light incident on the light receiving unit 254b is reduced, and the output from the light receiving unit 254b of the photoelectric sensor is changed; [0078]; Fig. 19D) in the step of sucking or not sucking the residual liquid, the residual liquid in the first reaction container is sucked when it is determined that the amount of the organic solvent contained in the first reaction container is the reference value or more, and the residual liquid is not sucked when it is determined that the amount of the organic solvent contained in the first reaction container is not the reference value or more (the amount of light incident on the light receiving unit 254b is reduced, and the output from the light receiving unit 254b of the photoelectric sensor is changed…The liquid inhalation operation stops…the suction operation is stopped; [0078]), and in the step of moving the reaction container, the first reaction container is moved to the disposal container holding unit (the used centrifuge tube 14 is discarded into the disposal pot 73; [0099]). Regarding claim 6, Sawada teaches the control method according to claim 1, wherein the liquid is at least one of: a sample liquid containing the sample (sample separation liquid in which the target component substance is dissolved in the organic solvent; [0044]); a reagent liquid containing a reagent that reacts with the sample a cleaning liquid used for cleaning an unnecessary component stored in the reaction container; an eluent by which the sample is eluted; and a composition adjustment liquid generated by adjusting a composition of a sample liquid supplied to an analyzer that analyzes a component of the sample. Regarding claim 9, Sawada teaches an automatic analyzer that analyzes a sample, the automatic analyzer comprising: a controller configured to control the automatic analyzer by performing the control method according to claim 1 (The controller 262 of the motor 260 that drives the syringe 258 and the drive motor (stepping motor) 204 (see FIG. 12) that drives the lifting member 220 that holds the dispensing nozzle 200 up and down are connected to the CPU 267, respectively; [0075]) . Claim Rejections - 35 USC § 103 07-20-aia AIA 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. 07-23-aia AIA 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. 07-20-02-aia AIA This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention. 07-21-aia AIA Claim s 2-3 are rejected under 35 U.S.C. 103 as being unpatentable over Sawada (JPH10260118 A, see attached English translation) in view of Agilent Technologies ("Applications Compendium for Agilent Technologies 7696A Sample Prep Workbench”) . Regarding claim 2, Sawada teaches the control method according to claim 1. Sawada fails to teach that in the step of acquiring the information, the amount of the organic solvent contained in the liquid is calculated using a concentration of the organic solvent contained in the liquid and an amount of the liquid, and the information is acquired according to a calculation result. Agilent Technologies teaches the amount of the organic solvent contained in the liquid is calculated using a concentration of the organic solvent contained in the liquid and an amount of the liquid, and the information is acquired according to a calculation result (The WorkBench stores the organic solvent identities and dispense volumes in the sample preparation method. The amount of organic solvent may therefore be calculated from the known solvent concentration and the known dispensed volume, such as 800 uL of 100% n-heptane dispensed into a sample vial containing other liquids for a final volume of 830 uL (See p. 3, Table 2 and p. 4 Table 3, Fig. 2). Agilent Technologies is considered to be analogous to the claimed invention because it is in the same field of endeavor for automated laboratory sample preparation for chemical analysis. Agilent Technologies already stores the identity, concentration, and volume of liquids introduced into a sample container. Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the control method taught by Sawada by using Agilent Technologies’ s stored information about the organic solvent present within the container before performing Sawada’s aspiration process because this would predict the liquid level, thereby reducing reliance on post aspiration measurements alone for improved process efficiency and reliability, and this includes combining prior art elements according to known methods to yield predictable results (See MPEP 2143(I)(A)). Regarding claim 3, Sawada teaches the control method according to claim 1. Sawada fails to teach a step of acquiring data describing a correspondence relationship between at least one of an analysis item during analyzing of the sample and a type of the sample, and an amount of the organic solvent contained in the liquid, wherein in the step of acquiring the information, the information is acquired by using at least one of the analysis item during analyzing of the sample and the type of the sample and referring to the data. Agilent Technologies teaches a step of acquiring data describing a correspondence relationship between at least one of an analysis item during analyzing of the sample (sample prep protocol; p. 4, Table 3) and a type of the sample (Biodiesel; p. 4, Table 3), and an amount of the organic solvent contained in the liquid (“Add 800 µL n-heptane to every sample vial and mix,” wherein the vials contain the other liquids in Table 3), wherein in the step of acquiring the information, the information is acquired by using at least one of the analysis item during analyzing of the sample and the type of the sample and referring to the data (It is displayed in the biodiesel preparation protocol that 800 uL of 100% n-Hexane is present in every sample vial and mix; See p. 4, Table 3). Agilent Technologies is considered to be analogous to the claimed invention because it is in the same field of endeavor for automated laboratory sample preparation for chemical analysis. Agilent Technologies already stores the identity, concentration, and volume of liquids introduced into a sample container. Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the control method taught by Sawada by using Agilent Technologies’ s stored information about the organic solvent present within the container before performing Sawada’s aspiration process because this would predict the liquid level, thereby reducing reliance on post aspiration measurements alone for improved process efficiency and reliability, and this includes combining prior art elements according to known methods to yield predictable results (See MPEP 2143(I)(A)) . 07-21-aia AIA Claim s 5, 7-8 are rejected under 35 U.S.C. 103 as being unpatentable over Sawada (JPH10260118 A, see attached English translation) in view of Kakizaki (US 20090041628 A1) . Regarding claim 5, Sawada teaches the control method according to claim 1, further comprising: a step of dispensing a sample liquid containing the sample into a first reaction container (sample liquid is discharged into the centrifuge tube 14; [0044]); a step of transferring the liquid in the first reaction container to a second reaction container (the sucked sample separation liquid is discharged into the test tube 24; [0044]); and a step of analyzing the liquid stored in the second reaction container (a predetermined amount of the inhaled sample solution is injected into the HPLC column, and the concentrations of the component substances are measured; [0101]; Fig. 2), in the step of moving the reaction container, the second reaction container is moved to the disposal container holding unit (the used test tube 24 is discarded into the disposal pot 73 using the centrifuge tube transfer chuck unit; [0101). Sawada is silent to teaching that in the determining step, it is determined whether or not the amount of the organic solvent contained in the second reaction container is the reference value or more after the analysis is completed, in the step of sucking or not sucking the residual liquid, the residual liquid in the second reaction container is sucked when it is determined that the amount of the organic solvent contained in the second reaction container is the reference value or more, and the residual liquid is not sucked when it is determined that the amount of the organic solvent contained in the second reaction container is not the reference value or more. Kakizaki teaches sucking a residual liquid after an analysis is completed (After the analysis is finished, the reaction vessel 7 is transferred to the disposal position. The wastewater suction device 20 drains the reaction wastewater after the reaction from the reaction vessel 7; [0032]; See wastewater tank in Fig. 2). Kakizaki is considered to be analogous to the claimed invention because it is in the same field of endeavor for automated clinical analyzers and automated laboratory analysis systems. Sawada teaches that the test tube is discarded after the analysis is completed and aims to “reduce the labor of the worker conventionally required for the series of operations” ([0103]). Also, it was well-known in the art to collect waste liquids containing hazardous solvents in dedicated waste containers to facilitate proper disposal and regulatory compliance. Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the control method taught by Sawada by aspirating the residual liquid in the container after analysis and before disposal as taught Kakizaki because automating the removal and collection of the residual separation liquid containing the hazardous solvent ethyl acetate (Sawada, [0004]) would increase laboratory efficiency and facilitate proper disposal of the organic solvent, and this includes combining prior art elements according to known methods to yield predictable results (See MPEP 2143(I)(A)). Modified Sawada fails to teach that the residual liquid in the second reaction container is sucked when it is determined that the amount of the organic solvent contained in the second reaction container is the reference value or more, and the residual liquid is not sucked when it is determined that the amount of the organic solvent contained in the second reaction container is not the reference value or more. However, Modified Sawada already teaches acquiring information regarding the amount of liquid in the first reaction container (centrifuge tube 14) and using that information to control aspiration operations (See claim 1). Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used the same information and determination logic already employed during transfer from the centrifuge tube to determine whether residual liquid should be aspirated from the test tube after analysis because this would provide a predictable means of automating the process (See MPEP 2144.04(III)). Regarding claim 7, Sawada teaches the control method according to claim 1. Sawada fails to teach the automatic analyzer includes a residual liquid tank configured to store the residual liquid and the control method further comprises: a step of discharging the sucked residual liquid to the residual liquid tank when the residual liquid is sucked from the reaction container, and not discharging the residual liquid to the residual liquid tank when the residual liquid is not sucked from the reaction container. Kakizaki teaches the automatic analyzer (An automatic analyzer; Abstract) includes a residual liquid tank configured to store a residual liquid and the (Reaction wastewater suctioned by the plural suction nozzles 21b from the reaction vessel 7 and a cleaning liquid suctioned from the cleaning tank 29 are disposed in the wastewater tank 24; [0025]; control method further comprises: a step of discharging the sucked residual liquid to the residual liquid tank when the residual liquid is sucked from the reaction container, and not discharging the residual liquid to the residual liquid tank when the residual liquid is not sucked from the reaction container (When there is the reaction vessel 7…though there is no reaction wastewater to suction, the vessel determination unit 15b determines whether there is reaction wastewater or not based on the optical signal output from the light-receiving device 9. The clog determination unit 15c distinguishes a case where there is the reaction vessel 7 though there is no reaction wastewater to suction from a case where there is no reaction vessel 7 and no reaction wastewater to suction based on the result of determination on the presence/absence of the reaction wastewater; [0031]). Kakizaki is considered to be analogous to the claimed invention because it is in the same field of endeavor for automated clinical analyzers and automated laboratory analysis systems. Sawada teaches that the test tube is discarded after the analysis is completed and aims to “reduce the labor of the worker conventionally required for the series of operations” ([0103]). Also, it was well-known in the art to collect waste liquids containing hazardous solvents in dedicated waste containers to facilitate proper disposal and regulatory compliance. Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the control method taught by Sawada by aspirating the residual liquid in the tank as taught Kakizaki because automating the removal and collection of the residual separation liquid containing the hazardous solvent ethyl acetate (Sawada, [0004]) would increase laboratory efficiency and facilitate proper disposal of the organic solvent, and this includes combining prior art elements according to known methods to yield predictable results (See MPEP 2143(I)(A)). Regarding claim 8, Sawada teaches the control method according to claim 1, wherein the automatic analyzer includes a residual liquid suction mechanism configured to suck the residual liquid from the reaction container (the drive of the syringe driving motor 260 is stopped by the signal from the controller 262, the syringe 258 is stopped, and the inside of the disposable chip 222 is stopped; [0078]). Sawada fails to teach that the control method further comprises: a step of driving the residual liquid suction mechanism so as to suck the residual liquid after analysis is performed when it is determined that the amount of the organic solvent contained in the reaction container is the reference value or more, and not driving the residual liquid suction mechanism when it is determined that the amount of the organic solvent contained in the reaction container is not the reference value or more. Kakizaki teaches driving a residual liquid suction mechanism so as to suck a residual liquid after an analysis is performed (After the analysis is finished, the reaction vessel 7 is transferred to the disposal position. The wastewater suction device 20 drains the reaction wastewater after the reaction from the reaction vessel 7; [0032]). Kakizaki is considered to be analogous to the claimed invention because it is in the same field of endeavor for automated clinical analyzers and automated laboratory analysis systems. Sawada teaches that the test tube is discarded after the analysis is completed and aims to “reduce the labor of the worker conventionally required for the series of operations” ([0103]). Also, it was well-known in the art to collect waste liquids containing hazardous solvents in dedicated waste containers to facilitate proper disposal and regulatory compliance. Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the control method taught by Sawada by aspirating the residual liquid in the container after analysis and before disposal as taught Kakizaki because automating the removal and collection of the residual separation liquid containing the hazardous solvent ethyl acetate (Sawada, [0004]) would increase laboratory efficiency and facilitate proper disposal of the organic solvent, and this includes combining prior art elements according to known methods to yield predictable results (See MPEP 2143(I)(A)). Modified Sawada fails to teach driving the residual liquid suction mechanism so as to suck the residual liquid when it is determined that the amount of the organic solvent contained in the reaction container is the reference value or more, and not driving the residual liquid suction mechanism when it is determined that the amount of the organic solvent contained in the reaction container is not the reference value or more. However, Modified Sawada already teaches acquiring information regarding the amount of liquid in the first reaction container (centrifuge tube 14) and using that information to control aspiration operations using the syringe driving motor 260 (Sawada, [0078])). Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used the same information and determination logic already employed during transfer from the centrifuge tube to determine whether residual liquid should be aspirated from the test tube after analysis because this would provide a predictable means of automating the process (See MPEP 2144.04(III)) . Conclusion 07-96 AIA The prior art made of record and not relied upon is considered pertinent to applicant's disclosure : No claims are allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to VALERIE SIMMONS whose telephone number is (703)756-1361. The examiner can normally be reached M-F 7:30-4:00. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Maris Kessel can be reached on 571-270-7698. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /V.S./Examiner, Art Unit 1758 /MARIS R KESSEL/Supervisory Patent Examiner, Art Unit 1758 Application/Control Number: 18/570,131 Page 2 Art Unit: 1758 Application/Control Number: 18/570,131 Page 3 Art Unit: 1758 Application/Control Number: 18/570,131 Page 4 Art Unit: 1758 Application/Control Number: 18/570,131 Page 5 Art Unit: 1758 Application/Control Number: 18/570,131 Page 6 Art Unit: 1758 Application/Control Number: 18/570,131 Page 7 Art Unit: 1758 Application/Control Number: 18/570,131 Page 8 Art Unit: 1758 Application/Control Number: 18/570,131 Page 9 Art Unit: 1758 Application/Control Number: 18/570,131 Page 10 Art Unit: 1758 Application/Control Number: 18/570,131 Page 11 Art Unit: 1758 Application/Control Number: 18/570,131 Page 12 Art Unit: 1758 Application/Control Number: 18/570,131 Page 13 Art Unit: 1758 Application/Control Number: 18/570,131 Page 14 Art Unit: 1758
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