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 .
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. 18328920, filed on 06/07/2022.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Response to Arguments
Applicant's arguments filed 04/14/2026 have been fully considered but they are not persuasive.
Applicant’s arguments with respect to claim(s) 1, 2, 4-12, and 14-20 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
The Applicant argued that the '079 application fails to disclose control circuitry configured to acquire, from a standard sample container containing the standard sample, standard sample information comprising at least one of item information, identification information for identification as a calibrator or an accuracy management sample, or concentration information, and update, upon acquisition of the standard sample information, condition information on a condition of the standard sample, wherein the condition information comprises information on at least one of an expiration timing of the standard sample or a remaining amount of the standard sample, as recited in amended Claim 1. However, ‘079 discloses the processing circuitry configured to “the standard data generated by the analyzing device 70 denotes data (a calibration curve or a standard curve) for determining an amount or the density of a substance” (See in [0022]-[0031] in Fig. 1).
In particular, that the '079 application is completely silent regarding acquiring, from a stand sample container containing the standard sample, standard sample information, as required by amended Claim 1. To add, that in the instant invention, the first reader 220 in Figure 2 and the information label of the standard sample container shown in Figure 3, that the standard sample container information can be obtained via reading the information label via the first reader 220. The Applicant argued that the '079 application fails to disclose that feature. Yet, the acquiring of data information from any liquid using circuitry is common in the art, a reader was not claimed in the instant claim 1. Thus, the additional structural limitation of ‘079 does not mean the instant application would not be anticipated by one with ordinary skills in the arts.
Moreover, Applicant notes that the '079 application relates to setting information for a reagent, not a standard sample, and that one of ordinary skill in the art would clearly recognize that a reagent and a standard sample are completely different objects. Yet, they are both liquids that can be manipulated an analyzed in similar manners.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., acquiring, from a stand sample container containing the standard sample, standard sample information via a reader) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
In response to applicant's argument that the control circuitry is not configured the same, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim.
Applicant's arguments fail to comply with 37 CFR 1.111(b) because they amount to a general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the references.
Applicant's arguments do not comply with 37 CFR 1.111(c) because they do not clearly point out the patentable novelty which he or she thinks the claims present in view of the state of the art disclosed by the references cited or the objections made. Further, they do not show how the amendments avoid such references or objections.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Claim Rejections - 35 USC § 102
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 (i.e., changing from AIA to pre-AIA ) 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.
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.
(a)(2) 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.
Claim(s) 1-2, 4-12, and 14-20 are rejected under 35 U.S.C. 102(a)(1) based upon a public use or sale or other public availability of the invention. The instant invention is anticipated by Nakasawa et al. (US20150369833A1).
Regarding Claim 1, Nakasawa et al. teaches an automatic analyzer (See the Abstract, the automated analyzing apparatus 1, and the Claim(s) 1-9 in [0007]-[0050] in Fig. 1-5), configured to dispense a subject sample or a standard sample and a reagent into a reaction container and to subject a mixture liquid in the reaction container to measurement (See how the sample dispensing mechanism 6 dispenses an analyte sample from the sample container 3 to the reaction container 5. Then, the reagent dispensing mechanism 9 dispenses a reagent used for the analysis from the reagent container 8 to the reaction container 5. Subsequently, a liquid mixture is stirred by the stirring mechanism 10. Light emitted from the light source 11 and transmitted through the reaction container 5 containing the liquid mixture is sensed and measured by the photometer (multi-wavelength photometer) 12 and transmitted to an interface 19 via the A/D converter 13. A computer 20 has a function as a control unit, and results obtained from calculations by the control unit are saved in memory means 21 and output to an information apparatus like the display unit 22 in [0020]-[0021] in Fig. 1), the automatic analyzer comprising:
control circuitry (See how all of the operation mechanisms of the analyzing apparatus are controlled by the control unit contained in the computer 20 via communication means 18 and the interface 19 in [0021] in Fig. 1) configured to
acquire, from a standard sample container containing the standard sample, standard sample information comprising at least one of item information, identification information for identification as a calibrator or an accuracy management sample, or concentration information (See how in step S1 the remaining amounts of the reagent containers during use to be recognized as times of reagent replacement by the apparatus are set with respect to all items or with respect of each item. In this regard, the remaining amount may be a volume, a number of remaining tests, a number of days after installation, or an expiration date. Further, as the way of registration, an operator may enter it in the apparatus or on a screen of another information system than the apparatus, or an ID (e.g. RFID or barcode) previously associated with the reagent container may be read and set in [0025] in Fig. 2 and in Claim(s) 2-9; Also see how samples A,B are monitored in the two-reagent measurement system in [0029]-[0039] in Fig. 3 and the determination criteria in [0040]-[0046] in Fig. 4-5; One with ordinary skills in the arts would correlate a liquid reagent with a liquid sample and configure their circuitry similarly), and
update, upon acquisition of the standard sample information, condition information on a condition of the standard sample, wherein the condition information comprises information on at least one of an expiration timing of the standard sample or a remaining amount of the standard sample (See how samples A,B are monitored in the two-reagent measurement system, the determination criteria, and the pause cycles in [0020]-[0039], [0040]-[0046] in Fig. 1-5 and in Claim(s) 1-9).
Note what is discussed in MPEP § 2114 I-II. "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987). The instant application recites the limitation “ a control circuitry configured to… acquire… and update…", but fails to cover the structural components that execute said “acquiring or updating" or define how that the other apparatus components functionally or structurally relates to a “sample/standard container”. For example, readers, labels, tags, wires, lens, detectors, sensors, condition parameters, etc.
Regarding Claim 2, Nakasawa et al. teaches the device limitations of claim 1.
Nakasawa et al. further teaches an automatic analyzer (See the Abstract, the automated analyzing apparatus 1, and the Claim(s) 1-9 in [0007]-[0050] in Fig. 1-5), wherein the control circuitry is configured to acquire the standard sample information at at least one of a timing where a user instruction is accepted or a timing where a preparation for measurement with the standard sample is started (See how samples A,B are monitored in the two-reagent measurement system, the determination criteria, and the pause cycles in [0020]-[0039], [0040]-[0046] in Fig. 1-5 and in Claim(s) 1-9).
Regarding Claim(s) 4-6, Nakasawa et al. teaches the device limitations of claim 1.
Nakasawa et al. further teaches an automatic analyzer (See the Abstract, the automated analyzing apparatus 1, and the Claim(s) 1-9 in [0007]-[0050] in Fig. 1-5), wherein the control circuitry (See how all of the operation mechanisms of the analyzing apparatus are controlled by the control unit contained in the computer 20 via communication means 18 and the interface 19 in [0021] in Fig. 1) is further configured to determine, based on the condition information, whether or not the standard sample is either in an expired state or in a state of showing a sign of expiration, and output, based on a result of the determination, information on the expired state or the state of showing a sign of expiration (See in [0025]-[0046]);
wherein the control circuitry is further configured to determine, based on the condition information, whether or not the standard sample is either in an insufficient remaining amount state or in a state of showing a sign of an insufficient remaining amount, and output, based on a result of the determination, information on the insufficient remaining amount state or the state of showing a sign of an insufficient remaining amount (See the memory means 21 and the display unit 22 in [0020]-[0046] and in Claim 8);
wherein the control circuitry is further configured to determine, based on the condition information, whether or not the standard sample is unusable, and if the standard sample is determined to be unusable, change the standard sample to an equivalent-type standard sample which is equivalent to the standard sample (See in Claim 1).
Regarding Claim(s) 7-9, Nakasawa et al. teaches the device limitations of claim 6.
Nakasawa et al. further teaches an automatic analyzer (See the Abstract, the automated analyzing apparatus 1, and the Claim(s) 1-9 in [0007]-[0050] in Fig. 1-5), wherein the standard sample information corresponding to the equivalent-type standard sample comprises item information, identification information, and concentration information equivalent to those included in the standard sample information corresponding to the standard sample determined to be unusable, respectively (See Claim(s) 1-9 in [0025]);
wherein the control circuitry is configured so that, if the standard sample determined to be unusable is an accuracy management sample, and if there is no equivalent-type standard sample but a calibrator having same item information as that of the standard sample determined to be unusable, the control circuitry changes the standard sample determined to be unusable to the calibrator (See how samples A,B are monitored in the two-reagent measurement system, the determination criteria, and the pause cycles in [0020]-[0039], [0040]-[0046] in Fig. 1-5 and in Claim(s) 1-9);
wherein the control circuitry is further configured to compare a result of measurement performed with the calibrator with a result of previous calibration measurement using the calibrator, and if a difference between the results falls outside a predetermined range, output an indication of an error (See Claim(s) 1-9).
Regarding Claim 10, Nakasawa et al. teaches the device limitations of claim 3.
Nakasawa et al. further teaches an automatic analyzer (See the Abstract, the automated analyzing apparatus 1, and the Claim(s) 1-9 in [0007]-[0050] in Fig. 1-5), further comprising a memory configured to store one or more sets of the standard sample information and the condition information for a predetermined placement quantity or a predetermined period (See the memory means 21 and the display unit 22 in [0020]-[0046] and in Claims 7-8).
Regarding Claim 11, Nakasawa et al. teaches the device limitations of claim 1.
Nakasawa et al. further teaches an automatic analyzer (See the Abstract, the automated analyzing apparatus 1, and the Claim(s) 1-9 in [0007]-[0050] in Fig. 1-5), wherein the control circuitry is further configured to output the condition information together with a measurement result (See the computer 20, the memory means 21, and the display unit 22 in [0020]-[0046] and in Claims 7-8).
Regarding Claim 12, Nakasawa et al. teaches an automatic analyzer (See the Abstract, the automated analyzing apparatus 1, and the Claim(s) 1-9 in [0007]-[0050] in Fig. 1-5), configured to dispense a subject sample or a standard sample and a reagent into a reaction container and to subject a mixture liquid in the reaction container to measurement (See how the sample dispensing mechanism 6 dispenses an analyte sample from the sample container 3 to the reaction container 5. Then, the reagent dispensing mechanism 9 dispenses a reagent used for the analysis from the reagent container 8 to the reaction container 5. Subsequently, a liquid mixture is stirred by the stirring mechanism 10. Light emitted from the light source 11 and transmitted through the reaction container 5 containing the liquid mixture is sensed and measured by the photometer (multi-wavelength photometer) 12 and transmitted to an interface 19 via the A/D converter 13. A computer 20 has a function as a control unit, and results obtained from calculations by the control unit are saved in memory means 21 and output to an information apparatus like the display unit 22 in [0020]-[0021] in Fig. 1), the automatic analyzer comprising:
control circuitry (See how all of the operation mechanisms of the analyzing apparatus are controlled by the control unit contained in the computer 20 via communication means 18 and the interface 19 in [0021] in Fig. 1) configured to
acquire standard sample information comprising item information, identification information for identification as a calibrator or an accuracy management sample, and concentration information, by accepting an input of the standard sample information given according to a user operation (See how in step S1 the remaining amounts of the reagent containers during use to be recognized as times of reagent replacement by the apparatus are set with respect to all items or with respect of each item. In this regard, the remaining amount may be a volume, a number of remaining tests, a number of days after installation, or an expiration date. Further, as the way of registration, an operator may enter it in the apparatus or on a screen of another information system than the apparatus, or an ID (e.g. RFID or barcode) previously associated with the reagent container may be read and set in [0025] in Fig. 2 and in Claim(s) 2-9; Also see how samples A,B are monitored in the two-reagent measurement system in [0029]-[0039] in Fig. 3 and the determination criteria in [0040]-[0046] in Fig. 4-5; One with ordinary skills in the arts would correlate a liquid reagent with a liquid sample and configure their circuitry similarly), and
update, upon acquisition of the standard sample information, condition information on a condition of the standard sample (See how samples A,B are monitored in the two-reagent measurement system, the determination criteria, and the pause cycles in [0020]-[0039], [0040]-[0046] in Fig. 1-5 and in Claim(s) 1-9).
Note what is discussed in MPEP § 2114 I-II. "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987). The instant application recites the limitation “ a control circuitry configured to… acquire… and update…", but fails to cover the structural components that execute said “acquiring or updating" or define how that the other apparatus components functionally or structurally relates to a “sample/standard container”. For example, readers, labels, tags, wires, lens, detectors, sensors, condition parameters, etc.
Regarding Claim(s) 14-16, Nakasawa et al. teaches the device limitations of claim 12.
Nakasawa et al. further teaches an automatic analyzer (See the Abstract, the automated analyzing apparatus 1, and the Claim(s) 1-9 in [0007]-[0050] in Fig. 1-5), wherein the control circuitry (See how all of the operation mechanisms of the analyzing apparatus are controlled by the control unit contained in the computer 20 via communication means 18 and the interface 19 in [0021] in Fig. 1) is further configured to determine, based on the condition information, whether or not the standard sample is either in an expired state or in a state of showing a sign of expiration, and output, based on a result of the determination, information on the expired state or the state of showing a sign of expiration (See in [0025]-[0046]);
wherein the control circuitry is further configured to determine, based on the condition information, whether or not the standard sample is either in an insufficient remaining amount state or in a state of showing a sign of an insufficient remaining amount, and output, based on a result of the determination, information on the insufficient remaining amount state or the state of showing a sign of an insufficient remaining amount (See the memory means 21 and the display unit 22 in [0020]-[0046] and in Claim 8);
wherein the control circuitry is further configured to determine, based on the condition information, whether or not the standard sample is unusable, and if the standard sample is determined to be unusable, change the standard sample to an equivalent-type standard sample which is equivalent to the standard sample (See in Claim 1).
Regarding Claim 17, Nakasawa et al. teaches the device limitations of claim 16.
Nakasawa et al. further teaches an automatic analyzer (See the Abstract, the automated analyzing apparatus 1, and the Claim(s) 1-9 in [0007]-[0050] in Fig. 1-5), wherein the standard sample information corresponding to the equivalent-type standard sample comprises item information, identification information, and concentration information equivalent to those included in the standard sample information corresponding to the standard sample determined to be unusable, respectively (See Claim(s) 1-9 in [0025]).Regarding Claim 18,
Regarding Claim 18, Nakasawa et al. teaches the device limitations of claim 13.
Nakasawa et al. further teaches an automatic analyzer (See the Abstract, the automated analyzing apparatus 1, and the Claim(s) 1-9 in [0007]-[0050] in Fig. 1-5), further comprising a memory configured to store one or more sets of the standard sample information and the condition information for a predetermined placement quantity or a predetermined period (See the memory means 21 and the display unit 22 in [0020]-[0046] and in Claims 7-8).
Regarding Claim 19, Nakasawa et al. teaches the device limitations of claim 12.
Nakasawa et al. further teaches an automatic analyzer (See the Abstract, the automated analyzing apparatus 1, and the Claim(s) 1-9 in [0007]-[0050] in Fig. 1-5), wherein the control circuitry is further configured to output the condition information together with a measurement result (See the computer 20, the memory means 21, and the display unit 22 in [0020]-[0046] and in Claims 7-8).
Regarding Claim 20, Nakasawa et al. teaches an automatic analyzing method (See the Abstract, the automated analyzing apparatus 1, and the Claim(s) 1-9 in [0007]-[0050] in Fig. 1-5), configured to dispense a subject sample or a standard sample and a reagent into a reaction container and to subject a mixture liquid in the reaction container to measurement (See how the sample dispensing mechanism 6 dispenses an analyte sample from the sample container 3 to the reaction container 5. Then, the reagent dispensing mechanism 9 dispenses a reagent used for the analysis from the reagent container 8 to the reaction container 5. Subsequently, a liquid mixture is stirred by the stirring mechanism 10. Light emitted from the light source 11 and transmitted through the reaction container 5 containing the liquid mixture is sensed and measured by the photometer (multi-wavelength photometer) 12 and transmitted to an interface 19 via the A/D converter 13. A computer 20 has a function as a control unit, and results obtained from calculations by the control unit are saved in memory means 21 and output to an information apparatus like the display unit 22 in [0020]-[0021] in Fig. 1), the automatic analyzing method comprising:
acquiring, from a standard sample container containing the standard sample, standard sample information comprising at least one of item information, identification information for identification as a calibrator or an accuracy management sample, or concentration information (See how in step S1 the remaining amounts of the reagent containers during use to be recognized as times of reagent replacement by the apparatus are set with respect to all items or with respect of each item. In this regard, the remaining amount may be a volume, a number of remaining tests, a number of days after installation, or an expiration date. Further, as the way of registration, an operator may enter it in the apparatus or on a screen of another information system than the apparatus, or an ID (e.g. RFID or barcode) previously associated with the reagent container may be read and set in [0025] in Fig. 2 and in Claim(s) 2-9; Also see how samples A,B are monitored in the two-reagent measurement system in [0029]-[0039] in Fig. 3 and the determination criteria in [0040]-[0046] in Fig. 4-5; One with ordinary skills in the arts would correlate a liquid reagent with a liquid sample and configure their circuitry similarly), and
updating, upon acquisition of the standard sample information, condition information on a condition of the standard sample (See how samples A,B are monitored in the two-reagent measurement system, the determination criteria, and the pause cycles in [0020]-[0039], [0040]-[0046] in Fig. 1-5 and in Claim(s) 1-9).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The following prior art teaches analyzers and methods: Hashimoto et al. (US20220308079A1), Hashimoto et al. (US20220244285A1), Shinohara (US 20180364267A1), Nakasawa et al. (US20150369833A1), Kanayama (US9046504B2), Nakamura et al. (US20080056944A1), and Wakamiya et al. (US20080241937A1).
THIS ACTION IS MADE FINAL. 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 BRITNEY N WASHINGTON whose telephone number is (703)756-5959. The examiner can normally be reached Monday-Friday 7:00am - 3:30pm CT.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lyle Alexander can be reached at (571) 272-1254. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BRITNEY N. WASHINGTON/Examiner, Art Unit 1797
/JENNIFER WECKER/Primary Examiner, Art Unit 1797
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