eNotice 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.
Claim Objections
Claim 2 is objected to because of the following informalities: Claim 2 line 19 recites the typo “sample information at at least one”. Appropriate correction is required.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim(s) 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim(s) 1-17 of U.S. Patent No. 20180364267. Although the claims at issue are not identical, they are not patentably distinct from each other because based on the various processing circuitry configuration limitation disclosed in Shinohara (US 20180364267A1) for acquiring sample information (e.g. expiration timing), manipulation, monitoring (e.g. calibration data), and identification within an automatic analyzer, would be anticipated and/or obvious to one with ordinary skills in the art.
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)(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) 1-3, 5-13, and 15-20 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Hashimoto et al. (US20220308079A1), herein referred to as Hashimoto et al. '0922.
The applied reference has a joint inventor and assignee with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
Regarding Claim 1, Hashimoto et al. '0922 teaches an automatic analyzer 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 analyzing device 70 includes a sample disk 5 holding a plurality of specimen containers 11 in Fig. 2 in [0015]-[0033], the Abstract, and the Claim(s) 1-14), the automatic analyzer comprising:
control circuitry (See the circuitry 30 in Fig. 1-2 in [0017]-[0024]) 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 (See how the data processing function 31 is configured to generate calibration data and analysis data of each of the test items, by processing the standard data and the tested data generated by the analyzing device 70 in Fig. 1-2 in [0017]-[0024]).
Regarding Claim(s) 2-3, Hashimoto et al. '0922 teaches the analyzer limitations of claim 1.
Hashimoto et al. '0922 further an automatic analyzer (See how the analyzing device 70 includes a sample disk 5 holding a plurality of specimen containers 11 in Fig. 2 in [0015]-[0033], the Abstract, and the Claim(s) 1-14), wherein the control circuitry is configured to acquire the standard sample information 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 in [0051] and in Claim(s) 3-6; Also, see the input device 50 in [0017]-[0018] in Fig. 1-2);
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 the measurement unit 13 is configured to perform the measuring process on the liquid mixture of a specimen and the reagent 120 in the one or more of the reaction cuvettes in [0043] in Fig. 2);
Regarding Claim 5, Hashimoto et al. '0922 teaches the analyzer limitations of claim 3.
Hashimoto et al. '0922 further an automatic analyzer (See how the analyzing device 70 includes a sample disk 5 holding a plurality of specimen containers 11 in Fig. 2 in [0015]-[0033], the Abstract, and the Claim(s) 1-14), wherein the control circuitry (See the circuitry 30 in Fig. 1-2 in [0017]-[0024]) 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 (See how the measurement unit 13 is configured to perform the measuring process on the liquid mixture of a specimen and the reagent 120 in the one or more of the reaction cuvettes in [0043] in Fig. 2 and in Claim(s) 14-17), 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 output interface 6 Fig. 1-2 in [0026]-[0031]).
Regarding Claim(s) 6-11, Hashimoto et al. '0922 teaches the analyzer limitations of claim(s) 1 and 3.
Hashimoto et al. '0922 further an automatic analyzer (See how the analyzing device 70 includes a sample disk 5 holding a plurality of specimen containers 11 in Fig. 2 in [0015]-[0033], the Abstract, and the Claim(s) 1-14), 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 how the calibration data output from the processing circuitry 30 denotes data indicating a result of the measuring process such as the amount or the density of the substance derived from the tested data and the standard data. in Fig. 1-2 in [0017]-[0024]);
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 in [0017]-[0025] in Fig. 1-5).
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 in [0017]-[0025] in Fig. 1-5);
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 in [0017]-[0025] 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 how the storage circuit 60 is, for example, a semiconductor memory element such as a Random Access Memory (RAM) or a flash memory, or a storage device such as a hard disk or an optical disk in [0017]-[0025] in Fig. 1-5);
wherein the control circuitry is further configured to output the condition information together with a measurement result (See the processing device 90 includes an input device 50, an output device 40, processing circuitry 30, and a storage circuit 60 in [0017]-[0025] in Fig. 1-5).
Regarding Claim 12, Hashimoto et al. '0922 teaches an automatic analyzer 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 analyzing device 70 includes a sample disk 5 holding a plurality of specimen containers 11 in Fig. 2 in [0015]-[0033], the Abstract, and the Claim(s) 1-14), the automatic analyzer comprising:
control circuitry (See the circuitry 30 in Fig. 1-2 in [0017]-[0024]) 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, and update, upon acquisition of the standard sample information, condition information on a condition of the standard sample (See how the data processing function 31 is configured to generate calibration data and analysis data of each of the test items, by processing the standard data and the tested data generated by the analyzing device 70 in Fig. 1-2 in [0017]-[0024]).
Regarding Claim 13, Hashimoto et al. '0922 teaches the analyzer limitations of claim 12.
Hashimoto et al. '0922 further an automatic analyzer (See how the analyzing device 70 includes a sample disk 5 holding a plurality of specimen containers 11 in Fig. 2 in [0015]-[0033], the Abstract, and the Claim(s) 1-14), 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 the measurement unit 13 is configured to perform the measuring process on the liquid mixture of a specimen and the reagent 120 in the one or more of the reaction cuvettes in [0043] in Fig. 2).
Regarding Claim 15, Hashimoto et al. '0922 teaches the analyzer limitations of claim 13.
Hashimoto et al. '0922 further an automatic analyzer (See how the analyzing device 70 includes a sample disk 5 holding a plurality of specimen containers 11 in Fig. 2 in [0015]-[0033], the Abstract, and the Claim(s) 1-14), wherein the control circuitry (See the circuitry 30 in Fig. 1-2 in [0017]-[0024]) 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 (See how the measurement unit 13 is configured to perform the measuring process on the liquid mixture of a specimen and the reagent 120 in the one or more of the reaction cuvettes in [0043] in Fig. 2 and in Claim(s) 14-17), 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 output interface 6 Fig. 1-2 in [0026]-[0031]).
Regarding Claim(s) 16-19, Hashimoto et al. '0922 teaches the analyzer limitations of claim(s) 12 and 13.
Hashimoto et al. '0922 further an automatic analyzer (See how the analyzing device 70 includes a sample disk 5 holding a plurality of specimen containers 11 in Fig. 2 in [0015]-[0033], the Abstract, and the Claim(s) 1-14), 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 how the calibration data output from the processing circuitry 30 denotes data indicating a result of the measuring process such as the amount or the density of the substance derived from the tested data and the standard data. in Fig. 1-2 in [0017]-[0024]);
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 in [0017]-[0025] 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 how the storage circuit 60 is, for example, a semiconductor memory element such as a Random Access Memory (RAM) or a flash memory, or a storage device such as a hard disk or an optical disk in [0017]-[0025] in Fig. 1-5);
wherein the control circuitry is further configured to output the condition information together with a measurement result (See the processing device 90 includes an input device 50, an output device 40, processing circuitry 30, and a storage circuit 60 in [0017]-[0025] in Fig. 1-5).
Regarding Claim 20, Hashimoto et al. '0922 teaches an automatic analyzing method for dispensing a subject sample or a standard sample and a reagent into a reaction container and subjecting a mixture liquid in the reaction container to measurement (See how the analyzing device 70 includes a sample disk 5 holding a plurality of specimen containers 11 in Fig. 2 in [0015]-[0033], the Abstract, and the Claim(s) 1-14), 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; and updating, upon acquisition of the standard sample information, condition information on a condition of the standard sample (See how the data processing function 31 is configured to generate calibration data and analysis data of each of the test items, by processing the standard data and the tested data generated by the analyzing device 70 in Fig. 1-2 in [0017]-[0024]; Also, see the circuitry 30 in Fig. 1-2 in [0017]-[0024]).
Claim Rejections - 35 USC § 103
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 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.
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.
Claim(s) 4 and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Hashimoto et al. '0922 (US20220308079A1) as applied to claim(s) 3 and 13 above, and further in view of Hashimoto et al. (US20220244285A1), herein referred to as Hashimoto et al. '0822.
Regarding Claim 4, Hashimoto et al. '0922 teaches the analyzer limitations of claim 1.
Hashimoto et al. '0922 fails to explicitly teach an automatic analyzer according to claim 3, wherein the control circuitry 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.
Yet, in the analogous art of automatic analyzers and standard sample containers, Hashimoto et al. '0822 teaches an automatic analyzer (See how the analyzing device 70 includes a sample disk 5 holding a plurality of specimen containers 11 in Fig. 2 in [0026]-[0038], the Abstract, and the Claim(s) 1-14), wherein the control circuitry (See the circuitry 9 Fig. 1-2 and 19 in [0026]-[0038]) 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 (See in [0146]-[0163], [0196] in Fig. 19)
output, based on a result of the determination, information on the expired state or the state of showing a sign of expiration (See the output interface 6 Fig. 1-2 and 19 in [0026]-[0038]).
Thus, it would be obvious to one with ordinary skills in the arts to modify the invention of Hashimoto et al. '0922 by incorporating a control circuitry that can determine the expiration state and an output to express the expired state (as taught by Hashimoto et al. '0822 for the benefit of using effective standard samples in an automatic analyzer.
Regarding Claim 14, Hashimoto et al. '0922 teaches the analyzer limitations of claim 13.
Hashimoto et al. '0922 fails to explicitly teach an automatic analyzer according to claim 3, wherein the control circuitry 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.
Yet, in the analogous art of automatic analyzers and standard sample containers, Hashimoto et al. '0822 teaches an automatic analyzer (See how the analyzing device 70 includes a sample disk 5 holding a plurality of specimen containers 11 in Fig. 2 in [0026]-[0038], the Abstract, and the Claim(s) 1-14), wherein the control circuitry (See the circuitry 9 Fig. 1-2 and 19 in [0026]-[0038]) 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 (See in [0146]-[0163], [0196] in Fig. 19)
output, based on a result of the determination, information on the expired state or the state of showing a sign of expiration (See the output interface 6 Fig. 1-2 and 19 in [0026]-[0038]).
Thus, it would be obvious to one with ordinary skills in the arts to modify the invention of Hashimoto et al. '0922 by incorporating a control circuitry that can determine the expiration state and an output to express the expired state (as taught by Hashimoto et al. '0822 for the benefit of using effective standard samples in an automatic analyzer.
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: Shinohara (US 20180364267A1), Nakasawa et al. (US20150369833A1), Kanayama (US9046504B2), and Wakamiya et al. (US20080241937A1).
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