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. JP2021-049452, filed on 03/24/2021.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
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) 1-4 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 closest prior art is Nakamura et al. (US20080056944A1).
Regarding Claim 1, Nakamura et al. teaches an automatic analyzer (See the Abstract, the Claim(s) 1-7, and the automatic analyzer in [0019]-[0049] in Fig. 1-5) comprising:
an input unit which receives a container including a specimen and a quality control sample (See how the sample rack feed unit 1, i.e. an input unit, feeds plural sample racks each holding plural assay samples in [0021]-[0022] in Fig. 1; Also, see how the sample rack holds quality control materials and standard samples which are to be analyzed at specified times can be stored in the buffer 91 and can be delivered to the analyzer modules at specified times in [0025]-[0032] in Fig. 1-2);
an ID reader which reads ID attached to the container (See the ID reader unit 2 and the sample rack feed unit 1 in [0021] in Fig. 1);
a control unit which assigns measurement items to the ID and controls each unit (See how the main control computer 11, i.e. a control unit, selects the analyzer modules for carrying out the specified analyses on the basis of the sample ID information and gives the information to the analyzer control computers included in the chosen analyzer modules among the analyzer computers in [0021], [0029] in Fig. 1) ; and
an analysis unit which dispenses the specimen and the quality control sample from the container and performs analysis, based on the measurement items (See the analyzer module 5 in [0032]-[0033] in Fig. 1),
wherein when a liquid amount of a first container including the quality control sample is not enough (See how the is capable of automatically selecting another quality control material other than the quality control material whose amount is expected to be insufficient in [0011]) , the control unit assigns measurement items not yet performed, of measurement items assigned to ID of the first container, to ID of a second container including the quality control sample and controls the analysis unit to perform analysis (See in claim(s) 1 and 4-7 in Fig. 1-3).
Note 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 “ the control unit assigns measurement items not yet performed, of measurement items assigned to ID of the first container, to ID of a second container including the quality control sample and controls the analysis unit to perform analysis”, but fails to cover the additional structural elements or configuration of said structural elements that aids to assigning measurement items to new ID containers. One with ordinary skills in the arts would anticipate configuring a control unit to alert on the levels of liquid reagents or to adjust reagent volume or reassign ID codes. The prior art would render similar results in view of Nakamura et al.
Regarding Claim 2, Nakamura et al. teaches the device limitations of claim 1.
Nakamura et al. further teaches an automatic analyzer (See the Abstract, the Claim(s) 1-7, and the automatic analyzer in [0019]-[0049] in Fig. 1-5), wherein the first container and the second container are held in a same rack (See the sample rack storage unit 9, the sample rack 30, and the sample disks 43-44 in [0028], [0032]-[0033] in Fig. 1-3), and
when the liquid amount of the first container is not enough, the control unit conveys the rack to the ID reader and assigns the measurement items not yet performed, of the measurement items assigned to the ID of the first container, to the ID of the second container (See the ID reader unit 2 in [0011], [0029], [0044] in Fig. 1-3 and in claim(s) 1 and 4-7).
Note in MPEP § 2144 VI. concerning the rearrangement of parts of a claimed invention in comparison to the prior art. In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950) (Claims to a hydraulic power press which read on the prior art except with regard to the position of the starting switch were held unpatentable because shifting the position of the starting switch would not have modified the operation of the device.); In re Kuhle, 526 F.2d 553, 188 USPQ 7 (CCPA 1975) (the particular placement of a contact in a conductivity measuring device was held to be an obvious matter of design choice). The current claimed arrangement of the first container and the second container are held in a same rack would render similar results as the apparatus in the prior art.
Regarding Claim 3, Nakamura et al. teaches the device limitations of claim 2.
Nakamura et al. further teaches an automatic analyzer (See the Abstract, the Claim(s) 1-7, and the automatic analyzer in [0019]-[0049] in Fig. 1-5), wherein the first container and the second container are held in a same rack (See the sample rack storage unit 9, the sample rack 30, and the sample disks 43-44 in [0028], [0032]-[0033] in Fig. 1-3), wherein while the rack is conveyed to the ID reader (See the ID reader unit 2 in [0021]-[0029] in Fig. 1), the control unit controls the analysis unit to analyze the measurement items other than the measurement items of the quality control sample (See the analyzer module 5 in [0032]-[0033] in Fig. 1 and in Claim(s) 1-7).
Regarding Claim 4, Nakamura et al. teaches the device limitations of claim 1.
Nakamura et al. further teaches an automatic analyzer (See the Abstract, the Claim(s) 1-7, and the automatic analyzer in [0019]-[0049] in Fig. 1-5), wherein the first container and the second container are held in individual racks (See the sample rack storage unit 9, the sample rack 30, and the sample disks 43-44 in [0028], [0032]-[0033] in Fig. 1-3), and
when the liquid amount of the first container is not enough, the control unit conveys the rack holding the second container to the ID reader and assigns the measurement items not yet performed, of the measurement items assigned to the ID of the first container, to the ID of the second container (See the ID reader unit 2 in [0011], [0029], [0044] in Fig. 1-3 and in claim(s) 1 and 4-7).
Note in MPEP § 2144 VI. concerning the rearrangement of parts of a claimed invention in comparison to the prior art. The current claimed arrangement of the first container and the second container are held in a same rack would render similar results as the apparatus in the prior art.
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.
Claim(s) 5 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Nakamura et al. (US20080056944A1) as applied to claim(s) 1 and 4 above, and further in view of Mimura et al. (US20060110288A1).
Regarding Claim 5, Nakamura et al. teaches the device limitations of claim 1.
Nakamura et al. fails to explicitly teach an automatic analyzer, wherein the rack holding the second container is kept in a cooling box for cold-insulating the quality control sample.
However, in the analogous art of analyzer systems having sample rack lines, Mimura et al. teaches an automatic analyzer (See the Abstract, the Claim(s) 13-14, and the automatic analyzer in [0016]-[0043] in Fig. 1-4), wherein the rack holding the second container is kept in a cooling box for cold-insulating the quality control sample (See how the reagent bottles 12 for the first reagent and the second reagent for the plurality of analysis items are arranged in the reagent cooler 62, i.e. a colling box, and their reagent temperature is maintained at a designated value in [0024] in Fig. 2).
Thus, it would be obvious to one with ordinary skills in the arts to modify the analyzer of Nakamura et al. by incorporating a rack holding the second container is kept in a cooling box (as taught by Mimura et al.) for the benefit of cold-insulating the quality control sample.
Regarding Claim 6, Nakamura et al. teaches the device limitations of claim 1.
Nakamura et al. fails to explicitly teach an automatic analyzer, wherein the analysis unit has a dispensing probe which dispenses the specimen and the quality control sample, and the dispensing probe is provided with a liquid surface detecting mechanism.
However, in the analogous art of analyzer systems having sample rack lines, Mimura et al. teaches an automatic analyzer (See the Abstract, the Claim(s) 13-14, and the automatic analyzer in [0016]-[0043] in Fig. 1-4), wherein the analysis unit has a dispensing probe which dispenses the specimen and the quality control sample, and the dispensing probe is provided with a liquid surface detecting mechanism (See how the fluid level sensor, i.e. a dispensing probe, attached to the reagent pipette nozzle detects the reagent fluid level in the reagent bottle when the corresponding reagent fluid is picked up and pipetted, or a pre-input maximum analyzable number is subtracted by one every pipetting of the reagent in [0037]-[0038] in Fig. 1-2).
Thus, it would be obvious to one with ordinary skills in the arts to modify the analyzer of Nakamura et al. by incorporating an analysis unit comprising a dispensing probe (as taught by Mimura et al.) for the benefit of dispensing the specimen and the quality control sample and of providing a liquid surface detecting mechanism.
Conclusion
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