DETAILED ACTION
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 .
Status of Claims
The claim set submitted on 04 FEBRUARY 2026 is acknowledged and considered. In the claim set, Claim 1 and 7 are ‘Currently Amended’; Claims 2, 3, 5, 6, and 8-9 are ‘Original’; and Claim 10 is ‘Withdrawn’.
Current pending claims are Claims 1-3 and 5-9 and are considered on the merits below.
Response to Amendment/Arguments
Applicant’s arguments, see REMARKS, filed 04 FEBRUARY 2026, with respect to the objection to the specification have been fully considered and are persuasive. The objection to the specification has been withdrawn.
Applicant's arguments filed 04 FEBRUARY 2026 have been fully considered but they are not persuasive.
In response to Applicant’s assertion that YOSHIDA does not disclose ‘wherein when the analyzers in the system are arranged…’ on page 6 of 8, this language is directed the intended use of the automatic analysis system rather than a structural feature that accomplishes these functions. The instant claim language does not require or is specifically design or arranged to perform the stated function or even programmed to do the specific function.
In the amendment to claim submitted on 04 FEBRAURY 2026, independent Claim 1 recites ‘wherein the control device is able to…’. It is interpreted by the Examiner that the phrase ‘able to’ is the same as ‘capable of’. Using the broadest reasonable interpretation, the control device that is able to …indicates that the structure, in this case, the analysis system has the potential or inherent ability to perform the desired function. The instant claim language does not require or is specifically design or arranged to perform the stated function or even programmed to do the specific function.
The amendment to the claim attempts to define a functionality of the control device when it is in use and/or when it is operating. “[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 language in Claim 1 of the control device is not limited to a specific structure covers all devices that are capable of performing the recited function. See In re Translogic Technology, Inc., 504 F.3d 1249, 1258, 84 USPQ2d 1929, 1935-1936 (Fed. Cir. 2007). “[I]t is elementary that the mere recitation of a newly discovered function or property, inherently possessed by things in the prior art, does not cause a claim drawn to those things to distinguish over the prior art”).
Furthermore, what the amended claim language : “wherein the control device is able to write and read the unique identification information and the cumulative information to an external storage medium.” is so well known in the art that any control device which includes/defined by display unit, input unit, storage unit, controller and output unit routinely write and read the unique identification information and the cumulative information to an external storage medium. This includes traditional computers with any well-known operating system and even smartphones and PDA with a processor/microprocessor.
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.
Claims 1-3, 5 and 8-9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by YOSHIDA, EP 3 410 442 A1, submitted on the Information Disclosure Statement on 29 OCTOBER 2024.
Applicant’s invention is directed towards a device, an automatic analyzer.
Regarding Claim 1, the YOSHIDA reference discloses an automatic analysis system, Figure 1, [0028, 0029], abstract, system, comprising:
two or more analyzers having unique identification information and cumulative information associated with the unique identification information, and configured to analyze a sample, Figure 1, 114a-c, detection units, [0007, 0030] with module identifier, [0013] ; and
a control device configured to control operations of the analyzers and manage the unique identification information and the cumulative information of each of the analyzers, Figure 1, server 150 is also a computer, [0032, 0033], LC information storage section 152 holds the following items of information associated with the identifier of the system controller 115a-c included in each of the LCs 110a-c: model numbers of a plurality of operation modules included in the LC concerned; the serial number of each operation; and information on the number of times of use or time of use of an expendable part included in each operation module,
wherein when the analyzers in a system are rearranged, [0051-0063], detecting when module is transferred to another unit, the control device takes over the cumulative information that a newly introduced analyzer has in a pre-rearrangement system based on the unique identification information, and manages cumulative information in a new system based on the taken-over cumulative information, [0051-0063], and
wherein the control device is able to write and read the unique identification information and the cumulative information to an external storage medium, Figure 2, [0031-0032].
Using the broadest reasonable interpretation, the control device that is able to …indicates that the structure, in this case, the analysis system has the potential or inherent ability to perform the desired function. The instant claim language does not require or is specifically design or arranged to perform the stated function or even programmed to do the specific function.
Additional Disclosures Included are: Claim 2: wherein the automatic analysis system according to claim 1, further comprising: a display unit configured to display information of the automatic analysis system, wherein the control device causes the display unit to display a setting screen for setting the unique identification information, Figure 2, [0030-0031, 0034].; Claim 3: wherein the automatic analysis system according to claim 2, wherein the control device causes the display unit to display a read-write screen on which the cumulative information 48 is readable and writable, Figure 2, [0030-0032].; Claim 5: wherein the automatic analysis system according to claim 1, further comprising: an internal record medium, wherein the control device records a device serial number on the internal record medium as the unique identification information, [0032]. ; Claim 8: wherein the automatic analysis system according to claim 3, 49wherein the control device is configured to, transmit the cumulative information to a record medium of a host computer connected to the automatic analysis system via a network, and manage the cumulative information on the record medium of the host computer, Figure 1, 6-8, [0004, 0007, 0029, 0032].; and Claim 9: wherein the automatic analysis system according to claim 8, wherein the control device is configured to, transmit the unique identification information input on the read-write screen to the host computer, [0034], Figure 2, information stored in the storage section 152-154 of the management server 150 can be read by the controller 151 and transmitted through the Internet 140 to the information communication terminal 130, to be displayed on the screen of the display unit , and when the record medium of the host computer includes the cumulative information associated with the unique identification information, receive the relevant cumulative information, [0034], displayed on the screen of the display unit connected to the information communication terminal 130, [0037], updating of information is considered to be cumulative information.
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 6 is rejected under 35 U.S.C. 103 as being unpatentable over YOSHIDA, EP 3 410 442 A1, submitted on the Information Disclosure Statement on 29 OCTOBER 2024, and further in view of AKUTSU, US Publication No. 2019/0317119 A1.
Regarding Claim 6, the reference YOSHIDA discloses the claimed invention, but is silent in regards to the system according to claim 1, further comprising: a barcode reader, wherein the control device is configured to write out the unique identification information as a barcode, and manage the bar-coded unique identification information read by the barcode reader.
The AKUTSU reference discloses an automatic analysis system, Figure 1, automatic analysis device 100, [0022], comprising:
two or more analyzers having unique identification information and cumulative information associated with the unique identification information, abstract, Figure 1 and 9-10, [0007, 0032], in graphs, the different patterns are the two analyzers/analysis occurring, and configured to analyze a sample, [0058]; and
a control device configured to control operations of the analyzers and manage the unique identification information and the cumulative information of each of the analyzers, Figure 1 and 2, control device 4 (control unit), [0022, 0035, 0036], wherein when the analyzers in a system are rearranged, the control device takes over the cumulative information that a newly introduced analyzer has in a pre-rearrangement system based on the unique identification information, and manages cumulative information in a new system based on the taken-over cumulative information, [0032, 0033-0038],
further comprising: a barcode reader, Figure 3, [0031], wherein the control device is configured to write out the unique identification information as a barcode, and manage the bar-coded unique identification information read by the barcode reader, Figure 7, [0046].
It would be obvious to one having ordinary skill in the art before the effective filing date to modify the claimed invention of YOSHIDA to include the barcode reader as taught by AKUTSU to decrease the turnaround time where there are a lot of specimens to be tested, [0054].
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over YOSHIDA, EP 3 410 442 A1, submitted on the Information Disclosure Statement on 29 OCTOBER 2024, and further in view of SHIBITA, US Publication No. 2012/0003121 A1.
Regarding Claim 7, the reference YOSHIDA discloses the claimed invention, but is silent in regards to wherein the system according to claim 1, wherein the external storage medium is one or more of a USB media, a CD media, and a DVD media.
SHIBATA discloses an automatic analysis system, abstract, Figure 1, comprising:
two or more analyzers having unique identification information and cumulative information associated with the unique identification information, Figure 1, 5a5b, [0023, 0024], and configured to analyze a sample, [0023, 0024]; and
a control device configured to control operations of the analyzers and manage the unique identification information and the cumulative information of each of the analyzers, Figure 1, control unit 12, [0023, 0024, 0027, 0028], wherein when the analyzers in a system are rearranged, the control device takes over the cumulative information that a newly introduced analyzer has in a pre-rearrangement system based on the unique identification information, and manages cumulative information in a new system based on the taken-over cumulative information, [0027-0029], wherein the control device is able to write and read the unique identification information and the cumulative information to an external storage medium, [0027-0030].
SHIBITA further teaches the memory device is configured to be downloaded by a portable disk drive from a portable recording medium such as a DVD, or a CD-ROM, [0029, 0030].
It would be obvious to one having ordinary skill in the art before the effective filing date to modify the claimed invention of YOSHIDA to include the external storage medium is of one or more of a USB media, a CD media, and a DVD media as taught by SHIBITA to have a media that is portable to be used in more than one location and/or in different device, [0029].
Conclusion
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 CHRISTINE T MUI whose telephone number is (571)270-3243. The examiner can normally be reached M-Th 5:30 -15:30 EST.
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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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CTM
/CHRISTINE T MUI/Primary Examiner, Art Unit 1797