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 .
This action is in response to applicant’s “Remarks/Arguments”, filed March 23, 2026. The amendments therein have been thoroughly reviewed and entered. Any previous objection/ rejection not repeated herein has been withdrawn.
Applicant's arguments have been thoroughly reviewed but are deemed moot in view of the amendments, withdrawn rejections, and new and/or modified grounds for rejection, necessitated by the amendments, discussed below.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1, 4-12 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because the machine-readable storage medium is not disclosed a “non-transitory”. The USPTO recognizes that applicants may have claims directed to computer readable media that cover signals per se, which the USPTO must reject under 35 U.S.C. § 101 as covering both non-statutory subject matter and statutory subject matter. In an effort to assist the patent community in overcoming a rejection under 35 U.S.C. § 101 in this situation, the USPTO suggests the following approach. A claim drawn to such a computer readable medium (memory) that covers both transitory and non-transitory embodiments may be amended to narrow the claim to cover only statutory embodiments overcome this rejection under 35 U.S.C. § 101 by adding the limitation "non-transitory" before “memory” found in claims 1, 4 and 8. This would overcome this rejection under 35 U.S.C. § 101. Such an amendment would typically not raise the issue of new matter, even when the specification is silent because the broadest reasonable interpretation relies on the ordinary and customary meaning that includes signals per se. The limited situations in which such an amendment could raise issues of new matter occur, for example, when the specification does not support a non-transitory embodiment because a signal per se is the only viable embodiment such that the amended claim is impermissibly broadened beyond the supporting disclosure. See, e.g., Gentry Gallery, Inc. v. Berkline Corp., 134 F.3d 1473 (Fed. Cir. 1998).
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 6, 7, 10 and 11 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
New claim 6 and 10 recite in the second reading mode, “the CPU disables reading by the second reader”. Similarly, claims 7 and 11 recite “the CPU restores operation from the second reading mode to the first reading mode upon determining that the reading error has been resolved”. Applicant cited support for the [0057]-[0062] of applicant’s specification as filed. However, after close inspection, the examiner finds that the specification recites after all of the steps in Figs. 8 and 9, the process is ended. This does not support the CPU disables the second reader in the second reading mode or that the CPU restores operation of the second reading mode upon determining the reading error has been resolved. These new claims are considered new matter.
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.
Claims 1 and 4-12 are rejected under 35 U.S.C. 103 as obvious over Wakamiya (US 2011/0223682) in view of Man (US 2014/0084064).
Regarding claims 1 and 4, Wakamiya discloses an automatic analyzer for executing an analysis process using a first consumable and a second consumable and a method of operating the same, the automatic analyzer comprising:
a biochemical detection unit including a detection section 14 configured to measure a reaction signal (see para [0051] et seq.);
a first reader (barcode reader 17 and RFID antenna 162b) configured to at least read identification information (barcode 105/ RFID tag 104) of the first consumable (first reagent container 100 containing reagent R1);
a second reader (RFID antenna 163b) configured to read identification information (RFID tag 114) of the second consumable (second reagent container 110 containing reagent R2);
a (non-transitory) memory (part of the control device 4) configured to store, the identification information of the first consumable and the identification information of the second consumable (see claim 13 of Wakamiya); and
a CPU (control device 4) configured to execute the instruction, which cause the CPU to:
operate in a first reading mode in which the first reader (barcode reader 17 and/or RFID antenna 162b) reads the identification information 104/105 of the first consumable 100 and the second reader reads the identification information 114 of the second consumable 110 by the second reader (RFID antenna 163b), see para [0066] et seq.,
determine that a reading error has occurred in reading the identification information of the second consumable by the second reader (e.g., controller determines that reagent management information in the RFID tag 114 in the second reagent container 110 is unreadable; see para [0072] et seq.); and
in response to determining that the reading error has occurred a switch is made from the first reading mode to a second reading mode (in a case where the reagent management information in the RFID tag 104 (or 114) is unreadable or the RFID system is damaged, the bar code label 105 (or 115) is used instead), wherein in the second reading mode the first reader (barcode reader 17 reads the identification information of the first consumable 100 and the identification of the second consumable (the bar code information from the bar code label of the reagent container is read by bar code reader 17 which is connected to the control apparatus 4. Accordingly, even if the RFID tag is unreadable, the reagent container to which the RFID tag is affixed can be identified, see para [0072] et seq. In other words, a first reading mode can be considered when antenna 162b cannot read RFID tag 104, and then the reading of barcode label 105 is made by barcode reader 17 (the first reader) and antenna 163b is operating (the second reader), and has a second reading mode which allows the first reader to read identification information of both the first and the second consumables (the second reading mode can be considered when both antennas 162b and 163b are not operating and the reading of both barcode labels 105 and 115 is performed by barcode reader 17), and
wherein the biochemical detection unit performs measurement of the reaction signal in the analysis process based on the identification information read in the first reading mode or the second reading mode (note: that it is inherent in Wakamiya, as with most if not all automatic analyzer systems, which are configured to read the reagent container identification information, this reagent information will be used/associated with the measurement results during the analysis process).
Wakamiya does not specifically discuss that in response to the CPU determining that the reading error has occurred, it will “automatically switch” from the first reading mode to the second reading mode.
In the related art of using a first reader and a second reader, Man teaches a system that includes a first reader (barcode/ RFID reader) and a second reader (the other RFID/barcode reader). The barcode and RFID reading apparatus includes: a micro-controller; at least a RFID antenna configured to detect a RFID tag in a first area proximate to the reading apparatus; a RFID reader connected to the at least one antenna and controlled by the micro-controller, the RFID reader being configured to receive a RFID tag data from the at least one antenna and send the RFID tag data to the micro-controller; and a barcode reader controlled by the micro-controller, the barcode reader being configured to detect a barcode in a second area proximate to the reading apparatus and send a barcode data from the barcode to the micro-controller; the micro-controller is configured to check whether the barcode reader or the RFID reader ends a data-reading process; if the barcode reader ends the data-reading process, the micro-controller switches off the barcode reader and switches on the RFID reader; and if the RFID reader ends the data-reading process, the micro-controller switches off the RFID reader and switches on the barcode reader (see para [0007] et seq.). The step of the reader ending the data-reading reading process could be reasonably interpreted as a failure in process of reading the information by the reader or the failure of the reader itself, and thus, the controller makes the automatic switch to use the other reading device. Like all automated processes this reduces the burden of the operator having to make the switch themselves.
Accordingly, it would have been obvious to one of ordinary skill in the art at the time the claimed invention was effectively filed to have made all of the steps performed by the operator in Wakamiya automatically performed like that in Man for the expected benefit of providing less work for the operator and the analyzer can still continue working without interruption. Furthermore, it would have been obvious to one having ordinary skill in the art at the time the invention was filed to automate the steps performed by the operator, since it has been held that broadly providing a mechanical or automatic means to replace manual activity which has accomplished the same result involves only routine skill in the art. In re Venner, 120 USPQ 192.
Regarding claims 5 and 9, Wakamiya teaches the CPU determines that the reading error has by determining that the identification information of the second consumable is unreadable by the second reader (see para [0120] et seq.)
Regarding claims 6 and 10, Wakamiya teaches in the second reading mode, the CPU disables reading by the second reader (when an error is determined in the reading of the information on the reagent container it is inherent that the controller stops the process; see para [0120] et seq.)
Regarding claims 7 and 11, Wakamiya teaches the CPU restores operation from the second reading mode to the first reading mode upon determining that the reading error has been resolved (the CPU controls the readers so it is expected that the CPU will restart the reading operations, which may be from an input by the operator, after the reading error has been resolved).
Regarding claim 8 and 12, Wakamiya teaches the identification information read in the first reading mode and the second reading mode is stored in the memory and associated with measurement results of the biochemical detection unit (see para [0129] et seq.)
Citations to art
In the above citations to documents in the art, an effort has been made to specifically cite representative passages, however rejections are in reference to the entirety of each document relied upon. Other passages, not specifically cited, may apply as well.
Response to Arguments
Applicant’s arguments with respect to claims 1 and 4-12 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.
Conclusion
No claims are allowed.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure include:
a. Yuta (JP 2022-158567) is similar to Wakamiya. Yuta discloses automatic analyzer 1 for executing an analysis process using multiple kinds of consumables including a first consumable and a second consumable (sample container 21, first reagent container 24, second reagent container 25), the automatic analyzer comprising: multiple readers including a first reader 55 and a second reader 50, 51, 52, which are allowed to read identification information of the consumable (barcodes on the sample container, first reagent and second reagent); and a control section (control unit 41) for controlling an operation of the automatic analyzer, wherein the control section has a first reading mode which allows the first reader 55 to read identification information of the first consumable, and the second reader 50-52 to read identification information of the second consumable, and has a second reading mode which allows the first reader to read identification information of both the first and the second consumables. Yuta discloses the fixed readers 50-52 and the manual reader 55 are provided for reading the bar codes on consumables (sample containers, first reagent container and second reagent containers). When code reading error occurs, which would inherently include that the second readers 50-52 are inoperable. The sample ID can be easily read by simply scanning the head of the manual reader 55 on the barcode label) When a code reading error occurs in the second reader 50-52, a second reading mode turned on by mode changeover switch 55a is operated on the first reader 55, such that the first reader is used to read both the bar codes of the priority sample and normal sample (see attached English translation).
b. Tanoshima et al., (US 2012/0129247) disclose a sample analyzer for analyzing a sample with a liquid in a container is disclosed. The sample analyzer comprises: a reader that reads an information of a liquid in a container, the information of the liquid being stored in a storage medium; a display; and a controller including a processor and a memory under control of the processor, the memory storing instruction causing the processor to carry out operations comprising: determining whether the sample analyzer is ready to read the information of the liquid by the reader; and causing, when the sample analyzer is determined to be ready, the display to display an indication that indicates the sample analyzer is ready to read the information of the liquid by the reader (abstract).
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 P. Kathryn Wright whose telephone number is (571)272-2374. The examiner can normally be reached on Monday-Thursday 6:30am-4pm EST.
Examiner interviews are available via telephone 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.
E-mail communication Authorization
Per updated USPTO Internet usage policies, Applicant and/or applicant’s representative is encouraged to authorize the USPTO examiner to discuss any subject matter concerning the above application via Internet e-mail communications. See MPEP 502.03. To approve such communications, Applicant must provide written authorization for e-mail communication by submitting the following statement via EFS Web (using PTO/SB/439) or Central Fax (571-273-8300):
Recognizing that Internet communications are not secure, I hereby authorize the USPTO to communicate with the undersigned and practitioners in accordance with 37 CFR 1.33 and 37 CFR 1.34 concerning any subject matter of this application by video conferencing, instant messaging, or electronic mail. I understand that a copy of these communications will be made of record in the application file.
Written authorizations submitted to the Examiner via e-mail are NOT proper. Written authorizations must be submitted via EFS-Web (using PTO/SB/439) or Central Fax (571-273-8300). A paper copy of e-mail correspondence will be placed in the patent application when appropriate. E-mails from the USPTO are for the sole use of the intended recipient, and may contain information subject to the confidentiality requirement set forth in 35 USC § 122. See also MPEP 502.03.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jill A Warden can be reached on 571-272-1267. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/P. Kathryn Wright/Primary Examiner, Art Unit 1798
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