DETAILED CORRESPONDENCE
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 .
Response to Amendment
As to the amended claims and remarks, the previous 101 rejection is withdrawn.
Based on the claim amendments are remarks, the previous 112(b) rejections are withdrawn.
Regarding the claim amendments, the previous prior art rejection has been withdrawn and a new prior art rejection has been set forth.
As to the Terminal Disclaimers filed on 9/4/26, the previous double patenting rejections are withdrawn.
Claim Status
Claims 1, 3, 4, 6 are pending.
Claim Rejections - 35 USC § 103
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.
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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 1, 3, 4, 6 is rejected under 35 U.S.C. 103 as being unpatentable over Capresta (Translation of “Special feature: Current situation of automated analyzer for clotting test", Features and availability of fully-automated coagulation analyzer "CAPRESTA 2000", Biological Sample Analysis Vol. 32, No. 5 (2009) translation includes pages 1-12; already of record with translation filed on 4/1/20 in parent application 15/554276; hereinafter “Capresta”) in view of Kaneko et al (US 20120239676; hereinafter “Kaneko”; already of record) in view of Mimura et al (US 5719059; hereinafter “Mimura”) or Kondou, K (US 20100104478; hereinafter “Kondou”).
As to claims 1 and 4, Capresta teaches an automatic analysis method of an automatic analysis device (Capresta teaches a method of operating the CP2000 measurement system; p. 1, 5, Fig. 4) which has at least a specimen container holding unit that accommodates and holds a plurality of specimen containers (Capresta teaches a sample rack which can hold sample cups; p. 5, 10, Fig. 4.), a specimen dispensing mechanism (Capresta teaches a sample probe which dispenses into a cuvette; p. 4, 5, 9, 10. Capresta teaches that test plasma, normal plasma, and a ratio of the two can be dispensed; p. 9, 10, 11, 12, Fig. 5.), a reagent dispensing mechanism (Capresta teaches a reagent probe; p. 4, 5. The reagent probe dispensing to the cuvette with the samples; p. 3, 5.), a measurement unit (Capresta teaches a light detection unit for detecting scattered light from a light source to determine coagulation times; p. 1, 2, 10.), and a control unit (Capresta teaches a computer; p. 2. Capresta also teaches that the analyzer is automatic which means that it would be run by a computer/controller to automate the device; p. 4, 5, 9, 12.), the method comprising: causing the specimen dispensing mechanism to dispense subject blood plasma alone, normal blood plasma alone and mixed blood plasma obtained by mixing the subject blood plasma and the normal blood plasma to be added to correct a coagulation time of the subject blood plasma, to a plurality of vacant specimen containers, respectively, accommodated in the specimen container holding unit (Capresta teaches a sample probe which dispenses into a cuvette; p. 4, 5, 9, 10. Capresta teaches that test plasma, normal plasma, and a ratio of the two can be dispensed; p. 9, 10, 11, 12, Fig. 5.. Capresta teaches a sample probe which dispenses into a cuvette; p. 4, 5, 9, 10. Capresta teaches that test plasma, normal plasma, and a ratio of the two can be dispensed; p. 9, 10, 11, 12, Fig. 5.); causing a reaction container to contain the mixed blood plasma which are prepared (Capresta teaches a sample probe which dispenses into a cuvette; p. 4, 5, 9, 10.), and causing the reagent dispensing mechanism to dispense a reagent to the reaction container (Capresta teaches a reagent probe; p. 4, 5. The reagent probe dispensing to the cuvette with the samples; p. 3, 5.); causing the measurement unit to irradiate the mixed blood plasma to which the reagent has been added in the reaction container with light emitted from a light source, and measure the coagulation time, based on obtained scattered light and/or transmitted light (Capresta teaches a light detection unit for detecting scattered light from a light source to determine coagulation times; p. 1, 2, 10.); and causing the control unit to control the specimen dispensing mechanism to perform an immediate-type measurement by dispensing the subject blood plasma alone, the normal blood plasma alone, and both the subject blood plasma and the normal blood plasma at the first predetermined mixing ratio immediately after they are prepared in the plurality of vacant specimen containers into the plurality of reaction containers, respectively, to measure immediate-type coagulation times, and control the specimen dispensing mechanism to automatically perform a delayed-type measurement by dispensing the subject blood plasma alone, the normal blood plasma alone, and both the subject blood plasma and the normal blood plasma at the first predetermined mixing ratio into another plurality of reaction containers, respectively, after a predetermined time elapses to measure delayed-type coagulation times (Capresta teaches that test plasma, normal plasma, and a ratio of the two can be dispensed; p. 9, 10, 11, 12, Fig. 5. Capresta teaches that a set number of automated tests per hour can be completed, where if another analysis after an initial analysis is possible then it would be performed in the automated number of tests; p. 3, 4).
Capresta does not teach when the immediate-type measurement request is received for the mixed blood plasma, confirm a required number of mixed blood plasma tests and a remaining number of reagent tests available in a plurality of reagent bottles and perform the immediate-type measurement only when the required number of mixed blood plasma tests does not exceed the remaining number of reagent tests in the reagent bottles. However, Kaneko teaches the analogous art of automated analysis (Kaneko; Title) with a display unit to display an alarm when the number of the tests exceeds the number of the reagent remaining tests, where the tests are performed when the required amount of remaining reagent does not exceed the remaining number of tests (Kaneko teaches determining whether there is necessary and sufficient reagents to perform analysis and displays a notification of insufficient reagent; Fig. 9, 10, [38, 39, 41]). It would have been obvious to one of ordinary skill in the art to have modified the display unit and the testing of the mixed blood plasma and reagents of Capresta to have displayed an alarm when the number of tests to be performed would exceed the amount of reagent (ie. that remaining reagent is insufficient) as in Kaneko because Kaneko teaches that providing an alert of insufficient reagents ensures that expendables are replaced prior to analysis thereby saving time and wasted analysis and preventing failure in analysis by shortages (Kaneko; Fig. 9, 10, [38, 39, 40, 41]).
Modified Capresta does not teach that the determination of insufficient reagents is made with respect to a singular reagent bottle. However, Mimura teaches the analogous art of reagent replacement where when insufficient reagent is remaining in one bottle then a warning is outputted (Mimura; col. 3 line 60-col. 4 line 7). It would have been obvious to one of ordinary skill in the art to have modified the displayed alarm of insufficient reagents of modified Capresta to have done so on a bottle by bottle basis as in Mimura because Mimura teaches that it is important to alert a user when a reagent bottle has insufficient amounts remaining (Mimura; col. 3 line 60-col. 4 line 7). Further, would have been obvious to one of ordinary skill in the art to have modified the displayed alarm of insufficient reagents of modified Capresta to have done so on a bottle by bottle basis because in instances where quality control required the same bottle to be used then this would enable only the same bottle of reagent to be used across tests to increase accuracy and decrease variability of results based on the reagents. Alternatively, Kondou teaches the analogous art of automated analysis, where each bottle amongst a plurality of reagent bottles can be evaluated to determine the number of tests remaining and that when there is insufficient reagent in that bottle that a warning can be presented (Kondou; [129, 132], Fig. 18). It would have been obvious to one of ordinary skill in the art to have modified the displayed alarm of insufficient reagents of modified Capresta to have done so on a bottle by bottle basis as in Kondou because Kondou teaches that it is important to alert a user when a reagent bottle has insufficient amounts remaining such that measurement is not interrupted (Kondou; [132], Fig. 18).
As to claim 3, Capresta teaches the automatic analysis device according to Claim 1, further comprising: a display unit that displays an alarm when the number of the mixed blood plasma exceeds the number of the reagent remaining tests (Capresta teaches a display which is capable of displaying anything; p. 6, 7, 9, 11, 12. The examiner notes that what is displayed is a matter of function/intended use).
As to claim 6, Capresta teaches the automatic analysis method according to Claim 4, with a display unit (Capresta teaches a display which is capable of displaying anything; p. 6, 7, 9, 11, 12.) and the number of mixed blood plasma (see above).
Capresta does not teach causing a display unit to display an alarm when the number of the mixed blood plasma exceeds the number of the reagent remaining tests. However, Kaneko teaches the analogous art of automated analysis (Kaneko; Title) with a display unit to display an alarm when the number of the tests exceeds the number of the reagent remaining tests (Kaneko teaches determining whether there is necessary and sufficient reagents to perform analysis and displays a notification of insufficient reagent; Fig. 9, 10, [38, 39, 41]). It would have been obvious to one of ordinary skill in the art to have modified the display unit and the testing of the mixed blood plasma and reagents of Capresta to have displayed an alarm when the number of tests to be performed would exceed the amount of reagent (ie. that remaining reagent is insufficient) as in Kaneko because Kaneko teaches that providing an alert of insufficient reagents ensures that expendables are replaced prior to analysis thereby saving time and wasted analysis and preventing failure in analysis by shortages (Kaneko; Fig. 9, 10, [38, 39, 40, 41]).
Other References Cited
The prior art of made of record and not relied upon is considered pertinent to applicant's disclosure include;
Kojima, K (US 20100001854; hereinafter “Kojima”; already of record) teaches a reagent insufficient screen; Fig. 3, 4.
Yabutani et al (WO2015098473 where 20160274133 is used as the corresponding document; hereinafter “Yabutani”; already of record) teaches a similar structure to the instantly claimed device; Fig. 1.
Applicants can overcome the Yabutani reference as a 102(a)(1) rejection by providing a certified translation of the foreign application. Further, the Yabutani reference has a common applicant 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.
Response to Arguments
Applicant’s arguments have been considered, but are moot because the arguments are towards the amended claims and not the current grounds of rejection.
Conclusion
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 BENJAMIN R WHATLEY whose telephone number is (571) 272-9892. The examiner can normally be reached Mon- Fri 8am-5pm.
Examiner interviews are available via telephone, in-person, 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.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Capozzi can be reached at (571) 270-3638. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Benjamin R Whatley/Primary Examiner, Art Unit 1798
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