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As to the claim amendments and remarks filed on 6/15/26, the previous 112(b) rejections have been withdrawn.
Regarding the claim amendments and remarks, the previous prior art rejection has been modified to address the claim amendments.
Claim Status
Claims 1, 4-12 are pending with claims 1, 4-10 being examined, and claims 11-12 deemed withdrawn. Claims 2-3 are canceled.
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 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.
Claims 1, 4-5, 9-10 are rejected under 35 U.S.C. 102a1/a2 as being anticipated by Kitamura et al (US 201110274584; already of record; hereinafter “Kitamura”).
As to claim 1, Kitamura teaches an automatic analysis system (Kitamura; Fig. 1, 2) comprising: an automatic analysis unit (Kitamura; Fig. 1, 2) including; a probe unit configured to perform aspiration and ejection of a sample (Kitamura; Fig. 1, 2, [30]), a probe moving unit configured to move the probe unit at least from a position of a sample container in which the sample is stored to a position of a reaction vessel into which the sample is dispensed (Kitamura; Fig. 1, 2, 3, [30]), and a cleaning unit configured to perform first cleaning in which a cleaning liquid is ejected to a periphery of the probe unit between the aspiration of the sample from the sample container and the ejection of the sample to the reaction vessel (Kitamura teaches cleaning unit 70/71; Fig. 2, 4-10. Kitamura teaches a first cleaning that takes place during second dispensing process A2/S2 where the probe is washed S23 between aspiration and dispensing; Fig. 3b, 10, [147-173]); and a control unit configured to: control ejection and stop of the cleaning liquid in the first cleaning (Kitamura teaches a controller 60/25/27 that controls the entire device including the probe and cleaning unit; Fig. 1, 2, [27, 44-47, 70-73]); distinguish between an inspection item requiring a first cleaning and an inspection item not requiring the first cleaning based on operation registration data set in advance depending on whether unstable components included in the sample adhering to an outside of the probe unit affect the inspection; cause, when an inspection performed by the automatic analysis unit is distinguishes as a first inspection item, the cleaning unit to perform the first cleaning; and cause, when an inspection performed by the automatic analysis unit is an inspection item not requiring the first cleaning, the cleaning unit to perform a second cleaning which includes a post-dispensing cleaning performed after the ejection of the sample into the reaction vessel and in which the cleaning liquid is not ejected to the outside of the probe unit between the aspiration of the sample from the sample container and the ejection of the sample to the reaction vessel (Kitamura teaches a probe that aspirates, in a first inspection, the lower sample including blood cells and that aspirates, in a second inspection, serum/plasma; [68], Fig. 3. Kitamura teaches a first cleaning S23/S25 for lower layer samples aspirated at A2 and then the probe is cleaned prior to dispensing; Fig. 3b, 10, [123, 147-173]. Kitamura teaches a second cleaning S13 for upper layer samples aspirated at A1 and the probe is not cleaned until after dispensing; Fig. 3a, 10 [100, 123, 129-139]. Although the cleaning is related to the depth, the depth is in fact related to the type of sample/inspection item that is aspirated (i.e. blood or serum/plasma), where the cleaning is different due to the type of sample/inspection item. Kitamura teaches that it is distinguished whether or not the sample contaminates the probe based on the suction depth/type of sample aspirated (Kitamura; [73, 75, 141, 171]). The instant application, also discusses how there can inherently be different unstable components at the surfaces of separated blood, which includes serum/plasma at the top and blood at the bottom (see Fig. 4, [29-31]) where the unstable components that are determined are directly a result of whether the serum/plasma or the blood is the inspection item/sample that is aspirated. Because Kitamura teaches the same concept, then it also makes the determination of whether or not a first cleaning is required based on data set in advance. The setting in advance automatically includes the determination that unstable components adhere to the probe since the cleaning operations are the same).
Note: The instant Claims contain a large amount of functional language (ex: “configured to…”). However, functional language does not add any further structure to an apparatus beyond a capability. Apparatus claims must distinguish over the prior art in terms of structure rather than function (see MPEP 2114 and 2173.05(g)). Therefore, if the prior art structure is capable of performing the function, then the prior art meets the limitation in the claims.
As to claim 4, Kitamura teaches the automatic analysis system according to claim 1, wherein the control unit is configured to: perform, in the first cleaning, cleaning of the probe unit after movement of the probe unit is stopped (Kitamura teaches that in the first cleaning s25, that the probe is stopped and the cleaning fluid is supplied while the probe is stopped; [167-169], Fig. 10).
As to claim 5, Kitamura teaches the automatic analysis system according to claim 4, wherein the cleaning unit is configured to: eject the cleaning liquid from a lower side to an upper side, and the control unit is configured to: perform, in the first cleaning, the ejection of the cleaning liquid before the probe unit reaches a position of the cleaning unit (Kitamura teaches that in the first cleaning s23, that cleaning liquid is supplied before the probe advances; [108-109, 151-154], Fig. 10. Kitamura teaches that fluid is ejected from a lower side 714 to an upper side in the cleaning unit 71; Fig. 9).
As to claim 9, Kitamura teaches the automatic analysis system according to claim 1, wherein in the first cleaning, the control unit is configured to perform intermediate cleaning of ejecting the cleaning liquid to the periphery of the probe unit between the aspiration of the sample from the sample container and ejection of the sample to the rejection vessel and post-dispensing cleaning of ejecting the cleaning liquid to the periphery of the probe unit after the ejection of the sample to the reaction vessel is completed, the first cleaning is divided into a plurality of cycles, and the intermediate cleaning and the post-dispensing cleaning are performed in different cycles (Kitamura teaches a first inspection as the lower layer sample which includes blood cells, and a second inspection as the upper layer sample which is serum/plasma; [68], Fig. 3. Kitamura teaches a first cleaning S23/S25 for lower layer samples aspirated at A2 and then the probe is cleaned prior to dispensing and then after dispensing; Fig. 3b, 10, [123, 147-173]. The first cleaning is shown in figure 10, which includes different cycles whereby the intermediate cleaning is defined by cycle S23 and the post-dispensing cleaning is defined by cycle S25).
As to claim 10, Kitamura teaches the automatic analysis system according to claim 9, wherein the intermediate cleaning and the post-dispensing cleaning are executed at the same timing within a respective one the cycles (Kitamura teaches that the first cleaning is shown in figure 10, which includes different cycles whereby the intermediate cleaning is defined by cycle S23 and the post-dispensing cleaning is defined by cycle S25. Each cleaning occurs at the same timing, and each respective cleaning begins at the beginning of the respective cycle S23 or S25).
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.
Claims 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over Kitamura et al (US 201110274584; already of record; hereinafter “Kitamura”) alone or alternatively in view of Onogi et al (Translation of JP2014085285; hereinafter “Onogi”; already of record).
As to claim 6, Kitamura teaches the automatic analysis system according to claim 1, wherein the control unit is configured to perform, in the first cleaning, cleaning of the probe unit with the probe moving in order to save time (Kitamura teaches that the probe can be washed while moving in a short time to speed up analysis process; [155]).
Although Kitamura suggests performing the cleaning without stopping movement of the probe unit, Kitamura does not specifically teach cleaning without stopping the probe. However, in light of the teachings of time savings of Kitamura, it would have been obvious to one of ordinary skill in the art to have modified the cleaning process which cleans during probe movement to save time of Kitamura to have not stopped the probe in order to provide the advantage of further time savings. However, Onogi teaches the analogous art of cleaning a probe, where the piercer is moved up/down while the cleaning operation takes place (Onogi; [52, 53]). It would have been obvious to one of ordinary skill in the art to have modified the cleaning of the probe to have continually moved up/down as in Onogi because Onogi teaches that this process can eliminate uneven cleaning (Onogi; [52, 53]) and that cleaning while the probe is stopped may not clean the probe sufficiently (Onogi; [19]).
As to claim 7, Kitamura teaches the automatic analysis system according to claim 6, wherein after starting the movement of the probe unit at a first movement speed which is a predetermined movement speed, the control unit is configured to set a movement speed of the probe unit to a second movement speed lower than the first movement speed before the cleaning of the probe unit is performed (The modification of the probe movement of Kitamura to continually move as in Onogi has already been discussed above in claim 6. Onogi teaches that the probe is slowly lowered during cleaning to help eliminate uneven cleaning; [52]).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Kitamura et al (US 201110274584; already of record; hereinafter “Kitamura”) view of Fukaya et al (WO 2018055928 where US 20200225256 is used as the corresponding document; hereinafter “Fukaya”; already of record).
As to claim 8, Kitamura teaches the automatic analysis system according to claim 1, with the control unit controlling the aspiration time of the sample in the probe unit and also the cleaning time (see claim 1 above).
Kitamura fails to teach adjusting the timing such that the shorter the aspiration time is, the longer the time for cleaning performed in the first cleaning is. Fukaya teaches the analogous art of an analyzer which cleans the probe, where the cleaning time and aspiration time can be adjusted (Fukaya; [46]). Fukaya teaches that flow velocity can be increased or decreased to change the timing of aspiration, and where the overall cycle time that includes cleaning and aspirating is a fixed time (Fukaya; [46]). Therefore, it is evident that Fukaya recognizes that the cleaning time and aspiration time that can be changed within the overall fixed cycle time are result effective variables since the timing can be adjusted within the overall fixed cycle time, where if the aspiration time is decreased then the cleaning time can be longer to complete the overall fixed cycle time (Fukaya; [46]). It would have been obvious to one of ordinary skill in the art to modify the cleaning and aspirating time within the fixed cycler of Kitamura to have adjusted the aspiration time such that when it is decreased then the cleaning time can be longer in order to provide the advantage of ensuring that the overall operation maintained the desired fixed overall cycle time.
Other References Cited
The prior art of made of record and not relied upon is considered pertinent to applicant's disclosure include;
Oonuma et al (US 20110223061; hereinafter “Oonuma”; already of record) teaches lower speeds for cleaning; [135, 136].
Yasui et al (US 20150204895; hereinafter “Yasui”; already of record) teaches that the cleaning cycle is maintained for all of the samples that process through analyzer; Fig. 3-4. Yasui also teaches that the cleaning cycles can vary; Figs. 5-7.
Response to Arguments
Applicant’s arguments filed on 6/15/26 have been considered but are moot because the arguments are towards the claim amendments and not the current ground of rejection. However, because the examiner is relying on the same prior art then the examiner has addressed applicants arguments for the sake of compact prosecution. Therefore, Applicant's arguments have been fully considered but they are not persuasive.
Applicants argue on pages 10-13 that prior art Kitamura does not specifically teach the type of cleaning distinguishes between an inspection item requiring a first cleaning and an inspection item not requiring the first cleaning based on operation registration data set in advance depending on whether unstable components included in the sample adhering to an outside of the probe unit affect the inspection, and then argues that Kitamura changes the depth but not the type of inspection. The examiner respectfully disagrees. Applicants have not discussed any of the citations provided previously and why they fail to meet the instant claimed language. Therefore, Applicant's arguments fail to comply with 37 CFR 1.111(b) because they amount to a general allegation that the claims define a patentable invention without specifically pointing out how the language of the claims patentably distinguishes them from the references. Further, Applicant's arguments do not comply with 37 CFR 1.111(c) because they do not clearly point out the patentable novelty which he or she thinks the claims present in view of the state of the art disclosed by the references cited or the objections made. Further, they do not show how the amendments avoid such references or objections. The depth of Kitamura in Figure 3 changes based on the inspection type. Kitamura teaches a probe that aspirates, in a first inspection, the lower sample including blood cells and that aspirates, in a second inspection, serum/plasma; [68], Fig. 3. Kitamura teaches a first cleaning S23/S25 for lower layer samples aspirated at A2 and then the probe is cleaned prior to dispensing; Fig. 3b, 10, [123, 147-173]. Kitamura teaches a second cleaning S13 for upper layer samples aspirated at A1 and the probe is not cleaned until after dispensing; Fig. 3a, 10 [100, 123, 129-139]. Although the cleaning is related to the depth, the depth is in fact related to the type of sample/inspection item that is aspirated (i.e. blood or serum/plasma), where the cleaning is different due to the type of sample/inspection item. Kitamura teaches that it is distinguished whether or not the sample contaminates the probe based on the suction depth/type of sample aspirated (Kitamura; [73, 75, 141, 171]). The instant application, also discusses how there can inherently be different unstable components at the surfaces of separated blood, which includes serum/plasma at the top and blood at the bottom (see Fig. 4, [29-31]) where the unstable components that are determined are directly a result of whether the serum/plasma or the blood is the inspection item/sample that is aspirated. Because Kitamura teaches the same concept, then it also makes the determination of whether or not a first cleaning is required based on data set in advance. The setting in advance automatically includes the determination that unstable components adhere to the probe since the cleaning operations are the same.
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.
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/BENJAMIN R WHATLEY/Primary Examiner, Art Unit 1798
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