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As to the amended claims and remarks filed on 2/12/26, the previous 112b rejections are withdrawn.
Based on the claim amendments, the previous 102 and 103 prior art rejection is withdrawn and a new prior art rejection has been set forth to address the amended claims.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 2/6/26 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Status
Claims 1-11, 14-16 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.
Claims 1-9, 11, 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Konishi et al (WO 2018230217 where US 20200200784 is used as the corresponding document; hereinafter “Konishi”; already of record) in view of Favuzzi et al (US 20090325309; hereinafter “Favuzzi”).
As to claim 1, Konishi teaches an automatic analysis device (Konishi; [3, 24], Fig. 1) for analyzing a target substance included in a sample, the automatic analysis device comprising: a detection unit that analyzes the sample (Konishi; [3, 24], Fig. 1); and a probe that pipettes a liquid, wherein the liquid is the sample or a reagent used to analyze the sample (Konishi; #12, Fig. 1, [56]. The examiner notes that the liquid is not positively recited as part of the device and that what the liquid is defined by is a matter of intended use), and a controller configured to control the probe, the controller causing the automatic analysis device to perform operations (Konishi teaches a controller/computer to control the device and probe; [25-30], Fig 1) including: causing the probe to be disposed over a container containing the liquid; based on an amount of the liquid to be aspirated into the probe exceeding a threshold: aspirating a first amount of the liquid into the probe from the container over which the probe is disposed; aspirating a first amount of air into the probe; and aspirating a second amount of a liquid into the probe, wherein the first amount of air is segmented between the first amount of the liquid and the second amount of liquid ((Konishi teaches aspirating and dispensing predetermined amounts of regents and samples, where the probe moves over containers to aspirate the sample from vessel 27 and then air and cleans the probe, and then aspirates reagent from vessel 29 and then dispenses to reaction vessel 28; Fig. 1, [55-56], claim 6. The aspiration occurs when the liquid is over a threshold in the sense that if there is enough liquid to be used in the aspiration then it is over a threshold. The examiner notes that there is not an actual comparison step to compare the liquid to a threshold and that the actions are just “based on” when the liquid does exceed a threshold and the examiner notes that the operations would not occur if there was not enough liquid to perform the automated operations, which serves as the threshold).
Note: The instant Claims contain a large amount of functional language (ex: “for…”, “that…”, “configured to…”, etc…). 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.
Konishi does not specifically teach aspirating a second amount of the liquid into the probe from the same container, wherein the first amount of air is segmented between the first amount of the liquid and the second amount of the liquid. However, Favuzzi teaches the analogous art of aspirating reagents and liquids where aspirating a first amount of the liquid into the probe from the container over which the probe is disposed; aspirating a first amount of air into the probe; and aspirating a second amount of the liquid into the probe, wherein the first amount of air is segmented between the first amount of the liquid and the second amount of the liquid (Favuzzi teaches aspirating a reagent, then aspirating air and then aspirating a second volume of the same reagent; [98]. Favuzzi teaches that when aspirating a predetermined threshold volume of fluid that it is advantageous to aspirate air to reduce the risk of losing a drop of reagent; [97]). It would have been obvious to one of ordinary skill in the art to have modified the aspirating of either the sample as the first amount of liquid or the reagent as the first amount of liquid with an air gap of Konishi to have aspirated the same liquid twice with an air gap in between as in Favuzzi because Favuzzi teaches that it is known to suction the same liquid with an air gap in between (Favuzzi; [98]) and also that it is advantageous to aspirate air to reduce the risk of losing a drop of liquid (Favuzzi; [97]).
As to claim 2, modified Konishi teaches the automatic analysis device according to claim 1, wherein the liquid is a reagent, and wherein, before discharging the aspirated first and second amounts of the reagent, the operations further include: aspirating a second amount of air into the probe; causing the probe to be disposed over a sample container containing the sample; aspirating the sample into the probe; causing the probe to be disposed over a reaction vessel; and discharging the sample, the second amount of the reagent, and the first amount of the reagent into the reaction vessel (Konishi teaches aspirating and dispensing predetermined amounts of regents and samples, where the probe aspirates the sample from vessel 27 and then air and cleans the probe, and then aspirates reagent from vessel 29 and then dispenses to reaction vessel 28; Fig. 1, [55-56], claim 6. The modification of the aspirating of the reagent as the first amount of liquid with an air gap of Konishi to have aspirated the same liquid twice with an air gap in between as in Favuzzi; see claim 1 above). Alternatively, it would have been obvious to have modified the order of aspirating a sample and reagent with an air gap of modified Konishi to have just switched the order of operations to aspirate the reagent prior to the sample as this would be a simple design choice and because this would achieve the same purpose and predictable result of resulting in dispensing the sample and reagent together regardless of the order (See MPEP 2143 I. B).
As to claim 3, modified Konishi teaches the automatic analysis device according to claim 2, the operations further comprising: causing the probe to be disposed at a cleaning position for cleaning at least an exterior of the probe or at least an exterior of a tip disposed on the probe prior to aspirating the sample into the probe (Konishi teaches aspirating and dispensing predetermined amounts of regents and samples, where the probe aspirates the sample from vessel 27 and then air and cleans the probe, and then aspirates reagent from vessel 29 and then dispenses to reaction vessel 28; Fig. 1, [55-56], claim 6. The cleaning operation would take place prior to pipetting the sample as the subsequent sample). Alternatively, it would have been obvious to have modified the order of aspirating a sample and reagent with an air gap of modified Konishi to have just switched the order of operations to aspirate the reagent prior to the sample as this would be a simple design choice and because this would achieve the same purpose and predictable result of resulting in dispensing the sample and reagent together regardless of the order (See MPEP 2143 I. B).
As to claim 4, modified Konishi teaches the automatic analysis device according to claim 1, further comprising a movement mechanism that moves the probe or a placement unit on which the container containing the liquid is placed to a pipetting position where the probe is disposed over the container, wherein the controller is configured to control the movement mechanism for controlling movement by which the probe or the placement unit is moved to the pipetting position according to the pipetting amount (Konishi teaches that probe moves to aspirate and dispense; [22, 56], Fig. 1. Konishi also teaches rotating sample disc; [11]. Konishi also teaches a transfer mechanism 23 to transfer vessel 28; [42]).
As to claim 5, modified Konishi teaches the automatic analysis device according to claim 4, wherein the probe is a first pipetting probe and the liquid is a first liquid, the automated analysis device further comprising a second pipetting probe, the first pipetting probe pipettes the first liquid at a first pipetting position, the second pipetting probe pipettes the liquid, at a second pipetting position, a second liquid contained in a container different from the container containing the first liquid, and the controller causes the movement mechanism to move the second pipetting probe or the placement unit to the second pipetting position after the first pipetting probe aspirates the first liquid at the first pipetting position (As best understood, Konishi also teaches first probe 12 that aspirates from 27 and dispenses to reaction cell 26 on disc 13, and second probe 14/17 that aspirates from reagent containers 30 on discs 15/16 and dispenses in reaction cell 26 on disc 13; [22, 23, 33, 34]).
As to claim 6, modified Konishi teaches the automatic analysis device according to claim 4, wherein the probe is a first pipetting probe, the automated analysis device further comprising a second pipetting probe, the first pipetting probe pipettes the liquid at a first pipetting position, the second pipetting probe pipettes, at a second pipetting position, the liquid contained in the container containing the liquid pipetted by the first pipetting probe, and the controller causes the movement mechanism to move the second pipetting probe or the placement unit to the second pipetting position after the first pipetting probe aspirates the liquid at the first pipetting position (As best understood, Konishi also teaches first probe 12 that aspirates from 27 and dispenses to reaction cell 26 on disc 13, and second probe 14/17 that aspirates from reagent containers 30 on discs 15/16 and dispenses in reaction cell 26 on disc 13; [22, 23, 33, 34].).
As to claim 7, modified Konishi teaches the automatic analysis device according to claim 1, wherein, based on the amount of the liquid to be aspirated into the probe exceeding the threshold, the controller causes the probe to be disposed at a cleaning position for cleaning at least an exterior of the probe or at least an exterior of a tip disposed on the probe prior to aspirating the second amount of the liquid (As best understood, Konishi also teaches first probe 12 that aspirates from 27; [22, 23, 33, 34]. Also, Konishi teaches aspirating and dispensing predetermined amounts of regents and samples, where the probe aspirates the sample from vessel 27 and then air and cleans the probe, and then aspirates reagent from vessel 29 and then dispenses to reaction vessel 28; Fig. 1, [55-56], claim 6. The cleaning occurs when the liquid is over a threshold in the sense that if there is enough liquid to be used in the aspiration then it is over a threshold).
As to claim 8, modified Konishi teaches the automatic analysis device according to claim 1, wherein the liquid is a first reagent, and the controller causes the probe to further aspirate a second reagent after aspirating the first and second amounts of the first reagent (Konishi teaches aspirating and dispensing predetermined amounts of regents and samples, where the probe aspirates the sample from vessel 27 and then air and cleans the probe, and then aspirates reagent from vessel 29 and then dispenses to reaction vessel 28; Fig. 1, [55-56], claim 6. Because Konishi is an automated device, at some point a second reagent would be aspirated by the probe. The modification of the aspirating of the reagent as the first amount of liquid with an air gap of Konishi to have aspirated the same liquid twice with an air gap in between as in Favuzzi; see claim 1 above). It would have been obvious to have modified the order of aspirating a sample and reagent with an air gap of modified Konishi to have just switched the order of operations to aspirate the reagent prior to the sample as this would be a simple design choice and because this would achieve the same purpose and predictable result of resulting in dispensing the sample and reagent together regardless of the order (See MPEP 2143 I. B).
Modified Konishi does not teach aspirating a second reagent after aspirating the first reagent to concurrently hold the first reagent and the second reagent inside the probe. However, Favuzzi teaches the analogous art of aspirating reagents and liquids where the probe aspirates a second reagent after aspirating the first reagent to concurrently hold the first reagent and the second reagent inside the probe (Favuzzi; [46, 47, 97, 98, 126]). It would have been obvious to one of ordinary skill in the art to have modified the aspirating of the sample and first reagent with an air gap of modified Konishi to have aspirated a second reagent with an air gap in between as in Favuzzi because Favuzzi teaches that this technique enables different reagents to be concurrently aspirated (Favuzzi; [46, 47, 97, 98, 126]) and because the air gap enables the reagents to be prevented from reacting while in the nozzle (Favuzzi; [47]).
As to claim 9, modified Konishi teaches the automatic analysis device according to claim 8, wherein the first reagent and the second reagent are contained in different containers (The modification of the aspirating of modified Konishi to be different reagents as in Favuzzi has already been discussed above in claim 8. Favuzzi teaches aspirating from different containers; [46, 47, 97, 98, 126]).
As to claim 11, modified Konishi teaches the automatic analysis device according to claim 5, wherein the first liquid is a first sample or reagent, and the first pipetting probe aspirates the first and second amounts of the first liquid and an amount of a second sample or reagent as the second liquid, and the first pipetting probe aspirates segmented air after aspirating the first and second amounts of the first liquid and before discharging the first liquid, and further aspirates the second liquid to concurrently hold the first and second amounts of the first liquid and the second liquid inside the probe (Konishi teaches aspirating and dispensing predetermined amounts of regents and samples, where the probe aspirates the sample from vessel 27 and then air and cleans the probe, and then aspirates reagent from vessel 29 and then dispenses to reaction vessel 28; Fig. 1, [55-56], claim 6. The modification of the aspirating of the sample as the first amount of liquid with an air gap of Konishi to have aspirated the same liquid twice with an air gap in between as in Favuzzi; see claims 1 and 5 above. The examiner notes that the function of the probe does not add further structure to the device beyond that of a capability and that any probe that aspirates and/or discharges would be capable of the claimed function).
As to claim 15, modified Konishi teaches the automatic analysis device according to claim 1, wherein the liquid is the sample, and wherein: before aspirating the first and second amounts of the sample, the operations further include: causing the probe to be disposed over a reagent container containing the reagent; aspirating the reagent into the probe; and aspirating a second amount of air into the probe before aspirating the first and second amounts of the sample into the probe; and subsequent to aspirating the first and second amounts of the sample, the operations further include: causing the probe to be disposed over a reaction vessel; and discharging the second amount of the sample, the first amount of the sample, and the reagent into the reaction vessel (Konishi teaches aspirating and dispensing predetermined amounts of regents and samples, where the probe aspirates the sample from vessel 27 and then air and cleans the probe, and then aspirates reagent from vessel 29 and then dispenses to reaction vessel 28; Fig. 1, [55-56], claim 6. Konishi would perform this operation again for the next sample/reagent. The modification of the aspirating of the sample as the first amount of liquid with an air gap of Konishi to have aspirated the same liquid twice with an air gap in between as in Favuzzi; see claim 1 above). It would have been obvious to have modified the order of aspirating a sample and reagent with an air gap of modified Konishi to have just switched the order of operations to aspirate the reagent prior to the sample as this would be a simple design choice and because this would achieve the same purpose and predictable result of resulting in dispensing the sample and reagent together regardless of the order (See MPEP 2143 I. B).
As to claim 16, modified Konishi teaches the automatic analysis device according to claim 15, the operations further comprising: causing the probe to be disposed at a cleaning position for cleaning at least an exterior of the probe or at least an exterior of a tip disposed on the probe after aspirating the reagent and prior to aspirating the sample into the probe (Konishi teaches aspirating and dispensing predetermined amounts of regents and samples, where the probe aspirates the sample from vessel 27 and then air and cleans the probe, and then aspirates reagent from vessel 29 and then dispenses to reaction vessel 28; Fig. 1, [55-56], claim 6). Further, it would have been obvious to one of ordinary skill in the art to clean the probe of modified Konishi after each separate liquid because this would provide the well-known advantage of ensuring that each separate liquid container was not contaminated with the previous liquid.
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Konishi et al (WO 2018230217 where US 20200200784 is used as the corresponding document; hereinafter “Konishi”; already of record) in view of Favuzzi et al (US 20090325309; hereinafter “Favuzzi”) in view of Tokiwa et al (US 7439076; hereinafter “Tokiwa”; already of record).
As to claim 14, modified Konishi teaches the automatic analysis device according to claim 1, with the probe that aspirates the liquid into the probe (see above).
Konishi does not specifically teach the probe configured to attach to a disposable pipetting tip. However, Tokiwa teaches the analogous art of a liquid probe with an attachable/detachable disposable pipetting tip (Tokiwa; col. 1 line 17-27, col 4 line 7-13, 29-43). It would have been obvious to one of ordinary skill in the art to have modified the probe for aspirating/dispensing of Konishi to have a disposable tip as in Tokiwa because Tokiwa teaches that disposable tips help avoid carryover and that disposable tips are frequently used in sample analysis (Tokiwa; col. 1 line 17-27).
Claim 6 is alternatively rejected under 35 U.S.C. 103 as being unpatentable over Konishi et al (WO 2018230217 where US 20200200784 is used as the corresponding document; hereinafter “Konishi”; already of record) in view of Favuzzi et al (US 20090325309; hereinafter “Favuzzi”) in view of Matsubara et al (US 20020031837; hereinafter “Matsubara”; already of record).
As to claim 6, in as much as claimed and as best understood, modified Konishi teaches the automatic analysis device according to claim 4, with a first pipetting probe that pipettes the liquid at a first pipetting position, with the movement mechanism (see claim 4 above).
Although the examiner believes Konishi is capable of these operations because Konishi includes a movement mechanism and multiple probes that also move and aspirate and dispense, if it is deemed that Konishi does not teach a second pipetting probe that pipettes the liquid contained in a same container as the container containing the liquid pipetted by the first pipetting probe at a second pipetting position, and the movement mechanism moves the second pipetting probe or the placement unit to the second pipetting position after the first pipetting probe aspirates the liquid at the first pipetting position; then Matsubara teaches the analogous art of an analysis device (Matsubara; Fig. 8) with a first pipetting probe and a second pipetting probe are included as the probes, the first pipetting probe pipettes the liquid at a first pipetting position, the second pipetting probe pipettes the liquid contained in a same container as the container containing the liquid pipetted by the first pipetting probe at a second pipetting position, and the movement mechanism moves the second pipetting probe or the placement unit to the second pipetting position after the first pipetting probe aspirates the liquid at the first pipetting position (Matsubara teaches probe 830 aspirates from the sample container at position a and then the reaction disc is rotated where probe 840 then aspirates from the same sample container at position b; Fig. 8, [125-126, and 122-128]). It would have been obvious to one of ordinary skill in the art to have modified the analysis device with a sample probe to aspirate the sample as in modified Konishi to have included multiple sample probes to aspirate from the same sample container as in Matsubara because Matsubara teaches that using two different sample probes enables the same sample to be used for two different types of analysis (Matsubara; [125, 126]) and also because this helps to decrease carry-over between samples (Matsubara; [128]).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Konishi et al (WO 2018230217 where US 20200200784 is used as the corresponding document; hereinafter “Konishi”; already of record) in view of Favuzzi et al (US 20090325309; hereinafter “Favuzzi”) and in view of Curran et al (US 20120045765; hereinafter “Curran”).
As to claim 10, modified Konishi teaches the automatic analysis device according to claim 1, wherein: the liquid is a first sample such that first and second amounts of the first sample are aspirated, and the controller controlling the probe to aspirate (see above).
Modified Konishi does not specifically teach aspirating a second sample after aspirating the first sample to concurrently hold the first sample and the second sample inside the probe, the first sample and the second sample are contained in different containers. However, Curran teaches the analogous art of aspirating with an air gap, and aspirating a second sample after aspirating the first sample to concurrently hold the first sample and the second sample inside the probe, the first sample and the second sample are contained in different containers (Curran teaches aspirating a sample at one container and then aspirating air and then aspirating another sample from another container; [73, 86], Fig. 4C, 10). It would have been obvious to one of ordinary skill in the art to have modified the probe which aspirates samples to dispense them in rection vessels of modified Konishi to have aspirated multiple different samples concurrently as in Curran because Curran teaches that aspirating the same sample or different samples are obvious variants (Curran; [73]) and because Curran teaches that that it is known to aspirate multiple different samples into the probe (Curran; [73]) where one of ordinary skill in the art would understand that this would provide the well-known advantage of ensuring that each separate liquid container was not contaminated with the previous liquid and also would provide efficient use of the aspiration probe if the reaction vessels being dispensed into were not available.
Other References Cited
The prior art of made of record and not relied upon is considered pertinent to applicant's disclosure include;
Yanami et al (US 20040245275; hereinafter “Yanami”; already of record) teaches two sample pipettes 1/516 that aspirate from the same sample container [51, 52], in order to provide plural sample dispensers to decrease processing time and improve processing capacity [26]; Fig. 2, 3, 6. Yanami teaches troubleshooting when the same sample is scheduled to be aspirated by each probe, thereby showing that each probe is scheduled to aspirate from the same container; [28, 29].
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