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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 1/20/2026 has been entered.
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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.
1. Claims 1, 2, and 5-8 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication No. 2018/0074027 to Kim et al. (hereafter “Kim et al. ‘027”), in view European Patent Application Publication No. EP3534140 to Kim et al. (hereafter “Kim et al. ‘140”), U.S. Patent No. 5,360,739 to Fan et al. and U.S. Patent Application Publication No. 2017/0269112 to Gerstel.
Kim et al. ‘027 teaches an analysis apparatus that includes a base frame shown in Fig. 1B.
A holder 411 (“cuvette tray”) is provided that moves back and forth on the base frame and is configured to hold a plurality of cuvettes. [0225]
A first driving unit (driving part 413) is provided to move the holder 411 (“cuvette holder”) back and forth. [0141]
In paragraph [0146] Kim et al. ‘027 teaches that a plurality of holders 411 can be provided in which case providing an additional holder 411 reads on applicant’s claimed tube tray inasmuch as the holders can received tubes.
Kim et al. ‘027 teaches that a plurality of driving parts can be provided [0146] rendering it obvious to provide a second driving unit (driving part 413) to move the holder 411 (“tube tray”) back and forth.
Kim et al. ‘027 teaches “a vertical moving unit 420 configured to move the sample collection member 100 vertically (upward and/or downward, or along the Z-axis) for sample suction, sample/reagent mixing, and dropping of a reaction product; a laterally moving unit 430 (left and/or right, or along the X-axis); and a pump unit 440 configured to provide a suction force or a discharge force to the sample collection member 100, [0139] that reads on applicant’s sampling operation unit. The drive units 400 that move the sample collection member read on applicant’s claim third driving unit.
Kim et al. ‘027 provides an optical reader 500 that analyzes reaction products [0196] that is movable by drive unit 600 (“fourth driving unit”).
As to the newly recited limitations in claim 1 that recites the use of belts and motors to supply driving force to the cuvette tray, tube tray, sampling operation unit and analysis unit, Kim et al. ‘027 teaches belts and motors for the mechanisms that move the cuvette tray, tube tray, sampling operation unit and analysis unit. [0040], [0048], [0051] and [0056].
Kim ‘027 et al. includes a vertical moving unit (“elevating module”) that is supported on a fixing bracket as shown in Fig. 2B, but does not does not teach a mixing unit for mixing the sample contained in the capless tube, comprising: a fixing bracket fixed to the base frame, an elevating module supported by the fixing bracket so as to move up and down, a fifth driving unit comprising an electric motor for driving the elevating module up and down, a fixing head supported by the elevating module so as to be able to rotate, and capable of getting fixed closely to an upper opening end of the capless tube, and a sixth driving unit comprising an electric motor provided for the elevating module, for rotating the fixing head; and a control/arithmetic unit for integratedly controlling the first driving unit to the sixth driving unit to operate according to a programmed procedure so that mixing, collection, and analysis are sequentially performed.
Kim et al. ‘027 does not teach contacting the open top of a capless tube and rotate the same for purposes of mixing the contents of the tube.
Kim et al. ‘140 teaches a gripping head 223 on an elevating module that is movable up and down so as to contact the open top of a capless tube and rotate the same for purposes of mixing the contents of the tube. (see Fig. 5 and [0049]-[0051]).
In Kim et al. ‘140 driving sources 122 (Fig. 2) and 222a (Fig. 5) are used to cause rotation of the gripper head 121 and vertical movement of frame 221.
It would have been obvious to one of ordinary skill in the art to modify Kim et al. ‘027 in view of Kim ‘140 to have a rotatable gripping head as taught by Kim et al. ‘140 for purposes of mixing the contents of the tubes and associated driving unit 220 and driving sources 122 and 222a for purposes of mixing the contents of capless tubes as taught by Kim et al. 140.
Kim et al. ‘027 in view of Kim ‘140 does not teach a buffer tube holder provided between rows of the cuvette holders for accommodating a plurality of buffer tubes, wherein the buffer tube holder is moved back and forth by a separate driving unit.
Kim et al. ‘027 teaches analysis of blood cells, nucleic acids, proteins and antigens.
Fan et al. teaches the known use of buffer solutions for analyzing blood cells. (Abstract)
It would have been obvious to modify Kim et al. ‘027 in view of Kim ‘140 to include a buffer tube holder for accommodating a plurality of buffer tubes for supplying buffer solution for blood cell analysis as taught by Fan et al. and provide the buffer tube holder in a convenient location such as between rows of the cuvette holders and move the buffer tube holder back and forth by a separate driving unit in view of Kim et al. ‘027 in view of Kim ‘140 teaching separate drive units for various components.
Kim et al. ‘027 in view of Kim ‘140 does not teach a camera module integrated therewith for taking an image while moving horizontally together with the sampling operation unit to identify at least one of cartridge information, tips, presence of a buffer tube and an identity of each patient sample by recognizing code information attached to the capless tubes.
Gerstel teaches a vertically movable camera 53 shown in Figs 15 and 16 that can read bar code information provided on a tube. [0093]
It would have been obvious to modify Kim et al. ‘027 in view of Kim ‘140 to include a camera module integrated therewith for taking an image while moving horizontally to identify at least one of cartridge information, tips, presence of a buffer tube and an identity of each patient sample by recognizing code information in the form of a bar code provided on the capless tubes as taught by Gerstel. Providing such a camera together with the sampling operation unit would have been obvious manner of integrating such a camera into system already present in Kim et al. ‘027 in view of Kim ‘140, Fan et al. and Gerstel.
I.) Regarding applicant’s claim 1, as noted above Kim et al. ‘027 in view of Kim et al. ‘140, Fan et al. and Gerstel teaches all the limitations of claim 1.
Therefore, Kim et al. ‘027 in view of Kim et al. ‘140 renders claim 1 obvious.
II.) Regarding applicant’s claim 2, as noted above Kim et al. ‘027 in view of Kim ‘140, Fan et al. and Gerstel renders claim 1 obvious from which claim 2 depends.
Claim 2 recites a code recognition unit adjacent to the tube tray, for recognizing code information attached to a sample tube or a tube holder.
Kim et al. ‘027 teaches that barcodes can be provided on the cuvettes [0063] and that a barcode scanner is provided [0077]. The dispensing of samples and/or reagents [0129] reads on mixing units for mixing samples.
Therefore, Kim et al. ‘027 in view of Kim ‘140, Fan et al. and Gerstel renders claim 2 obvious.
III.) Regarding applicant’s claim 5, as noted above, Kim et al. ‘027, in view of Kim et al. ‘140, Fan et al. and Gerstel renders claim 1 obvious from which claim 5 depends.
Claim 5 recites that the fixing bracket further comprises a guide rail for guiding the vertical movement of the elevating module.
Kim et al. ‘027 teaches that “the vertical moving unit 420 may comprise a second connecting bracket 421, a vertical guiding rail 422, an arm 423, and a vertical driving part 424.” [0154].
Therefore, Kim et al. ‘027 in view of Kim ‘140, Fan et al. and Gerstel renders claim 5 obvious.
IV.) Regarding applicant’s claim 6, as noted above, Kim et al. ‘027 in view of Kim ‘140, Fan et al. and Gerstel renders claim 1 obvious from which claim 6 depends.
Claim 6 recites that the elevating module further comprises a linear driving unit for transmitting a driving force generated by the sixth driving unit as a linear driving force.
Kim et al. ‘027 teaches a vertical driving part 424 that has to move linearly. [0154]
Therefore, Kim et al. ‘027 in view of Kim ‘140, Fan et al. and Gerstel renders claim 6 obvious.
V.) Regarding applicant’s claim 7, as noted above, Kim et al. ‘027 in view of Kim ‘140, Fan et al. and Gerstel renders claim 1 obvious from which claim 7 depends.
Claim 7 recites that the fixing head further comprises a contact pad in close contact with the open end of the capless tube.
Kim et al. ‘027 does not teach a contact pad in close contact with the open end of a capless tube.
In Kim et al. ‘140 teaches that the gripping head 223 is provided at a lower end thereof a contact pad 223a coming into close contact with the upper end of the capless tube 10. [0153]
It would have been obvious to modify Kim et al. ‘027 in view of Kim ‘140, Fan et al. and Gerstel to include a contact pad in close contact with the open end of the capless tube for purposes of rotating the capless tube.
Therefore, Kim et al. ‘027 in view of Kim ‘140, Fan et al. and Gerstel renders claim 7 obvious.
VI.) Regarding applicant’s claim 8, as noted above Kim et al. ‘027 in view of Kim ‘140, Fan et al. and Gerstel renders claim 1 obvious from which claim 8 depends.
Claim 8 recites that the sampling operation unit comprises: a main plate for moving left and right by the third driving unit; a tip adapter provided on the main plate so as to be movable up and down, and capable of being assembled with a tip provided in the cuvette holder; a seventh driving unit for driving the tip adapter up and down; a pump unit provided on the main plate in parallel with the tip adapter so as to be movable up and down, and for supplying suction or discharge power to the tip adapter; and an eighth driving unit for driving the pump unit up and down.
Kim et al. ‘027 teaches a sample collection member 100 (“tip”) may be made of a flexible material so that it can be easily fixed to the arm 423 (“tip adapter”) and easily separated from the arm 423. (see Fig. 9 and [0128]).
The arm (“tip adaptor”) is moved vertically by the vertical driving part 424.
Kim et al. teaches that the driving unit of arm (“tip adaptor”) is driven by a mechanism that includes a belt and motor.
It would have been obvious to modify Kim et al. ‘027 in view of Kim ‘140, Fan et al. and Gerstel to include a seventh driving unit comprising an electric motor, an idle pulley, and a belt for driving the tip adapter up and down, based on Kim et al. teaching driving the arm (“tip adaptor”) vertically using a belt and motor. Providing an idler pulley to guide alignment of the would have been obvious to one of ordinary skill in the art.
Therefore, Kim et al. ‘027 in view of Kim ‘140, Fan et al. and Gerstel renders claim 8 obvious.
2. Claim 10 is rejected under 35 USC 103 as being unpatentable over Kim et al. ‘027 in view of Kim ‘140, Fan et al. and Gerstel as applied to claims 1 and 5 above and further in view of U.S. Patent Application Publication No. 2005/0196867 to Bower et al.
I.) Regarding applicant’s claim 10, as noted above, Kim et al. ‘027 in view of Kim ‘140, Fan et al. and Gerstel renders claim 5 obvious from which claim 10 depends.
Claim 10 recites that the elevating module further comprises a linear driving unit for transmitting a driving force generated by the fifth driving unit as linear driving force.
Kim et al. ‘027 in view of Kim ‘140, Fan et al. and Gerstel does not teach elevating module further comprises a linear driving unit for transmitting a driving force generated by the fifth driving unit as linear driving force.
Bower et al. teaches an automatic analyzer and that vertical movement of a probe can be accomplished by any of the well-known mechanisms for affecting vertical motion such as gear train with step motor, belt and pulley assembly, pneumatic or hydraulic lifts, or the like. [0035]
It would have been obvious to modify Kim et al. ‘027 in view of Kim ‘140, Fan et al. and Gerstel to provide the elevating module with a linear driving unit for transmitting a driving force generated by the fifth driving unit as linear driving force in view of Bower et al. et teachings equivalent mechanism for producing linear vertical movement.
Therefore, Kim et al. ‘027 in view of Kim ‘140, Fan et al. and Gerstel and Bower et al. renders claim 10 obvious.
3. Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Kim et al. ‘027 in view of Kim ‘140, Fan et al. and Gerstel as applied to claim 8 above, and further in view of U.S. Patent Application Publication No. 2013/0183769 to Tajima.
I.) Regarding applicant’s claim 9, as noted above Kim et al. ‘027 in view of Kim ‘140, Fan et al. and Gerstel renders claim 8 obvious from which claim 9 depends
Claim 9 recites that the pump unit further comprises a perforating structure fixed in the vertical direction, for removing sealing paper for sealing the reagent chamber of the cuvette.
Kim et al. ‘027 in view of Kim ‘140, Fan et al. and Gerstel does not teach that that the cuvette compartments are sealed or that the pump unit comprises a perforating structure for unsealing the cuvette compartments.
Tajima teaches cartridges for an automatic analysis device that includes sealed compartments and further teaches a seal breaking tool 18 that can be attached to nozzle 45 to break the seal on the compartments. [0118]
It would have been obvious to one of ordinary skill in the art to modify Kim et al. ‘027 in view of Kim ‘140, Fan et al. and Gerstel to provide seals over the cuvette compartments and to include a perforating structure as taught by Tajima for purposes of to seal in reagents in the cuvette compartments and otherwise keep out pollutants until performing analysis using the cuvettes.
Note, perforating the seals in interpreted as removing at least a portion of the seals form sealing the cuvette compartments.
Therefore, Kim et al. ‘027 in view of Kim ‘140, Fan et al., Gerstel and Tajima renders claim 9 obvious.
Response to Arguments
Applicant’s arguments with respect to claims 1, 2 and 5-10 have been considered but are moot because the new ground of rejection that relies upon new prior art to Fan et al. and Gerstel as necessitated by applicant’s claim amendments.
Conclusion
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/M.S.G./Examiner, Art Unit 1798
/CHARLES CAPOZZI/Supervisory Patent Examiner, Art Unit 1798