DETAILED ACTION
Notice of AIA Status
The present application, filed on 7/28/23, is being examined under the first inventor to file provisions of the AIA .
Status of Claims
Claims 1-21 are pending.
Claims 1-5, 7 and 9-10 are rejected.
Claims 1-11 are objected to.
Claims 12-21 are withdrawn from consideration.
Election/Restrictions
Claims 1-11 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Response to Election/Restrictions Traversal
Applicant timely traversed the restriction requirement in the reply filed on 5/21/2026. The traversal is on the grounds that claims 1, 12, 15, and 21 all require an apparatus configured to select and transfer sample racks on testing priorities even though the independent claims of Groups I-IV do not use identical terminology. However, upon consideration, applicant’s grounds for the traversal are not found persuasive because the applicant asserted common technical feature is not recited across all of the independent claims 1, 12, 15, and 21. Specifically, the applicant’s asserted common feature isn’t found common to all independent claims. More specifically, claim 1 does not require selecting based on testing priorities. In fact, in claim 1 “the shuttle is configured to pick out arbitrarily a sample rack to be tested”, where “arbitrary” appears inconsistent with ‘based on testing priorities” and therefore isn’t reasonably interpreted as requiring selection based on testing priorities. In addition, Claim 12 recites a testing system including the device of claim 1. In addition, Claim 15 recites determining testing priorities as a method step; however, claim 15 does not require that the determination be performed by an apparatus configured to select and transfer sample racks based on testing priorities. In addition, claim 21 recites a computer-readable medium for implementing the method of claim 15. As a result, the restriction requirement is deemed proper.
In addition, Groups I-IV lack unity of invention because even though the inventions of these groups require the technical feature of “transfer of samples rack to be tested”, this technical feature is not a special technical feature as it does not make a contribution over the prior art in view of Suzuki (US2013/0197690) which teaches transfer of samples rack to be tested (see the abstract, which recites “a method for controlling an automated sample test system includes a samples conveyance line for conveying samples racks, each holding samples, to a plurality of processing units”).
As a result, the restriction requirement is deemed proper and made final.
Claim Objections
Claims 1-11 are objected to because of the following informalities:
Claim 1 recites “a loading/unloading area configured to accommodate a plurality of sample racks arranged side by side, wherein each of the plurality of sample racks is configured to carry one or more sample containers containing samples;
a sampling area in which a sample in each sample container on the sample rack is sampled by the automatic testing apparatus”.
For the sake of clarity consider rephrasing to ‘a loading[[/]] and unloading area configured to accommodate a plurality of sample racks arranged side by side, wherein each of the
a sampling area in which a sample in each of the one or more sample containers on a sample rack can be sampled by the automatic testing apparatus’.
Claim 3 recites “the shuttle is configured to preferentially transfer a sample rack to be tested which has been loaded in the emergency channel to the sampling area”. For the sake of clarity of clarity consider rephrasing to ‘the shuttle is configured to transfer a sample rack to be tested before transferring a sample rack located in a non-emergency-channel area of the loading and unloading area’.
Claim 3 recites “wherein an emergency channel is arranged in the loading/unloading area”. For the sake of clarity, consider rephrasing to ‘further comprising and unloading area’ or ‘wherein the loading and unloading area comprises an emergency channel’.
Claim 4 recites “the conveyor belt is movable back and forth in its extension direction in a continuous or step-by-step manner”. For the sake of clarity consider rephrasing to ‘the conveyor belt is movable back and forth in [[its]] an extension direction of the conveyor belt in a continuous manner or in a step-by-step manner’.
Claim 5 recites “wherein two adjacent rack accommodating sections are arranged in the sampling area, wherein the sample rack is loaded in one of the rack accommodating sections for sampling, and the other of the rack accommodating sections provides a backup sampling position”. For the sake of clarity consider rephrasing to ‘wherein the sampling area includes a first rack accommodation section and a second rack accommodating section adjacent to the first rack accommodating section, wherein the sample rack can be loaded in the first rack accommodating section for sampling, and the second rack accommodating section provides a backup sampling position.
Claim 6 recites “unload a tested sample rack from the one rack accommodating section so as to enable the next sample rack to be tested in the backup sampling position to move to the sampling position during sampling interval of the automatic testing apparatus, thereby realizing uninterrupted continuous sampling of the automatic testing apparatus”. For the sake of clarity consider rephrasing to ‘unload a tested sample rack from the first rack accommodating section so as to enable the next sample rack to be tested in the backup sampling position to move to the backup sampling position during a sampling interval of the automatic testing apparatus, thereby realizing uninterrupted continuous sampling using the automatic testing apparatus’.
Claim 7 recites “further comprising: a buffer area and a transfer area,
wherein a label reader is provided in the transfer area and/or the buffer area”. For the sake of clarity consider rephrasing to ‘further comprising: a buffer area; ; and a label reader in the transfer area or in the buffer area or in both
Claim 7 recites “the label reader is configured to read a label attached to the sample rack and/or the sample container to obtain rack identification information and/or sample identification information related to the sample rack”. For the sake of clarity, consider rephrasing to ‘the label reader is configured to read a label attached to the sample rack or to the sample container or to both, to obtain rack identification informationor sample identification information related to the sample rack or both’.
Claim 8 recites “based on the read information”. For the sake of clarity consider rephrasing to ‘based on the read label’ or ‘based on the obtained rack identification information or based on the sample identification information related to the sample rack or based on both’.
Appropriate correction is required.
Any claim dependent on objected claim is objected to because a claim in dependent is construed under 35 U.S.C. 112(d) to incorporate all limitations of the base claim to which the dependent claim refers.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
Claims 3 and 9-10 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claim 3 recites “the shuttle is configured to preferentially transfer a sample rack to be tested which has been loaded in the emergency channel to the sampling area”. The phrase "preferentially" renders the claim indefinite because it is unclear whether the limitation following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim 9 recites “the shuttle is configured to preferentially transfer a sample rack to be tested which has been loaded in the one or more emergency channels to the transfer area and/or the buffer area for reading information”. The phrase "preferentially" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Any claim dependent on claim rejected under 35 U.S.C. §112(b) is rejected under 35 U.S.C. §112(b) because a claim in dependent is construed under 35 U.S.C. 112(d) to incorporate all limitations of the base claim to which the dependent claim refers.
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 (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 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.
Claim 1 is rejected under 35 U.S.C. 102(a)(1) as being anticipated by Luoma (US20020169518) (cited in the information disclosure statement dated 12/16/24).
With respect to Claim 1, Luoma teaches a sample rack manipulation device (sample handling system 10 in [0032]) for (suitable for operating in conjunction with) an automatic testing apparatus (diagnostic module in [0006]), wherein the sample rack manipulation device (sample handling system 10) comprises:
a loading/unloading area (‘routine loading area 31’ and ‘urgent or stat sample area 33’ in [0024]) configured to accommodate a plurality of sample racks (sample carriers 40 in [0024]) arranged side by side (see Figs. 1-2), wherein each (sample carrier 40) of the plurality of sample racks (sample carriers 40) is configured to carry one or more sample containers (one or more containers 42 in [0023]) (see Fig. 5) containing samples (samples in [0023], which recites “each carrier 40 can hold a plurality of containers 42, such as tubes or cups, filled with samples”);
a sampling area (sample testing area in [0015]) in which a sample (sample in [0023]) in each sample container (in each of the containers 42) on the sample rack (sample carriers 40) is sampled by the automatic testing apparatus (diagnostic module 20 in [0031], which recites “a diagnostic module 20 for conducting tests on the samples in the test tubes 42 (see FIG. 5)”)) (see also Fig. 4); and
a shuttle (robotic means in [0015]) configured to transfer the sample rack (carrier 40) between the loading/unloading area (routine loading area 31 and urgent or stat sample area 33) and the sampling area (sample testing area) (see [0015], which recites “a robotic means for moving a carrier with a plurality of test samples from a loading rack to a sample testing area”) wherein the shuttle (robotic means) is configured to pick out arbitrarily (see [0006], which recites “random sample handling system”) a sample rack (sample carriers 40) to be tested which has been loaded in the loading/unloading area (routing loading area 31) and transfer the picked-out sample rack (sample carrier 40) to be tested to the sampling area (sample testing area) for sampling (testing) (see claim 15, which recites “a system having a robotic means for moving a carrier with a plurality of test samples from a loading rack to a sample testing area and returning the carrier to the loading rack and having a programmable computer for (1) controlling the robotic means”).
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.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Luoma (US20020169518) in view of VanSicker (US20200319219).
With respect to Claim 2, Luoma teaches the sample rack manipulation device according to claim 1.
Luoma doesn’t teach that the shuttle is configured to transfer sample racks to be tested which have been loaded in a same batch in the loading/unloading area to the sampling area in an order from left to right.
In the analogous art of analytical devices, VanSicker teaches a shuttle (one of shuttles 280 in [0171], which recites “As depicted in FIG. 7, system 10 includes two shuttle transport assemblies 300 a and 300 b which can each feed shuttles 280 to a respective analyzer A1 . . . An.”) is configured to transfer sample racks (container 03 in [0148], which recites “shuttle 280, as best shown in FIG. 12B, includes a body 284 and a plurality of receptacles 283 extending into body 284 from a top surface thereof. The shuttle 280 depicted includes twelve receptacles 283 which are each sized to receive a third-type sample container 03”) to be tested (at the respective analyzer) which have been loaded in a same batch (see [0315], which recites “shuttle processing/transport module 750 loads batches or partial batches of samples leaving pre-preprocessing module 730 or preprocessing module 740 into shuttles 280 and distributes them to analyzers”) in the loading/unloading area (pre-processing module 730) to the sampling area in an order from left to right (Under the broadest reasonable interpretation, the recited order from left to right encompasses transferring sample racks from a loading/unloading area to a sampling area having analyzers arranged left-to-right along the system) (the sampling area comprises analyzers arranged from left to right along the system) (see Fig. 7 and [0178], which recites “processor 804 also recalls information regarding the assay to be performed and determines, based on analyzer information that is stored on memory 806, which analyzer coupled to system 10 is suitable to perform the particular assay. For example, a first analyzer 830 coupled to a right side of system 10 may perform a first assay, such as a Gonorrhea assay, while a second analyzer 840 coupled to a left side of system 10 may perform a second assay, such as an HPV assay. If the batch requires the first assay, then processor 804 chooses first analyzer 830 and operates transfer arm 270 so that transfer arm 270 places shuttle 280 onto first shuttle transport assembly 300 a. First transport assembly 300 a is then operated to transport shuttle 280 to first analyzer 830”) (see Fig. 7).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the sample rack manipulation device disclosed by Luoma such that the shuttle is configured to transfer sample racks to be tested which have been loaded in a same batch in the loading/unloading area to the sampling area in an order from left to right as disclosed by VanSicker with a reasonable expectation of success for the benefit of improving predictability, throughput and efficiency of batch sample processing and transport within the automated workflow (see [0373] of VanSicker).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Luoma (US2002/0169518) in view of VanSicker (US202/00319219) further in view of Mitsumaki (US 5,876,670).
With respect to Claim 3, Luoma in view of VanSicker teaches the sample rack manipulation device according to claim 2, wherein an emergency channel (urgent or stat sample area in claim 3) is arranged in the loading/unloading area (routine loading area 31 and urgent or stat sample area 33).
Luoma doesn’t teach that the shuttle is configured to preferentially transfer a sample rack to be tested which has been loaded in the emergency channel to the sampling area.
In the analogous art of providing analytical devices, Mitsumaki teaches the shuttle (sample rack transporting line 3 in column 3, see Fig. 1) is configured to preferentially transfer a sample rack (urgent sample rack 11 in column 5, see Fig. 1) to be tested (see column 6, which recites “the sample rack sampled in the first analyzing module 4”) which has been loaded in the emergency channel (urgent sample supplying portion 10 in column 5, see Fig. 1) to the sampling area (first analyzing module 4) (see column 5, which recites “if an urgent sample rack 11 is placed at the urgent sample supplying portion 10 when a sample rack is placed at the sample supplying portion 1, the urgent sample rack 11 placed at the urgent sample supplying portion 10 is transferred to the transporting line 3 in preference to the general sample rack placed at the sample supplying portion 1”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the sample rack manipulation device disclosed by Luoma such that the shuttle is configured to preferentially transfer a sample rack to be tested which has been loaded in the emergency channel to the sampling area as disclosed by Mitsumaki with a reasonable expectation of success for the benefit of enabling expedited processing of urgent samples prioritizing high-priority samples ahead of routine samples by transferring urgent sample racks loaded in the emergency channel ahead of routine sample racks thereby improving throughout management and reducing turnaround time for high priority testing (see summary of the invention section in Matsumaki).
Claims 4-5 are rejected under 35 U.S.C. 103 as being unpatentable over Luoma (US2002/0169518) in view of Zhang (CN211697836).
With respect to Claim 4, Luoma teaches the sample rack manipulation device according to claim 1.
Luoma doesn’t teach the sampling area is in a form of a conveyor belt and the conveyor belt is movable back and forth in its extension direction in a continuous or step-by-step manner.
In the analogous art of analytical devices, Zhang teaches a conveyor belt (conveyor belt 65 on page 10) movable back and forth in its extension direction in a continuous or step-by-step manner (see page 10, which recites “the transport device includes a driving member for driving the conveyor belt 65 to move, so as to drive the sample rack 20 on the conveyor belt 65 to move. The drive member may be an electric motor. The conveyor belt 65 may be moved in the feeding direction or in a direction opposite to the feeding direction”) (the broadest reasonable interpretation of step-by step movement encompasses continuous movement over one of the step ranges).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the sample rack manipulation device disclosed by Luoma by incorporating the conveyor belt disclosed by Zhang such that the sampling area is in a form of a conveyor belt and the conveyor belt is movable back and forth in its extension direction in a continuous or step-by-step manner with a reasonable expectation of success for the benefit of improving flexibility in sample rack handling and transport by enabling the movement of sample racks in either direction along the conveying path, thereby facilitating efficient delivery, retrieval and repositioning of sample racks during operation (see page 10 of Zhang).
With regard to Claim 5, Luoma in view of Zhang teaches the sample rack manipulation device according to claim 4, wherein two adjacent rack accommodating sections (see Fig. 5 of Luoma) are arranged in the sampling area (sample testing area), wherein the sample rack (sample carrier 40) is loaded in one of the rack accommodating sections for sampling, and the other of the rack accommodating sections provides a backup sampling position (see [0031] of Luoma, which recites “carrier positioner 80 has a plurality of openings 86 for receiving carriers. The positioner 80 can position at least two complete carriers underneath the testing point(s) of a processing module, allowing the processing module to aspirate from one carrier 40 while the transporter 50 loads another carrier 40 on the positioner 80 to maintain system throughput”) (see also [0032]).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Luoma (US2002/0169518) in view of Kodama (US6,117,683).
With respect to Claim 7, Luoma teaches the sample rack manipulation device according to claim 1, further comprising:
a label reader (barcode reader in [0009]) configured to read a label (coded labels in [0009]) attached to the sample rack (carriers in [0009], which recites “a barcode reader is provided to read carrier and sample identification. A bar code reader in the system reads barcoded labels attached to the carriers and the sample tubes”).
Luoma doesn’t teach a buffer area and a transfer area, wherein a label reader is provided in the transfer area and/or the buffer area.
In the analogous art of providing, Kodama teaches a buffer area (conveyance path 6, see Fig. 2) and a transfer area (transmission port 10,see Fig. 2), wherein a label reader (identification information reader 50, see Fig. 2) is provided in the buffer area (conveyance path 6, see Fig. 2) (see columns 7 and 8, which recite “when the identification information reader 50 which also serves as … detector detects that the sample rack has arrived at the transmission port 10 just before the main conveyance line, a conveyance request of the rack from the rack supplying unit 3 to the main conveyance line 13 is sent and the rack waits for a permission of transmission. The sample ID read by the identification information reader 50 is stored in the storage 81 of the control unit 1”).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the sample rack manipulation device disclosed by Luoma such that the label reader is provided in the buffer area as disclosed Kodama with a reasonable expectation of success for the benefit of acquiring sample rack identification information before sample sampling thereby facilitating identification, tracking and management of sample racks during operations (see columns 7 and 8 of Kodama).
Allowable Subject Matter
Claims 6 and 8 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claims 9-11 would be allowable if rewritten to overcome the rejection under 35 U.S.C. 112(b) set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
With regard to Claim 6, neither cited prior, Luoma and Zhang, teaches or reasonably suggests a shuttle is configured to:
load a next sample rack to be tested onto the other rack accommodating section during a sampling cycle of the automatic testing apparatus; and
to unload a tested sample rack from the one rack accommodating section so as to enable the next sample rack to be tested in the backup sampling position to move to the sampling position during sampling interval of the automatic testing apparatus, thereby realizing uninterrupted continuous sampling of the automatic testing apparatus.
With respect to Claims 8-11, Luoma teaches a controller (programmable computer in [0015] of Luoma). Komada also teaches a controller (controller 1 in Fig. 1 of Komada).
Neither cited prior, Luoma and Kodama, teaches or reasonably suggests a controller configured to determine, based on the read information, testing priorities of the individual sample racks to be tested, and determine a transferring and testing order of the sample racks to be tested,
wherein the shuttle is configured to transfer, based on the determined transferring and testing order, the sample racks to be tested in the buffer area to the sampling area for sampling.
Conclusion
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/JONATHAN BORTOLI/Examiner, Art Unit 1797
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