DETAILED ACTION
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 Amendments
The amendments and remarks, filed on 9/17/2025, has been entered. The claim amendments overcome the previous prior art rejection a new prior art rejection is applied to address the claim amendments.
Claim Status
Claims 1-5 are pending and being examined.
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 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(s) 1-2 and 4-5 are rejected under 35 U.S.C. 103 as obvious over Yamato et al (US 20110123397 A1; hereinafter “Yamato”; already of record) in view of Tatsutani (US 20130260412 A1; hereinafter “Tatsutani”; already of record).
Regarding claim 1, Yamato teaches a transport mechanism that is disposed in a measuring device used for dispensing biological samples from sample containers1 configured to contain the biological samples to cuvettes, so as to perform a predetermined measurement, and transports a sample rack configured to hold the sample containers2 (Yamato; Abstract; A sample processing apparatus, including: a sample processing unit for obtaining a sample from a sample container positioned at a sample obtaining position and performing a predetermined process of the sample), the transport mechanism comprising:
a table on which the sample rack is provided in plurality and sequentially placed (Yamato; Fig. 2; examiner interprets the table as the bottom portion comprising the rack set region A, transport region B, and rack placement region C);
a container sensor unit configured to identify the sample containers held on the sample rack3 (Yamato; Fig. 2, 4A; para [53]; In the sample rack L transferred to the transport region B, the barcode reader 51 reads the barcode BL1 of the sample container T; examiner interprets the barcode reader to be part of the container sensor unit because the barcode reader is capable of identifying the sample containers held on the sample rack);
a transport pathway comprising a carry-in lane (Yamato; Fig. 2; para [50]; The rack set region A is equipped with a rack feed mechanism A1 which transports the sample rack L disposed therein in the Y-axis positive direction; the carry in lane is interpreted as region A), a sampling lane (Yamato; Fig. 2; para [52]; The transport region B is provided with a transport path B1 which supports the bottom surface of the sample rack L; the sampling lane is interpreted as region B) and a carry out lane (Yamato; Fig. 2; para [57]; The rack placement region C is provided with a rack feed mechanism C1 which transports the sample rack L disposed therein in the Y-axis negative direction; the carry out lane is interpreted as region C);
a carry-in device configured to move sample racks along the carry-in lane and into a first position of the sampling lane (Yamato; Fig. 1; para [50]; The rack set region A is equipped with a rack feed mechanism A1 which transports the sample rack L disposed therein in the Y-axis positive direction);
a transport device configured to transport the sample racks holding the sample containers identified by the container sensor unit from the first position of the sampling lane to a dispensing position at which the biological samples are dispensed4 (Yamato; Fig. 4A, 4B; para [53]; The sample rack L, for which the barcode pre-read at the pre-read position is completed, is transported to the sample suctioning position 52 or 53); and
a carry-out device configured to move processed sample racks along a carry out lane and out of the dispensing position in the sampling lane (Yamato; Fig. 2; para [57]; The rack placement region C is provided with a rack feed mechanism C1 which transports the sample rack L disposed therein in the Y-axis negative direction);
wherein:
the container sensor unit is connected to the transport device (Yamato; Fig. 4A, 4B).
Yamato does not teach wherein the transport device and the container sensor move in tandem as one unit.
However, Tatsutani teaches an analogous art of a sample processing apparatus (Tatsutani; Abstract) comprising a transport device (Tatsutani; Fig. 3; para [32]; a sample rack L holding 10 sample containers T. FIG. 2B also shows the orientation (the front, rear, left, and right directions shown in FIG. 1) of a sample rack L when it is placed on the loading unit 21) and a container sensor (Tatsutani; Fig. 3; para [36]; a bar code unit B), wherein the transport device and the container sensor move in tandem as one unit (Tatsutani; Fig. 4A, 4B; para [36, 55]; the preprocessing unit 22 reads a sample ID of each sample container T and detects the support position at which each sample container T is held in the sample rack L, by means of a bar code unit B…the bar code reader B13 of the left moving part B1 reads sample IDs of sample containers T held at the support positions 1 to 5, and the bar code reader B13 of the right moving part B1 reads sample IDs of sample containers T held at the support positions 6 to 10). It would have been obvious to one of ordinary skill in the art before the effective filing date to have modified the transport device of Yamato to move in tandem with the container sensor as taught by Tatsutani, because Tatsutani teaches that the bar code unit moves to determine if a sample container is present (Tatsutani; para [54]) which rotates the container to be read by the bar code reader (Tatsutani; para [55]). The examiner notes that the sample container and sample rack L are held by bar code unit B, thus connected/moves in tandem with the transport device.
Thus, modified Yamato teaches while the transport device transports a preceding sample rack from the first position to the dispensing position (Yamato; Fig. 4A; para [50]; the event that a plurality of sample racks L are disposed in the rack set region A, as illustrated in the figure, the rack feed mechanism A similarly pushes the side surface of the sample rack L which is nearest thereto (in Y-axis negative direction) so that the sample rack L which is farthest thereto (in Y-axis positive direction) is transferred to the transport region B), the container sensor unit, which moves integrally with the transport device that moves the preceding rack, sequentially identifies the sample containers held on a subsequent sample rack, wherein rack holding units of the transport device are configured to grasp the sample racks and to simultaneously move the sample racks along the sampling lane from the first position to a dispensing position, while the container sensor unit identifies the sample containers held on the sample racks (Yamato; para [101]; a subsequent sample rack L that follows the sample rack L currently positioned at the sample suctioning position 52 or 53, the processing steps in S2 and after S2 start for the subsequent sample rack L. In this case, the barcode reader 51 is moved in the X-axis positive and negative directions to post-read the preceding sample rack L with a higher priority but pre-read the subsequent sample rack L as well; Tatsutani; para [167]).
1 The limitation “a transport mechanism that is disposed in a measuring device” is interpreted as intended use. Examiner notes “the measuring device” is not a positively recited element of the claim, and therefore, is not an element of the claimed transport mechanism. The Courts have held that the manner in which a claimed apparatus is intended to be employed does not differentiate an apparatus claim from the prior art, if the prior art apparatus teaches all of the structural limitations of the claim. See Ex parte Masham, 2 USPQ2d 1647 (BPAI 1987). A functional recitation of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. See MPEP § 2114.
2 The limitations are directed to the function and/or the manner of operating the transport mechanism, all the structural limitations of the claim has been disclosed Yamato and the transport mechanism of Yamato is capable of “transports a sample rack configured to hold the sample containers”. As such, it is deemed that the claimed apparatus is not differentiated from the transport mechanism of Yamato (see MPEP §2114).
3 The limitations are directed to the function and/or the manner of operating the container sensor unit, all the structural limitations of the claim has been disclosed Yamato and the container sensor unit of Yamato is capable of being “configured to identify the sample containers held on the sample rack”. As such, it is deemed that the claimed apparatus is not differentiated from the container sensor unit of Yamato (see MPEP §2114).
4 The limitations are directed to the function and/or the manner of operating the transport device, all the structural limitations of the claim has been disclosed Yamato and the transport device of Yamato is capable of being “configured to transport the sample rack holding the sample containers identified by the container sensor unit to a dispensing position at which the biological samples are dispensed”. As such, it is deemed that the claimed apparatus is not differentiated from the transport device of Yamato (see MPEP §2114).
Regarding claim 2, Yamato in view of Tatsutani teaches the transport mechanism according to claim 1, further comprising a sample rack detecting device configured to determine whether the subsequent sample rack exists (Yamato; Fig. 4A; para [51]; a pair of sensors A2 are provided at an end thereof in the Y-axis positive direction and an end thereof in the Y-axis negative direction. An optically transparent photosensor or the like constitutes the sensor A2. The sensor A2 blocks light when the sample rack L is present in the rack set region A, and transmits light when there is no sample rack L in the rack set region A), and
when the sample rack detecting device determines that the subsequent sample rack exists, the container sensor unit identifies sample containers held on the subsequent sample rack (Yamato; para [50, 51, 52, 53]; examiner notes that the sensor A2 detects if a rack is present in region A, which is moved to region B for reading the barcodes referred to as “pre-read position”). Examiner notes that
Regarding claim 4, Yamato in view of Tatsutani teaches the transport mechanism according to Claim 1, wherein
the sample rack holds a plurality of the sample containers in a row in a first direction in plan view (Yamato; Fig. 4A),
a plurality of the sample racks are placed on the table in a second direction, which is perpendicular to the first direction, in plan view (Yamato; Fig. 4A), and
the transport device transports the preceding sample rack in the first direction while the container sensor unit identifies the sample containers held on a subsequent sample rack (Yamato; para [50, 51, 52, 53]; examiner notes that the sensor A2 detects if a rack is present in region A, which is moved to region B for reading the barcodes referred to as “pre-read position”). Examiner interprets the first direction as region A and the second direction as region B which is perpendicular to region A as seen in Fig. 4A.
Regarding claim 5, Yamato in view of Tatsutani teaches an analyzing device comprising the transport mechanism according to claim 1,
the analyzing device including a computer that controls operation of the transport mechanism and identifying processing of sample containers by the container sensor unit (Yamato; Fig 2; para [78]; The measurement device 2 includes a controller 200).
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Yamato in view of Tatsutani, and in further view of Streibl et al (US 20160018427 A1; hereinafter “Streibl”; already of record).
Regarding claim 3, Yamato in view of Tatsutani teaches the transport mechanism according to claim 1, wherein
predetermined identification information is indicated on an outer surface of each of the sample containers (Yamato; Fig. 3A, 3B, 3C; para [53]; the barcode BL1 of the sample container T),
the container sensor unit includes: a sample container identifying device configured to read the identification information indicated on each of the sample containers (Yamato; Fig. 4A; para [53]; he barcode reader 51 reads the barcode BL1 of the sample container T and the barcode label BL2 of the sample rack L (hereinafter, referred to as “pre-read”) before the sample container T is transported to the sample suctioning position 52, 53); and
the transport device transports the preceding sample rack, while the sample container identifying device reads the identification information indicated on each of the sample containers held on the subsequent sample rack (Yamato; para [50, 51, 52, 53]). Examiner notes that multiple racks are processed and the transport device is capable of feeding the sample rack while the sample container identifying device reads the identification information as seen in Fig. 4A.
Yamato with/without Yamasaki does not disclose a type determining device configured to determine a type of each of the sample containers, and the type determining device determines the type of each of the sample containers held on the subsequent sample rack.
However, Streibl teaches an analogous art of a container inspection unit (Streibl; Abstract) comprising a sample container identifying device configured to read the identification information indicated on each of the sample containers (Streibl; para [83]; analysis of the image may include analyzing a barcode attached to the container) and a type determining device (Streibl; para [104]; the LLD 114 may perform the measurement using an infrared measurement device that can scan the container vertically) configured to determine a type of each of the sample containers, and the type determining device determines the type of each of the sample containers held on the subsequent sample rack (Streibl; para [104]; The transmission characteristics of liquids/blood/gel can create measurement values that can allow identification of the contents as well as their heights or volumes within a container). It would have been obvious to one of ordinary skill in the art by the effective filing date to have modified the container sensor unit of Yamato to comprise the type determining device as taught by Streibl, because Streibl teaches that the LLD can detect the characteristics of the contents in the container for further analysis (Streibl; para [187]). Examiner notes that Yamato teaches an apparatus with different measurement modes (Yamato; para [36]), thus it would have been obvious to detect different characteristics to determine the proper measurement modes.
Response to Arguments
Applicant’s arguments filed, 9/17/2025, have been considered and the arguments are not found to be persuasive.
In the Applicant’s arguments, on page 4, the Applicant argues that Yamato in view of Tatsutani fails to teach the amended limitations of “the container sensor unit, which moves integrally with the transport device that moves the preceding rack, sequentially identifies the sample containers held on a subsequent sample rack”. The examiner respectfully disagrees. Modified Yamato teaches while the transport device transports a preceding sample rack from the first position to the dispensing position (Yamato; Fig. 4A; para [50]; the event that a plurality of sample racks L are disposed in the rack set region A, as illustrated in the figure, the rack feed mechanism A similarly pushes the side surface of the sample rack L which is nearest thereto (in Y-axis negative direction) so that the sample rack L which is farthest thereto (in Y-axis positive direction) is transferred to the transport region B), the container sensor unit, which moves integrally with the transport device that moves the preceding rack, sequentially identifies the sample containers held on a subsequent sample rack, wherein rack holding units of the transport device are configured to grasp the sample racks and to simultaneously move the sample racks along the sampling lane from the first position to a dispensing position, while the container sensor unit identifies the sample containers held on the sample racks (Yamato; para [101]; a subsequent sample rack L that follows the sample rack L currently positioned at the sample suctioning position 52 or 53, the processing steps in S2 and after S2 start for the subsequent sample rack L. In this case, the barcode reader 51 is moved in the X-axis positive and negative directions to post-read the preceding sample rack L with a higher priority but pre-read the subsequent sample rack L as well). Yamato teaches the claimed limitation as the amendments are directed to function and/or the manner of operating the transport mechanism, all the structural limitations of the claim has been disclosed by Yamato in view of Tatsutani and the transport mechanism of modified Yamato is capable of “transports a preceding sample rack from the first position to the dispensing position, the container sensor unit, which moves integrally with the transport device that moves the preceding rack, sequentially identifies the sample containers held on a subsequent sample rack, wherein rack holding units of the transport device are configured to grasp the sample racks and to simultaneously move the sample racks along the sampling lane from the first position to a dispensing position, while the container sensor unit identifies the sample containers held on the sample racks”. As such, it is deemed that the claimed transport mechanism is not differentiated from the transport mechanism of modified Yamato (see MPEP §2114).
In the Applicant’s arguments, on page 4-5, the Applicant argues that Tatsutani does not move in tandem with the transport mechanism. The examiner respectfully disagrees. The examiner notes that Tatsutani teaches the preprocessing unit 22 reads a sample ID of each sample container T and detects the support position at which each sample container T is held in the sample rack L, by means of a bar code unit B (Tatsutani; para [36]). The examiner notes that the limitation is directed to function and/or the manner of operating the transport mechanism and container sensor, all the structural limitations of the claim has been disclosed by Yamato in view of Tatsutani and the transport mechanism and container sensor of modified Yamato is capable of “moving in tandem”. As such, it is deemed that the claimed transport and container sensor is not differentiated from the transport mechanism and container sensor of modified Yamato. Further, the examiner notes “moving in tandem” may be accomplished by moving the entire apparatus. The limitation may be met by moving the apparatus which carries both the container sensor unit and the transport device.
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 Austin Q Le whose telephone number is (571)272-7556. The examiner can normally be reached Monday - Friday 9am - 5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Robinson can be reached at (571)272-7129. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/A.Q.L./Examiner, Art Unit 1796
/ELIZABETH A ROBINSON/Supervisory Patent Examiner, Art Unit 1796