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 .
Status of Claims
Applicant’s reply filed 8/6/26 is acknowledged. Claims 1-29 are pending and are under examination.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 12/14/23, 12/6/24, 1/17/25 and 3/24/26 were acknowledged. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Interpretation
The Office asserts that terms and phrases like “configured to” and “wherein” constitute recitations of intended use language for purposes of examination. The Office asserts that in the examined claims reciting such “configured to” language, the claim language that follows such recitations does not necessarily denote structure MPEP 2173.05(g). The functional limitation was evaluated and considered, for what it fairly conveys to a person of ordinary skill in the art. Similarly, a “wherein” clause may have a limiting effect on a claim if the language limits the claim to a particular structure. MPEP 2111.04. The determination of whether a “wherein” clause is a limitation in a claim depends on the specific facts of the case. While all words in each claim are considered in judging the patentability of the claim language, including functional claim limitations, not all limitations provide a patentable distinction.
During patent examination, the examined claims must be given their broadest reasonable interpretation consistent with the specification, unless a term has been given a special definition in the specification (“BRI”). See MPEP 2111.
Prior Art Rejections
In light of applicant’s claim amendments, the prior art rejections are modified.
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.
Claims 1-9, 11, 13 and 25-29 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Takaya et al. (“Takaya,” US Pub. No. 2018/0052183, cited in IDS and previously cited).
As to claim 1, Takaya teaches a method of monitoring an item (e.g., test tube) in a diagnostic laboratory system (e.g., [0030] et seq.), comprising:
moving the item on a track (e.g., belt conveyor) within the diagnostic laboratory system (e.g., rack 11 holds and conveys a test tube 17 one by one, or a plurality of test tubes 17 on a multi-holder rack 12 in [0035]);
moving a sensor module on the track (see sensor 102 or 702 on rack on belt conveyor in [0071] et seq.) to accompany the item such that the sensor module stays within a predetermined range of distances from the item (a configuration in which an analysis module for analysis is disposed on the downstream side of the specimen pretreatment system may be employed as described in [0034]; or sensor can be on a single-holder rack or on a rack with a plurality of specimen containers so the sensor is within a predetermined ranges of distances from each test tube (“item”) on the rack as described in [0071] et seq.); and
monitoring at least one characteristic of the item using the sensor module (e.g., a sensor for acceleration, an angle, a temperature, illuminance, sound, or the like in [0036] et seq.).
As to claim 2, Takaya teaches the sensor module comprises at least one sensor configured to monitor the at least one characteristic (e.g., reference sign 102 represents a sensor for acceleration, an angle, a temperature, illuminance, sound, or the like in [0036] et seq.).
As to claim 3, Takaya teaches positioning the item on a transport component at a first location (e.g., on the top of the rack) and positioning the sensor module on the transport component at a second location (e.g., on the side of the rack), wherein moving the item and moving the sensor module comprises moving the transport component on the track (e.g., see inspection device mounted on rack 407 and is conveyed over the belt conveyor 406 in [0061] et seq.), and wherein a distance between the first location and the second location is within a predetermined range (see distance between locations in e.g., fig. 9).
As to claim 4, Takaya teaches the monitoring comprises monitoring the at least one characteristic at a first time and monitoring the at least one characteristic at a subsequent second time (e.g., temperature in the device is measured on a regular basis in [0048] et seq.).
As to claims 5 and 29, Takaya teaches the monitoring comprises monitoring vibration (e.g., [0042] et seq.).
As to claims 6 and 27, Takaya teaches the monitoring comprises capturing an image including at least a portion of the item (e.g., [0052] et seq.).
As to claim 7, Takaya teaches the monitoring comprises monitoring sound (e.g., [0036] et seq.).
As to claim 8, Takaya teaches the at least one characteristic is tilt of the item (e.g., [0036] et seq.).
As to claim 9, Takaya teaches moving the item comprises moving a specimen container (e.g., [0035] et seq.).
As to claim 11, Takaya teaches the monitoring comprises monitoring at least one interaction of the specimen container with a moveable component (e.g., [0030] et seq.).
As to claim 13, Takaya teaches moving the item comprises moving a reagent pack. See e.g., [0060], which teaches a reagent container, which is a pack because Takaya teaches in fig. 2(b) a pack of containers, which can be holding reagent.
As to clams 25 and 26, Takaya discloses a sensor module comprising: at least one sensor configured to monitor at least one characteristic of an item (e.g., specimen container, [0030]) configured to be transported on a track in a diagnostic laboratory system; a range finder (e.g., distance sensor in Example 10 in [0094] et seq.; “configured to”, see claim interpretation above) configured to measure a distance between the sensor module and the item; and a transport component configured to transport the sensor module on the track in the diagnostic laboratory system to accompany the item such that the sensor module stays within a predetermined range of distances from the item based on measurements made by the range finder. See e.g., [0030] et seq. and “configured to”, see claim interpretation above.
As to claim 28, Takaya discloses at least one sensor is an acoustic sensor (e.g., [0036] et seq.
Claim Rejections - 35 USC § 103
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.
Claims 14-21 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Takaya.
See Takaya above.
As to claim 14, Takaya teaches a method of monitoring a specimen container or a specimen in a diagnostic laboratory system, comprising: moving the specimen container on a track within the diagnostic laboratory system; moving a sensor module on the track; and monitoring at least one characteristic of the specimen container or a specimen located in the specimen container using the sensor module. See e.g., [0030] et seq.
Regarding claim 14, Takaya does not specifically teach the sensor module on the track is in front of or behind the specimen container in the described figures. Takaya does teach in e.g., [0034], FIG. 1 illustrates an example of a system in which a module for specimen pretreatment is disposed; however, a configuration in which an analysis module for analysis is disposed on the downstream side of the specimen pretreatment system may be employed. In light of Takaya’s teaching, Takaya teaches the sensor module on the track is in front of or behind the specimen container such that the sensor module stays within a predetermined range of distances from the specimen container. It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to modify at least one of Takaya’s described figures to have the sensor module on the track to be in front of or behind the specimen container, because Takaya recognizes that the taught embodiments and alternative embodiments make it possible to perform installation, adjustment, or inspection work of a test tube conveyance device in a highly effective manner (e.g., [0009] of Takaya).
As to claim 15, Takaya teaches the sensor module comprises at least one sensor configured to monitor the at least one characteristic (e.g., reference sign 102 represents a sensor for acceleration, an angle, a temperature, illuminance, sound, or the like in [0036] et seq.).
As to claim 16, Takaya teaches positioning the item on a transport component at a first location (e.g., on the top of the rack) and positioning the sensor module on the transport component at a second location (e.g., on the side of the rack), wherein moving the item and moving the sensor module comprises moving the transport component on the track (e.g., see inspection device mounted on rack 407 and is conveyed over the belt conveyor 406 in [0061] et seq.), and wherein a distance between the first location and the second location is within a predetermined range (see distance between locations in e.g., fig. 9).
As to claim 17, Takaya teaches the monitoring comprises monitoring the at least one characteristic at a first time and monitoring the at least one characteristic at a subsequent second time (e.g., temperature in the device is measured on a regular basis in [0048] et seq.).
As to claim 18, Takaya teaches the monitoring comprises monitoring vibration (e.g., [0042] et seq.).
As to claim 19, Takaya teaches the monitoring comprises capturing an image including at least a portion of the item (e.g., [0052] et seq.).
As to claim 20, Takaya teaches the monitoring comprises monitoring sound (e.g., [0036] et seq.).
As to claim 21, Takaya teaches the at least one characteristic is tilt of the item (e.g., [0036] et seq.).
As to claim 24, Takaya teaches the monitoring comprises monitoring at least one interaction of the specimen container with a moveable component (e.g., [0030] et seq.).
Claims 10 and 22-23 are rejected under 35 U.S.C. 103 as being unpatentable over Takaya in view of Kluckner et al. (“Kluckner,” US Pub. No. 2018/0365530, cited in IDS and previously cited).
See Takaya above.
As to claims 10 and 23, Takaya does not specifically teach at least one characteristic is a status of a cap configured to be located on the specimen container. Kluckner teaches in e.g., [0049], quantification of physical attributes of the specimen container 102 may take place at the quality check module 130 (i.e., determining HT, cap color, cap type, TC, tube type, and/or W). It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to have at least one characteristic be the status of a cap configured to be located on the specimen container, because the cap color, for example, may be used to identify the different additives and may be indicative of the test type to be run on the specimen or simply tube type (e.g., [0008] of Kluckner).
As to claim 22, Takaya does not specifically teach the at least one characteristic is height of a specimen in the specimen container. Kluckner teaches imaging methods and apparatus configured to, and capable of, being operated (operable) to determine physical attributes of a specimen container, such as width (W), and height of the specimen container (HT) in e.g., [0026]. It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to have at least one characteristic be the height of a specimen in the specimen container, because knowing the height of the specimen container HT may be used by the robotic system to establish a home height for the pipette of an aspiration system to minimize specimen container-pipette collisions. Further, the HT may be used so that the any robot grippers may appropriately grasp the specimen container. (e.g., [0027] of Kluckner).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Takaya in view of Yasui et al. (“Yasui,” US Pub. No. 2016/0327587, cited in IDS and previously cited).
See Takaya above.
As to claim 12, Takaya does not specifically teach at least one characteristic is pressure applied to the item during an interaction with a component of the diagnostic laboratory system. Yasui teaches in e.g., [0102], with regard to whether or not the liquid level of the sample is present during the suction, whether the sample suction is normally performed can be determined based on a pressure change in a pressure sensor installed inside a flow path; and teaches in e.g., [0121], a pressure sensor may be arranged in a portion of the sample nozzle 12a inside the arm 42 so as to detect a pressure value actually applied to the sample nozzle 12a. In this manner, it is also possible to control the operation of the sample nozzle 12a and the vertically rotating mechanism 41. It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to have at least one characteristic be the pressure applied to the item during an interaction with a component of the diagnostic laboratory system because it would help control the accuracy of the sample dispensing and prevent spillage.
Response to Arguments
Applicant's arguments filed 8/6/26 on p. 13-15 of the reply have been fully considered but they are not persuasive. Takaya and/or Takaya and the combination of references taught above properly read on the amended claim language, as explained in the modified rejections above.
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 LORE RAMILLANO JARRETT whose telephone number is (571)272-7420. The examiner can normally be reached Monday to Friday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lyle Alexander can be reached at 571-272-1254.
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/LORE R JARRETT/Primary Examiner, Art Unit 1797
10/13/2026
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