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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 31 March 2026 has been entered.
Response to Amendment
This is an office action in response to Applicant’s arguments and remarks filed on 31 March 2026. Claims 1-3 and 5-15 are currently pending in the application. Claim 4 has been previously cancelled. Claims 10-15 are withdrawn from consideration. Claims 1-3 and 5-9 are being examined herein.
Status of Objections and Rejections
The rejection of claims 1-3 and 5-9 under 35 U.S.C. § 103 in view of Pollack, et. al. (US 20180164335 A1) are withdrawn.
Response to Arguments
Applicant’s arguments, see Remarks, pg. 6-10, filed 31 March 2026, with respect to the rejections of claims 1-3 and 5-9 under 35 U.S.C. § 103 in view of Pollack, et. al. (US 20180164335 A1) have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of German, et. al. (US 20150355208 A1) in view of Menhardt, et. al. (US 20190331702 A1).
Applicant rises two primary arguments in view of the rejection in view of Pollack.
First, the data as disclosed by Pollack is not stored on the RFID tag attached to the sample carrier but stored remotely in memory of the system (Remarks, pg. 7, par. 05 - pg. 9, par. 01), to which examiner agrees.
Second, the RFID tag of Pollack is only readable as Pollack does not teach, disclose, or suggest that the RFID tag is also writable (Remarks, pg. 9, par. 02 – pg. 10, par. 01), to which examiner agrees.
Applicant ultimately argues in light of the above two reasons, a simple rearrangement of parts, moving the RFID tag from a sample vessel carrier to the sample vessel itself, does not teach, disclose, or suggest the limitations recited in claim 1 (Remarks pg. 10).
Examiner believes these shortcomings are remediated by German in view of Menhardt, see below for further detail.
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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 6 and 7 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 6, recites the limitation "specifying a container-processing step" in lines 1-2 of the claim. “A container-processing step” is previously recited in claim 5 from which claim 6 depends. It is unclear if “a container-processing step” in claim 6 is the same or different “container-processing step” as recited in claim 5. Examiner believes these are the same container-processing steps and will be examined as such. Examiner recommend amending the claim to recite “specifying the container-processing step” or an equivalent thereof.
Claim 7, recites the limitation "specifying a container-processing step" in in lines 1-2 of the claim. “A container-processing step” is previously recited in claim 5 from which claim 7 depends. It is unclear if “a container-processing step” in claim 7 is the same or different “container-processing step” as recited in claim 5. Examiner believes these are the same container-processing steps and will be examined as such. Examiner recommend amending the claim to recite “specifying the container-processing step” or an equivalent thereof.
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.
Claims 1-3, 5, 6, 8, and 9 are rejected under 35 U.S.C. 103 as being unpatentable over German, et. al. (US 20150355208 A1) in view of Menhardt, et. al. (US 20190331702 A1).
Regarding claim 1, German teaches a system and method for physical characterization of sample vessels in an automated system (Abstract) specifically for patient samples for in vitro diagnostics in a clinical analyzer (par. 0002) (for handling an in-vitro diagnostics (IVD) container in an IVD laboratory). German teaches a system comprising at least one of a testing station and a processing station in which a carrier 514 holding at least one sample vessel (par. 0008-0015). German teaches the system operates through the following steps. At characterization station 502, the geometry of the samples position/shape relative to the carrier 514 is measured (Steps 550-552 in Fig. 14) (Fig. 11; par. 0143, 0156-0158) by an optical measuring device 60 (par. 0071) (measuring at least one physical quantity of an IVD container). The position/shape is determined in Step 552 and the data is communicated to a processor (par. 0159) like microcontroller 301 that operates the whole system like communicating data with memory 304 (Fig. 9; par. 120) with sample carrier also having onboard memory 300 (par. 0120) (storing the at least one physical quantity in a read… data carrier attached to the IVD container). Finally, German teaches the carrier 514 moves to a second station, like a processing station 504 (Step 554 in Fig. 14) (Fig. 11; par. 0143, 0161), wherein the sample vessel position/shape data is accessed to position the sample vessel within the carrier 514 to adjust for the offset of the sample vessel (Step 556 in Fig. 14; par. 0161) (and retrieving the at least one physical quantity).
German is silent to storing the data in a read and writeable data carrier attached to the IVD container and retrieving the data from the read and writeable data carrier attached to the IVD container.
Menhardt teaches a method of tracking a sample and associated sample data from the initial point of sample collection to the final point of sample testing (Abstract). Menhardt teaches often during patient sample processing, the sample itself is often moved between several environments including the point of collection, preparation site, and point of testing (Fig. 1; par. 0031). Menhardt teaches, in addition to a network 110 connected to a central monitor 120 (Fig. 1; par. 0031), identifiers 324 are attached to the sample holder 322 itself (Fig. 3; par. 0034) wherein the identifier, like an RFID tag, can be in proximity of an RFID detector/writer 340 to encode identifying data into the RFID tag (par. 0039-0041). Menhardt additionally teaches the RFID tag attached to the sample holder 322 is able to attach to sensors to collect environmental data during transport (par. 0050) (storing the [data]… in a read and writeable data carrier attached to the IVD container). Finally, Menhardt teaches upon arriving at the testing site, the RFID tag, holding data related to the identity of the sample (par. 0041) and transportation data (par. 0050), relays the data to an RFID detector/writer from the RFID tag (par. 0050) (retrieving the [data]… from the read and writeable data carrier attached to the IVD container). Menhardt teaches RFID tags "contain more data capabilities, can be programmed, and have high levels of security" (par. 0040) and the addition of a readable and writable tag to the sample container itself allows for multiple levels of tracking and data recording to avoid errors (par. 0034).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the onboard memory of the sample carrier of German to specifically be a readable and writable RFID tag as taught by Menhardt because doing so allows more data to be safely collected, stored, transported, and relayed by the sample container itself which in turn allows for multiple levels of (sample) tracking and data recording to prevent errors as suggested by Menhardt. MPEP 2143(I)(G).
Regarding claim 2, modified German teaches sample vessel positioning/shape is determined at a characterization station (German, Fig. 11; par. 0143) by an optical measuring device 60 (German, par. 0071) (the step of measuring is performed at a first IVD laboratory instrument), and then the carrier 514 moves to a second station, like a processing station 504 (German, Step 554 in Fig. 14) (German, Fig. 11; par. 0143, 0161), wherein the sample vessel position/shape data is accessed to position the sample vessel within the carrier 514 to adjust for the offset of the sample vessel (German, Step 556 in Fig. 14; par. 0161) (and the step of retrieving is performed at a second IVD laboratory instrument).
Regarding claim 3, modified German teaches characterization station 502 comprises an optical measuring device 60 that only measures position/shape of the sample vessel (German, Fig. 4, 11; par. 0070-0071, 0143) (the first IVD laboratory instrument is a pre-analytic IVD laboratory instrument). German teaches processing station 504 comprises elements like pipettes 512 to access the sample within the vessel (German, Fig. 11; par. 0143) (and the second IVD laboratory instrument is an analytic IVD laboratory instrument).
Regarding claim 5, modified German teaches t characterization station 502, the geometry of the samples position/shape relative to the carrier 514 is measured (Steps 550-552 in Fig. 14) (Fig. 11; par. 0143, 0156-0158) by an optical measuring device 60 (par. 0071). This positional information is pulled from the carrier 514 at the processing station 504, the carrier 514 is moved so as to align the sample vessel to be centered for processing (Fig. 11; par. 0143) (the step of specifying a container-processing step related to the handling of the IVD container based on the retrieved at least one physical quantity comprises choosing a container-processing step).
Regarding claim 6, modified German teaches in addition to the positional data captured at the characterization station 504 and used to center the sample vessel for processing at a processing station 504 (see claim 4) the system can have a plurality of modules/stations included like a capping/decapping station wherein the characterization data not only includes positional data, but data on the presence or absence of a cap to be removed before and after additional sample-specific processing occurs (par. 0056, 0058, 0147) (the step of specifying a container-processing step related to the handling of the IVD container based on the retrieved at least one physical quantity comprises choosing a processing-parameter of a container-processing step).
Regarding claim 8, modified German teaches optical measuring device 60 (of the characterization station) can measure distances in one, two, or the dimension, for example, how far off a sample vessel is from a predetermined mark or relative to the carrier (Fig. 4; par. 0070-0072) (the at least one physical quantity comprises at least one dimension of at least a part of the IVD container).
Regarding claim 9, modified German teaches optical measuring device 60 (of the characterization station) can comprise multiple cameras in which the multiple cameras can provide a three dimensional information about the positional orientation of the sample vessel within the carrier (par. 0072). It is understood that this three dimensional measurement will correspond with the shape of the sample vessel because the sides of the samples vessel will be measured with respect to the carrier or a predetermined mark and this offset is used in positioning in later stations (par. 0071-0072) (an outer 3D-shape of the IVD container). German goes on to teach the optical measuring device can also determine the centerline of the sample vessel with respect to the carrier so that the geometric center (and therefore opening) of the sample vessel can be aligned with respect to the carrier at later stations (par. 0075) (a 3D-shape of the IVD container).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over German, et. al. (US 20150355208 A1) and Menhardt, et. al. (US 20190331702 A1) as applied to claim 5 above, and further in view of Stein, et. al. (US 20190277869 A1).
Regarding claim 7, modified German teaches optical measuring device 60 (of the characterization station) can comprise multiple cameras in which the multiple cameras can provide a three dimensional information about the positional orientation of the sample vessel within the carrier ultimately determining a shape of the sample vessel (par. 0072) (the retrieved at least one physical quantity).
Modified German is silent to the step of specifying a container-processing step related to the handling of the IVD container based on the retrieved at least one physical quantity comprises specifying a gripping force with which a gripper grips the IVD container.
Stein teaches an in vitro diagnostic analysis system with a robot arm to transfer sample throughout the module (Abstract). Stein teaches the automated clinical analyzer comprises a process control manager to control all operations of the system including sample data (par. 0052), and a sample handler comprising a robot arm 20 and grippers to apply a force to a sample tube to transfer the sample tube from one location to the next (par. 0053, 0065-0066). Stein teaches in order for the robot arm 20 to gather the information to interact with the sample tube, drawer vision system 22 provides visual data of the sample tubes in their current location wherein the data is interpreted by control manager and relayed to the robot arm 20 to determine how end effectors of the robot arm will interact with the samples including force (Fig. 1; par. 0075-0077) (the step of specifying a container-processing step related to the handling of the IVD container based on the retrieved at least one physical quantity comprises specifying a gripping force with which a gripper grips the IVD container). Stein teaches this is beneficial for accommodating a plurality of differently sized and shaped sample containers) (par. 0077).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the container processing step of modified German to specifically be data that influences grip force of a gripper based on vessel size as taught by Stein because doing so allows for multiple sample vessel sizes to be used in the automated diagnostic system as taught by Stein. MPEP 2143(I)(G).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Fritchie, (US 20100123551 A1): Fritchie teaches an automated analyzer system that tracks identification information for samples and sample vessels by RFID tags that are readable and writable by stationary antenna (Abstract).
Fujita (US 20130316461 A1): Fujita teaches a sample analyzer system that has a reading unit to read stored data regarding the sample and sample vessel from a storage medium attached to the sample (Abstract).
Tatsutani (US 20130260412 A1): Tatsutani teaches a sample processing apparatus with a reader that reads a storage medium attached to a sample container, wherein the storage medium holds analysis value to influence the processing of the sample and respective sample vessel (Abstract).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MADISON T HERBERT whose telephone number is (571)270-1448. The examiner can normally be reached Monday-Friday 8:30a-5:00p.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Maris Kessel can be reached at (571) 270-7698. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/M.T.H./Examiner, Art Unit 1758
/MARIS R KESSEL/Supervisory Patent Examiner, Art Unit 1758
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