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 Amendment
This is an office action in response to Applicant’s arguments and remarks filed on 12 September 2025. Claims 1-3 and 5-15 are pending in the application. Claim 4 is cancelled. Claims 10-15 are withdrawn from consideration but not cancelled.
Status of Objections and Rejections
The rejection of Claim 4 under 35 U.S.C. § 101 is withdrawn in view of its cancellation.
The rejection of Claim 4 under 35 U.S.C. § 103 is withdrawn in view of its cancellation.
The rejection of Claims 5-7 under 35 U.S.C. § 101 are withdrawn in view of amendments. Amendments overcome the rejection by integrating the abstract idea into practical application.
The rejection of Claims 1-3 and 5-9 under 35 U.S.C. § 103 are maintained.
Examiner Note
Examiner notes on amended claim set provided 12 September 2025 claim 4 is canceled. However, on page one of the remarks, no acknowledgment is made of the cancellation of claim 4. Examiner is proceeding with the cancellation of claim 4 as on the provided amended claim set but wants to draw attention to the the discrepancy between the two.
Response to Arguments
Applicant's arguments filed 12 September 2025 have been fully considered but they are not persuasive.
Applicant argues the prior art Pollack, et. al. (US 20180164335 A1) “fails to disclose a ‘local’ storage on board of the IVD container for writing and reading physical quantities relating to the individual IVD container” (pg. 06, end of page) and only discloses remote readable and writable storage options (pg. 08, par. 02).
Pollack teaches barcodes are located on the sample vessel (par. 0105). As Applicant point out, Pollack teaches the barcode is associated with physical attributes of the sample vessel by means of a camera (par. 0104). However, Pollack additionally teaches the identity of the sample vessel and its associated carrier can further be identified “by associating the identity of each sample with a carrier, each carrier can convey its identity using any suitable means including RFID” (par. 0106).
While Pollack does not specifically disclose and RFID on the vessel itself, Pollack does teach the barcode (a readable storage form) as a local storage option on the vessel itself.
It would be reasonable for one of ordinary skill in the art to modify the readable storage form (barcode) located on the sample vessel and associated with physical attributes of the vessel to which it is attached to instead be a readable and writeable storage from (RFID tag) in order to minimize data transferring steps to allow for faster processing times. Because Pollack already discloses the use of an RFID tag on a sample vessel carrier, modifying the location to replace the barcode on the sample vessel itself provides likewise sought functionality with reasonable expectation of success. MPEP 2143(I)(G).
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-3 and 5-9 are rejected under 35 U.S.C. 103 as being unpatentable over Pollack, et. al. (US 20180164335 A1; as cited in IDS dated 1 June 2022).
With regards to Claim 1, Pollack teaches a system and method for use in an in vitro diagnostic laboratory (Abstract). Pollack teaches an automation system configured to carry sample vessels in an in vitro diagnostic environment (par. 0010-0011) (for handling an in-vitro diagnostics (IVD) container in an IVD laboratory). Pollack teaches a processor configured to analyze and characterize at least one physical attribute related to each carrier (par. 0011-0013, 0018) (measuring at least one physical quantity of an IVD container). Pollack teaches the device performs the steps of carrier 55 holding samples moves along a track 68 wherein cameras 67A-C capture data in the form of images of the carrier and containers it is holding. The image data, including height and width of sample vessel, is transferred to CPU 74 and stored in memory 76 (Fig. 8; par. 104) (storing the at least one physical quantity in a read and writeable data carrier). Pollack teaches once stored to memory 76, it can be accessed by other portions of the automation system (par. 104) (and retrieving the at least one physical quantity from the… data carrier).
Pollack is silent to a read and writeable data carrier attached to the IVD container.
Pollack teaches barcodes holding readable data are placed on the sample vessel held within the carrier and the barcode data is picked up by cameras (par. 104-105). Pollack additionally teaches the carriers holding sample vessels can be affixed with an RFID tag, the RFID holding data about the samples vessels within the carrier (par. 106). RFID tags are a known form of readable and writable data carrier to those skilled in the art. Pollack teaches the sample's barcode is associated with (but not limited to) physical characteristics of the sample vessel characteristics of the sample itself (par. 104). This information is then used to interact with the carrier and determine how the carrier will continue with the processing of the sample vessels (par. 104-105). This data (identity) is then stored by the carrier (par. 106). Pollack teaches having an instrument capable of characterizing physical attributes of a sample allows for faster processing time for each sample (par. 0065).
Pollack teaches that the data stored on the vessel barcode (a readable data carrier) is also stored on the vessel carrier RFID tag (a readable and writable data carrier). Further, rearranging the parts so that moving an RFID tag from the vessel carrier to the sample vessel itself, does not change the operation and steps the device takes to measure, store, and retrieve physical data about the sample vessel. MPEP § 2144 (VI)(C). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filling data of the invention to rearrange the location of a readable and writable data carrier so that a read and writeable data carrier attached to the IVD container (sample vessel). Further, the readable and writable data carrier (RFID tag) can perform all the tasks plus more of just the readable data carrier (barcode).
It would have been obvious to one skilled in the art before the effective filing date of the invention to modify the barcode on the sample vessel and RFID on the vessel carrier as taught by Pollack to instead use a read and writeable data carrier attached to the IVD container (sample vessel) in order to minimize data transferring steps to allow for faster processing times. It would have been a matter of rearranging parts to attach the readable and writable data carrier to the sample vessel itself without changing the steps of the method. Because a readable and writable data carrier is used, modifying the location of the data carrier to the sample vessel itself, provides likewise sought functionality that would have reasonable expectation of success. MPEP § 2143 (1)(G).
With regards to Claim 2, modified Pollack teaches one of the first steps in the system is the movement of the sample within the sample carrier to a characterization station, step 457 (Fig. 18; par. 0177) (the step of measuring is performed at a first 1VD laboratory instrument). Pollack teaches in step 473, the physical attributes are associated with the carrier and sample vessel and in step 475 the carrier with the sample vessel is moved to a secondary station additional processing, step 477, based on the pulled (retrieved) data from the laboratory information system database that was determined during the characterization station (Fig. 18; par. 0184). For example, Pollack teaches in subsequent processing stations , orientation data for the sample can be retrieved to the processing station can make adjustments to the position of the carrier and vessel in order to be accessed by the processing instruments like a pipette (par. 0067) (the step of retrieving is performed at a second IVD laboratory instrument).
With regards to Claim 3, Pollack teaches the characterization station involves gathering and storing data about the physical attributes of a sample vessel as well as relevant patient information associated with the sample (Fig. 18; par. 0177-0178) (the first |1VD laboratory instrument is a pre-analytic IVD laboratory instrument). Pollack teaches once that information is processed and stored, the sample is moved to a secondary station where sample processing, including running an entire test panel as determined by stored sample type/information, is run (Fig. 18, par. 0184) (the second IVD laboratory instrument is an analytic IVD laboratory instrument).
With regards to Claim 5, modified Pollack teaches, as seen with some of the examples outlined in claim 4 above, the measured physical attributes of the sample vessel help determine the next processing steps. For example, Pollack teaches if a cap is detected by the characterization system, the system will change the destination of the carrier with the sample vessel to go de-capper before sending the carrier and vessel to the testing stations (par. 105) (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).
With regards to Claim 6, modified Pollack teaches as seen with some of the examples outlined in claim 4 above, the measured physical attributes of the sample vessel help determine parameters that will determine the processing step the vessel undergoes. For example, Pollack teaches the device is capable of using vessels/tubes of different sizes as seen in Figure 3 (par. 0074). Because one of the physical attributes measured is width of the tube and offset from the centerline the device must determine if the size of the test tube is changing the centerline or if the test tube is actually off center and needs to be readjusted before moving forward to additional processing steps (par. 0074) (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).
With regards to Claim 7, modified Pollack teaches one quantity measured is the longitudinal/lateral offset or tilt error of the sample tube in the carrier (Fig. 1; par. 0069). Pollack teaches the device is capable of detecting the offset of the tube 42 and hold (grip) and realign the tube 42 with tine 47 with attached support leaf spring 46 (Fig. 3; par. 0076). Spring 46 applies a force in the longitudinal direction to tube 42 to hold it in place and straighten it against block 44 or tines 43, 45 (Fig. 3; par. 0076-0078) (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).
With regards to Claim 8, modified Pollack teaches Pollack teaches data associated with the sample's barcode includes but is not limited to height and width of the sample vessel (par. 0104) (at least one physical quantity comprises at least one dimension of at least a part of the IVD container).
With regards to Claim 9, Pollack teaches data associated with the sample's barcode includes but is not limited to height and width of the sample vessel (a 3D-shape of the IVD container) and longitudinal/lateral offset of the vessel in the carrier (an angle of the IVD container) (par. 104) as well as the shape of the bottom of a tube, like if the tube as a rounded bottom (a curvature of the IVD container) (par. 0097).
Conclusion
THIS ACTION IS MADE FINAL. 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 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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/M.T.H./Examiner, Art Unit 1758
/MARIS R KESSEL/Supervisory Patent Examiner, Art Unit 1758
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