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 .
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Claim status
Claims 1-15 are pending.
Claims 2-12 are amended.
Claim 15 is new.
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.
Claims 1-12 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Brian et. al. (WO 2010056890 A1).
Regarding Claim 1 Brian teaches “A device for handling samples” (Title, Para [0039], Pre-analytic system “PAS” 100); “that are located in sample wells” (Fig. 32 and Para [0035], 96- well format or number 1900 in Fig. 32); “of a sample vessel” (Fig. 32 and Para [0035], provided in standard sample collection tubes or number 208 in Fig. 32); “and contain magnetically responsive particles, the device comprising” (Para [00164], use a magnetic probe inserted into the tube to attract the beads); “a sample handling area where the samples can be processed,” (Paras [0042] and [0053], a sample rack input 102, a sample rack output 104, a control vial and reject vial access point 106, a first pipette tip input 108, an ETU input 110 are all parts of the sample handling area. The devices has a path and three different processing stages which are three different sample handling areas. The initial transfer stage where samples are transferred to vessel and other processing can happen, a second stage where samples are analyzed or processed, and a final stage where samples are transferred to a standardized output vessel.); “and a plurality of probes that are insertable into the sample wells for removing magnetically responsive particles from the sample wells or for inserting magnetically responsive particles into the sample wells” (Paras [00164], [00168], and Fig. 15A, a magnetic probe inserted into the tube to attract the beads, which could then be either withdrawn or simply held to allow liquid aspiration. In addition the aspirator 1500 (which in Fig. 15A has 8 of the aspirator tips 1510) may be used during a processing step in which magnets are used to attract magnetic beads in the tubes 1104.) Therefore the plurality of aspirator tips could be used during the processing step and use magnets with them to attract magnetic beads.
Brian does not explicitly teach wherein the device comprises a display which is located underneath the sample handling area.”
However Brian does teach a display within the device which is between the taught device and an analytical system. (Paras [0041] and [0042], The device includes a suitable electrical interface for connecting to a CCU that controls the device. And or a human interface to receive operating instructions and/or display system status. Such an interface may include a monitor, touch-screen monitor, keyboard, mouse, microphone, speaker, barcode reader, and so on. A central control unit (CCU) may be used to control and/or monitor the PAS 100 and/or a downstream analytical system, and an exemplary CCU may provide a processing interface between the PAS and the analytical system.) Therefore the display could be placed between the sample handling area and an additional system. Between the sampling handling area and an additional system encompasses an orientation in which the display is underneath the sampling handling area.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Brian to have the display underneath the sample handling area. Sample handling devices are typically placed on a table or laboratory bench. Having the display area underneath the sample handling area would allow it to be more readily accessible to the user in order to make inputs on it.
Regarding Claims 2-7 Brian teaches all of claim 1 which includes a commensurate structure of a display and the taught display is fully capable (configured to) display as recited in Claims 2-7 in as much as recited and required herein. It would have been obvious to one having ordinary skill in the art at the time of the invention to provide any information relevant to the processing of the samples or sample vessel on the display,
Claim 2, “The device according to claim 1, wherein the device is configured to show on the display information instructing a user of the device.”
Claim 3, “The device according to claim 1, wherein the device is configured to indicate on the display when the sample vessel can be loaded into the device.”
Claim 4, “The device according to any of claim 1, wherein the device is configured to indicate on the display when the sample vessel can be removed from the device.”
Claim 5, “The device according to claim 1, wherein the device is configured to indicate on the display that the sample vessel is/is not correct for a selected sample handling process.”
Claim 6, The device according to claim 1, wherein the device is configured to instruct on the display how to load the sample vessel into the device.”
Claim 7, The device according to claim 1, wherein the device is configured to identify on the display the sample vessel or sample wells requiring a specific action from a user of the device.”
Regarding Claim 8 Modified Brian teaches all of claim 1 as above in addition to teaching “wherein the device comprises a barcode or a QR-code reader or an RFID tag reader” (Para [0055], barcode reader 218). The recitation “for reading information from a code or tag located in the sample vessel and the device is configured to show on the display information based on the code or tag.” is the capability of the barcode reader. Brian discloses the positively claimed structural elements of the barcode reader as claimed, such barcode reader are said to be fully capable of the recited adaption in as much as recited and required herein.
Regarding Claim 9 Modified Brian teaches all of claim 1 as above in addition to teaching “wherein the sample handling area comprises at least two predetermined sample handling locations,” (Paras [0042] and [0053], a sample rack input 102, a sample rack output 104, a control vial and reject vial access point 106, a first pipette tip input 108, an ETU input 110 are all parts of the sample handling area. The devices has a path and three different processing stages which are three different sample handling areas. The initial transfer stage where samples are transferred to vessel and other processing can happen, a second stage where samples are analyzed or processed, and a final stage where samples are transferred to a standardized output vessel.).
Brian does not explicitly teach “and the display is located underneath one of the at least two predetermined sample handling locations”.
However modified Brian does teach a display within the device which is between the taught device and an analytical system. (Paras [0041] and [0042], The device includes a suitable electrical interface for connecting to a CCU that controls the device. And or a human interface to receive operating instructions and/or display system status. Such an interface may include a monitor, touch-screen monitor, keyboard, mouse, microphone, speaker, barcode reader, and so on. A central control unit (CCU) may be used to control and/or monitor the PAS 100 and/or a downstream analytical system, and an exemplary CCU may provide a processing interface between the PAS and the analytical system.) Therefore the display could be placed downstream and/ or between one of the predetermined sample handling areas and an additional system. Downstream and/ or between the sampling handling area and an additional system encompasses an orientation in which the display is underneath one of the predetermined sampling handling locations.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Brian to have the display located underneath one of the at least two predetermined sample handling locations. Sample handling devices are typically placed on a table or laboratory bench. Having the display area underneath one of the predetermined sample handling locations would allow it to be more readily accessible to the user in order to make inputs on it.
Regarding Claim 10 Modified Brian teaches all of claim 1 as above in addition to teaching “, wherein the device comprises a rotatable platform for moving the sample vessel between the at least two at predetermined sample handling locations” (Paras [00104] and [00110], The decapper/capper unit has a rotating platform which may be rotated to position the bottles at various locations of the processing steps.).
Regarding Claim 11 Modified Brian teaches all of claim 1 as above in addition to “wherein the display is located underneath a predetermined sample handling location of the at least two predetermined sample handling locations” which is also taught in claim 1. The recitation “which is configured to allow loading of the sample vessel into the device and/or removing a sample vessel from the device.” is capability of the sample handling location. Brian discloses the positively claimed structural elements of the sample handling location as claimed, such sample handling location are said to be fully capable of the recited adaption in as much as recited and required herein. In addition, Brian teaches in (Paras [0042] and [0053], a sample rack input 102, a sample rack output 104, a control vial and reject vial access point 106, a first pipette tip input 108, an ETU input 110 are all parts of the sample handling area.) The sample rack input and sample rack output teaches the loading and removal of the sample vessels from the device.
Regarding Claim 12 Modified Brian teaches all of claim 11 as above. The recitation “wherein the display is configured to be visible to a user of the device while the sample vessel is being loaded into the device and/or removed from the device.” is capability of the display. Brian discloses the positively claimed structural elements of the display as claimed, such display is said to be fully capable of the recited adaption in as much as recited and required herein.
In addition, It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Brian to incorporate the configuration of having the display visible to the user during sample vessel loaded or removed from the device. This would allow the user to see any device statuses that may show up on the display during the loading and unloading of the sample vessel. Also changing the position of the display in regards to the loading and unloading of the sample vessels would not have modified the operation of the device and therefore is not patentable per eMPEP 2144.04.VI.C
Regarding claim 15 modified Brian teaches all of claim 1 as above in addition to “the device further comprising an enclosure,” (Para [0042] The exemplary PAS 100 is a generally self-contained unit having various input and output locations at which an operator can provide supplies and remove waste and processed samples.); “the enclosure having therein the sample handling area” (Paras [0042] and [0053], a sample rack input 102, a sample rack output 104, a control vial and reject vial access point 106, a first pipette tip input 108, an ETU input 110 are all parts of the sample handling area. The devices has a path and three different processing stages which are three different sample handling areas. The initial transfer stage where samples are transferred to vessel and other processing can happen, a second stage where samples are analyzed or processed, and a final stage where samples are transferred to a standardized output vessel.); “ and wherein the display is located within the enclosure” (Para [0042] The PAS 100 also may include a suitable electrical interface (not shown) for connecting to a CCU that controls the device. Of course, the CCU, or various parts of it, may be integrated into the PAS 100 itself, in which case the PAS 100 may be provided with a human interface to receive operating instructions and/or display system status.) Therefore the intergration to the self-contained PAS teaches to the display being within the enclosure.
Brian does not explicitly teach “and underneath the sample handling area.”
However Brian does teach a display within the device which is between the taught device and an analytical system. (Paras [0041] and [0042], The device includes a suitable electrical interface for connecting to a CCU that controls the device. And or a human interface to receive operating instructions and/or display system status. Such an interface may include a monitor, touch-screen monitor, keyboard, mouse, microphone, speaker, barcode reader, and so on. A central control unit (CCU) may be used to control and/or monitor the PAS 100 and/or a downstream analytical system, and an exemplary CCU may provide a processing interface between the PAS and the analytical system.) Therefore the display could be placed between the sample handling area and an additional system. Between the sampling handling area and an additional system encompasses an orientation in which the display is underneath the sampling handling area.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Brian to have the display underneath the sample handling area. Sample handling devices are typically placed on a table or laboratory bench. Having the display area underneath the sample handling area would allow it to be more readily accessible to the user in order to make inputs on it.
Claims 13, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Brian as applied to claim 1 above, and further in view of Duerr et. al. (US 20130045473).
Regarding Claim 13 Modified Brian teaches all of claim 1 as above in addition to “a method of operating a device” (Para [0034] The present disclosure provides various exemplary embodiments of automated or semi-automated sample processing systems, methods for automated, high-throughput sample processing, control systems for coordinating and controlling the operations of a high-throughput specimen processing systems, and various devices that may be used in the foregoing sample processing systems or in other processes, devices or systems.); “according to claim 1,” (see teachings within claim 1). In addition, Modified Brian teaches also teaches a human interface and or a display system status and that the device and method could be adapted to set steps of protocol (Para [0042] and [0038], The CCU, or various parts of it, may be integrated into the PAS 100 itself, in which case the PAS 100 may be provided with a human interface to receive operating instructions and/or display system status. The invention may be adapted to provide the ability to perform a diverse set of common laboratory operations in a standard tube format, with different systems readily constructed from combinations of processing stations to perform steps required in virtually any protocol.)
However Modified Brian does not explicitly teach “the method comprising the steps of indicating on the display that the device is ready for a user action or for a selection or input by a user, - waiting for the user action, selection or input, - determining whether the correct action has been accomplished or asking for confirmation of the selection or input, and - in case of a correct action or confirmed selection or input, proceeding to a following step of operation.”.
Duerr teaches laboratory apparatus for handling laboratory samples and ‘the method comprising the steps of- indicating on the display that the device is ready for a user action or for a selection or input by a user,- waiting for the user action, selection or input,” (Paras [0069], [0071], and [0171], The laboratory apparatus may have one or more user input device (operator control panel), display, indicator of the detected type of a sample vessel element, (warning) indicator for signaling at least one operating state of the laboratory apparatus and other components. After indication of the selected operating parameter or independently of such an indication, that is to say generally, the user inputs its own user operating parameter.) Therefore the device having a user input device, display, and indicator for the operating state of the device in addition to the step of after selected a independent indication of the operating parameter the user inputs own operating parameters teaches to the ready status on the display and the user inputting things. The device can not start on the sample processing until the parameters are correct and that is the first indication of changing them to start the processing. Further taught “ determining whether the correct action has been accomplished or asking for confirmation of the selection or input, and - in case of a correct action or confirmed selection or input, proceeding to a following step of operation.” (Para [0041], The control device is preferably designed for receiving a confirmation of the selected operating parameter or the selected changing of an operating parameter by the user by an individual user input or by a number of user inputs taking place by way of a user interface device, and, in dependence on this manual confirmation, continuing or terminating the starting of the process of changing the operating parameter.).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified Brian to incorporate the teachings of Duree wherein the display asks for confirmation and if correct moves on to the next processing step. Doing so would prevent an error in the sensor device having the wrong measurement and then the parameter of the sampling process is also wrongly set up. Asking for user input would prevent these types of errors which happen in fully automatic devices as taught in Para [0069] of Duree.
Regarding Claim 14 Modified Brian teaches all of claim 13 as above however Brian does not teach “wherein a wrong action or a cancelled selection or input is indicated on the display.”.
Duerr teaches “wherein a wrong action or a cancelled selection or input is indicated on the display.” (Para [0172], The control program and the control device are designed to compare the input of parameters with the measured values before starting the process of changing the operating parameters. If they differ an optical and or/ acoustic warning signal may be output by the control device.).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have further modified Brian to incorporate the further teachings of Duree wherein the a wrong action or input is indicated on the display. Doing so would notify the user of any errors that occur so they could be corrected in a timely manner which speeds the sample handling process.
Response to Amendments
Claim Amendments
Applicants’ amendments have overcome the 112 rejections for those claims in the non-final office action.
Response to Arguments
Applicant's arguments filed 9/18/2025 have been fully considered.
Applicant argues that Brian does not teach or suggest every feature of claim 1, in particular the features of "a sample handling area where the samples can be processed . .. wherein the device comprises a display which is located underneath the sample handling area”. Examiner agrees that Brian does not teach every feature of claim 1. However it would be obvious to one ordinary skill in the art as disclosed within the rejection under 35 USC 103. Placement of the display is considered an obvious choice in design. One of ordinary skill in the art would place the display within a conveniently viewable position.
Applicant argues that Brian does not provide any particular teaching or suggestion to place that interface below a sample handling area and the rejection stating it would be obvious to a person ordinary skilled in the art is misplaced and contrary to MPEP. Examiner disagrees in that Brian teaches an interface between the analytical system and PAS in addition it would be obvious to have the display under the sample handling area as it would be more readily accessible to the user. This is not misplaced and not contrary to the MPEP.
Applicant argues that the present application has a number of advantages of placing a display underneath the sample handling area and Brian does not describe or even suggest. Examiner agrees that all the advantages are not taught by Brian. However the advantages are not claim limitations and therefore Brian does not have to disclose all of the advantages disclosed within the present application.
Applicant argues that the office does not identify disclosure in Brian to establish that a person of ordinary skill in the art would read Brian and then - without any particular suggestion in the reference - modify Brian in all the ways necessary to arrive at Applicant's claimed subject matter. As MPEP 2142 explains, the legal conclusion of obviousness "must be reached on the basis of the facts gleaned from the prior art" and not on an applicant's own disclosure, and in the present case, the only teaching in the record of the features of Applicant's claim 1 is found in Page 6 of 8 Applicant's own disclosure.
Applicant argues that the Office should reconsider and withdraw the obviousness rejections of independent claim 1 and all related dependent claims. Examiner maintains the obviousness rejections set forth within the non-final office action.
Applicant argues that the office does not identify disclosure in Brian that teaches or suggests every feature of independent claim 1 as those features are arranged in the claim nor does Duerr for claims 13 and 14 cure the deficiencies in Brian. In addition, applicant argues that that a person of ordinary skill in the art who reads Duerr would not have any motivation to modify Brian in all of the ways necessary to arrive at the technology of Applicant's independent claim 1. Examiner disagrees and has already pointed out that Brian does not disclose but its obvious to modify Brain to teach the claimed features of claim 1. In addition, Duerr does teach further deficiencies of the claims as set out in the non-final office action.
Applicant argues that the legal conclusion of "must be reached on the basis of the facts gleaned from the prior art" and not on an applicant's own disclosure, and in the present case, the only teaching in the record of the Examiner disagrees and maintains that Brian teaches an interface between the analytical system and PAS.
Applicant argues the office should withdraw the obviousness rejections of independent claim 1 and all related dependent claims. Based on the above the examiner maintains the obviousness rejection set forth in the non-final office action.
Applicant argues that the office action does not identify disclosure in the cited art that teaches or suggests the features of claim 15. Applicant submits that claim 15 is patentable over the cited art. Although claim 15 is new examiner discloses prior art rejection above.
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.
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/V.E.H./Examiner, Art Unit 1798
/JILL A WARDEN/ Supervisory Patent Examiner, Art Unit 1798