DETAILED ACTIONNotice 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 .
Drawings
New corrected drawings in compliance with 37 CFR 1.121(d) are required in this application because the drawings are illegible. Applicant is advised to employ the services of a competent patent draftsperson outside the Office, as the U.S. Patent and Trademark Office no longer prepares new drawings. The corrected drawings are required in reply to the Office action to avoid abandonment of the application. The requirement for corrected drawings will not be held in abeyance.
Claim Objections
Claims 2, 11 and 14 are objected to because of the following informalities: Claim 2 “GS1” is an anonym not defined in the claim, and should not be abbreviated for clarity. Claim 11 "Method according to one claim 10[...]" has "one", likely missed from claim amendments. Removal recommended. Claim 14 “[…] the remaining volume of a reconstituted media in the media bag, ,and the [...]” there is an extra comma between bag & and. Appropriate correction is required.
The examiner is objecting to claim 1-15, due to numbered reference elements being present within the claims. It is recommended that each numbered reference element is removed in the claims for further prosecution.
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 1-7, 9-12, and 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Castaneda et al (US PG-Pub 20180100137 A1, as cited in the IDS), in view of Pighin et al (US Pg-Pub 20170128905 A1, as cited in the IDS).
Regarding claim 1, Castaneda et al teaches an automated media preparation system, controlled by an electronic controller 50 (i.e. a computer), in electronic communication or otherwise operably connected to many of the components of the system. An electronic controller may be referred to a single unit or multiple units of integrated circuits and/or a computer processor (see Castaneda et al, [0033], [0044], Fig. 6A-6F and Fig. 7A-7G). Media is prepared for microbiology testing, by batch by mixing proportions of dry/premade media and water within a connecting sterile container, such as a bag, and creating the prepared media in the automated culture media preparation system. Said water is purified of pathogenic bacteria from using the steps of filtering, and heated to a predetermined incubation temperature within the water dispensing system. (see Castaneda et al, Abstract, [0003], [0005], [0014], [0017]-[0019]).
Castaneda et al further teaches an attachable machine-readable code of the media, such as QR codes and barcodes, where when scanned, conveys and stores information relating to the particular media and/or media packet at the electronic controller. The scanned code may indicate a particular recipe to use in connection with the microbiology testing to be performed, such as the volume of water required for the scanned media (see Castaneda et al, [0050]).
Castaneda et al fails to teach a dispensing module for delivering and/or storing media in a finally prepared state.
However, in the analogous art of multiple identification point automated parameter assurance method, Pighin et al teaches the dispensing module operation and method, where information from the flow path is used to dispense processed product for collection such as into storage containers. The system is able to dispense product according to the container volume indicated by the flow path. Dispensing occurs from the intermediate storage container according to the embodiment, thereby quantifying the amount of processed product to be dispensed (see Pighin et al, [0107], Fig. 38). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the automated media preparation system of Castaneda et al by incorporating the dispensing module operations (as taught by Pighin et al) into the system of Castaneda et al, for the benefit of being able to use the dispensing module function in a method to dispense some product for sampling purposes, such as in quality control (see Pighin et al, [0109], Fig. 39).
Regarding claim 2, the combination of Castaneda et al and Pighin et al teaches the exact limitations of claim 2. Specifically, Castaneda et al teaches system according to claim 1, wherein the adjustable machine-readable data storage is an either an RFID label or a barcode, preferably a data matrix code according to the GS1 standard, which is attached to the media bag and/or the water sterilization filter set (see Castaneda et al, [0003], [0022] and [0050], disclosing the sample held in a sterile container, such as a beaker or bag, labeled and manually logged or recorded. The label having indicia, including the electronically stored information, which may include such as barcodes, two-dimensional symbologies, QR codes, and the like.).
Regarding claim 3, the combination of Castaneda et al and Pighin et al teaches the exact limitations of claim 3. Specifically, Castaneda et al teaches the system according to claim 1, wherein the water providing system is integrated into the Media Preparation Module (see Castaneda et al, [0033], automated media preparation system, media preparation used for microbiology testing.) and further comprises a water supply for the temperature adjustable water, a four-way-valve for connecting the media bag with the Dispensing Module and the water supply and the filter set between the water supply and the four-way-valve (see Castaneda et al, [0040], Fig. 5, disclosing that the water is heated before being dispensed, done by heating the water within the water tank 14. Further see [0021] and [0037]-[0038], Fig. 5, disclosing a pump assembly 22, used to circulate the water through the system, such as at least between the water tank 14 and an outlet dispenser 24 through the filter cartridge 20, which dispenses heated and purified water into a container for mixing with a culture media. The system plumbing utilities numerous valves, regulators, solenoids, and pressure transducers and the like to control the flow of the water through the system, including a valve ball 38.).
Regarding claim 4, Castaneda et al teaches the recording of process parameters, including the identity of the user, sample, and media, water volume dispensed, and temperature of the water (see Castaneda et al, [0033]). Castaneda et al also teaches circulating heated water throughout the system for a predetermined period of time before allowing it to cool to ambient or maintenance temperature (see Castaneda et al, [0043]).
Castaneda et al fails to teach the required conditions comprise specific set values for the operating parameters like the life time of filter set and/or media bag, and safety keys for ensuring the use of suitable system components and also comprise further specific set values for the system components like a global trade item number, a product catalogue number, a lot number, a serial number and an expiry date.
However, Pighin et al teaches systems and methods provide automated parameter assurance features and results for consumables used in bioprocessing and particularly for purifying, filtering, harvesting and collecting bioprocessing fluids. The consumables are characterized by at least one readable tolerance specification, such as a parameter specification. Such specifications include the model of the consumable; consumable ID; date of manufacture; capacity specifications; pressure specifications; temperature specifications; flow rate or other parameter specifications such as limits, safety limits, shelf life, use life (time or volume), time, volume or other parameter logged to date on the component, device or system; number of connections and disconnections; and combinations thereof (see Pighin et al, Abstract, [0058]). Furthermore, Pighin et al teaches that the parameter specifications can have different objectives, such as ensuring that only a genuine consumable is being used, such as a fluid management device for that system. For example, after an automated system check, a specific consumable can be recognized as non-genuine for use in that manifold system, and/or it can be recognized as having been used previously in order to lower cross-contamination risk. Non-compliance such as in these examples can be noted, communicated and/or used to prevent use and/or continued use. (see Pighin et al, [0061]). Pighin et al additionally teaches the labeling (e.g. RFID) of these consumables containing information such as serial numbers, lots, manufacturing information, material, and calibration details (see Pighin et al, [0065]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the process parameters of Castaneda et al to incorporate the parameter specification, and label information (as taught by Pighin et al), for the benefit of establishing automation in parameter assurance, where features of consumables and other components may exhibit multiple identification points, for ensuring compliance with desired parameters (see Pighin et al, [0005]).
Regarding claim 5, the combination of Castaneda et al and Pighin et al teaches the exact limitations of claim 5. Specifically, Castaneda et al teaches the system according to claim 1, wherein the computer is integrated into the Media Preparation Module in form of a microcontroller or industrial pc and provides a user interface to control and/or adjust the information about and set values for the current state and/or operating parameters (see Castaneda et al, [0044], Fig. 6A-6F and Fig. 7A-7G, disclosing an electronic controller 50 is in electronic communication, or otherwise operably connected to, many of the components of the system. An electronic controller may be referred to a single, or multiple units, integrated circuits, a computer processor, volatile and/or non-volatile memory, and the like commonly used in connection with electronic controllers and computers to monitor and control various components and subsystems and provide a user interface and storage and retrieval of information.).
Regarding claim 6, the combination of Castaneda et al and Pighin et al teaches the exact limitations of claim 6. Specifically, Castaneda et al teaches system according to claim 1, wherein in case of using a barcode as attachable machine readable data storage the system additionally comprises a barcode reader device which is connected to the computer for data transmission (see Castaneda et al, [0016], [0044], Fig. 6A-6F and Fig. 7A-7G, disclosing a data entry device, such as a keypad, a touch screen, and/or a machine code reading scanner, is in electronic communication with the electronic controller, where the electronic controller 50 provides user interface and storage and retrieval of information.).
Regarding claim 7, Castaneda et al teaches machine readable code of the media, such as QR codes and barcodes, where when scanned, conveys and stores information relating to the particular media and/or media packet at the electronic controller, where said controller provides storage and retrieval of information (see Castaneda et al, [0044], [0050]).
Castaneda et al fails to teach using a RFID label as attachable machine-readable data storage, the system additionally comprises a RFID reader device which reads and if necessary, powers the RFID labels.
However, Pighin et al teaches information storage means attached to consumables, such as a RFID. The operating system in the present disclosure interrogates the consumable through a wired, visual and/or wireless communication, which can include reading a single or several RFIDs (see Pighin et al, [0063], [0065]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the machine-readable code and scanners of Castaneda et al, to incorporate the RFID information storage means and reader (as taught by Pighin et al), for the benefit of decreasing the likelihood of operational failure due to incorrectly selecting automated or manual parameters (see Pighin et al, [0063]).
Regarding claim 9, Castaneda et al teaches an electronic controller in electronic communication, or otherwise operably connected to, many of the components of the automated media preparation system (see Castaneda et al, [0033], [0044]). The electronic controller is capable of scanning machine readable code of the media, such as QR codes and barcodes where when scanned, conveys and stores information relating to the particular media and/or media packet at the electronic controller. The scanned machine-readable code labeled on the media may indicate a particular recipe to use in connection with the microbiology testing to be performed (see Castaneda et al, [0050]). Furthermore, Castaneda et al teaches that the media is prepared as a batch by mixing proportions of dry media and water, requiring that the human operators provide the correct proportions (see Castaneda et al, [0005]). The water is heater before being dispensed, done by heating the water within the water tank 14 (see Castaneda et al, [00040]). A Pump assembly 22 is further disclosed, used to circulate the water through the system, such as at least between the water tank 14 and an outlet dispenser 24 through the filter cartridge 20, which dispenses heated and purified water into a container for mixing with a culture media. The system plumbing utilities numerous valves, regulators, solenoids, and pressure transducers and the like to control the flow of the water through the system, including a valve ball 38 (see Castaneda et al, [0021] and [0037]-[0038], Fig. 5).
Castaneda et al fails to teach filling the dispensing module with a required amount of the finally prepared media.
However, Pighin et al teaches the dispensing module operation and method, where information from the flow path is used to dispense processed product for collection such as into storage containers. The system is able to dispense product according to the container volume indicated by the flow path. Dispensing occurs from the intermediate storage container according to the embodiment, thereby quantifying the amount of processed product to be dispensed (see Pighin et al, [0107], Fig. 38). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the methods and electronic controller of Castaneda et al, to incorporate the dispensing module operations (as taught by Pighin et al) within the system of Castaneda et al, for the benefit of being able to use the dispensing module function in a method to dispense some product for sampling purposes, such as in quality control (see Pighin et al, [0109], Fig. 39).
Regarding claim 10, Castaneda et al teaches that an electronic controller 50 is in electronic communication, or otherwise operably connected to, many of the components of the system. An electronic controller may be referred to a single, or multiple units, integrated circuits, a computer processor, volatile and/or non-volatile memory, and the like commonly used in connection with electronic controllers and computers to monitor and control various components and subsystems and provide a user interface and storage and retrieval of information (see Castaneda et al, [0044], Fig. 6A-6F and Fig. 7A-7G).
Castaneda et al fails to teach adjusting the system settings to check if the acquired state and/or operating parameters of the system parts are matching their required set values and in case of critical exceedance performs actions to stop or adapt the media preparation process.
However, Pighin et al teaches systems and methods to ensure that an operator and/or automated system is unable to use the system outside the recommended safe tolerances, or ensure the device is genuine, by engaging interlock(s) when out of compliance. Interlocks can occur when the operating logic detects operation that is inconsistent with the readable tolerance specification or specifications. An example being the interlock activating a stoppage function with respect to the manifold system capable of avoiding out-of-compliance-operation (See Pighin et al, [0067]-[0068]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the electronic controller of Castaneda et al to incorporate the interlocks (as taught by Pighin et al), for the benefit of decreasing the likelihood of operational failure due to incorrectly selecting automated or manual parameters (see Pighin et al, [0063]).
Regarding claim 11, Castaneda et al teaches the recording of process parameters, including the identity of the user, sample, and media, water volume dispensed, and temperature of the water (see Castaneda et al, [0033]).
Castaneda et al fails to teach the method according to claim 10, wherein, the actions to stop or adapt the media preparation process includes rejecting a recognized unsuitable media bag or filter set, rejecting a filter set or media bag if maximum allowed amount of heated water or media quantity has been used, correction of used heated water volume, prevent the filling of the Dispensing Module if dissolving has not been reached, adjust a wrongly set water flow rate and /or temperature.
However, Pighin et al teaches systems and methods for use in providing assurance of compliance with requirements for proper operation of single-use bioprocessing fluid handling systems. This ensures the bioprocessing handling system has the correct consumable (e.g. containers, bags, tangential flow filtration, etc.) installed. Operational parameters are also monitored and operated on by a processor. Such parameters include but are not limited to pressure, pump rate, fluid flow at a location in the system, limits, range of operation, safety limits, use life (time or volume), time, temperature, volume of dispense quantity, and concentration factor. The system includes a reference system (spec storage device or median device, e.g. RFID, label, barcode, etc.) that contains the application and/or operation limits of the consumable of the particular system. The operating system interrogates the system for compliance for these specifications and parameters, and engages interlocks when the system falls outside the recommended safe tolerances, or ensures the device is genuine, by engaging interlocks when out of compliance (see Pighin et al, [0058], [0067]). Furthermore, Pighin et al teaches a prime module, with the function to fill the system, such as manifold tubing and other components, with product prior to the dispense unit operation. It has an option to abort, which closes the dispensing manifold, in case of any failure (see Pighin et al, [0103], Fig. 37). Pighin et al additionally teaches automatically monitoring normal flow filtration units, and adjusts pre-back filter pressure and flow rate to optimize flirtation speed, maximize filter throughput and eliminate the need for constant supervision during filtration runs (see Pighin et al, [0084]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the process parameters of Castaneda et al to integrate the operational limits, compliance, adjustments, and interlocks for components (as taught by Pighin et al), for the benefit of establishing automation in parameter assurance, where features of consumables and other components may exhibit multiple identification points, for ensuring compliance with desired parameters (see Pighin et al, [0005]).
Regarding claim 12, the combination of Castaneda et al and Pighin et al teaches the exact limitations of claim 12. Specifically, Castaneda et al teaches the method according to claim 9, wherein, additionally a maintenance and/or a sanitization process is performed (see Castaneda et al, [0043], disclosing that the entire system may be periodically sterilized within the system to a temperature which will kill all microbes that would otherwise interfere with the microbiology testing.), supported by the computer (see Castaneda et al, [0044], Fig. 6A-6F and Fig. 7A-7G, electronic communicator 50.) by reading, processing and using further information from the attachable machine readable data storage which is related to that maintenance and/or a sanitization process (see Castaneda et al, [0015], [0050] disclosing machine code reading scanner in electronic communication with the electronic controller, reading printed machine code such as barcodes for associated instructions sent to the system.).
Regarding claim 14, Castaneda et al teaches preparing media by mixing proportions of dry media and water, and the recording of process parameters, including the identity of the user, sample, and media, water volume dispensed, and temperature of the water (see Castaneda et al, [0005], [0033]). For each media sample tested, a label 60 is printed which includes information relating to the record, including user or operator identification, culture media identification, machine identification, date, time, water temperature, water volume, container/sample weight, container/sample/sample media weight, and weight of the container/sample/media/water (see Castaneda et al, [0060], Fig. 8).
Castaneda et al fails to teach the method according to claim 9, wherein, a RFID with read and write capability is used and the computer is reading, processing and using not only the initial values of the information but recording in the RFID also all changed values which are impacting the media preparation process, like the remaining volume of water that can flow in the filter set before to be rejected, the remaining number of connections for the filter, and the remaining time before end of use for the media bag.
However, Pighin et al teaches an RFID transmitter/receiver, as a system for obtaining the specifications and/or operation limit of a given consumable component. These specifications and/or operational limits can be operational parameters for these consumables (e.g. containers, bags, filters, etc.) such as use time (volume or time), time and volume logged to date on the component, as well as volume of dispense quantity and concentration factor of the media (see Pighin et al, [0058], [0067]). While it does not explicitly teach writing capabilities, a RFID transmitter/receiver implies two-way communication between the transmitter/receiver and the RFID tag, meaning information (such as updated operational parameters) can be transmitted back to the RFID. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the data logging of Castaneda et al to incorporate the RFID transmitter/receiver and operational parameters (as taught by Pighin et al), for the benefit of establishing automation in parameter assurance, where features of consumables and other components may exhibit multiple identification points, for ensuring compliance with desired parameters (see Pighin et al, [0005]).
Regarding claim 15, the combination of Castaneda et al and Pighin et al teaches the exact limitations of claim 15. Specifically, Castaneda et al teaches a software product performing the method according to claim 9 (see Castaneda et al, [0049], Fig. 6A-6F and Fig. 7A-7G, disclosing the system including a laboratory information management system (LIMS) which is a software-based laboratory and information management system which works in conjunction with the electronic controller 50 in providing the automated processes of the system of the present invention.).
Claims 8 and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Castaneda et al as applied to claims 1 and 12 above, and further in view of Lehtonen et al (US PG-Pub 20150314246 A1, as cited in the IDS).
Regarding claim 8, Castaneda et al teaches a printer for printing labels is also in electronic communication with the electronic controller, where the electronic controller provides a user interface and storage and retrieval of information (see Castaneda et al, [0016], [0044]).
Castaneda et al fails to teach that an external web tool is used to generated, preferable two-dimensional, barcodes which are read via the user via an web app and used to configure the computer.
However, in the analogous art of automated solution dispenser, Lehtonen et al teaches the systems and methods of allowing for the use of user interfaces facilitating the interactions of users with the computer system, where such examples of interfaces described include web-based user interfaces, that of which accepts input and output by generating webpages, which are transmitted via the Internet and viewed by the user using a web browser program, for example those that utilize Java, Ajax, Adobe Flex, Microsoft .NET, or similar technologies to provide real-time control in a separate program (see Lehtonen et al, [0192]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the electronic controller of Castaneda et al to integrate the web-based user interface (as taught by Lehtonen et al), for the benefit of eliminating the need for refreshing a traditional HTML based web browser (see Lehtonen et al, [0192]).
Regarding claim 13, Castaneda et al teaches periodically sterilizing the entire system by heating water within the system to a temperature that will kill all microbes that would otherwise interfere with the microbiology testing. The water may be cycled throughout the system for a predetermined period of time, before being allowed to cool down to ambient or maintenance temperature, or drained and replaced with new water brought into the water tank (see Castaneda et al, [0043], Fig. 2).
Castaneda et al fails to teach the further information about the sanitization process includes the number of sanitizing cycles, the volume of sanitizer liquid, the waiting time between each sanitization cycle, the number of rinsing cycle, the volume of rinsing liquid, and the waiting time between each rinsing cycle.
However, Lehtonen et al teaches one or more sensors of the system of the disclosed invention. The system has various sensors which can be calibrated with sensor references for use in standard operations. Such sensors include but are not limited to volume or temperatures (see Lehtonen et al, [0039]). Additionally, Lehtonen et al teaches self-cleaning methods, where some embodiments include a controller configured to control the dispenser to implement a cleaning cycle, which may utilize it before, after, or during calibration procedures (see Lehtonen et al, [0039]). The system may perform at least one self-cleaning cycle using cleaning and/or flushing fluid, based on the cleanliness level measured by a sensor for cleanliness, additional cycles can be performed until the desired level is reached (see Lehtonen et al, [0027]. [0151]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the sterilization process of Castaneda et al to incorporate the self-cleaning cycles and sensors (as taught by Lehtonen et al), for the benefit of reducing the risk of cross-contamination in a system handling multiple solutions, without the need for manual human intervention (see Lehtonen et al, [0011]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Tracy C Colena whose telephone number is (571)272-1625. The examiner can normally be reached Mon-Thus 8:00am-5:00pm.
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/TRACY CHING-TIAN COLENA/ Examiner, Art Unit 1797
/JENNIFER WECKER/ Primary Examiner, Art Unit 1797