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 .
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.
Claims 17 and 31-34 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claim 17 recites the limitation "the at least one bioreactor" in line 2. There is insufficient antecedent basis for this limitation in the claim. It is believed that claim 17 should be dependent on claim 16.
Independent claim 31 recites the limitation "the system" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim.
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 1-14, 17-29 and 31-33 are rejected under 35 U.S.C. 103 as being unpatentable over Washington (US 20220040862) in view of Rodgers (US 20070048863).
With respect to claims 1 and 31, Washington discloses a system and method for planning parallel biomanufacturing processes. A plurality of cartridges (e.g., microplates, incubators) are provided as lab equipment (Figure 2A:170A) and are configured to be received within a biomanufacturing workcell (Figure 2A:140C and Figure 2C:170D,E). Instruments (“Examples of equipment 170 may include pipettes, beakers, flasks, plates, storage equipment, incubators, plate readers, washers, centrifuges, liquid handlers, sealers, desealers, or any other suitable equipment used in labs 140”) interface with respective modules of each one of the cartridges in order to perform biomanufacturing process on the cell sample therein. Washington indicates that a computing device (Figure 1:100) includes a processor and is configured to receive one or more inputs associated with the biomanufacturing processes to be performed on the cell sample within each of the plurality of cartridges. The computing device simulates the biomanufacturing processes based on the received inputs and identifies potential contentions based on the simulation. This is described in paragraphs [0053]-[0057] and [0065]-[0068]. Paragraphs [0057] and [0086] specifically discuss steps to identify and remedy predicted contentions (“The simulation module 340 may determine, for each projection, potential errors that may occur if the protocol were performed according to the projection, such as running out of lab equipment 170 or reagents 180, robots 150 blocking one another in the lab 140, scheduling conflicts, and the like”). Washington provides a detailed description of a graphical user interface (Figure 3:355). Washington, however, does not appear to indicate that the graphical user interface is used to output a chart including a displayed series of intervals and time periods, wherein the plurality of instruments are displayed as a function of the series of intervals and time periods.
Rodgers discloses a system and method for planning parallel biomanufacturing processes. Rodgers describes how a plurality of cartridges, each containing a cell sample, are handled by a plurality of instruments in a biomanufacturing workcell. See, for example, paragraphs [0064] and [0065]. Rodgers teaches that a the biomanufacturing processes are simulated based on inputs. Paragraph [0082] indicates that an output based on the inputs is generated, such that the plurality of instruments are displayed as a function of the series of intervals and time periods (“The computer may also determine (and report) the time necessary to perform the experimental protocols (for example, using one or more Gantt charts). If the computer determines that a certain condition of the experimental protocol is impossible or at least impractical, e.g. due to conflicting constraints or lack of resources, the computer can then alert the user, who can alter the experimental protocols and/or the system as necessary”).
Before the effective filing date of the claimed invention, it would have been obvious to organize and display the instruments required by the Washington biomanufacturing process as a function of time on a generated chart. Rodgers teaches that this allows one to quickly understand that potential conflicts (“contentions”) may be predicted when multiple operations are performed in parallel, and that the graphical output allows a user to more readily consider possible remedial measures. For example, Rodgers specifically recommends displaying information in the form of a Gantt chart to show instrument activity as a function of different time periods.
With respect to claim 2, Washington and Rodgers disclose the combination as described above. Washington teaches that microplates (i.e., bioreactor instruments) and liquid handlers are provided. Similarly, Rodgers states that cell culture reactors and liquid transfer means are used.
With respect to claims 3 and 32, Washington and Rodgers disclose the combination as described above. Washington teaches in paragraphs [0033] and [0034] that one or more robotic arms (Figure 2B:225) are configure to move the plurality of cartridges within the biomanufacturing workcell to or from locations associated with the instruments.
With respect to claim 4, Washington and Rodgers disclose the combination as described above. Washington and Rodgers each indicate that control inputs may include information relating to the type of instrument, a number of instruments, and process step constraints.
With respect to claim 5, Washington and Rodgers disclose the combination as described above. Washington and Rodgers indicate that the simulation may be a discrete-event simulation, as it is well known in the art to simulate and track specific events over a predetermined period of time.
With respect claim 6, Washington and Rodgers disclose the combination as described above. Washington and Rodgers each describe phase contentions, instrument contentions, and workflow step contentions. Washington teaches that the “simulation module 340 may determine, for each projection, potential errors that may occur if the protocol were performed according to the projection, such as running out of lab equipment 170 or reagents 180, robots 150 blocking one another in the lab 140, scheduling conflicts”. Similarly, Rodgers provides a planning simulation to account for projected instrument/workflow/phase contentions (“the computer may perform a "mapping" operation, in which one or more experimental protocols are mapped to one or more reaction sites in one or more chips. In some cases, the mapping may be performed to ensure that each chip (which may contain more than one reaction site, and more than one experimental protocol mapped to the chip) will not be subjected to conflicting or inconsistent conditions”).
With respect to claims 7-14, Washington and Rodgers disclose the combination as described above. As described above, Rodgers indicates that the graphical user interface is configured to produce a Gantt chart that displays instrument scheduling, wherein the Gantt chart is used to identify phase contentions, instrument contentions and workflow contentions.
With respect to claim 17, Washington and Rodgers disclose the combination as described above. The Washington system may include essentially any number of cartridges and bioreactors, including an equal number of cartridges and bioreactors.
With respect to claim 18, Washington and Rodgers disclose the combination as described above. Washington and Rodgers each teach automated processes.
With respect to claims 19-23, Washington and Rodgers disclose the combination as described above. Washington shows in at least Figs. 2A and 2C that a fluid storage vault is provided for holding one or more closed volume fluid devices. A robotic arm 150C is used to move closed volume fluid devices between processing locations within the workcell. Rodgers shows a similar configuration where a robotic arm 20 and a sterile liquid transfer instrument 23 are utilized to transfer closed volume fluid devices from a fluid storage vault 32, 33, 34, 35 (see paragraph [0065]) to any number of processing locations within the workcell.
With respect to claim 24, Washington and Rodgers disclose the combination as described above. Washington and Rodgers each show systems in which the modules are shared by multiple cartridges.
With respect to claim 25, Washington and Rodgers disclose the combination as described above. As previously discussed, Rodgers discloses cultivation in a bioreactor instrument (“the invention is directed to controlling a plurality of cell culture experiments, e.g., using an automated cell culture device”).
With respect to claims 26-29, Washington and Rodgers disclose the combination as described above. Those of ordinary skill would have found it obvious to consider the effect of varying process step min/max duration when scheduling and modeling different operations in the Washington system. Those of ordinary skill would have understood that the periodicity of the generated Gantt chart will be a function of and responsive to the requirements of the particular biomanufacturing operation.
With respect to claim 33, Washington and Rodgers disclose the combination as described above. As previously discussed, Washington and Rodgers each teach optimizing the simulation based on identified potential contentions. See, for example, paragraph [0056] of Washington (“The simulation module 340 may select one or more variants to simulate for the protocol to optimize satisfying the parameters (e.g., selecting operations that take less time, cost within the budget, etc.)”).
Claims 15, 30 and 34 are rejected under 35 U.S.C. 103 as being unpatentable over Washington (US 20220040862) in view of Rodgers (US 20070048863) as applied to claims 1 and 31, and further in view of Barbera-Guillem (US 20030040104).
Washington and Rodgers disclose the combination as described above, however do not appear to show that the workcell includes a feedthrough.
Barbera-Guillem discloses a biomanufacturing system and process in which a plurality of cartridges (Figure 3:22) and instruments are disposed within a workcell (Figure 2:10). The workcell includes a feedthrough (Figure 1:50) that allows for the controlled delivery of cartridges into system. This is described in paragraphs [0040]-[0043].
Before the effective filing date of the claimed invention, it would have been obvious to ensure that a feedthrough is used to introduce cartridges into the workcell when practicing the system and method of Washington. Barbera-Guillem teaches that the feedthrough allows for the controlled transfer of a high volume of cartridges into the system so that the cartridges immediately contact other handling, tracking and processing instruments inside the workcell. Barbera-Guillem further indicates that the feedthrough is automatically opened and closed to promote sterile conditions.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Washington (US 20220040862) in view of Rodgers (US 20070048863) as applied to claim 1, and further in view of Bernate (US 20220081687).
Washington and Rodgers disclose the combination as described above. As previously discussed, Washington and Rodgers teach at least one bioreactor and at least one sterile liquid transfer device. These references, however, do not expressly disclose an electroporation instrument, a counterflow centrifugal elutriation instrument, and a magnetic-activated cell selection instrument.
Bernate discloses a biomanufacturing system comprising a workcell that includes a plurality of cartridges and instruments. See Fig. 1A. Paragraphs [0131]-[0147] describe that at least one bioreactor instrument is provided for culturing cells. At least one sterile liquid transfer instrument comprising a robotic handling system (Figure 2A:210) is used to transfer fluid between stations. Paragraphs [0166]-[0193] describe an electroporation instrument that receives cells for transformation, and paragraphs [0149]-[0154] and [0200] indicate that a counterflow centrifugal elutriation instrument is used to collect and concentrate cells. At least paragraph [0151] states that a magnetic-activated cell selection instrument is also used to isolate cells.
Before the effective filing date of the claimed invention, it would have been obvious to use the Washington system to simulate and perform a wide variety of biomanufacturing processes, including cell growth, treatment and purification methods that require electroporation, centrifugation and magnetic separation. As evidenced by Bernate, these modules are typically included in cell editing systems and may be readily automated using known techniques. Bernate teaches that the applications for multi-module cell editing systems are wide ranging in the fields of drug discovery, nutrition and disease treatment.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The Ozawa (US 20240327935) reference teaches the state of the art regarding systems and methods for planning and simulating biomanufacturing processes.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NATHAN ANDREW BOWERS whose telephone number is (571)272-8613. The examiner can normally be reached M-F 7am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Marcheschi can be reached at (571) 272-1374. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NATHAN A BOWERS/Primary Examiner, Art Unit 1799
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