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 .
Allowable Subject Matter
The indicated allowability of claim 7 is withdrawn in view of the newly discovered reference(s) to U.S. Patent Application 2023/0065504, Wagner et al. (hereinafter Wagner) in view of U.S. Patent Application 2022/0397387, Oda et al. (hereinafter Oda). Rejections based on the newly cited reference(s) follow.
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.
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.
1. Claim(s) 1, 2, 3, 11-20 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application 2023/0065504, Wagner et al. (hereinafter Wagner) in view of U.S. Patent Application 2022/0397387, Oda et al. (hereinafter Oda).
2. Regarding Claim 1, Wagner discloses A monitoring method for monitoring an analysis apparatus configured to observe a target object ([0021], “monitor a cell culture process”), the monitoring method comprising:
acquiring self-diagnostic data on the analysis apparatus in a self- diagnostic possible period during which the analysis apparatus is in a state of not executing observation of the target object ([0190], “The computing subsystem may apply machine learning to data collected by the system (e.g., imaging data, sensor data, input, and output assay data) to determine how to effectively edit the cell culture to reach the desired output (i.e., check device status/readiness, i.e., not during observation). This allows for dynamic monitoring and control of how the cell culture develops from input cells to output cell products. The automated nature of the system removes the need for manual human intervention at many stages of cell culture development, thus reducing the time and cost of making output cell products.”);
diagnosing a state of the analysis apparatus based on the self-diagnostic data ([0198], “Sensors that sense the state of the cell culture 104”); and
outputting a diagnostic result of the state of the analysis apparatus ([0889], “Information and data can be displayed through a display 13932”).
Wagner does not explicitly disclose the self-diagnostic data comprising data that can be measured by setting a jig on the analysis apparatus
Oda teaches the self-diagnostic data comprising data ([0052], “The operation accuracy of the processing feed mechanism is deduced from changes in interference fringes captured by the white light interferometer 40.” See also [0040], “it is desirable to measure the operation accuracy of each of the linear motion mechanisms.”) that can be measured by setting a jig ([0052], “while the upper surface of the measuring jig 1 is being observed using the white light interferometer 40, the processing feed mechanism, i.e., a linear motion mechanism, is actuated.”) on the analysis apparatus ([0053], “placing step S10 is first carried out to place the measuring jig 1 on the chuck table 8 or the table base 8b.” [0029], “A table base 8b is disposed on the X-axis movable table 6,” i.e., on the apparatus. See also Fig. 6 (S10, “Placing Step”) and Fig. 3 (measuring jig 1 set on table base 8b.)
It would have been obvious to incorporate Oda’s jig-measured self-diagnostic data into Wagner’s method to obtain a known reference for assessing and maintaining the apparatus’s accuracy before it degrades (Oda [0040], [0066]), yielding predictable, more reliable self-diagnosis.
3. Regarding Claim 2, Wagner discloses The monitoring method according to claim 1, wherein the self- diagnostic possible period includes a period during which the analysis apparatus is not set to an observation mode ([0195], “The cell culture container 106 may be in a format that allows for observation of the cell culture 104 at regular intervals using an imaging subsystem 112.” [0319], “reprogramming observation.” [0337], “determined by manual observation.” Not set to observation mode).
4. Regarding Claim 3, Wagner discloses The monitoring method according to claim 1, wherein when the analysis apparatus is operating in a continuous observation mode that is a mode of continuously executing observation of the target object ([0008], “The cell culture container or chamber can be configured within a modular cell culture cassette capable of maintaining a cell culture for extended periods of time within a closed sterile environment without breaching that closed environment.”),
the self-diagnostic possible period includes a period before the analysis apparatus starts operations in the continuous observation mode (Claimed in the alternative),
or a period after the analysis apparatus terminates the operations in the continuous observation mode ([0467], “The colony editor 5730A may also terminate a cell culture in order to dispose of it or to harvest output cell products 5718A”).
5. Regarding Claim 11, Wagner discloses The monitoring method according to claim 1, wherein the self-diagnostic data includes data measured by a sensor provided in the analysis apparatus ([0019], “more sensors comprise a temperature sensor, a humidity sensor, a gas-phase oxygen concentration sensor, a gas-phase carbon dioxide concentration sensor, a dissolved oxygen concentration sensor, a dissolved carbon dioxide concentration sensor, a gas flow rate sensor, a liquid flow rate sensor, a pH sensor, an optical absorption sensor, an optical scattering sensor, a mass spectroscopic sensor, a viscosity sensor, or any combination thereof. In some implementations, each cell culture chamber comprises a gas-permeable surface” [0011], “integrated component of an overall platform.” integrated into the apparatus and used to monitor operating conditions).
6. Regarding Claim 12, Wagner discloses The monitoring method according to claim 11, wherein the sensor includes at least one of an illuminance sensor configured to measure intensity of laser light used by the analysis apparatus to observe the target object, a temperature sensor configured to measure temperature inside a chamber in which the target object is placed, or a gas sensor configured to measure gas concentration inside the chamber ([0019], “more sensors comprise a temperature sensor, a humidity sensor, a gas-phase oxygen concentration sensor, a gas-phase carbon dioxide concentration sensor, a dissolved oxygen concentration sensor, a dissolved carbon dioxide concentration sensor, a gas flow rate sensor, a liquid flow rate sensor, a pH sensor, an optical absorption sensor, an optical scattering sensor, a mass spectroscopic sensor, a viscosity sensor, or any combination thereof. In some implementations, each cell culture chamber comprises a gas-permeable surface”.
7. Regarding Claim 13, Wagner discloses The monitoring method according to claim 1, further comprising notifying outside a network connected to the analysis apparatus of a result of analyzing the state of the analysis apparatus in the diagnostic result ([0205], [0583], “The resulting images/data may be further processed using a machine learning system that is located either locally or remotely (e.g., elsewhere on the premises or in the cloud).”).
8. Regarding Claim 14, Wagner discloses The monitoring method according to claim 1, further comprising notifying outside a network connected to the analysis apparatus of the diagnostic result ([0205], [0576], “alerting users of emergency conditions in any modular bioprocessing system 7400.” [0583], “The resulting images/data may be further processed using a machine learning system that is located either locally or remotely (e.g., elsewhere on the premises or in the cloud).”).
9. Regarding Claim 15, Wagner discloses The monitoring method according to claim 1, further comprising notifying a user of the analysis apparatus of the diagnostic result by displaying the diagnostic result ([0206], “The computing subsystem 110 may include display screens, monitors, communications/interface ports, keyboards, audio systems, and the like.”).
10. Regarding Claim 16, Wagner discloses The monitoring method according to claim 1, further comprising notifying a user of the analysis apparatus of a result of analyzing the state of the analysis apparatus in the diagnostic result [0576], “alerting users of emergency conditions in any modular bioprocessing system 7400, and presenting real-time operational data for any modular bioprocessing system 7400.”).
11. Regarding Claim 17, Wagner discloses The monitoring method according to claim 1, further comprising:
acquiring a log that records operations of the analysis apparatus in a period during which the analysis apparatus is observing the target object (Fig. 57A; [0460], “the resulting feature to the cell record in the instant cell feature database 5708A’); and
outputting the log (Fig. 57A: 5726A Output Cell Product Assays Results).
12. Regarding Claim 18, Wagner discloses The monitoring method according to claim 17, further comprising, when at least one item included in the log ([0406], “cell record” [0451]], ”The cell imaging subsystem 5712A may employ CMOS, CCD, or other image sensors to capture images.”) is out of a log monitoring criterion ([0063], “33A-B are diagrams illustrating removal of cells outside of designated regions during an iPSC reprogramming process”), notifying outside a network connected to the analysis apparatus of an analysis result of the log [0576], “alerting users of emergency conditions in any modular bioprocessing system 7400, and presenting real-time operational data for any modular bioprocessing system 7400.”.
13. Regarding Claim 19, Wagner discloses A non-transitory computer readable medium storing ([0875], “non-transitory computer readable medium having instructions stored thereon that when executed by one or more processors perform the methods.”) a monitoring program configured to cause a processor to monitor an analysis apparatus configured to observe a target object ([0021], “monitor a cell culture process.” [0902], “a computing subsystem configured to monitor a status of each of the plurality of process modules and each cell culture cassette”),
the monitoring program configured to cause the processor to execute operations ([0875], “non-transitory computer readable medium having instructions stored thereon that when executed by one or more processors perform the methods.”), the operations comprising:
acquiring self-diagnostic data on the analysis apparatus, outside an observation period of the target object by the analysis apparatus [0583], “The resulting images/data may be further processed using a machine learning system that is located either locally or remotely (e.g., elsewhere on the premises or in the cloud).”);
diagnosing a state of the analysis apparatus based on the self-diagnostic data ([0198], “Sensors that sense the state of the cell culture 104”); and
outputting a diagnostic result of the state of the analysis apparatus ([0889], “Information and data can be displayed through a display 13932”).
Wagner does not explicitly disclose the self-diagnostic data comprising data that can be measured by setting a jig on the analysis apparatus
Oda teaches the self-diagnostic data comprising data ([0052], “The operation accuracy of the processing feed mechanism is deduced from changes in interference fringes captured by the white light interferometer 40.” See also [0040], “it is desirable to measure the operation accuracy of each of the linear motion mechanisms.”) that can be measured by setting a jig ([0052], “while the upper surface of the measuring jig 1 is being observed using the white light interferometer 40, the processing feed mechanism, i.e., a linear motion mechanism, is actuated.”) on the analysis apparatus ([0053], “placing step S10 is first carried out to place the measuring jig 1 on the chuck table 8 or the table base 8b.” [0029], “A table base 8b is disposed on the X-axis movable table 6,” i.e., on the apparatus. See also Fig. 6 (S10, “Placing Step”) and Fig. 3 (measuring jig 1 set on table base 8b.)
It would have been obvious to incorporate Oda’s jig-measured self-diagnostic data into Wagner’s method to obtain a known reference for assessing and maintaining the apparatus’s accuracy before it degrades (Oda [0040], [0066]), yielding predictable, more reliable self-diagnosis.
14. Regarding Claim 20, Wagner discloses A monitoring apparatus configured to monitor an analysis apparatus configured to observe a target object ([0021], “monitor a cell culture process.” [0902], “a computing subsystem configured to monitor a status of each of the plurality of process modules and each cell culture cassette”), the monitoring apparatus configured to:
acquire self-diagnostic data on the analysis apparatus in a self-diagnostic possible period during which the analysis apparatus is in a state of not executing observation of the target object ([0190], “The computing subsystem may apply machine learning to data collected by the system (e.g., imaging data, sensor data, input, and output assay data) to determine how to effectively edit the cell culture to reach the desired output (i.e., check device status/readiness, i.e., not during observation). This allows for dynamic monitoring and control of how the cell culture develops from input cells to output cell products. The automated nature of the system removes the need for manual human intervention at many stages of cell culture development, thus reducing the time and cost of making output cell products.”);
diagnose a state of the analysis apparatus based on the self-diagnostic data ([0198], “Sensors that sense the state of the cell culture 104”); and
output a diagnostic result of the state of the analysis apparatus ([0889], “Information and data can be displayed through a display 13932”).
Wagner does not explicitly disclose the self-diagnostic data comprising data that can be measured by setting a jig on the analysis apparatus
Oda teaches the self-diagnostic data comprising data ([0052], “The operation accuracy of the processing feed mechanism is deduced from changes in interference fringes captured by the white light interferometer 40.” See also [0040], “it is desirable to measure the operation accuracy of each of the linear motion mechanisms.”) that can be measured by setting a jig ([0052], “while the upper surface of the measuring jig 1 is being observed using the white light interferometer 40, the processing feed mechanism, i.e., a linear motion mechanism, is actuated.”) on the analysis apparatus ([0053], “placing step S10 is first carried out to place the measuring jig 1 on the chuck table 8 or the table base 8b.” [0029], “A table base 8b is disposed on the X-axis movable table 6,” i.e., on the apparatus. See also Fig. 6 (S10, “Placing Step”) and Fig. 3 (measuring jig 1 set on table base 8b.)
It would have been obvious to incorporate Oda’s jig-measured self-diagnostic data into Wagner’s method to obtain a known reference for assessing and maintaining the apparatus’s accuracy before it degrades (Oda [0040], [0066]), yielding predictable, more reliable self-diagnosis.
Allowable Subject Matter
Claims 4, 5, 6, 8, 9, 10 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding Claim 4, Wagner discloses The monitoring method according to claim 1,
Wagner does not explicitly disclose wherein when the analysis apparatus is operating in a time lapse mode that is a mode of intermittently executing observation of the target object,
the self-diagnostic possible period includes at least part of a period before the analysis apparatus starts a series of operations to be executed in a section of a period during which the analysis apparatus is operating in the time lapse mode,
or at least part of a period after the analysis apparatus terminates the series of operations.
Regarding Claim 5, Wagner in view of Oda discloses The monitoring method according to claim 1,
Wagner in view of Oda does not explicitly disclose wherein the self- diagnostic data is acquired immediately after the self-diagnostic possible period is started,
or immediately before the self-diagnostic possible period is terminated.
Regarding Claim 6, Wagner in view of Oda discloses The monitoring method according to claim 1,
Wagner in view of Oda does not explicitly disclose further comprising: accepting input from a user of the analysis apparatus to set time of acquiring the self-diagnostic data, wherein the self-diagnostic data is acquired at or after the time set by the user of the analysis apparatus, and acquired within the self-diagnostic possible period.
Regarding Claim 8, Wagner in view of Oda discloses The monitoring method according to claim 7claim 1,
Wagner in view of Oda does not explicitly disclose wherein the jig is provided with an aperture, and when the analysis apparatus includes a camera, the aperture is configured to enable analysis of noise contained in an image generated by the camera, or dust or dirt adhering to the camera, by imaging the aperture by the camera.
Regarding Claim 9, Wagner in view of Oda discloses The monitoring method according to claim 1,
Wagner in view of Oda does not explicitly disclose wherein the jig includes a pattern area displaying a specific pattern, and when the analysis apparatus includes a camera and a stage on which the target object can be placed, the pattern area is configured to enable generation of an image to check movement accuracy of the stage, by placing the jig on the stage, moving the stage to multiple positions, and imaging, by the camera, the specific pattern of the pattern area when the stage is moved to each of the positions.
Regarding Claim 10, Wagner in view of Oda discloses The monitoring method according to claim 1,
Wagner in view of Oda does not explicitly disclose wherein the jig is provided with a holder, and when the analysis apparatus has an autofocus function, the holder is configured to enable placement of a sample used by the analysis apparatus to acquire an autofocus optical signal.
Conclusion
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/OMER KHALID/Examiner, Art Unit 2422
/BRIAN P YENKE/Primary Examiner, Art Unit 2422
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