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 § 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.
Claim 67 70-73, 76-79, 81,84,88-89,91-92,94,96,99,104 are rejected under 35 U.S.C. 103 as being unpatentable over Chang et al. (US 2006/0257999) and further in view of Liu (US 2015/0291927).
Regarding claim 67 Chang discloses an automated real time fermentation control system for, the automated fermentation control system comprising a computing system, (See Chang Abstract Figs. 33-35 and 44-47F and [0371], [400]-[0403], and [0428] wherein a computerized fermentation control system allows for real time control of a fermentation system.)
wherein said computing system comprises a digital computer with access to a computing platform, wherein said digital computer comprises a computer processor and a computer memory comprising a computer program executable by said computer processor to generate an fermentation protocol for a fermentation system wherein said computer platform is operably linked to said fermentation system, wherein said fermentation system comprises: (See Chang Abstract Figs. 33-35 and 44-47F and [0371], [0403], and [0428] wherein a computing system 4400 is linked to a fermentation system comprises a digital computer with a CPU 4407 and a memory 4422/4415 which comprises instructions, i.e. software, which are executed by said computer to control the fermentation system 4427, i.e. such control is in response to a fermentation protocol generated by computer software instructions)
a fermentation system comprising:
a) a plurality of bioreactors configured to receive a fermentation agent, wherein at least one of the bioreactors of said plurality of bioreactors is removable and capable of having a different configuration responsive to change instructions received from a remote control system with data from at least one other bioreactor of said plurality of bioreactors; and (See Chang Figs. 33 -35 and [0366]-[0375] wherein there are a plurality of bioreactors, i.e. sample vessels 3315, receive various fermentation agents which are dispensed therein. Said bioreactors are removable and capable of having different materials therein, i.e. capable of having different configurations, said materials are added based upon a instructions received from a remote control system in response to data received from other bioreactors.)
Chang also discloses the bioreactors having sensors disposed therein configured to detect one or more characteristics of fermentation within a bioreactor and said sensors being configured to allow control over configuration of the bioreactors responsive to data from the one or more sensors disposed thereon. (See Chang [0358] [0377] wherein sensors 3590 are located inside individual sample vessels 3315 and the controller responds adjusts the configuration of bioreactors in response to detected parameters, i.e. data, from the sensors.)
b) a first robotic component configured to provide said fermentation agent to at least one of the plurality of bioreactors. (See Chang Fig. 2 and 4E [0197] and [0211], [0229]-[0230] [0257] wherein a first robotic component, i.e. dispenser head mounted on gantry/arm, delivers a fermentation agent to at least one of the bioreactors.)
A remote control system comprises a display for presenting data from the one or more sensors, an input receiver for receiving user instructions from a user, and a commander for sending said change instructions directing a configuration change in at least one of the bioreactors;. (See Chang [0400]-[0402] and Figs. 46A-48B wherein a remote control system, i.e. computer remote over a network, has a display provided which may display data from one or more sensors, an input receiver, i.e. keyboard or mouse, to receive instructions from a user, and a commander, i.e. software which converts instructions to language for operation of devices, which sends configuration changes to bioreactors.)
wherein said change instructions comprise fermentation change instructions to effect modifications to said fermentation protocol in real time during said fermentation of said fermentation agent in said at least one of the plurality of bioreactors, said modifications comprising adjustments to a plurality of biological parameters of said fermentation system for achieving a fermentation protocol set-point.(See Change [0377] and [0403]-[0404] Figs. 46A-47F where changes are made via instructions which are sent by a process controller, i.e. change instructions. These instructions effect modifications to the fermentation protocol in real time during fermentation, i.e. sensor data dictates a change in the fermentation protocol in real time. The modifications include adjustments to a plurality of biological parameters, i.e. pH, temperature, redox potential, protein expression, etc., to achieve set points of these parameters as dictated by the fermentation protocol set automatically of via user input.)
Chang further discloses that the control system may utilize a network but does not specify a remote cloud based storage.
Liu discloses a fermentation control system wherein software to perform said fermentation is stored on a cloud based system. (See Liu Abstract [0013] and [0032])
It would have been obvious to one of ordinary skill in the art at the time of filing to utilize a cloud based computing system storing software for fermentation control as described by Liu in the device of Chang because such cloud based systems reduce computer hardware costs and increased computing ability as would be desirable in the device of Chang.
Regarding claim 70 modified Chang discloses all the claim limitations as set forth above as well as the device wherein said modification to the fermentation protocol nis executed in a subsequent performing of a fermentation. (See Chang [0403]-[0404] Figs. 46A-47F wherein, i.e. software instructions, may modify by a user at any point, i.e. in a subsequent protocol.)
Such limitations are directed to intended uses of the claimed device which do not define structural limitations which differentiate the claimed invention from the cited prior art.
Regarding claim 71 modified Chang discloses all the claim limitations as set forth above as well as the device wherein said fermentation protocol comprises i) said fermentation agent for use in said fermentation system; ii) said culture medium for said fermentation agent; iii) and a duration for said fermentation protocol; (See Chang [0403]-[0404] Figs. 46A-47F wherein such information may be provided by a user.)
Regarding claim 72 modified Chang discloses all the claim limitations as set forth above as well as the device wherein said fermentation protocol provides a direction for movement of said first robotic component. (See Chang [0403]-[0404] Figs. 46A-47F wherein there is a planning module, i.e. software instructions, which receives fermentation system protocol from a user which includes experimental protocol and fermentation protocol. The fermentation system protocol directs fermentation operations including direction of movements of said robotic components, See Chang [0211], and [0257] Fig. 2 , and Fig. 35.))
Regarding claim 73 modified Chang discloses all the claim limitations as set forth above as well as the device wherein said direction for movement of said first robotic component comprises directing said first robotic component to move said fermentation agent from a sample tube to at least one of said plurality of bioreactors, directing said first robotic component to move a sample tube to a cold storage container, or directing said first robotic component to move a fermentable substrate of at least one of said plurality of bioreactors.(See Chang [0211], and [0257] Fig. 2 , and Fig. 35 wherein a direction of movement of said first robotic component comprises moving a fermentation agent from a sample tube to a bioreactor or a moves a fermentable substrate via fluid transfer.)
Regarding claim 76 modified Chang discloses all the claim limitations as set forth above as well as the device wherein said change instruction directs modification of a configuration of at least one of said plurality of bioreactors in response to an experimental protocol. (See Chang [0403]-[0404] Figs. 46A-47F [0211], and [0257] Fig. 2 , and Fig. 35 wherein in a configuration module, i.e. software instructions, performs configuration, i.e. movement, material addition, etc., of said bioreactors based on the experimental protocol.
Regarding claim 77 modified Chang discloses all the claim limitations as set forth above as well as the device wherein user instruction directs the computer to assess said experimental protocol for said fermentation system. (See Chang Fig. 35 and [0371] wherein the instructions include a monitoring module monitors experimental protocol and provides an alarm after an assessment of suitability thereof and [0403]-[0404] Figs. 46A-47F wherein said instructions may be user sent instrucitons.)
Regarding claim 78 modified Chang discloses all the claim limitations as set forth above as well as the device wherein display provides to said user data obtained from said fermentation system based on said experimental protocol. (See Chang Fig. 44 wherein a display module 4405 and Figs. 47A-47E wherein various data obtained from said fermentation system based on the experimental protocol is displayed to the user.)
Regarding claim 79 modified Chang discloses all the claim limitations as set forth above as well as the device wherein said first robotic component is a robotic arm or gantry. (See Chang Fig. 2 [0197] and [0211], [0257] wherein a first robotic component 208, 210, or 212 is a robotic arm.)
Regarding claim 81 modified Chang discloses all the claim limitations as set forth above as well as the device said fermentation system further comprising a second robotic component, wherein said second robotic component is configured to aid in sample handling, wherein said second robotic component is a robotic arm or gantry. (See Chang Fig. 4E and [0229] wherein a second robotic component, i.e. material handling components 400, comprise a gantry and aid in sample handling. Also See Chang Fig. 2 wherein other robotic arms 210 and 212, i.e. second robotic components, aid in sample handling.)
Regarding claims 84, 88, and 89 Chang discloses all the claim limitations as set forth above as it is noted the fermentation agent is a material worked on by the device which does not further limit the structural elements of the device. See MPEP 2114 and 2115. The device of change is fully capable of working with fermentation agent is a yeasts bacterium, an alga, or a fungus, a mammalian cell, animal cell or insect cell.
Regarding claim 91 modified Chang discloses all the claim limitations as set forth above as well as the device wherein said duration for the fermentation protocol is from about 24 hours to about one week. (See Chang Fig. 47A and [0376] wherein duration, i.e. start and end time, is user definable and fully capable of being between 24 hours to a week. Also See [0476] wherein a specific example of a 5 day fermentation, i.e. incubation, is provided.)
Regarding claim 92 modified Chang discloses all the claim limitations as set forth above as well as the device wherein said biological parameters comprise pH. temperature, or dissolved oxygen. (See Change [0376]-[0377] wherein temperature and pH are biological parameters modified by change instructions and monitored to achieve a defined set point.)
Regarding claim 94 modified Chang discloses all the claim limitations as set forth above as well as the device wherein said biological parameter is an optical density of the culture medium. (See Chang Fig. 46A [0377] wherein optical density is measured and change instructions cause changes therein to determine a set point cell density.)
Regarding claim 96 modified Chang discloses all the claim limitations as set forth above as well as the device wherein said display presents a status of said experimental protocol to said user, a progress of said experimental protocol to said user, or data associated with a biological parameter of said fermentation system. (See Chang Figs. 46A-47E wherein a progress of the experimental protocol and/or data associated with a biological parameter is displayed to a user.)
Regarding claim 99 modified Chang discloses all the claim limitations as set forth above as well as the device wherein said user adjusts said set-point of said biological parameter of said fermentation protocol in real-time.(See Chang [0376]-[0377] wherein a user may program biological parameters, i.e. fermentation conditions, in real-time utilizing the provided software.)
Regarding claim 104 modified Chang discloses all the claim limitations as set forth above as well as the device wherein said fermentation change instructions are configured to swap in a new fermentation protocol. (See Change [0377] wherein the change instructions result in a change in operation from the existing condition and thus swap in a new fermentation protocol which was being carried out prior to said change instructions.)
Response to Arguments
Applicant's arguments filed 3/9/2026 have been fully considered but they are not persuasive.
In response to applicant’s request for an interview it is noted that the examiner does not believe such an interview request is submitted in a timely manner or likely to advance prosecution at this time. The examiner is happy to hold an interview if applicant has specific issues they wish to discuss to advance prosecution and is invited to contact the examiner to request and hold such an interview.
Applicant argues that “Applicant submits that these cited passages do not teach or suggest "change instructions comprise fermentation change instructions to effect modifications to said fermentation protocol in real time during said fermentation of said fermentation agent in said at least one of the plurality of bioreactors, said modifications comprising adjustments to a plurality of biological parameters of said fermentation system for achieving a fermentation protocol set-point," as recited in amended claim 67. (emphasis added).”
Applicant further argues “Chang does not teach or suggest, at least, "...fermentation change instructions to effect modifications to said fermentation protocol in real time during said fermentation of said fermentation agent in said at least one of the plurality of bioreactors, said modifications comprising adjustments to a plurality of biological parameters of said fermentation system for achieving a fermentation protocol set-point," such as recited in amended claim 67. (emphasis added). Chang does not teach or suggest modification of a plurality of biological parameters to achieve a set-point for its fermentation protocol. Rather, Chang provides that its controller can adjust one component of its station in response to a measurement parameter corresponding to that one component.”
It is noted that the claims require “change instructions” not a “change instruction” being sent. The controller of Chang is fully configured to send a plurality of instructions, i.e. change instructions, based on the plurality of sensor measurements to effect multiple changes of multiple biological parameters to meet a set point and thus change a fermentation protocol. See Chang [0377] wherein sensors measure at least, redox potential, pH, protein expression, etc, and the controller sends “change instructions” to effect modifications to the fermentation protocol and adjust these biological parameters and achieve a desired set point of these parameters. It is unclear how applicant envisions the system of Chang which measures and adjusts a plurality of parameters in real time to change biological parameters to meet desired set points differs from the claimed invention. Applicant has not described why the claimed change instructions claimed are not taught by the instructions sent by Chang which alter biological parameters within a fermentation based on measurements form multiple sensors as this is explicitly what Chang describes.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 JONATHAN M HURST whose telephone number is (571)270-7065. The examiner can normally be reached on M-F 7AM-4PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Marcheschi can be reached on 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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/JONATHAN M HURST/ Primary Examiner, Art Unit 1799