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 § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1-3 and 6 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Seitz et al. (US 2023/0243791).
Per claim 1, Seitz et al. teach a chromatography system (Abstract,
Disclosed herein are chromatography support systems, as well as related methods, computing devices, and computer-readable media. For example, in some embodiments, the systems and methods disclosed herein may enable the automatic identification of error or fault conditions in a chromatography system.) comprising:
a chromatography unit (1810; [0148] The chromatography system 1810 may include any appropriate chromatography apparatus, such as an HPLC system or another chromatography system.) communicatively configured in connection with a system controller (1820; [0149] In some embodiments, the user local computing device 1820 may also be local to the chromatography system 1810, but this need not be the case; for example, a user local computing device 1820 that is in a user's home or office may be remote from, but in communication with, the chromatography system 1810 so that the user may use the user local computing device 1820 to control and/or access data from the chromatography system 1810.) and a user workstation (1700; [0143] The computing device 1700 may have any suitable form factor for its application and setting, such as a handheld or mobile computing device (e.g., a cell phone, a smart phone, a mobile internet device, a tablet computer, a laptop computer, a netbook computer, an ultrabook computer, a personal digital assistant (PDA), an ultra mobile personal computer, etc.), a desktop computing device, or a server computing device or other networked computing component.), said system controller comprising at least one processor ([0136] The computing device 1700 may include a processing device 1702 (e.g., one or more processing devices). As used herein, the term “processing device” may refer to any device or portion of a device that processes electronic data from registers and/or memory to transform that electronic data into other electronic data that may be stored in registers and/or memory.) and at least one memory having computer-readable instructions disposed thereon and configured for operation of said chromatography unit ([0137] The computing device 1700 may include a storage device 1704 (e.g., one or more storage devices). The storage device 1704 may include one or more memory devices such as random access memory (RAM) (e.g., static RAM (SRAM) devices, magnetic RAM (MRAM) devices, dynamic RAM (DRAM) devices, resistive RAM (RRAM) devices, or conductive-bridging RAM (CBRAM) devices), hard drive-based memory devices, solid-state memory devices, networked drives, cloud drives, or any combination of memory devices….In some embodiments, the storage device 1704 may include non-transitory computer readable media having instructions thereon that, when executed by one or more processing devices (e.g., the processing device 1702), cause the computing device 1700 to perform any appropriate ones of or portions of the methods disclosed herein. [0149] The user local computing device 1820 may be a computing device (e.g., in accordance with any of the embodiments of the computing device 1700 discussed herein) that is local to a user of the chromatography system 1810. In some embodiments, the user local computing device 1820 may also be local to the chromatography system 1810, but this need not be the case; for example, a user local computing device 1820 that is in a user's home or office may be remote from, but in communication with, the chromatography system 1810 so that the user may use the user local computing device 1820 to control and/or access data from the chromatography system 1810.);
said user workstation configured in input/output communication with said system controller [0138] The computing device 1700 may include an interface device 1706 (e.g., one or more interface devices 1706). The interface device 1706 may include one or more communication chips, connectors, and/or other hardware and software to govern communications between the computing device 1700 and other computing devices. For example, the interface device 1706 may include circuitry for managing wireless communications for the transfer of data to and from the computing device 1700.; and
said system controller configured for operation by a control system (1606; [0132] The chromatography control region 1606 may include options that allow the user to control a chromatography system (e.g., the chromatography system 1810 discussed herein with reference to FIG. 18). For example, the chromatography control region 1606 may include error messages, warning messages, component replacement messages, service messages, options to begin diagnostic or corrective procedures, or other control information or options.), said control system configured to define at least one recipe to be performed by said chromatography unit ([0132] The chromatography control region 1606 may include options that allow the user to control a chromatography system (e.g., the chromatography system 1810 discussed herein with reference to FIG. 18). For example, the chromatography control region 1606 may include error messages, warning messages, component replacement messages, service messages, options to begin diagnostic or corrective procedures, or other control information or options.; [0275] Example 91 is a system comprising: a chromatography device configured to perform one or more chromatography operations; and a computing device comprising one or more processors, and a memory, wherein the memory stores instructions that, when executed by the one or more processors, cause the computing device to perform the methods of any one of Examples 1-88.).
Per claim 2, said control system comprising a setup system (1830) configured to define at least one step of said at least one recipe ([0150] In some embodiments, the service local computing device 1830 may communicate with the chromatography system 1810, the user local computing device 1820, and/or the remote computing device 1840 (e.g., via a direct communication pathway 1808 or via multiple “indirect” communication pathways 1808, as discussed above) to transmit data to the chromatography system 1810, the user local computing device 1820, and/or the remote computing device 1840 (e.g., to update programmed instructions, such as firmware, in the chromatography system 1810, to initiate the performance of test or calibration sequences in the chromatography system 1810, to update programmed instructions, such as software, in the user local computing device 1820 or the remote computing device 1840, etc.).).
Per claim 3, wherein said setup system is communicatively configured in connection with a support system (1840; [0144] FIG. 18 is a block diagram of an example chromatography support system 1800 in which some or all of the chromatography support methods disclosed herein may be performed, in accordance with various embodiments.; [0150] In some embodiments, the service local computing device 1830 may communicate with the chromatography system 1810, the user local computing device 1820, and/or the remote computing device 1840 (e.g., via a direct communication pathway 1808 or via multiple “indirect” communication pathways 1808, as discussed above) to transmit data to the chromatography system 1810, the user local computing device 1820, and/or the remote computing device 1840 (e.g., to update programmed instructions, such as firmware, in the chromatography system 1810, to initiate the performance of test or calibration sequences in the chromatography system 1810, to update programmed instructions, such as software, in the user local computing device 1820 or the remote computing device 1840, etc.).).
Per claim 6, wherein said system controller is communicatively configured in communication with said chromatography unit through at least one intermediary
Controller (1606; [0132] The chromatography control region 1606 may include options that allow the user to control a chromatography system (e.g., the chromatography system 1810 discussed herein with reference to FIG. 18). For example, the chromatography control region 1606 may include error messages, warning messages, component replacement messages, service messages, options to begin diagnostic or corrective procedures, or other control information or options.).
Per claim 7, Seitz et al. teach a chromatography system (Abstract,
Disclosed herein are chromatography support systems, as well as related methods, computing devices, and computer-readable media. For example, in some embodiments, the systems and methods disclosed herein may enable the automatic identification of error or fault conditions in a chromatography system.) comprising:
a user workstation (1700) communicatively configured in connection with a chromatography system (1700; [0143] The computing device 1700 may have any suitable form factor for its application and setting, such as a handheld or mobile computing device (e.g., a cell phone, a smart phone, a mobile internet device, a tablet computer, a laptop computer, a netbook computer, an ultrabook computer, a personal digital assistant (PDA), an ultra mobile personal computer, etc.), a desktop computing device, or a server computing device or other networked computing component.), said user workstation comprising a processor ([0136] The computing device 1700 may include a processing device 1702 (e.g., one or more processing devices). As used herein, the term “processing device” may refer to any device or portion of a device that processes electronic data from registers and/or memory to transform that electronic data into other electronic data that may be stored in registers and/or memory.) disposed in connection with a memory having computer-readable instructions disposed thereon ([0137] The computing device 1700 may include a storage device 1704 (e.g., one or more storage devices). The storage device 1704 may include one or more memory devices such as random access memory (RAM) (e.g., static RAM (SRAM) devices, magnetic RAM (MRAM) devices, dynamic RAM (DRAM) devices, resistive RAM (RRAM) devices, or conductive-bridging RAM (CBRAM) devices), hard drive-based memory devices, solid-state memory devices, networked drives, cloud drives, or any combination of memory devices….In some embodiments, the storage device 1704 may include non-transitory computer readable media having instructions thereon that, when executed by one or more processing devices (e.g., the processing device 1702), cause the computing device 1700 to perform any appropriate ones of or portions of the methods disclosed herein. [0149] The user local computing device 1820 may be a computing device (e.g., in accordance with any of the embodiments of the computing device 1700 discussed herein) that is local to a user of the chromatography system 1810. In some embodiments, the user local computing device 1820 may also be local to the chromatography system 1810, but this need not be the case; for example, a user local computing device 1820 that is in a user's home or office may be remote from, but in communication with, the chromatography system 1810 so that the user may use the user local computing device 1820 to control and/or access data from the chromatography system 1810.), said processor configured in input/output relation with a user interface (1706, 1806) configured to display a setup system configured to define at least one recipe (such as, for example, a communication step) to be performed by said chromatography system ([0138] The computing device 1700 may include an interface device 1706 (e.g., one or more interface devices 1706). The interface device 1706 may include one or more communication chips, connectors, and/or other hardware and software to govern communications between the computing device 1700 and other computing devices.; [0146] The interface device 1806 may take any suitable form, including the form of any of the interface devices 1706 discussed herein with reference to FIG. 4, and the interface devices 1806 included in different ones of the chromatography system 1810, the user local computing device 1820, the service local computing device 1830, or the remote computing device 1840 may take the same form or different forms.);
said setup system comprising a step definition sequence module configured to define at least one step definition detail for at least one step of said at least one recipe ([0137] In some embodiments, the storage device 1704 may include non-transitory computer readable media having instructions thereon that, when executed by one or more processing devices (e.g., the processing device 1702), cause the computing device 1700 to perform any appropriate ones of or portions of the methods disclosed herein.).
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 5 is rejected under 35 U.S.C. 103 as being unpatentable over Seitz et al. (‘791).
Per claim 5, Seitz et al. disclose wherein said system controller comprises a distributed control system comprising a remote control side control (1840) component and a plant-side (i.e., local to the chromatograph) control component (1830; [0144] One or more computing devices implementing any of the chromatography support modules or methods disclosed herein may be part of a chromatography support system. FIG. 18 is a block diagram of an example chromatography support system 1800 in which some or all of the chromatography support methods disclosed herein may be performed, in accordance with various embodiments. The chromatography support modules and methods disclosed herein (e.g., the chromatography support module 1400 of FIG. 14 and the method 1500 of FIG. 15) may be implemented by one or more of the chromatography system 1810, the user local computing device 1820, the service local computing device 1830, or the remote computing device 1840 of the chromatography support system 1800.). Seitz et al. do not explicitly disclose wherein said distributed control system comprising a client-side control component.
It is submitted that it would have been readily obvious to provide wherein said distributed control system comprises a client-side control component using, for example, the remote-side control component in order to facilitate a client having control over the recipe steps to be taken based on data received.
Allowable Subject Matter
Claims 13-20 are allowed.
Claims 4 and 8-12 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: While claims 2 and 8 are not patentable for the reasons provided above, in the examiner’s opinion, the prior art fails to teach or render obvious the system further comprising elements having the recited positioning and configuration as recited in claims 4 and 8-12.
Per claim 13, while it is known in the art to provide a chromatography system comprising:
a chromatography unit communicatively configured in connection with at least one user workstation;
said chromatography unit comprising at least one column station disposed in fluid communication with an inlet manifold assembly and an outlet manifold assembly via a fluid transfer assembly;
said fluid transfer assembly disposed in connection with a pump assembly.
said at least one user workstation comprising a processor disposed in connection with a memory having computer-readable instructions disposed thereon, said processor configured in input/output relation with a user interface configured to display a setup system for operating said chromatography system by defining at least one recipe therefor,
a raw material module configured to define at least one raw material used in said
at least one recipe;
an input manifold connection module associate said at least one raw material with at least a portion of said inlet manifold assembly;
an output module configured to define at least one output detail for at least a
portion of said outlet manifold assembly;
a column definition module configured to define at least one column definition
detail for at least a portion of said at least one column station (see, for example, US 2023/0280319 to Sun et al.); in the examiner’s opinion, the prior art fails to teach or render obvious the system further comprising:
said at least one column station further disposed in connection with at least one bubble trap;
said setup system comprising:
a security module configured to provide access to said setup system by a user of
said at least one user workstation;
a skid definition module configured to define at least one skid detail;
a phase module configured to define at least one phase detail;
a recipe step module configured to perform at least one recipe function associated with said at least one raw material; and
a step definition sequence module configured to define at least one step definition detail for at least one step of said at least one recipe.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to FRED PRINCE whose telephone number is (571)272-1165. The examiner can normally be reached M-W: 0900-1730.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Bobby Ramdhanie can be reached at (571)270-3240. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/FRED PRINCE/
Primary Examiner
Art Unit 1779
Prosecution Insights