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 .
Continued Examination
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 11/25/25 has been entered.
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.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 5 and 7-12 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 5 recites the limitation "said two or more chromatography columns”. There is insufficient antecedent basis for this limitation in the claim.
In regard to claim 7, the limitation “further comprising plural chromatography columns” renders the claim is indefinite; claim 1 previously required “plural chromatography column”, thus the limitation lacks antecedent and it is unclear if more columns are added.
Claim 8 recites the limitations "the plural modules” and “the system housing”. There is insufficient antecedent basis for this limitation in the claim. Claims 9-10 are rejected as well for being dependent on claim 8.
In regard to claim 11, the limitation “and air trap vent and a UV monitor” renders the claim indefinite. The scope of the list is not clear. Claim 12 is rejected as well for being dependent on claim 11.
Claim 12 recites the limitations “a UV light absorption monitor”, “pH monitor”, “the signals”, “the three monitors”. There is insufficient antecedent basis for this limitation in the claim. Claim 13 is rejected as well for being dependent on claim 12.
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-3, 8-11, 14, and 16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Blomberg (US 8,821,718).
With regard to Claim 1, Blomberg discloses an automated fluid handling system comprising a housing and two or more fluid handling units (Abstract). Blomberg discloses a chromatography system comprising: a plurality of modules including at least one pump and a column valve unit connectable to plural chromatography columns (C1/L14-18, the fluid handling system may be a liquid chromatography system; C2/L32-63, the liquid chromatography system comprises a housing, two or more high pressure pumps, a plurality of fluid control valves including a column valve with integrated pressure sensors).
Blomberg discloses a controller, the controller being operable to control the at least one pump and the column valve to perform different chromatographic processes, including chromatography employing just one column, as well as chromatography employing two or more columns by selective valve opening in said column valve unit (C3/L6-16, the two pump heads are controlled by a microprocessor; C4/L14-20, the column valve is used for connection of up to five columns to the system, and to direct the flow onto the column; the valve has a built in bypass capillary that enables bypassing of connected columns; C8/L29-42, the master control unit comprises a system controller for communicating with internal and external components).
Blomberg discloses wherein at least one of said plurality of modules is demountable from an apertured front panel of a housing of the chromatography system (Figure 1, C5/L26-44, the interchangeability of modules provides improved service and upgrade possibilities and also a possibility to customize the positions of the respective liquid handling components, such as the fluid control valves). Therefore, Blomberg clearly suggests that at least one of said plurality of modules is demountable from an apertured front panel of a housing of the chromatography system in order to e.g., optimize the fluid path for a specific experimental setup.
Blomberg discloses wherein the controller is further operable to perform column packing testing of the system without the need to break down fluid conduits of the chromatography system through the column valve unit, capable of providing in-process column packing (C8/L1-28).
It is noted that claims are directed to a “system”, which does not clearly set forth the statutory category to which the invention belongs to. It has been determined that the claims are directed to an apparatus and the appropriate principles for interpreting claims for that particular category of invention have been applied.
Regarding limitations recited in the claims which are directed to a manner of operating disclosed chromatography system, it is noted that neither the manner of operating a disclosed device nor material or article worked upon further limit an apparatus claim. Said limitations do not differentiate apparatus claims from prior art. See MPEP § 2114 and 2115. "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987). Claim analysis is highly fact-dependent. A claim is only limited by positively recited elements. Thus, "[i]nclusion of the material or article worked upon by a structure being claimed does not impart patentability to the claims." In re Otto, 312 F.2d 937, 136 USPQ 458, 459 (CCPA 1963); see also In re Young, 75 F.2d 996, 25 USPQ 69 (CCPA 1935).
With regard to Claim 2, Blomberg discloses wherein said at least one said plurality of modules is mounted in one generally vertical plane, such that liquid connections required between respective modules can be made only at a front face of the chromatography system (Figure 2, C5/L26-35, Figure 2 shows a plurality of modules mounted in one generally vertical plane, such that liquid connections required between respective modules can be made only at a front face of the chromatography system).
With regard to Claim 3, Blomberg discloses wherein said selective valve opening allows a reversal of flow directions in use in one or more of said plural chromatography columns (C4/L21-32, both top and bottom of each column is connected to the column valve; the flow direction can be set either from top to bottom of column or from bottom to top of the columns (reversal of flow directions)).
With regard to Claims 8 and 9, Blomberg discloses wherein the plural modules are interchangeably mountable in apertures of one generally vertical face of the system housing, the modules being adapted for selective fluidic interconnection by tubing, and wherein at least one of said modules includes said column valve unit (Claim 8), wherein the modules are adapted for selective fluidic interconnection by tubing substantially at said one generally vertical face such that in use the modules and tubing occupy a generally vertically extending volume to minimize the footprint of the system (Claim 9) (Figure 2, C5/L26-35, Figure 2 shows a plurality of modules mounted in one generally vertical plane, such that liquid connections required between respective modules can be made only at a front face of the chromatography system; C2/L32-63, the liquid chromatography system comprises a housing, two or more high pressure pumps, a plurality of fluid control valves including a column valve with integrated pressure sensors; Figure 10, C8/L43-56, Figure 10 shows plurality of modules mounted in one generally vertically plane interconnected by tubing).
With regard to Claim 10, Blomberg discloses wherein, other than said one generally vertical face, the system housing has flat or curved faces without joints other than at the edges of the faces (Figure 2, C5/L26-57, at least Figure 2 shows that only one face has the generally vertical face for mounting interchangeable plural modules, with the system housing otherwise having flat or curved faces without joints).
With regard to Claim 11, Blomberg discloses wherein the modules comprise one or more of: a pH monitor; an outlet valve; a conductivity monitor; a column valve; an inlet valve; a system liquid pump; a flow restrictor; a mixer; an air trap; an air trap valve; and air trap vent and a UV monitor (C5/L26-35).
With regard to Claim 14, Blomberg discloses wherein the system includes two liquid pumps, one of said pumps being selectively operable alone or both pumps being selectively operable together, thereby to provide a range of fluid flow which is suitable for more than one mode of chromatography process (C2/L64-C3/L4, the two system pumps may be used individually or in combination to generate isocratic or gradient elution).
With regard to Claim 16, Blomberg discloses wherein the column valve unit further comprises a port (C4/L14-32, column valve will inherently comprise ports for connection of the valve to one or more chromatography columns).
Claim Rejections - 35 USC § 103
Claims 4-5 are rejected under 35 U.S.C. 103 as being unpatentable over Blomberg (US 8,821,718), as applied to the claims above, in view of Iovanni (US 2013/0218352).
With regard to Claims 4 and 5, Blomberg discloses all the limitations in the claims as set forth above.
Blomberg discloses further comprising a controller operable to control said modules (C8/L29-42, the master control unit comprises a system controller, which comprises a suitable CPU, bus controller, external communications controller, and a storage device).
However, Blomberg is silent to the controller operable to control said modules according to software, and further comprising a display screen, said software being suitable to display plural icons on said screen and allowing user manipulation of the icon on the screen to drag and drop the icons to form a series of icons representative of a user defined chromatography control method (Claim 4), wherein the user defined method includes a continuous chromatography process employing said two or more chromatography columns (Claim 5).
Iovanni discloses valves, pumps, detectors, sample loops, fraction collectors, and the like are individually incorporated into modules that are mountable in an interchangeable manner at individual mounting sites on a base unit which also supports one or more chromatography columns (Abstract). Iovanni discloses that certain embodiments of the invention also contain programmable software ([0033]). The software can record the identity and location of each component and display this information on the graphical user interface (GUI) (display) in the forms of icons with the position of each icon on the GUI representing the location of the corresponding component on the mounting frame ([0033]).
Various libraries can contain pre-designed flow schemes and component combinations from which the user can select a particular flow scheme in a drag and drop manner ([0033]).
The Examiner notes that a manner of operation does not further limit an apparatus claim. In Claim 5, “wherein the user defined method includes a continuous chromatography process employing said two or more chromatography columns” is a manner of operation. Said limitations do not differentiate apparatus claims from prior art. See MPEP § 2114 and 2115. See Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App & Inter. 1987) that states a “recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus” if the prior art apparatus teaches all the structural limitations of the claim.
Therefore, the software of Iovanni is suitable to allow user manipulation of the icon on the screens and to form a series of icons representative of a user defined chromatography control method.
It would have been obvious to one of ordinary skill in the art at the effective filing date of the invention for the controller of Blomberg to be operable to control said modules according to software, and further comprising a display screen, said software being suitable to display plural icons on said screen and allowing user manipulation of the icon on the screen to drag and drop the icons to form a series of icons representative of a user defined chromatography control method (Claim 4), wherein the user defined method includes a continuous chromatography process employing said two or more chromatography columns (Claim 5), as taught by Iovanni, in order for the user to select a particular flow scheme in a drag and drop manner.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Blomberg (US 8,821,718), as applied to the claims above, in view of Andersson (EP 1,886,133).
With regard to Claim 7, Blomberg discloses all the limitations in the claims as set forth above.
Blomberg discloses the chromatography system comprising plural chromatography columns (C4/L14-20, the column valve is used for connection of up to five columns to the system, and to direct the flow onto the column; the valve has a built in bypass capillary that enables bypassing of connected columns).
However, Blomberg is silent to each column including a chamber of changeable volume for housing chromatographic separation media and an adapter moveable to increase or decrease said volume, and wherein the valve unit is in fluid communication with each said adapter and is selectively operable to move independently or collectively each said adapter by means of fluid pressure changes to consequently change each said volume and in use to cause compression or relief from compression of media within each said column volume.
Andersson discloses an invention relating to packing devices and methods for improving the packing of chromatography media into chromatography columns ([0001]). Andersson discloses an automated column packing system ([0011]). A movable adapter is movable in the longitudinal direction of the column by an actuator, and the operation of the actuator and the corresponding up or downwards movement of the movable adapter is controllable by the automated control unit ([0011]). The actuator may be a hydraulic actuator (means of fluid pressure changes) ([0011]). The control unit controls the opening and the closing of valves, and the speed and amount of movable adapter movement ([0011]). The automated column packing system can aid the operator of a chromatography system in successfully compressing the bed to allow for a good and robust chromatographic performance, which is particularly difficult to perform manually ([0003]).
It would have been obvious to one of ordinary skill in the art at the effective filing date of the invention for each column of Blomberg to include a chamber of changeable volume for housing chromatographic separation media and an adapter moveable to increase or decrease said volume, and wherein the valve unit is in fluid communication with each said adapter and is selectively operable to move independently or collectively each said adapter by means of fluid pressure changes to consequently change each said volume and in use to cause compression or relief from compression of media within each said column volume, as taught by Andersson, in order to aid the operator of a chromatography system in successfully compressing the bed to allow for a good and robust chromatographic performance, which is particularly difficult to perform manually.
Claims 12-13 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Blomberg (US 8,821,718), as applied to the claims above.
With regard to Claim 12, Blomberg discloses all the limitations in the claims as set forth above. Blomberg discloses that the automated fluid handling system includes a conductivity monitor, UV monitor, and pH valve for enabling in-line monitoring of pH during the run (C4/L33-41).
Blomberg discloses a controller, the controller being operable to control the at least one pump and the column valve to perform different chromatographic processes, including chromatography employing just one column, as well as chromatography employing two or more columns by selective valve opening in said column valve unit (C3/L6-16, the two pump heads are controlled by a microprocessor; C4/L14-20, the column valve is used for connection of up to five columns to the system, and to direct the flow onto the column; the valve has a built in bypass capillary that enables bypassing of connected columns; C8/L29-42, the master control unit comprises a system controller for communicating with internal and external components).
Blomberg discloses that the outlet valve may be used to direct the flow to a fraction collector (C4/L42-46).
However, Blomberg is silent to wherein output from the chromatography column(s) is passed out through a port to a conductivity monitor, a UV light absorption monitor, and a pH monitor, and is thence directed into an appropriate storage vessel in dependence on the signals from the three monitors such that separated fractions are collected in an appropriate vessel.
One of ordinary skill in the art of chromatography would understand that the conductivity, UV, and pH monitors may be used to evaluate the separation of sample components on a chromatography column and make decisions about separating the components into fractions depending on the presence or absence of peaks on the UV monitor or changes in conductivity and pH associated with the components of the sample.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention for wherein output from the chromatography column(s) of Blomberg is passed out through a port to a conductivity monitor, a UV light absorption monitor, and a pH monitor, and is thence directed into an appropriate storage vessel in dependence on the signals from the three monitors such that separated fractions are collected in an appropriate vessel, since an ordinary chromatographer may use the conductivity, UV, and pH monitors to evaluate the separation of sample components on a chromatography column and make decisions about separating the components into fractions depending on the presence or absence of peaks on the UV monitor or changes in conductivity and pH associated with the components of the sample.
With regard to Claim 13, Blomberg discloses that output from the column may be collected on a waste vessel (C4/L42-46). Washing the column is a manner of operation that does not have patentable weight in an apparatus claim. See MPEP § 2114 and 2115. See Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App & Inter. 1987) that states a “recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus” if the prior art apparatus teaches all the structural limitations of the claim.
With regard to Claim 15, Blomberg discloses all the limitations in the claims as set forth above.
Blomberg discloses that the automated fluid handling system includes a conductivity monitor, UV monitor, and pH valve for enabling in-line monitoring of pH during the run (C4/L33-41).
Blomberg discloses a controller, the controller being operable to control the at least one pump and the column valve to perform different chromatographic processes, including chromatography employing just one column, as well as chromatography employing two or more columns by selective valve opening in said column valve unit (C3/L6-16, the two pump heads are controlled by a microprocessor; C4/L14-20, the column valve is used for connection of up to five columns to the system, and to direct the flow onto the column; the valve has a built in bypass capillary that enables bypassing of connected columns; C8/L29-42, the master control unit comprises a system controller for communicating with internal and external components).
Blomberg discloses the interchangeability of modules provides improved service and upgrade possibilities and also a possibility to customize the positions of the respective liquid handling components, such as the fluid control valves (Figure 1, C5/L26-44).
However, Blomberg is silent to the conductivity monitor being placed upstream of the column as a pre-column conductivity monitor.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to place the conductivity monitor of Blomberg upstream of the column as a pre-column conductivity monitor, in order to measure any changes in conductivity in the mobile phase or sample before separation of the sample components on the column.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Blomberg (US 8,821,718), as applied to the claims above, in view of Brann (US 2013/0206653) or Stewart et al (US 2007/0141720).
With regard to Claim 17, Blomberg discloses all the limitations in the claims as set forth above. Blomberg discloses wherein the chromatography system includes control of at least one pump and where the column valve unit is switched to provide fluid flow from the at least one pump in both directions in each of the columns employed (C3/L6-16, the two pump heads are controlled by a microprocessor; C4/L14-20, the column valve is used for connection of up to five columns to the system, and to direct the flow onto the column; the valve has a built in bypass capillary that enables bypassing of connected columns; C8/L29-42, the master control unit comprises a system controller for communicating with internal and external components; C4/L21-32, both top and bottom of each column is connected to the column valve; the flow direction can be set either from top to bottom of column or from bottom to top of the columns (reversal of flow directions)).
However, it is not clear from Blomberg whether configuration of the control of the at least one pump would allow the column valve unit to be switched to provide fluid flow from the at least one pump in both directions in each of the columns employed during a continuous chromatography process. The Examiner notes that the continuous chromatography process itself is not patentable in an apparatus claim. See MPEP § 2114.
Brann discloses a cartridge for chromatography separations comprising a housing (Abstract). Brann discloses that fluid tubing lines may be used for bidirectional flow because sample fractions previously concentrated in a first cleanup column may be released from the column and transferred back to the valve system by back-flushing the column with solvent in the reverse flow direction from that used to load the column ([0014]).
Furthermore, Stewart et al (Stewart) discloses a matrix elimination apparatus for eliminating an acidic matrix including at least one column packed with a weak anion exchange resin (Abstract). Stewart discloses that columns may be regenerated using both flow directions, which ensures the best regeneration possible ([0026]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention for the configuration of the control of the at least one pump of Blomberg to allow the column valve unit to be switched to provide fluid flow from the at least one pump in both directions in each of the columns employed during a continuous chromatography process, as taught by Brann or Stewart, for elution or regeneration of chromatography columns.
Claim 1 is rejected under 35 U.S.C. 103 as being unpatentable over Blomberg (US 8,821,718) in view of Andersson (EP 1,886,133).
With regard to Claim 1, Blomberg discloses an automated fluid handling system comprising a housing and two or more fluid handling units (Abstract). Blomberg discloses a chromatography system comprising: a plurality of modules including at least one pump and a column valve unit connectable to plural chromatography columns (C1/L14-18, the fluid handling system may be a liquid chromatography system; C2/L32-63, the liquid chromatography system comprises a housing, two or more high pressure pumps, a plurality of fluid control valves including a column valve with integrated pressure sensors).
Blomberg discloses a controller, the controller being operable to control the at least one pump and the column valve to perform different chromatographic processes, including chromatography employing just one column, as well as chromatography employing two or more columns by selective valve opening in said column valve unit (C3/L6-16, the two pump heads are controlled by a microprocessor; C4/L14-20, the column valve is used for connection of up to five columns to the system, and to direct the flow onto the column; the valve has a built in bypass capillary that enables bypassing of connected columns; C8/L29-42, the master control unit comprises a system controller for communicating with internal and external components).
Blomberg discloses wherein at least one of said plurality of modules is demountable from an apertured front panel of a housing of the chromatography system (Figure 1, C5/L26-44, the interchangeability of modules provides improved service and upgrade possibilities and also a possibility to customize the positions of the respective liquid handling components, such as the fluid control valves). Therefore, Blomberg clearly suggests that at least one of said plurality of modules is demountable from an apertured front panel of a housing of the chromatography system in order to e.g., optimize the fluid path for a specific experimental setup.
However, Blomberg is silent to wherein the controller is further operable to perform one or more of column packing and column packing testing.
Andersson discloses an invention relating to packing devices and methods for improving the packing of chromatography media into chromatography columns ([0001]). Andersson discloses an automated column packing system ([0011]). A movable adapter is movable in the longitudinal direction of the column by an actuator, and the operation of the actuator and the corresponding up or downwards movement of the movable adapter is controllable by the automated control unit ([0011]). The control unit controls the opening and the closing of valves, and the speed and amount of movable adapter movement ([0011]). The automated column packing system can aid the operator of a chromatography system in successfully compressing the bed to allow for a good and robust chromatographic performance, which is particularly difficult to perform manually ([0003]).
It would have been obvious to one of ordinary skill in the art at the effective filing date of the invention for wherein the controller of Blomberg is further operable to perform one or more of column packing and column packing testing, as taught by Andersson, in order to aid the operator of a chromatography system in successfully compressing the bed to allow for a good and robust chromatographic performance, which is particularly difficult to perform manually.
Response to Arguments
Applicant's arguments filed 11/17/2025 have been fully considered but they are not persuasive.
In regard to the arguments directed towards Blomberg, the Examiner notes the rejection above has been updated in light of the current amendments.
In regard to the applicant’s argument that Andersson does not teach in process column packing, the Examiner notes the rejection above has been updated in light of the current amendments.
Conclusion
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/KARA M PEO/ Primary Examiner, Art Unit 1777