DETAILED ACTION
The present application is being examined under the pre-AIA first to invent provisions.
Claim Status
Claims 1-3, 5-7, and 9-10 are pending. Claims 4, 8, and 11-22 are cancelled.
Claim Rejections - 35 USC § 103
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, 5-7, and 9-10 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over U.S. Patent Publication No. 2010/0176058 by Bryntesson et al. (Bryntesson), previously published as PCT/SE08/00393 on 12/18/2008, in view of U.S. Patent Publication No. 2009/0149638 by Ley et al. (Ley), further in view of U.S. Patent Publication No. 2008/0116122 by Wheelwright et al. (Wheelwright).
It is noted that the 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.
A preamble is generally not accorded any patentable weight where it merely recites the purpose of a process or the intended use of a structure, and where the body of the claim does not depend on the preamble for completeness but, instead, the process steps or structural limitations are able to stand alone. See In re Hirao, 535 F.2d 67, 190 USPQ 15 (CCPA 1976) and Kropa v. Robie, 187 F.2d 150, 152, 88 USPQ 478, 481 (CCPA 1951). This applies to the following limitation: “for separating biopolymers” (claim 1).
In regard to claim 1, Bryntesson teaches a chromatography system (Figure 1-5; [0016]-[0020]; [0002]; [0003]); capable of separating biopolymers.
Byntesson teaches a group of chromatography columns, each column having at least one inlet end and at least one outlet end (Figures 1-5; specifically Figure 5, columns, three column periodic counter current system; [0074]). Bryntesson teaches the first and second chromatography column are packed with a first and second resin which are the same kind, comprising the same kind of packing material ([0031]; [0037]). Bryntesson does not explicitly state the columns are identical; however, one of ordinary skill in the art at the time of the invention would be motivated to incorporate identical resins in order to achieve desired separation parameters such as purity. Furthermore, mere duplication of parts has no patentable significance, unless a new and unexpected result is produced, since it involves only routine skill in the art. In re Harza, 124 USPQ 378, 380 (CCPA 1960). Further, it has been held that mere duplication of the essential working parts of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8.
Byntesson teaches a system of tanks comprising a feed tank (Figure 1, feed; [0016]-[0020]), an elution buffer tank ([0058]-[0059]), and an eluate tank ([0074], eluted protein A was collected). Bryntesson teaches a regeneration tank (Figure 4; [0019]); capable of performing a regeneration process.
Byntesson teaches a feed disposed in the at least one feed tank (Figure 1, flow path for feed solution; [0016]-[0020]; [0024]); the feed is capable of comprising a target biopolymer.
Bryntesson teaches a group of pumps each being fluidically connected to a column of the group of columns (Figures 1-5; specifically Figure 5, two independent pumps; [0074]).
Byntesson teaches an outlet detector fluidically connected to each column of the group of column (Figures 1-5; specifically Figure 5, 3 UV detectors, pH and conductivity meters; [0074]).
Bryntesson teaches a control unit (Figures 1-5; specifically Figure 5; [0074]; [0068]). Bryntesson teaches the control unit is connected to at least one valve of a system of valves, the pump, and the outlet detector (Figures 1-5; specifically Figure 5; [0074]; [0068]).
Byntesson does not teach at least two hold tanks; comprising a first and second hold tank; wherein every one of the at least two chromatography columns of the system is downstream of one or more of the at least two hold tanks. Byntesson does not teach the first hold tank of the group of hold tanks fluidically connected to at least one inlet end of a first chromatography column and at least one inlet end of a second chromatography column; wherein each of the first chromatography column and the second chromatography column independently is downstream of the first hold tank, the second hold tank, or the first and second hold tank. Bryntesson does not teach the hold tank is connected to the inlet end of a column via a pump of the group of pumps. Bryntesson does not teach each hold tank of the group of hold tanks is configured to function as a temporary storage vessel to handle any mismatch flows between a first column and a second column; functioning as a buffer reservoir to accommodate fluid and at least about 50% smaller than each of the feed tank and elution buffer tank. Bryntesson does not teach the hold tanks are configured to receive fluid from the at least one outlet end of the first chromatography column after a biopolymer concentration thereof has reached a first predetermined level as measured by the corresponding outlet detector, convey fluid to the at least one inlet end of the second chromatography column for further separation and temporarily hold the fluid to balance the flow rates between the first and second column when there is a mismatch of flow rates.
Ley teaches an apparatus for antibody production and purification ([0002]-[0003]; [0007]-[0011]). Ley teaches an apparatus for protein purification with packed bed chromatography ([0008]). Ley teaches two chromatography columns in series with a feed and an eluate (Figure 1; culture, second column 36, second eluate 40, third column 60, third eluate 64 [0033]-[0036]). Further, Ley teaches a group of hold tanks between chromatography columns (holding tank 30, holding tank 44, [0033]-[0036]). Ley teaches a group of hold tanks fluidically connected to at least one inlet end of one column and at least one outlet end of a second column (second column 36, holding tank 30, second column 36, third column 60, holding tank 44, [0033]-[0036]). Ley teaches a hold tank adapted to receive fluid from an outlet of a first column and convey fluid to the inlet of the second column (holding tank 30, holding tank 44, [0033]-[0036], second column 36; holding tank 44, second column 36, third column 60; [0033]-[0036]). Ley teaches the hold tanks are capable of functioning as a temporary storage vessel to handle any mismatch of flows between the first and second columns (holding tank 30, holding tank 44, [0033]-[0036], second column 36, third column 60). Ley teaches that the conditions of the eluate streams are manipulated for further desired elution through another chromatography column in series ([0033]-[0036]). Ley teaches wherein every one of the at least two chromatography columns of the system is downstream of one or more of the at least two hold tanks (Figure 1, holding tank 30, holding tank 44, [0033]-[0036], second column 36, third column 60). The holding tank is located in between chromatography columns in order to achieve desired elution conditions (dilute, concentrated, basic, acidic, neutral); the hold tank is thus capable of providing storage between each column of the at least two chromatography columns. Ley teaches the hold tank comprises a level indicator (holding tank 30, holding tank 44, [0033]-[0036]; holding tank 30 is a viral inactivation tank; Figures 2-8A show concentration plots; [0023]-[0029]); the level indicator of modified Bryntesson is connected to the control unit and capable of preventing overfilling of the hold tank. Ley teaches the first hold tank of the group of hold tanks has a first end connected to the inlet end of a first column of the group of chromatography columns and a second end connected to an outlet end of the third column of the group of chromatography columns; a second hold tank has one end connected to the inlet end of a second column and a second end connected to the outlet end of the first column; a third hold tank has a first end connected to the inlet end of a third chromatography column and a second end connected to the outlet of the second column (holding tank 30, holding tank 44, [0033]-[0036], second column 36, third column 60). Ley teaches each hold tank of the group of hold tanks is adapted to receive a fluid from the outlet of one column of the group of columns and convey fluid to the inlet of a second column (holding tank 30, holding tank 44, [0033]-[0036], second column 36, third column 60). Ley teaches the first and the second chromatography columns are independently downstream of the first hold tank, the second hold tank, or the first and second hold tank (holding tank 30, holding tank 44, [0033]-[0036], second column 36, third column 60).
It would have been obvious for one of ordinary skilled in the art at the time the invention was made to incorporate the hold tanks, as taught by Ley, between the series of chromatography columns of Bryntesson in order to achieve the desired elution conditions for subsequent separations. The hold tank of modified Bryntesson will be fluidically connected to the inlet end of a column via a pump, each pump having a first end directly connected to the inlet end of the column and a second end directly connected to the hold tank of the at least one pump and the outlet end of the at least one outlet detector. One of ordinary skill in the art at the time the invention was made filed would be motivated to chose the size of the tanks based on system parameters and the volume of fluid processed.
Bryntesson does not teach a peristaltic pump.
Wheelwright teaches a peristaltic pump (Figure 1, peristaltic pump 6; [0005]-[0007]; [0011]; [0044]-[0048]). Wheelwright teaches that the peristaltic pump can be a MasterFlex® L/S Positive Displacement Peristaltic Pump. While Wheelwright does not explicitly teach that the peristaltic pump is a multichannel pump; one of ordinary skill in the art at the time of the invention would be motivated to use multiple channels in the packed bed chromatography system to deliver multiple solvents without contamination. Mere duplication of parts has no patentable significance, unless a new and unexpected result is produced, since it involves only routine skill in the art.
It would have been obvious to one ordinary skilled in the art at the time the invention was made to incorporate a peristaltic pump, as taught by Wheelwright, in the system of modified Byrntesson as peristaltic pumps are known pumping system is biopolymer separations.
Regarding limitations recited in the claims which are directed to a manner of operating 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). This applies to the following limitations: “a target biopolymer wherein the target biopolymer is disposed in the at least one feed tank”.
In regards to claim 2, Bryntesson does not teach the control system is controlled electrically, pneumatically, or hydraulically.
Wheelwright teaches a packed bed chromatography system comprising a control unit ([0007]; [0025]) which is electrically connected to the system of valves ([0007]; [0025]).
It would be obvious to one of ordinary skill in the art at the time the invention was made to incorporate an electrical control system, as taught by Wheelwright, in the system of modified Byrntesson as electrical control is a known way to control chromatographic systems.
In regard to claim 3, Bryntesson teaches a wash buffer tank (Figure 3; [0018]).
In regard to claim 5-6, Bryntesson teaches the resin is a proteinaceous ligand such as Protein A which binds a biopolymer ([0031]; [0037]).
In regards to claim 7, Bryntesson teaches the chromatography system comprises disposable flow paths ([0053]). The term "disposable" is not particularly limiting in the absence of a special definition from the instant specification. The applicant's specification does not have a special definition for the term "disposable". The flow paths of Bryntesson are capable of being disposed of.
In regards to claims 9-10, Bryntesson does not teach pinch valves.
Wheelwright teaches the system of valves are pinch valves (Figure 1, pinch valves 8; [0054]). Wheelwright teaches pinch valves are used in order to control the flow of fluids through the flow path without forming direct contact with the materials in the tubing.
It would be obvious to one of ordinary skill in the art at the time the invention was made to incorporate a pinch valve, as taught by Wheelwright, in the system of modified Byrntesson as pinch valves are known valves system use to control fluid flow without direct contact and contamination.
Response to Arguments
Applicant's arguments filed 1/23/2026 have been considered but are not relevant to the current rejection.
In regard to the Applicants’ argument that column 1 of Ley is not downstream of any reservoir that is a holding tank; the Examiner does not find this persuasive.
The claim requires “at least two hold tanks, wherein every one of the at least two chromatography columns of the system is downstream of one or more of the at least two hold tanks”. The claim requires “every one of the at least two chromatography columns” which the Examiner interprets as the two chromatography columns (not all the columns in the whole system). The two chromatography columns of Ley are “downstream of one or more of the at least two hold tanks”.
The Rejection is not mapped to column 1 of Ley but is mapped to columns 2 (second column 36; [0033]-[0036]) and 3 (third column 60; [0033]-[0036]) which satisfy the claim limitations. Furthermore, column 1 is downstream of holding tank 20 ([0034]) which also meets the claim limitation.
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 KARA M PEO whose telephone number is (571)272-9958. The examiner can normally be reached on 9 to 5:30.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Claire Wang can be reached on 571-270-1051. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/KARA M PEO/Primary Examiner, Art Unit 1777
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