Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claim Status
Claims 1-7, 11, 13-17, and 20-21 are pending.
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 1-2, 5-7, and 11 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over U.S. Patent No. 7642089 by Pieper et al. (Pieper) in view of WO2006/119435 by Pope et al. (Pope) as evidenced by Wikipedia “Microparticle” and further in view of U.S. Patent Publication No. 2010/0176058 by Bryntesson et al. (Bryntesson).
In regard to claims 1-2, Pieper teaches a chromatography system (Figure 2; C2/L48-49). Pieper teaches a main column comprising a chromatography resin (Figure 2, see annotation below; C2/L48-49). Pieper teaches a guard column (Figure 2, see annotation below; C2/L48-49). Pieper teaches a secondary column (Figure 2, see annotation below; C2/L48-49). Pieper teaches the guard column is connected to a first end of the main column (Figure 2, see annotation below; C2/L48-49). Pieper teaches the secondary column is connected to a second end of the main column (Figure 2, see annotation below; C2/L48-49).
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In an alternative embodiment, Pieper teaches a chromatography system (Figure 1; C2/L44-47; C18/L11-25). The chromatography system has a main column (Figure 1, column 2; C18/L11-25), a first guard column before the main column (figure 1, column 1; C18/L11-25), and a third successive column (Figure 1, column 3; C18/L11-25). Further, Pieper teaches multiple UV concentration detectors at different positions in the chromatography system configured to determine a concentration of all substances in the streams (Figure 1, D1, D2, D3; C18/L11-25; reading on claim 2). Pieper teaches a first concentration detector connected between a guard column and a main column (Figure 1, column 1, D1, column 2; C18/L11-25). Pieper also teaches a concentration detector connected between the main column and the second guard column (Figure 1, column 2, column 3, D2; C18/L11-25). Pieper teaches the detector are UV concentration detectors and they measure the saturation process as well as being used to determine binding capacity (C18/L23-25; C21/L7-19). Pieper teaches the UV readings are further used to control reproducibility and column performance (C22/L62-63). One of ordinary skill in the art would recognize that the first signal is a feed signal being representative of the composition of a feed material provided to the first end of the main column (reading on claim 3). One of ordinary skill in the art would recognize that the second signal is an effluent signal being representative of the composition of an effluent from the second end of the main column (reading on claim 3).
It would have been obvious to one of ordinary skill in the art at the time of the invention to have incorporated UV concentration detectors, as shown in Figure 1, between the first guard column and the main column and between the second end of the main column and the second guard column in Figure 2 in order to measure the saturation process, determine binding capacity, and control reproducibility and column performance of each individual column.
Pieper teaches the guard column and the secondary column each comprise the same type of chromatography resin as the chromatography resin in the main column (Figure 2; C2/L48-49, affinity chromatography column). Pieper teaches the main column, the guard column, and the secondary column comprise a chromatography resin with Fc fragment-binding affinity ligands (C7/L13-20).
Pieper teaches microparticles (C6/L46-60). Pieper does not explicitly teach an average particle size of 50-100 microns. Pope teaches chromatography system (abstract, [0019], [0115]). Pope teaches a main column comprising a chromatography resin (abstract, [0019], [0115]). Pope teaches removing proteins ([0115]). Pope teaches microparticles with an average particle size of 50-100 microns ([0115], 65 microns).
It would be obvious to one of ordinary skill in the art at the time of the invention to utilize particles with an average particle size of 50-100 microns, as taught by Pope, in the system of Pieper as it is a known microparticle size for the separation of proteins.
Additionally, Wikipedia provides evidence that microparticles are particles between 0.1 and 100 microns in size.
Furthermore, as the chromatography system cost of construction and efficiency of operation are variables that can be modified, among others, by adjusting said average particle size, the average particle size would have been considered a result effective variable by one having ordinary skill in the art at the time the invention was made. As such, without showing unexpected results, the claimed average particle size cannot be considered critical. Accordingly, one of ordinary skill in the art at the time the invention was made would have optimized, by routine experimentation, the average particle size in the apparatus of Pieper to obtain the desired balance between the construction cost and the operation efficiency (In re Boesch, 617 F.2d. 272, 205 USPQ 215 (CCPA 1980)), since it has been held that where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. (In re Aller, 105 USPQ 223).
Pieper teaches separation is dependent on volume and void volume (C6/L41-46). Pieper teaches binding capacity it related to volume of matrix (C12/L38-55). Pieper binding capacity and efficiency of removing particulates is related to volume (C12/L38-55). Pieper does not explicitly teach the main column has a volume of at least one liter. As the chromatography system binding capacity and efficiency of removal are variables that can be modified, among others, by adjusting said column volume, the column volume would have been considered a result effective variable by one having ordinary skill in the art at the time the invention was made. As such, without showing unexpected results, the claimed column volume size cannot be considered critical. Accordingly, one of ordinary skill in the art at the time the invention was made would have optimized, by routine experimentation, the column volume in the apparatus of Pieper to obtain the desired balance between the binding capacity and the removal efficiency (In re Boesch, 617 F.2d. 272, 205 USPQ 215 (CCPA 1980)), since it has been held that where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. (In re Aller, 105 USPQ 223).
Further, Bryntesson teahces a multi column chromatography system (abstract). Bryntesson teaches the volume of the adsorbent is at least 1 liter ([0051]). Bryntesson teaches large volumes provide advantages for large scale biopharmaceutical processes ([0051]).
It would be obvious to one of ordinary skill int eh art at the time of the invention to incorporate at least a liter volume, as taught by Brytnesson, in the system of modified Pieper as it is a known volume of multi columns system for protein separation utilizing affinity chromatography.
In regard to claims 5-6, Pieper teaches a chromatography system (Figure 1; C2/L44-47; C18/L11-25). The chromatography system has a main column (Figure 1, column 2; C18/L11-25), a first guard column before the main column (Figure 1, column 1; C18/L11-25), and a third successive column (Figure 1, column 3; C18/L11-25). Pieper teaches the first guard column is connected to a feed tank (Figure 1, “solvents” tank) through a first valve (Figure 1, V1; C18/L11-25) and the final column is connected to a waste receptacle (C14/L60-62).
Pieper teaches the first guard column is connected to a first waste receptacle through a first valve (Figure 1, “antiserum” tank) through a first valve (Figure 1, V1; C18/L11-25) and the final column is connected to a second feed tank (C14/L62-64; “bound associated proteins are then directly analyzed or eluted and analyzed by any of the techniques known per se to determine their identity”). One of ordinary skill in the art would recognize that if the proteins are eluted and analyzed, they would be transferred to a tank beforehand.
In regard to claim 7, Pieper teaches a third valve between the main column and the first guard column (Figure 1, V2; C18/L11-25). V2 is capable of diverting fluid from the main column to a tank. Pieper teaches a fourth valve between the main column and the second guard column (Figure 1, V3; C18/L11-25). V3 is capable of diverting fluid from the main column to an eluate tank or waste receptacle.
In regard to claim 11, Pieper teaches the bed column of the guard column is smaller than the bed volume of the main column (Figure 1; C18/L11-25). Pieper does not explicitly teach the bed volume of the guard and secondary column are each less than about 50% of the bed volume of the main column. Since the instant specification is silent to unexpected results, it would have been obvious to one of ordinary skill in the art to change the bed volume of the main column, since such a modification would have involved a mere change in the size (or dimension) of a component. A change in size (dimension) is generally recognized as being within the level of ordinary skill in the art. In re Rose, 220 F.2d 459, 105 USPQ 237 (CCPA 1955). Where the only difference between the prior art and the claims is a recitation of relative dimensions of the claimed device, and the device having the claimed dimensions would not perform differently than the prior art device, the claimed device is not patentably distinct from the prior art device, Gardner v. TEC Systems, Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984). It is well known in the art that the larger the bed volume of a chromatography column the more volume the column can accommodate and that many design parameters are taken into consideration when considering the volume of the column, such as flux and desired purity. It would be obvious to tune the bed volume of the guard columns in relation to the bed volume of the main column in order to accommodate design parameters and purification standards.
Claims 3-4 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over U.S. Patent No. 7642089 by Pieper et al. (Pieper) in view of WO2006/119435 by Pope et al. (Pope) as evidenced by Wikipedia “Microparticle” and further in view of U.S. Patent Publication No. 2010/0176058 by Bryntesson et al. (Bryntesson), as noted above, further in view of U.S. Patent No. 6344172 by Afeyan et al. (Afeyan).
In regard to claim 3-4¸ Pieper teaches the UV readings are further used to control reproducibility and column performance (C22/L62-63). One of ordinary skill in the art would recognize that the first signal is a feed signal being representative of the composition of a feed material provided to the first end of the main column (reading on claim 3). One of ordinary skill in the art would recognize that the second signal is an effluent signal being representative of the composition of an effluent from the second end of the main column (reading on claim 3). Pieper teaches the determining unit can detect a breakthrough point based on signals from the detector (C14/L1-20; C18/L11-25; reading on claim 4).
Pieper does not explicitly teach the detector is electronically connected to the determining unit.
Afeyan teaches a detector is electronically connected to a determining unit and UV detectors (C12/L32-40). It would be obvious to one of ordinary skill in the art at the time the invention was effectively filed to incorporate electronic connections, as taught by Afeyan, in the chromatography system of Pieper as it is a known way to connect UV detectors in the art of affinity chromatography systems.
Response to Arguments
Applicant’s arguments with respect to claims have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
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/KARA M PEO/Primary Examiner, Art Unit 1777
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