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 Status
Claims 1-17 are pending.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(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.
Claims 1-6, 11-12, 15, and 17 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipate by U.S. 2017/0252672 by Ghosh et al. (Ghosh).
In regard to claim 1, Ghosh teaches a chromatography device (abstract, chromatography device). Ghosh teaches at least one chromatography material unit (abstract, membrane stack; Figure 1, membrane stack 109; [0067]). Ghosh teaches said chromatography material unit comprises a convection-based chromatography material and is of a substantially rectangular shape having a length and a width ([0004], Figure 1, membrane stack 109; [0067]).
Ghosh teaches at least one fluid distribution system (Figure 1, [0067]-[0073]); capable of distributing fluid into and out from the at least one chromatography material unit. Ghosh teahces said fluid distribution system comprises a distribution device and a collection device between which said chromatography material unit is sandwiched (Figure 1, top plate 102, bottom plate 106; [0067]-[0073]).
Ghosh teaches an inlet (Figure 1, inlet 103; [0067]). Ghosh teaches an inlet fluid channel connecting the inlet with each chromatography material unit via the fluid distribution system (Figure 1, inlet 103; [0067]). Ghosh teaches an outlet (Figure 1, outlet 123; [0073]). Ghosh teaches an outlet fluid channel connecting the outlet with each chromatography material unit via the fluid distribution system (Figure 1, outlet 123; [0067]-[0073]).
Ghosh teaches said distribution device and said collection device each comprise a number of discrete parallel grooves (Figure 1, [0067]-[0073]; Figure 2); capable of distribution and collection respectively of a fluid to be passed through the chromatography material unit.
Ghosh teaches parallel grooves are in fluid connection with the inlet and the outlet respectively via an inlet common rail of the distribution device and an outlet common rail of the collection device (Figure 1, [0067]-[0073]; Figure 2). Ghosh teaches said parallel grooves are reaching over substantially the whole length of the chromatography material unit from a first end to a second end of the parallel grooves and are distributed over substantially the whole width of the chromatography material unit (Figure 1, [0067]-[0073]; Figure 2).
Ghosh teaches the parallel grooves are defined within an inner surface of each of the distribution device and the collection device (Figure 1, [0067]-[0073]; Figure 2). Ghosh teaches the inlet and the inlet rail is positioned in a first corner and the outlet and the outlet rail are positioned within a second corner diagonally opposed from the first corner (Figure 1, [0067]-[0073]).
Ghosh teaches said inlet and outlet common rails are fluid channels provided in a perpendicular direction to the direction of the parallel grooves and which inlet and outlet common rails are in fluid connection with the first end of each of the parallel grooves (Figure 1, [0067]-[0073]).
In regard to claim 2, Ghosh teaches said distribution device comprises a distribution plate which is provide abutting an inlet surface of the chromatography material unit (xx). xx teaches said distribution plate comprises the parallel grooves for distributing a fluid feed provided from the inlet of the chromatography device to the chromatography material unit and wherein said collection device comprises a collection plate which is provided abutting an outlet surface of the chromatography material unit (Figure 1, top plate 102, bottom plate 106; [0067]-[0073]). Ghosh teaches wherein said collection plate comprises the parallel grooves for collecting a fluid from the chromatography material unit (Figure 1, top plate 102, bottom plate 106; [0067]-[0073]; Figure 2).
In regard to claim 3, Ghosh teaches said parallel grooves each has a cross-section area which is decreasing from the first end toward the second end ([0124]).
In regard to claim 4, Ghosh teaches said inlet and outlet common rails are provided reaching over substantially the whole width of the chromatography material unit from a first end to a second end of the inlet and outlet common rails (Figure 1, top plate 102, bottom plate 106; [0067]-[0073]; Figure 2). Ghosh teaches the inlet fluid channel is connected to the first end of the inlet common rail such that fluid is provided into the distribution device from a first corner of the fluid distribution system and wherein the outlet fluid channel is connected to the first end of the outlet common rail such that fluid is collected from the collection device from a second corner of the fluid distribution system which second corner is diagonally opposite to said first corner (Figure 1, top plate 102, bottom plate 106; [0067]-[0073]; Figure 2).
In regard to claim 5, Ghosh teaches the inlet common rail and the outlet common rail are provided along opposite side edges of the chromatography material unit (Figure 1, top plate 102, bottom plate 106; [0067]-[0073]).
In regard to claim 6, Ghosh teaches said inlet common rail has a cross-section area which is decreasing from a first end toward a second end of the inlet common rail ([0124]).
In regard to claim 11, Ghosh teaches said chromatography device comprises at least one cassette wherein each cassette comprises a fluid distribution system and a chromatography material unit ([0092]).
In regard to claim 12, Ghosh teaches at least two cassettes which are stacked together and which cassettes each comprises a part of the inlet fluid channel which is in fluid connection with the inlet common rail provided in this cassette and which can be in fluid communication with the inlet of the chromatography device, possibly via one or more other cassettes of the chromatography device ([0092]). Ghosh teaches each cassette comprises a part of the outlet fluid channel which is in fluid connection with the outlet common rail provided in this cassette and which can be in fluid communication with the outlet of the chromatography device possibly via one or more other cassettes of the chromatography device ([0092]).
In regard to claim 15, Ghosh teaches each said chromatography material unit comprises at least one adsorptive membrane ([0061]; [0072]).
In regard to claim 17, Ghosh teaches each chromatography material unit comprises at least one adsorptive membrane sandwiched between at least one top spacer layer and at least one bottom spacer layer or at least two adsorptive membranes stacked above each other and interspaced with spacer layers and sandwiched between at least one top spacer layer and at least one bottom spacer layer ([0077]).
Claims 7 and 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. 2017/0252672 by Ghosh et al. (Ghosh), as noted above.
In regard to claim 7, Ghosh teaches the limitations as noted above. Ghosh does not teach a combined total area of a wall surface provided in between the parallel grooves in the distribution device and the collection device and facing the chromatography material unit is larger than two times the combined total area of the grooves facing the chromatography material unit.
As the chromatography device efficiency of operation, flow pattern, and flow separation are variables that can be modified, among others, by adjusting said distances and surface areas, the precise surface areas and distances 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 surface areas and distances 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 surface areas and distances in the chromatography device of Ghosh to obtain the desired balance between the operation efficiency, flow pattern, and flow separation (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).
In regard to claims 9-10, Ghosh teaches the limitations as noted above. Ghosh does not explicitly teach the holdup volume for the chromatography device is less than 1.5 times the membrane volume of the unit. Ghosh does not explicitly teach the outlet common rail has a larger fluid volume than the inlet common rail (claim 10).
Ghosh teaches reducing dead volume ([0077]). Ghosh teaches changing the size of the feed and permeate channels affects dead volume ([0111]). Ghosh teaches tuning the dimensions of the inlet and outlet to reduce the dead volume in addition to adjusting for priming and removing bubbles ([0113]).
As the chromatography device efficiency of operation, flow pattern, and flow separation are variables that can be modified, among others, by adjusting said hold up volume, the precise holdup volume and outlet/inlet volumes 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 holdup volume 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 holdup volume in the chromatography device of Ghosh to obtain the desired balance between the operation efficiency, flow pattern, and flow separation (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).
Claims 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. 2017/0252672 by Ghosh et al. (Ghosh), as noted above, in view of U.S. Patent Publication No. 2017/0259189 by de los Reyes (Reyes).
In regard to claim 13, Ghosh teaches the limitations as noted above. Ghosh further teaches multiple chromatography systems can be operated in series so that a continuous stream is delivered ([0092]). Ghosh teaches a first end plate and a second end plate between which said at least two cassettes are provide ([0072]; [0089]).
Ghosh does not teach a locking member.
Reyes teaches a series of chromatography units are attached using fasteners ([0057]). It would be obvious to one of ordinary skill in the art at the time the invention was effectively filed to incorporate fasteners (locking members), as taught by Reyes, in the device of modified Ghosh as it is a known way to attach a series of plates in a chromatography system.
In regard to claim 14, Ghosh teaches the limitations as noted above. Ghosh further teaches multiple chromatography systems can be operated in series so that a continuous stream is delivered ([0092]). Ghosh teaches the plates are sealed when sandwiched together ([0072]; [0089]).
Ghosh does not teach an elastomeric seal on the outer perimeter for sealing the distribution device and the connection device and surrounding parallel grooves.
Reyes teaches an elastomeric sealing provide to an outer perimeter of the chromatography material unit for sealing against the distribution device and the collection device and surrounding parallel grooves ([0029]-[0031]; [0058]-[0065]).
It would be obvious to one of ordinary skill in the art at the time the invention was effectively filed to incorporate elastomeric seals, as taught by Reyes, in the device of modified Ghosh as it is a known way to attach a series of plates in a chromatography system and prevent leaking.
Claims 8 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. 2017/0252672 by Ghosh et al. (Ghosh), as noted above, in view of WO2018/037244 by Williams et al. (Williams).
In regard to claim 8, Ghosh teaches the limitations as noted above. Ghosh does not teach the parallel grooves each has a width being less than 1.5 mm or the parallel grooves are spaced apart at more than 2 mm.
Williams teaches the parallel grooves each has a width being less than 1.5 mm (P14/L41-45). Williams teaches the parallel grooves are spaced apart at more than 2 mm (P14/L3-10).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to utilize grooves with a width less than 1.5 mm and spaced apart at more than 2 mm, as taught by Williams, in the chromatography unit of Ghosh as it is a known configuration for chromatography separation units and spacing of grooves.
In regard to claim 16, Ghosh teaches the limitations as noted above. Ghosh does not teach said adsorptive membrane is a polymer nanofiber membrane.
Williams teaches said adsorptive membrane is a polymer nanofiber membrane (P20/L30-39; P21/L2-6).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to utilize a polymer nanofiber membrane, as taught by Williams, in the chromatography unit of Ghosh as it is a known adsorptive membrane composition.
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
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.
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/KARA M PEO/Primary Examiner, Art Unit 1777
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