DETAILED ACTION
Status of Claims:
Claims 1-10 and 12-16 are pending.
Claim 1 is amended.
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 Under 37 CFR 1.114
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 01/30/2026 has been entered.
Response to Arguments
Applicant’s arguments, see Remarks, filed 01/30/2026, with respect to the rejection(s) of claim(s) 1-10 and 12-16 under 35 USC 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of the previously cited prior art, and further in view of Allen, Jr (USPN 4,537,217). Allen teaches a distribution system comprising a plate abutting an inlet surface of a chromatography material unit, the plate comprising a plurality of openings defining fluid channels, wherein said opening are connected to a distribution device inlet through at least one fluid conduit defining two or more interconnected fluid flow channels, wherein the plate abuts a surface of the fluid conduit such that each opening of the plurality of openings are directly aligned with one or more endpoints of the two or more interconnected channels (See Allen figs. 8 and 9, col. 6 lines 37-66).
Claim Rejections - 35 USC § 103
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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1, 7, 9, and 12-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hurwitz et al (WO 00/550888) in view of Allen, Jr (USPN 4,537,217).
Regarding Claim 1:
Hurwitz teaches the chromatography device comprising: - at least one chromatography material unit (porous medium module 20) (see pg. 8 lines 10-12), wherein said chromatography material unit comprises a convection-based chromatography material (membrane) (see pg. 11 lines 29-30); - at least one fluid distribution system which is configured to distribute fluid into and out from the at least one chromatography material unit (first flow distributor arrangement 52 and second flow distributor arrangement 54) (see pg. 9 lines 3-6); - an inlet (inlet 12); - at least one inlet fluid channel (passage 16) connecting the inlet with each chromatography material unit via the fluid distribution system (see pg. 8 line 29- pg. 9 line 2, fig, 1); - an outlet (outlet 14); and - at least one outlet fluid channel (passage 18) connecting the outlet with each chromatography material unit via the fluid distribution system (see pg. 8 line 29- pg. 9 line 2, fig, 1), wherein at least some parts of said chromatography device are overmolded and sealed together(sealant 24 around stacked porous media 22) (see pg. 10 lines 26-30) by plastic (thermoplastic) (see pg. 14 lines 6-10) or elastomer leaving at least the inlet and the outlet open (inlet and outlet function, therefore they are open), and wherein said fluid distribution system comprises a distribution device which comprises a plate which is provided abutting an inlet surface of the chromatography material unit (medium support 30).
Hurwitz does not teach each of the at least one fluid distribution systems comprise a distribution device comprising a plate abutting an inlet surface of each of the chromatography material units, the plate comprising a plurality of openings defining fluid channels therein for distributing a fluid feed provided from the inlet of the chromatography device to the chromatography material unit, wherein a total area of said openings in the plate is less than 20% of the area of the plate, wherein said openings are connected to a distribution device inlet via at least one fluid conduit defining two or more interconnected fluid flow channels, wherein the plate abuts a surface of the fluid conduit such that each opening of the plurality of openings are directly aligned with one or more endpoints of the two or more interconnected channels of the at least one fluid conduit to pass fluid from the openings, through the two or more interconnected fluid flow channels of the at least one fluid conduit, and to the distribution device inlet, channels of the at least one fluid conduit.
Allen each a chromatography device (see col. 1 lines 6-11)comprising at least one fluid distribution system, wherein each of the at least one fluid distribution systems comprise a distribution device comprising a plate (underlying plate 86) (see col. 6 lines 59-66) abutting an inlet surface of each of the chromatography material units, the plate comprising a plurality of openings (distribution openings 0’’’) (see col. 6 lines 63-66) defining fluid channels (channels C’’’ in plate 86) (See col. 6 lines 67-68) therein for distributing a fluid feed provided from the inlet of the chromatography device to the chromatography material unit, wherein said openings are connected to a distribution device inlet via at least one fluid conduit defining two or more interconnected fluid flow channels (coplanar channels C’’) (see col. 6 lines 50-55), wherein the plate abuts a surface of the fluid conduit such that each opening of the plurality of openings are directly aligned with one or more endpoints of the two or more interconnected channels of the at least one fluid conduit to pass fluid from the openings (fluid flows directly into the beginning points P of a correspondingly numbered series of channels C’’’ formed in underlying plate 86) (see col. 6 lines 59-63), through the two or more interconnected fluid flow channels of the at least one fluid conduit, and to the distribution device inlet, channels of the at least one fluid conduit (see figs. 8 and 9 annotated below).
Allen does not explicitly teach a total area of said openings in the plate is less than 20% of the area of the plate. Allen further teaches that there are only three concentric circles of openings within the plate and that the spacing of the openings is controlled to ensure even flow to the openings (see col. 7 lines 1-30). Therefore it would have been obvious to have said openings in the plate is less than 20% of the area of the plate. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). The discovery of an optimum value of a known result effective variable, without producing any new or unexpected results, is within the ambit of a person of ordinary skill in the art. See In re Boesch, 205 USPQ 215 (CCPA 1980) (see MPEP § 2144.05, II.). Further the applicant has not identified any significance or unexpected results with respect to the area of the openings being less than 20% of the total area.
Hurwitz and Allen are analogous inventions in the art of chromatography devices. It would have been obvious to one skilled in the art to replace the distribution device of Hurwitz with the distribution device of Allen because it allows for a low pressure drop while ensuring uniform distribution (see Allen col. 2 lines 25-35) and a low pressure drop within the distribution device is desirable in Hurwitz (see pg. 17 lines 13-17). Further it is the simple substitution of one know distribution system with another distribution system, obviously resulting in fluid distribution into a chromatography column with an expectation of success, and the device of Allen is designed to be incorporated into other chromatography devices (see Allen col. 2 lines 38-43). The simple substitution of one known element for another is likely to be obvious when predictable results are achieved. See KSR International Co. v. Teleflex Inc., 550
U.S. __,__, 82 USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, B.).
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Regarding Claim 7:
Hurwitz, as modified, teaches the chromatography device according to claim 1, wherein each of the at least one chromatography material units comprises at least one adsorptive membrane (used for adsorptive separation, therefore the membrane is adsorptive) (see Hurwitz pg. 4 lines 11-12, pg. 12 lines 5-9).
Regarding Claim 9:
Hurwitz, as modified teaches the chromatography device according to claim 1, wherein each chromatography material unit comprises at least one adsorptive membrane (porous medium module) sandwiched between at least one top spacer layer and at least one bottom spacer layer (opposed plates 42 and 44) (see Hurwitz pg. 8 lines 20-30) 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.
Regarding Claim 12:
Hurwitz, as modified, teaches the chromatography device according to claim 1, wherein said fluid distribution system comprises a collection device (lower fluid distributor as modified by Allen) (see Allen col. 4 lines 9-12, col. 6 lines 36-36) which comprises a plate (low4er identical plate 86) which is provided abutting an outlet surface of the chromatography material unit wherein said plate comprises a number of openings for collecting a fluid from the chromatography material unit, wherein said openings are connected to a collection device outlet via one or more fluid conduits provided in the collection device (see Allen col. 16 lines 33-66).
Hurwitz, as modified, does not explicitly teach wherein a total area of said openings in the plate is smaller than the rest of the area of the plate. Allen further teaches that there are only three concentric circles of openings within the plate and that the spacing of the openings is controlled to ensure even flow to the openings (see Allen col. 7 lines 1-30). Therefore it would have been obvious to have said openings in the plate is less than the total are of the rest of the plate. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). The discovery of an optimum value of a known result effective variable, without producing any new or unexpected results, is within the ambit of a person of ordinary skill in the art. See In re Boesch, 205 USPQ 215 (CCPA 1980) (see MPEP § 2144.05, II.). Further the applicant has not identified any significance or unexpected results with respect to the area of the openings being less than 20% of the total area.
Regarding Claim 13:
Hurwitz, as modified, teaches the chromatography device according to claim 1.
Hurwitz is silent as to the total volume of inlet and outlet fluid channels.
wherein a total volume of inlet and outlet fluid channels in the chromatography device including fluid conduits in the at least one fluid distribution system of the chromatography device is less than 20% of the volume of the chromatography material in the chromatography material unit.
Hurwitz further teaches that the configurations of the support (fluid distribution channels are in the supports) (see Hurwitz pg. 9 lines 3-15) can be adjusted for the desired function and that the desired function is as a flow distributor (see Hurwitz pg. 16 lines 1-8). Therefore, it would have been obvious to one skilled in the art to adjust the volume of the channels wherein a total volume of inlet and outlet fluid channels in the chromatography device including fluid conduits in the at least one fluid distribution system of the chromatography device is less than 20% or less than 10% of the volume of the chromatography material in the chromatography material unit. “[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation.” See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). The discovery of an optimum value of a known result effective variable, without producing any new or unexpected results, is within the ambit of a person of ordinary skill in the art. See In re Boesch, 205 USPQ 215 (CCPA 1980) (see MPEP § 2144.05, II.).
Regarding Claim 14:
Hurwitz, as modified, teaches the method for producing a chromatography device according to claim 1, said method comprising the steps of: providing said at least one chromatography material unit (plurality of stacked porous media 22) in the chromatography device; overmolding and sealing together (providing sealant 24 around the periphery) (see Hurwitz pg. 10 lines 24-30) by plastic or elastomer (thermoplastic) (see Hurwitz pg. 14 lines 6-10) leaving at least the inlet and the outlet open (inlet and outlet function, therefore they are open).
Regarding Claim 15:
Hurwitz, as modified, teaches the method according to claim 14, further comprising the steps of: providing each chromatography material unit together with a fluid distribution system in a cassette, wherein said chromatography material unit is sandwiched between a distribution device and a collection device of said fluid distribution system in each cassette (first and second flow distributor arrangements 52 and 54) (see Hurwitz pg. 9 lines 3-7); overmolding each cassette (providing sealant 24 around the periphery) (see Hurwitz pg. 10 lines 24-30); and providing said at least one cassette in a housing (module holder 40) (see pg. 10 lines 7-10) of said chromatography device, said housing comprising said inlet, said outlet (see fig. 1), said at least one inlet fluid channel and said at least one outlet fluid channel and said housing comprising at least a top plate and a bottom plate (porous media supports 30 and 32) between which said at least one cassette is provided (see pg. 11 lines 5-9).
Claim(s) 2-5 and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hurwitz et al (WO 00/550888) and Allen, Jr (USPN 4,537,217) as applied to claim 1 above, and further in view of Conroy et al (USPN 6,001,253).
Regarding Claim 2:
Hurwitz, as modified, teaches the chromatography device according to claim 1, wherein said chromatography device further comprises a housing (module holder 40) (see Hurwitz pg. 10 lines 7-9) which the at least one chromatography material unite is provided, said housing comprising said inlet, said outlet, said at least one inlet fluid channel and said at least one outlet fluid channel (see fig. 1), wherein said housing comprises at least a top plate and a bottom plate (plates 42 and 44) between which said at least one chromatography material unit is provided (see Hurwitz pg. 10 lines 7-9).
Hurwitz does not explicitly teach the chromatography device after the overmolding can withstand an operating pressure of at least 10 bar or at least 15 bar. Hurwitz further teaches that clamps or bolts can be used to secure the housing (see pg. 34 lines 18-24) and that the system can be designed to operate at different pressures (see pg. 11 lines 18-19).
Conroy teaches a chromatography unit able to withstand at least 10 bar (greater than 10 to 15 bar) (See col. 2 lines 8-10).
Hurwitz and Conroy are analogous inventions in the art of chromatography units. It would have been obvious to one skilled in the art to adjust the seals on the housing of Hurwitz to withstand at least 10 bar in order to accommodate different flow rates and pressure drops within the device (see Hurwitz pg. 11 lines 17-19) because it is known in the art that chromatography deices can be operated above 10 bar (see Conroy col. 2 lines 8-10).
Regarding Claim 3:
Hurwitz, as modified, teaches the chromatography device according to claim 2, wherein said chromatography device comprises at least one cassette, wherein each of the at least one cassettes comprises one of the at least one fluid distribution systems and one of the at least one chromatography material unit (cassette comprises the first and second flow distributor arrangements and the porous medium module) (see Hurwitz pg. 9 lines 3-5), wherein said chromatography material unit is sandwiched between a distribution device and a collection device of said fluid distribution system (porous fluid distributors 30, 32, 56, and 58) (see Hurwitz pg. 9 lines 3-8), wherein said at least one cassette is provided within said housing (see Hurwitz fig. 1).
Regarding Claim 4:
Hurwitz, as modified, teaches the chromatography device according to claim 3, wherein said chromatography device comprises at least two cassettes (plurality of porous medium modules) (see Hurwitz pg. 8 lines 20-23), wherein each cassette is overmolded (the stacks of porous media are sealed, and the cassettes are made up for stacks of media) (see Hurwitz pg. 13 lines 27-30) and wherein the at least two cassettes are provided in the housing (arranged in the holder) (see Hurwitz pg. 8 lines 20-23).
Regarding Claim 5:
Hurwitz teaches the chromatography device according to claim 3, wherein the housing comprises one inlet fluid channel (fluid passage 16) between the inlet and the distribution device (first flow distributor arrangement 52) of each of the cassettes (see Hurwitz pg. 9 lines 10-15).
Hurwitz does not explicitly teach said inlet fluid channels are equal in length and dimensions. However, as the inlet fluid channel is part of the cassette (porous medium module 20) and Hurwitz teaches that a plurality of modules can be used (see Horwitz pg. 8 lines 20-23) it would have been obvious to one skilled in the art to make the second cassette identical to the first, such that the inlet fluid channels are equal in length, because it is a mere duplication of parts, obviously resulting in multiple modules within the same housing, with an expectation of success. The mere duplication of parts, without any new or unexpected results, is within
the ambit of one of ordinary skill in the art. See In re Harza, 124 USPQ 378 (CCPA
1960) (see MPEP § 2144.04).
Regarding Claim 10:
Hurwitz, as modified, teaches the chromatography device according to claim 2, wherein said housing and said fluid distribution system (porous medium supports can be polymers) (see Hurwitz pg. 17 lines 18-25) for each of said at least one chromatography material unit are made from plastic (plastic material) (see Hurwitz pg. 20 lines 10-14) or silicone and wherein said chromatography device is a single-use chromatography device (any device can be single use).
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hurwitz et al (WO 00/550888), Allen, Jr (USPN 4,537,217), and Conroy et al (USPN 6,001,253)as applied to claim 2 above, and further in view of Conner, JR (US 2005/0126981).
Regarding Claim 6:
Hurwitz, as modified, teaches the chromatography device according to claim 2, wherein said chromatography device comprises two chromatography material units (plurality of modules) (see Hurwitz pg. 8 lines 20-23).
Hurwitz does not teach wherein the housing further comprises a central plate and wherein one chromatography material unit is provided between the top plate and the central plate and one chromatography material unit is provided between the central plate and the bottom plate, wherein said central plate comprises the inlet and the outlet and wherein said top plate, said central plate and said bottom plate comprise cooperating connecting devices allowing correct connection of the housing such that fluid channels provided in the top plate, bottom plate and central plate are mated correctly. Hurwitz further teaches that the inlet and outlet for the device can serve multiple modules (see Hurwitz pg. 8 lines 20-23).
Conners teaches a chromatography device comprises two chromatography material units (two cassettes stacked) (see para. 0048) and wherein the housing further comprises a central plate (cover plate 60) (see para. 0048)and wherein one chromatography material unit is provided between the top plate (top pressure plate 92) and the central plate (cover plate 60) and one chromatography material unit is provided between the central plate and the bottom plate (bottom pressure plate 94) (see para. 0049, fig. 13), wherein said central plate comprises the inlet and the outlet (plate 60 has conduits 76A 76B, 76C, and 76D which correspond to an inlet and an outlet on the plate) (see para. 0048) and wherein said top plate, said central plate and said bottom plate comprise cooperating connecting devices ( stacking notch, means for stacking) allowing correct connection of the housing such that fluid channels provided in the top plate, bottom plate and central plate are mated correctly (see para. 0012, 0014).
Hurwitz and Conners are analogous inventions in sealed chromatography cassettes. It would have been obvious to one skilled in the art to use a housing with a central plate with the inlet and outlet, a top plate and a bottom plate, as disclosed by Conners, as the housing of Hurwitz because Hurwitz is open to different housing designs (see Hurwitz pg. 20 lines 1-3) and it is the simple substitution of one known housing for another known housing, obviously resulting in a chromatography device through which fluid can flow into the center, with an expectation of success. The simple substitution of one known element for another is likely to be obvious when predictable results are achieved. See KSR International Co. v. Teleflex Inc., 550
U.S. __,__, 82 USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, B.).
Claim(s) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hurwitz et al (WO 00/550888) and Allen, Jr (USPN 4,537,217) as applied to claim 1 above, and further in view of Bracewell et al (WO 2013/068741).
Regarding Claim 8:
Hurwitz, as modified, teaches the chromatography device according to claim 7.
Hurwitz does not explicitly teach wherein said adsorptive membrane is a polymer nanofiber membrane. Hurwitz further teaches that and material suitable for membrane chromatography can be used (see pg. 11 lines 29-30).
Bracewell teaches an adsorptive membrane made of a polymer nanofiber membrane (nanofiber cartridge) (see pg. 15 lines 31-33, pg. 17 lines 16-20).
Hurwitz and Bracewell are analogous inventions in the art of chromatography. It would have been obvious to one skilled in the art to replace the membrane material of Hurwitz with the polymer nanofiber of Bracewell because it is the simple substitution of one known membrane material for another known membrane material, obviously resulting in separation through the chromatography device, with an expectation of success. The simple substitution of one known element for another is likely to be obvious when predictable results are achieved. See KSR International Co. v. Teleflex Inc., 550 U.S. __,__, 82 USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, B.). And because nanofiber membranes have improved separation compared to other materials (see Bracewell pg. 17 lines 19-31)
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hurwitz et al (WO 00/550888) and Allen, Jr (USPN 4,537,217) as applied to claim 15 above, and further in view of Straeffer et al (US 2005/0276964).
Regarding Claim 16:
Hurwitz, as modified, teaches the method according to claim 15.
Hurwitz does not teach the step of: overmolding said housing with said at least one cassette provided in said housing leaving at least the inlet and the outlet open.
Straeffer teaches overmolding the housing for a chromatography unit (see para. 0033).
Hurwitz and Straeffer are analogous inventions in the art of chromatography. It would have been obvious to one skilled in the art before the effective filing date of the invention to overmold the housing of Hurwitz, as disclosed by Straeffer because it helps to ensure the flow path is watertight (see Straeffer para. 0033) and a watertight flow path (preventing leaks) is desirable in Straeffer (see Hurwitz pg. 10 lines 7-9).
Conclusion
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/CLAIRE A NORRIS/Primary Examiner, Art Unit 1779 3/5/2026