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 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 1-18 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.
Regarding claim 1, the phrase "in particular" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention.
Claim 13 recites the limitation "the recirculation bag" in line 2. There is insufficient antecedent basis for this limitation in the claim.
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.
Claim(s) 1 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Milano et al. (US 2019/0270769A1).
Regarding claim 1, Milano teaches a device assembly (refer fig. 4) (the limitation “for producing bioconjugates, in particular antibody-drug conjugates” is reciting intended use of the limitation without imparting additional structure to an apparatus claim), the device assembly comprising:
a conjugation unit (Refer fig. 4 and [0074] indicating conjugation reaction) for performing a bioconjugation reaction in a medium;
a first filtration unit (ILC in fig. 4) for separating precipitates and/or agglomerates (refer [0148]);
a second filtration unit (ILDF) for performing an ultrafiltration or diafiltration (refer 4, [0148]),
the first filtration unit being arranged in a flow path between the conjugation unit and the second filtration unit (Refer fig. 4 indicating first filter unit ILC being placed between conjugation unit and second filter unit ILDF); and
the device assembly further comprising a single control unit for controlling a transfer of the medium from the conjugation unit through the first filtration unit to the second filtration unit and for controlling the ultrafiltration and/or the diafiltration process (refer [0082] disclosing in-line process automation technology being used to increase control and detectability implying that the system is automated using a controller; also refer [0145], [0148]).
Claim(s) 1 and 7 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lingen et al. (US 2020/0164338).
Regarding claim 1, Lingen teaches a device assembly (refer fig. 2, 3, 4) (the limitation “for producing bioconjugates, in particular antibody-drug conjugates” is reciting intended use of the limitation without imparting additional structure to an apparatus claim), the device assembly comprising:
a conjugation unit (1 or 2);
a first filtration unit (refer 25 in fig. 4) for separating precipitates and/or agglomerates (refer [0075] disclosing said modular system for the continuous, pathogen reduced production and/or processing of a guidance molecule drug conjugate comprises more than one filter);
a second filtration unit (refer 22 in fig. 4) for performing an ultrafiltration (refer [0156] disclosing 22 being an ultrafiltration device),
the first filtration unit being arranged in a flow path between the conjugation unit and the second filtration unit (Refer fig. 4 indicating first filter unit 25 being placed between conjugation unit and second filter unit 22); and
the device assembly further comprising a control unit (refer [0087] , [0129]) disclosing computer implemented control) for controlling the process.
Regarding claim 7, Lingen teaches limitations of claim 1 as set forth above. Lingen further teaches that the conjugation unit comprises a controllable draining valve (7 or 8) and the first filtration unit comprises a transfer pump (28a) for transferring the medium from the conjugation unit through the first filtration unit to the second filtration unit.
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, 8, and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Milano et al. (US 2019/0270769A1), in view of Goodrich et al. (US 2021/0170336A1).
Regarding claim 1, Milano teaches a device assembly (refer fig. 4) (the limitation “for producing bioconjugates, in particular antibody-drug conjugates” is reciting intended use of the limitation without imparting additional structure to an apparatus claim), the device assembly comprising:
a conjugation unit (Refer fig. 4 and [0074] indicating conjugation reaction) for performing a bioconjugation reaction in a medium;
a first filtration unit (ILC in fig. 4) for separating precipitates and/or agglomerates (refer [0148]);
a second filtration unit (ILDF) for performing an ultrafiltration or diafiltration (refer 4, [0148]),
the first filtration unit being arranged in a flow path between the conjugation unit and the second filtration unit (Refer fig. 4 indicating first filter unit ILC being placed between conjugation unit and second filter unit ILDF); and
the device assembly further comprising a single control unit ([0082] discloses that “in-line process automation technology (PAT) can be used to increase control and detectability”).
Milano does not disclose that the controller controls a transfer of the medium from the conjugation unit through the first filtration unit to the second filtration unit and for controlling the ultrafiltration and/or the diafiltration process.
Goodrich teaches a device assembly comprising tanks (102, 104), a filter unit (1024), a plurality of valves and pumps (refer fig. 1), and a controller (160) controlling operation of the valves and pumps (refer [0070]). Goodrich also teaches that the device assembly can be used for purification of antibody drug conjugates (Refer [0099]).
Automating a manual activity by using a controller in the device assembly of Milano would have been obvious to one of ordinary skill in the art because In re Venner, 262 F.2d 91, 95, 120 USPQ 193, 194 (CCPA 1958), the court held that broadly providing an automatic or mechanical means to replace a manual activity which accomplished the same result is not sufficient to distinguish over the prior art.
Regarding claim 8, modified Milano teaches limitations of claim 1 as set forth above. Milano teaches that the first filtration unit comprises ultrafiltration membrane (Refer fig. 4 indicating UF). Ultrafiltration membranes are known to have a pore size in a range of 0.01 to 0.1 micrometers. "[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." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding claim 18, modified Milano teaches limitations of claim 1 as set forth above. Modified Milano does not teach that components of the device are mounted on a trolley. However, making a device assembly portable is not sufficient by itself to patentably distinguish over an otherwise old device unless there are new or unexpected results. In re Lindberg, 194 F.2d 732, 93 USPQ 23 (CCPA 1952).
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Milano et al. (US 2019/0270769A1), in view of Goodrich et al. (US 2021/0170336A1) as applied to claim 1 above, and further in view of Nutalapati et al. (US 2018/0221823A1).
Regarding claim 2, modified Milano teaches limitations of claim 1 as set forth above. Milano discloses that reactor vessel can be made from stainless steel, glass, polymers, etc (Refer [0101]). Goodrich discloses that tanks can be single-use or multi-used composed of plastic, glass or metal (Refer [0055]). Milano or Goodrich does not disclose which materials are used for other components of the system However, membrane made from polyamides, polypropylene, PTFE, and polyamides are known in the art (Refer [0028] of Nutalapati. Nutalapati also discloses that “construction materials used in the system can suitably be compatible with commonly used sterilization methods, such as e.g. gamma irradiation and/or autoclaving. For reusable components, stainless steel (e.g. with corrosion resistance at least equivalent to 316 L) or engineering plastics such as polysulfone, PEEK, etc. may be used, while for single-use components, plastics, such as, e.g. polysulfone, polypropylene, polyethylene or ethylene copolymers, may be used. Tubing material may comprise materials such as silicone or TPE (thermoplastic elastomers); tubing may be weldable. All materials used in the construction of the system which come into contact with a solution (e.g., system treatment solution), biofluid, retentate and/or permeate are selected to avoid any chemical interaction and to minimize physical adsorption with the components within the solution. Typically, the valves are made of glass, ceramics, stainless steel or external tube pinch valves and the tubing of an inert plastic polymer.” Refer [0039].
Selection of material based on its suitability from known materials would have been an obvious matter of choice to one of ordinary skill in the art.
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Milano et al. (US 2019/0270769A1), in view of Goodrich et al. (US 2021/0170336A1), as applied to claim 1 above, and further in view of Nutalapati et al. (US 2018/0221823A1), and Patil et al. (US 2019/0017011A1).
Regarding claim 3, modified Milano teaches limitations of claim 1 as set forth above. Milano discloses that reactor vessel can be made from stainless steel, glass, polymers, etc (Refer [0101]). Goodrich discloses that tanks can be single-use or multi-used composed of plastic, glass or metal (Refer [0055]). Milano or Goodrich does not disclose that the conjugation unit comprises a flexible bag.
Nutalapati discloses a system for purification of bio fluids (abstract), the system comprises a reservoir made from flexible plastic material (refer [0026]).
It would have been an obvious matter of choice to one of ordinary skill in the art to use a known flexible plastic material for conjugation bag in the system of modified Milano because Nutalapati establishes that such material is known in the art.
Modified Milano does not teach a first bag holder holding the conjugation bag.
Patil teaches a biomanufacturing apparatus comprising a holder (40) for supporting a conjugation bag (bioreactor) (Refer abstract). Patil discloses that the tray comprises a mechanism for rocking the tray and heating means to enable heating of the bag (Refer [0027]).
It would have been obvious to one of ordinary skill in the art to modify the system of modified Milano to include a holder for the bag to support the bag and also provide additional features such as shacking and heating, if desired, as taught by Patil.
Claim(s) 3-4 and 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Milano et al. (US 2019/0270769A1), in view of Goodrich et al. (US 2021/0170336A1), as applied to claim 1 above, and further in view of Barrett et al. (US 9228166).
Regarding claims 3-4, modified Milano teaches limitations of claim 1 as set forth above. Milano discloses that reactor vessel can be made from stainless steel, glass, polymers, etc (Refer [0101]). Goodrich discloses that tanks can be single-use or multi-used composed of plastic, glass or metal (Refer [0055]). Milano or Goodrich does not disclose that the conjugation unit comprises a flexible bag and a first bag holder holding the conjugation bag, wherein the conjugation bag has a bottom portion and an outlet formed therein, the first bag holder having a bottom surface and a draining opening formed at a lowest point of the bottom surface, the bottom portion of the conjugation bag resting on the bottom surface of the first bag holder such that the outlet of the conjugation bag is located at the draining opening of the first bag holder.
Barrett teaches a flexible biocontainer (refer col. 6:lines 1-7) having a flexible wall forming a fluid impermeable bottom wall (refer fig. 1A, 1B, Col. 5:L53-63 disclosing a closed container having a plurality of ports), wherein the bottom wall of the flexible bioreactor comprises a port (refer port 64 in fig. 1B). Barrett further teaches a holder (500) for holding the flexible bioreactor (refer fig. 3), wherein the holder comprises an opening at bottom surface thereof (refer opening in fig. 4 that aligns with port 64 of biocontainer-refer fig. 5), wherein the bottom portion of the biocontainer is resting on the bottom surface of the holder such that the outlet of the conjugation bag is located at the port (draining opening) of the holder (refer fig. 5 disclsing bottom port 64 of biocontainer aligning with opening of the holder 500).
It would have been obvious to one of ordinary skill in the art before the effective filing date of invention to modify the system of modified Milano to provide conjugation bag that is a flexible bag and a first bag holder holding the conjugation bag, wherein the conjugation bag has a bottom portion and an outlet formed therein, the first bag holder having a bottom surface and a draining opening formed at a lowest point of the bottom surface, the bottom portion of the conjugation bag resting on the bottom surface of the first bag holder such that the outlet of the conjugation bag is located at the draining opening of the first bag holder to enable supporting the conjugation bag while maintaining form and shape of the bag while also enabling providing a shaking/rocking movement to allow mixing of the contents of the bag as taught by Barrett (refer col. 2:lines 58 – Col. 3:line 6).
Regarding claim 6, modified Milano teaches limitations of claim 4 as set forth above. Barrett further teaches that the conjugation bag (or bioreactor) comprises a pH sensor (Refer col. 8:Lines 54-60).
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Milano et al. (US 2019/0270769A1), in view of Goodrich et al. (US 2021/0170336A1) and Barrett et al. (US 9228166) as applied to claim 1 above, and further in view of Broadley et al. (US 2010/0075405A1).
Regarding claim 5, modified Milano teaches limitations of claim 1 as set forth above. Barrett further teaches (refer col. 4:lines56-60) that “temperature of the cell culture fluid can be controlled, e.g., by placing the biocontainer and apparatus including a rocking platform inside a temperature controlled chamber, or by placing the biocontainer on the platform wherein the platform further comprises includes a heater or heating element.” Barrett does not teach that the first bag holder includes a double-walled containment, and a heat transfer fluid flowing through the double-walled containment.
Broadley teaches a bioreactor system (40 in fig. 4) comprising a bioreactor (402), placed in a holder (404), wherein the holder is a double-walled holder (refer [0033]) and a heating fluid is flowing through the double walled jacket (refer [0033]) for controlling temperature of bioreactor media.
It would have been obvious to one of ordinary skill in the art before the effective filing date of invention to modify the holder of modified Milano to include a double-walled holder having heat transfer fluid flowing through the double-walled holder for controlling temperature of media in the conjugation bag as taught by Broadley.
Claim(s) 3, 5 and 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lingen et al. (US 2020/0164338) in view of Broadley et al. (US 2010/0075405A1).
Regarding claims 3 and 5, Lingen teaches limitations of claim 1 as set forth above. Lingen does not teach that the conjugation unit comprises a flexible conjugation bag and a first bag holder holding the conjugation bag, wherein the first bag holder includes a double-walled containment, and the conjugation unit further comprises a temperature control system for controlling temperature of medium in the conjugation bag, the temperature control system including a heat transfer fluid flowing through the double-walled containment.
Broadley teaches a bioreactor system (40 in fig. 4) comprising a bioreactor (402) made of flexible bag (abstract), placed in a holder (404), wherein the holder is a double-walled holder (refer [0033]) and a heating fluid is flowing through the double walled jacket (refer [0033]) for controlling temperature of bioreactor media. A temperature control mechanism (410) controls the flow of heat transfer fluid (refer [0033]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of invention to modify the holder of modified Milano to include a double-walled holder having heat transfer fluid flowing through the double-walled holder for controlling temperature of media in the conjugation bag as taught by Broadley.
Claim(s) 9-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lingen et al. (US 2020/0164338) in view of Broadley et al. (US 2010/0075405A1) as applied to claim 5 above, and further in view of Kopf (US 6214221).
Regarding claims 9 and 10, modified Lingen teaches limitations of claim 5 as set forth above. Lingen further teaches that the second filtration unit comprising a loop assembly for recirculating the medium (refer 22 having recirculation loop), wherein the loop assembly comprises a recirculation pump (28b), a sensor (26) and tubing (refer fig. 4). Providing connectors to connect the filter (22), pump (28b), sensor (26) with tubing are inherent/obvious to provide connections between the components of the assembly. Modified Lingen does not teach a recirculation bag.
Kopf teaches an apparatus (fig. 5) for purifying a biological substance (Col. 1:Lines 7-15), the apparatus comprises a conjugation bag (34), a first filtration assembly (42), a second filtration assembly (82), a recirculation loop associated with the second filtration assembly (refer fig. 5), and recirculation bag (68) associated with the recirculation loop.
Providing an additional bag in the recirculation loop of modified Lingen would have been obvious matter of choice to one of ordinary skill in the art since Kopf establishes that providing a recirculation bag is known in the art.
Regarding the limitation “single-use”, whether to use components of an apparatus as single-use or multi-use would have been an obvious matter of choice to one of ordinary skill in the art based on material being processed by the apparatus and economics of use of the apparatus. Regarding the limitation “can be mounted to and/or dismounted from a basic structure of the device assembly as a whole” claims that parts of the system are made separable. Making integral or separable have found to be obvious by the court. In re Dulberg, 289 F.2d 522, 523, 129 USPQ 348, 349 (CCPA 1961); In re Larson, 340 F.2d 965, 968, 144 USPQ 347, 349 (CCPA 1965).
Regarding claim 14, modified Lingen teaches limitations of claim 10 as set forth above. Kopf discloses (refer fig. 5) a recirculation loop associated with second filter (Refer 2nd filter 82 comprising a loop), the recirculation loop comprises a valve (86) and pump (8) controlling flow of liquid through the loop.
Claim(s) 11-12 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lingen et al. (US 2020/0164338) in view of Broadley et al. (US 2010/0075405A1) and Kopf (US 6214221) as applied to claim 10 above, and further in view of Barrett et al. (US 9228166).
Regarding claims 11 and 12, modified Lingen teaches limitations of claim 10 as set forth above. Modified Lingen teaches providing a first bag holder comprising double-walled casing where heating fluid is supplied to control temperature using a temperature controller (refer rejection of claims 3 and 5 above). Providing similar features such as a holder comprising double-walled casing where heating fluid is supplied to control temperature using a temperature controller for the recirculation bag would have been obvious to one of ordinary skill in the art for providing support and temperature control for the recirculation bag.
Modified Lingen does not teach that the recirculation bag has a bottom portion and an outlet formed therein, the recirculation bag being held in a second bag holder having a bottom surface and a draining opening formed at a lowest point of the bottom surface, the bottom portion of the recirculation bag resting on the bottom surface of the second bag holder such that the outlet of the recirculation bag is located at the draining opening of the second bag holder.
Barrett teaches a flexible biocontainer (refer col. 6:lines 1-7) having a flexible wall forming a fluid impermeable bottom wall (refer fig. 1A, 1B, Col. 5:L53-63 disclosing a closed container having a plurality of ports), wherein the bottom wall of the flexible bioreactor comprises a port (refer port 64 in fig. 1B). Barrett further teaches a holder (500) for holding the flexible bioreactor (refer fig. 3), wherein the holder comprises an opening at bottom surface thereof (refer opening in fig. 4 that aligns with port 64 of biocontainer-refer fig. 5), wherein the bottom portion of the biocontainer is resting on the bottom surface of the holder such that the outlet of the conjugation bag is located at the port (draining opening) of the holder (refer fig. 5 disclsing bottom port 64 of biocontainer aligning with opening of the holder 500).
It would have been obvious to one of ordinary skill in the art before the effective filing date of invention to modify the system of modified Milano to provide recirculation bag that is a flexible bag and a second bag holder holding the recirculation bag, wherein the recirculation bag has a bottom portion and an outlet formed therein, the second bag holder having a bottom surface and a draining opening formed at a lowest point of the bottom surface, the bottom portion of the recirculation bag resting on the bottom surface of the second bag holder such that the outlet of the recirculation bag is located at the draining opening of the second bag holder to enable supporting the recirculation bag while maintaining form and shape of the bag while also providing a shaking/rocking movement to allow mixing of the contents of the bag as taught by Barrett (refer col. 2:lines 58 – Col. 3:line 6).
Regarding claim 17, modified Lingen teaches limitations of claim 12 as set forth above. Lingen further suggest automatic control of valves (refer [0057]).
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lingen et al. (US 2020/0164338) in view of Broadley et al. (US 2010/0075405A1) and Kopf (US 6214221) as applied to claim 5 above, and further in view of Shevitz (US 2013/0059371A1).
Regarding claim 13, modified Lingen teaches limitations of claim 10 as set forth above. Modified Lingen does not teach that a conductivity sensor is arranged in the recirculation bag.
Shevitz teaches a devise assembly (fig. 10) comprising a first reservoir (30), a first filter element (5), a second reservoir (60), a second filter element (75), wherein the second reservoir comprises a conductivity sensor to adjust conductivity parameter to desired setting (refer [0280]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of invention to modify the recirculation bag of modified Lingen to comprise a conductivity sensor to adjust conductivity parameter to desired setting as taught by Shevitz. Regarding the limitation “single-use”, whether to use components of an apparatus as single-use or multi-use would have been an obvious matter of choice to one of ordinary skill in the art based on material being processed by the apparatus and economics of use of the apparatus.
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lingen et al. (US 2020/0164338) in view of Broadley et al. (US 2010/0075405A1), and Kopf (US 6214221) as applied to claim 9 above, and further in view of Husemann et al. (US 2018/0187140A1).
Regarding claim 15, Lingen teaches limitations of claim 9 set forth above. Modified Lingen does not teach that a dip dray is arranged below the single use loop- assembly, the dip tray having a bottom surface and a draining means formed at a lowest point of the bottom surface.
Husemann teaches a bioreactor system (fig. 1) having a receiving container for receiving a disposable bag, in which a collecting tray for collecting a fluid exiting the receiving container is positioned below the receiving container (refer [0038]. Husemann further discloses that “Usually, no medium should exit the receiving container in an uncontrolled way. In case of a defect or leak in the disposable bag and/or in the receiving container, as well as in case of a defect or leak in the temperature regulating circuit, the collecting tray may collect the exiting liquid, before it flows on the ground. Thus the danger of contaminating the ground is reduced and the disposal of the exited liquid is simplified” (refer [0038]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the device assembly of modified Lingen to provide a dip tray arranged below the single use loop- assembly to collect any leakage and prevent contaminating the ground as taught by Husemann. Providing outlets/ports at bottom of tray would have been obvious to one of ordinary skill in the art for removal of the collected leakage.
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lingen et al. (US 2020/0164338), in view of Kopf (US 6214221).
Regarding claim 16, Lingen teaches limitations of claim 1 set forth above. Lingen does not teach that the second filtration unit comprises at least one cross-flow filter cassette held in a filter press.
Kopf teaches an apparatus (fig. 5) for purifying a biological substance (Col. 1:Lines 7-15), the apparatus comprises a conjugation bag (34), a first filtration assembly (42), a second filtration assembly (82), a recirculation loop associated with the second filtration assembly (refer fig. 5), and recirculation bag (68) associated with the recirculation loop. Kopf teaches that the second filtration unit comprises a filter cassette held in a filter press (refer col. 3:lines 18-22; col. 8:lines 16-54 references patents that disclose filter cassette held in end plates).
It would have been obvious to one of ordinary skill in the art to modify the second filtration unit of Lingen to use cross-flow filter cassette held in a filter press because Kopf establishes that ultrafiltration crossflow filters made from cassette held in filter press is known in the art.
Conclusion
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PRANAV PATEL
Examiner
Art Unit 1777
/PRANAV N PATEL/Primary Examiner, Art Unit 1777