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 .
Election/Restrictions
Applicant's election with traverse of Group I, reading on amended claims 1-15, in the reply filed on 6/22/2026 is acknowledged. The traversal is on the ground(s) that Group III recites a method of clarifying biopharma feed stock using the charged depth filter of claim 1. This is not found persuasive because the restriction is based on Unity of Invention and the technical feature is not a special technical feature which makes a contribution over the prior art.
The requirement is still deemed proper and is therefore made FINAL.
Claims 16-24 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected group III, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 6/22/2026.
Applicant’s election of species A1, B1, C polypropylene, and D1 in the reply filed on 6/22/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they include the following reference character(s) not mentioned in the description: Figure 7, reference number 8. Corrected drawing sheets in compliance with 37 CFR 1.121(d), or amendment to the specification to add the reference character(s) in the description in compliance with 37 CFR 1.121(b) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Objection
Claim 6 is objected to because of the following informalities: “the charges depth filter” should be “the charged depth filter”. Appropriate correction is required.
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 1-16 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.
Claims 1 and 6 recite the limitation "the direction of the biopharma feedstock flow”. There is insufficient antecedent basis for this limitation in the claim. This term has not previously been defined. The terms direction and flow specifically have not been defined in conjunction with biopharma feedstock. Claims 2-16 are rejected as well since they depend from claim 1 and do not rectify the issues.
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.
Claims 1-3, 6-10, and 13-15 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication No. 2015/0133643 by EMD Millipore Corporation (EMD) in view of U.S. Patent Publication No. 2011/0006007 to Kuruc et al. (Kuruc).
Regarding limitations recited in the claims which are directed to a manner of operating disclosed charged depth filter, 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: “for removing cells and/or cellular debris from a biopharma feedstock” (claim 1); “water permeable” (claim 9).
In regard to claim 1, EMD teaches a charged depth filter (abstract; [0024]; [0040]; capable of removing cells and/or cellular debris from a biopharma feedstock. EMD teaches a first functionalized nonwoven layer having a first calculated pore size and a first dynamic charge capacity ([0095]-[0100]; [0070]). EMD teaches a second functionalized nonwoven layer having a second calculated pore size and a second dynamic charge capacity positioned after the first functionalized nonwoven layer in the direction of the biopharma feedstock flow ([0095]-[0100]; [0070]). EMD teaches the first calculated pore size is greater than the second calculated pore size ([0024]; [0081]; [0089]).
EMD does not teach the first dynamic charge capacity is less than the second dynamic charge capacity.
Kuruc teaches filtration media (abstract). Kuruc teaches a first dynamic charge capacity is less than the second dynamic charge capacity (a plurality of filter pads including a metanil yellow dye capacity including at least one filter pad with metanil yellow dye capacity less than 300 mg/g and at least one filter pad with metanil yellow dye capacity more than 300 mg/g; [0053]; table 2).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the filtration media of EMD to include the relative dynamic charge capacities of Kuruc in order to provide increased binding capacity, impart improved efficiency for removal of unwanted contaminants.
In regard to claim 2, EMD teaches the first functionalized nonwoven layer the first calculated pore size is from 40.8 to 65.0 um and the second functionalized nonwoven layer the second calculated pore size is from 5.0 µm to less than 40.8 µm (abstract; [0024]; [0040]; [0055]; [0062]; [0081]; [0089]; first layer having a nominal pore size of about 50 mircons, second layer having a nominal pore size of about 25 microns, third layer having a nominal pore size of about 10 microns).
EMD does not teach the first dynamic charge capacity is from 150 MY DCC mg/g to 300 MY DCC mg/g and the second dynamic charge capacity is from greater than 300 MY DCC mg/g to 650 MY DCC mg/g.
Kuruc teaches the first dynamic charge capacity is from 150 MY DCC mg/g to 300 MY DCC mg/g ([0053]; table 2). Kuruc teaches the second dynamic charge capacity is from greater than 300 MY DCC mg/g to 650 MY DCC mg/g ([0053; table 2).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the filtration media of EMD to include the relative dynamic charge capacities of Kuruc in order to provide increased binding capacity, impart improved efficiency for removal of unwanted contaminants.
In regard to claim 3, EMD teaches the first functionalized nonwoven layer the first calculated pore size is from 40.8 to 65.0 um and the second functionalized nonwoven layer the second calculated pore size is from 5.0 µm to less than 40.8 µm (abstract; [0024]; [0040]; [0055]; [0062]; [0081]; [0089]; first layer having a nominal pore size of about 50 mircons, second layer having a nominal pore size of about 25 microns, third layer having a nominal pore size of about 10 microns).
EMD does not teach the first dynamic charge capacity is from 150 MY DCC mg/g to 300 MY DCC mg/g or the second dynamic charge capacity is from 300 MY DCC mg/g to 650 MY DCC mg/g.
Kuruc teaches the first dynamic charge capacity is from 150 MY DCC mg/g to 300 MY DCC mg/g ([0053]; table 2). Kuruc teaches the second dynamic charge capacity is from greater than 300 MY DCC mg/g to 650 MY DCC mg/g ([0053; table 2).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the filtration media of EMD to include the relative dynamic charge capacities of Kuruc in order to provide increased binding capacity, impart improved efficiency for removal of unwanted contaminants.
In regard to claim 6, EMD teaches a third functionalized non-woven layer having a third calculated pore size and a third dynamic charge capacity positioned after the second functionalized nonwoven layer in the direction of the biopharma feedstock flow ([0040]; [0055]; [0062]; [0081]). EMD teaches the first calculated pore size is greater than the second calculated pore size and the second calculated pore size is greater than the third calculated pore size (abstract; [0024]; [0081]; [0089]).
EMD does not teach the first dynamic charge capacity is less than the second dynamic charge capacity and the second dynamic charge capacity is less than the third dynamic charge capacity.
Kuruc teaches filtration media (abstract). Kuruc teaches a first dynamic charge capacity is less than the second dynamic charge capacity (a plurality of filter pads including a metanil yellow dye capacity including at least one filter pad with metanil yellow dye capacity less than 300 mg/g and at least one filter pad with metanil yellow dye capacity more than 300 mg/g; [0053]; table 2). Kuruc teaches a second dynamic charge capacity is less than the third dynamic charge capacity ([0053]; table 2).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the filtration media of EMD to include the relative dynamic charge capacities of Kuruc in order to provide increased binding capacity, impart improved efficiency for removal of unwanted contaminants.
In regard to claim 7, EMD teaches the first functionalized nonwoven layer the first calculated pore size is from 40.8 to 65.0 um, the second functionalized nonwoven layer the second calculated pore size is from 20.6 µm to less than 40.8 µm, and the third functionalized nonwoven layer the third calculated pore size is from 5.0 to less than 20.6 µm (abstract; [0024]; [0040]; [0055]; [0062]; [0081]; [0089]; first layer having a nominal pore size of about 50 mircons, second layer having a nominal pore size of about 25 microns, third layer having a nominal pore size of about 10 microns).
EMD does not teach the first dynamic charge capacity is from 150 MY DCC mg/g to 300 MY DCC mg/g or the second dynamic charge capacity is from 300 MY DCC mg/g to 475 MY DCC mg/g or the third dynamic charge capacity is from greater than 300 MY DCC mg/g to MY DCC 650 mg/g.
Kuruc teaches the first dynamic charge capacity is from 150 MY DCC mg/g to 300 MY DCC mg/g ([0053]; table 2). Kuruc teaches the second dynamic charge capacity is from greater than 300 MY DCC mg/g to 475 MY DCC mg/g ([0053; table 2). Kuruc teahces the third dynamic charge capacity is from greater than 300 MY DCC mg/g to MY DCC 650 mg/g ([0053]; table 2).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the filtration media of EMD to include the relative dynamic charge capacities of Kuruc in order to provide increased binding capacity, impart improved efficiency for removal of unwanted contaminants.
In regard to claim 8, EMD teaches the first functionalized nonwoven layer the first calculated pore size is from 55 to 65.0 um, the second functionalized nonwoven layer the second calculated pore size is from 20.6 µm to less than 55 µm, and the the third functionalized nonwoven layer the third calculated pore size is from 5.0 to less than 20.6 µm (abstract; [0024]; [0040]; [0055]; [0062]; [0081]; [0089]; first layer having a nominal pore size of about 50 mircons, second layer having a nominal pore size of about 25 microns, third layer having a nominal pore size of about 10 microns).
EMD does not teach the first dynamic charge capacity is from 150 MY DCC mg/g to 300 MY DCC mg/g or the second dynamic charge capacity is from 200 MY DCC mg/g to 475 MY DCC mg/g or the third dynamic charge capacity is from greater than 300 MY DCC mg/g to MY DCC 650 mg/g.
Kuruc teaches the first dynamic charge capacity is from 150 MY DCC mg/g to 300 MY DCC mg/g ([0053]; table 2). Kuruc teaches the second dynamic charge capacity is from greater than 300 MY DCC mg/g to 650 MY DCC mg/g ([0053; table 2). Kuruc teahces the third dynamic charge capacity is from greater than 300 MY DCC mg/g to MY DCC 650 mg/g ([0053]; table 2).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the filtration media of EMD to include the relative dynamic charge capacities of Kuruc in order to provide increased binding capacity, impart improved efficiency for removal of unwanted contaminants.
In regard to claim 9, EMD teaches the third functionalized nonwoven layer is water permeable ([0101).
In regard to claim 10, modified EMD does not explicitly teach wherein on a plot of dynamic charge capacity versus calculated pore size a water permeability line extends through a point 1 having a calculated pore size of 5.0 µm and a dynamic charge capacity of 300 MY DCC mg/g through a point 2 having a calculated pore size of 20.6 µm and a dynamic charge capacity of 525 MY DCC mg/g and a third functionalized nonwoven layer has a point 3 on the plot for the third dynamic charge capacity and the third calculated pore size that places the point 3 beneath the water permeability line.
EMD teaches three porous layers including and first, second, and third charge modified fibrous layer with respective charge capacities and optimized pore sizes that gradually decrease from the first layer towards the third layer to achieve a desired level of clarification. It would have been obvious to one of ordinary skill in the art before the effective filing date to modify and plot a pore size and a dynamic charge capacity, since discovering optimum or workable ranges involves routine skill in the rt and optimizing pore sizes and binding strength of filtration media are well established in the art.
In regard to claim 13, EMD teaches a repeated first layer is positioned between the first layer and the second layer (abstract; Figure 1D; [0056]; [0089]).
In regard to claim 14, EMD teaches a membrane layer is positioned after the third functionalized nonwoven layer (abstract; Figure 1D; [004]; [0055]; [0062]; [0081]; [0089]).
In regard to claim 15, EMD teaches a nonfunctionalized nonwoven layer is positioned after the membrane layer (abstract; Figure 1D; [004]; [0055]; [0062]; [0081]; [0089]).
Claims 4-5 and 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Publication No. 2015/0133643 by EMD Millipore Corporation (EMD) in view of U.S. Patent Publication No. 2011/0006007 to Kuruc et al. (Kuruc), as noted above, in view of U.S. Patent Number 9821276 by 3M (3M).
In regard to claim 4, modified EMD teaches the limitations as noted above.
Modified EMD does not teach the first functionalized nonwoven layer, the second functionalized nonwoven layer, and the third functionalized nonwoven layer are grafted with copolymers comprising interpolymerized monomer units of a quaternary ammonium containing monomer, an amide containing monomer, and an epoxy containing monomer.
3M teaches layers grafted with copolymer comprising interpolymerized monomer units of a quaternary ammonium containing monomer, an amide containing monomer, and an epoxy containing monomer (MAPTAC, GMA, N-vinyl pyrrolidone; abstract; C2/L49-53; C7/L 17-20; C9/L4-12; C10/L9-13,35-40; C17/L1-8; C18/L14-19).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify EMD to include layers grafted with copolymer comprising interpolymerized monomer units of a quaternary ammonium containing monomer, an amide containing monomer, and an epoxy containing monomer for the benefit of filtering mammalian cell cultures capable of removing charged contaminants from a cell broth with improved filtration efficiency.
In regard to claim 5, modified EMD teaches the limitations as noted above.
Modified EMD does not teach the first functionalized nonwoven layer, the second functionalized nonwoven layer, and the third functionalized nonwoven layer are grafted with copolymers comprising interpolymerized monomer units of 3-methacrylamidopropyltrimethylammonium chloride, N-vinyl pyrrolidone, and glycidyl methacrylate.
3M teaches the first functionalized nonwoven layer, the second functionalized nonwoven layer, and the third functionalized nonwoven layer are grafted with copolymers comprising interpolymerized monomer units of 3-methacrylamidopropyltrimethylammonium chloride, N-vinyl pyrrolidone, and glycidyl methacrylate (MAPTAC, GMA, N-vinyl pyrrolidone; abstract; C2/L49-53; C7/L 17-20; C9/L4-12; C10/L9-13,35-40; C17/L1-8; C18/L14-19).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify EMD to include layers grafted with copolymer comprising 3-methacrylamidopropyltrimethylammonium chloride, N-vinyl pyrrolidone, and glycidyl methacrylate for the benefit of filtering mammalian cell cultures capable of removing charged contaminants from a cell broth with improved filtration efficiency.
In regard to claim 11, modified EMD teaches the limitations as noted above.
Modified EMD does not teach the first functionalized nonwoven layer, the second functionalized nonwoven layer, and the third functionalized nonwoven layer are grafted with copolymers comprising interpolymerized monomer units of a quaternary ammonium containing monomer, an amide containing monomer, and an epoxy containing monomer.
Modified EMD does not teach the first functionalized nonwoven layer, the second functionalized nonwoven layer, and the third functionalized nonwoven layer are grafted with copolymers comprising interpolymerized monomer units of a quaternary ammonium containing monomer, an amide containing monomer, and an epoxy containing monomer.
3M teaches layers grafted with copolymer comprising interpolymerized monomer units of a quaternary ammonium containing monomer, an amide containing monomer, and an epoxy containing monomer (MAPTAC, GMA, N-vinyl pyrrolidone; abstract; C2/L49-53; C7/L 17-20; C9/L4-12; C10/L9-13,35-40; C17/L1-8; C18/L14-19).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify EMD to include layers grafted with copolymer comprising interpolymerized monomer units of a quaternary ammonium containing monomer, an amide containing monomer, and an epoxy containing monomer for the benefit of filtering mammalian cell cultures capable of removing charged contaminants from a cell broth with improved filtration efficiency.
In regard to claim 12, modified EMD teaches the limitations as noted above.
Modified EMD does not teach the first functionalized nonwoven layer, the second functionalized nonwoven layer, and the third functionalized nonwoven layer are grafted with copolymers comprising interpolymerized monomer units of 3-methacrylamidopropyltrimethylammonium chloride, N-vinyl pyrrolidone, and glycidyl methacrylate.
3M teaches the first functionalized nonwoven layer, the second functionalized nonwoven layer, and the third functionalized nonwoven layer are grafted with copolymers comprising interpolymerized monomer units of 3-methacrylamidopropyltrimethylammonium chloride, N-vinyl pyrrolidone, and glycidyl methacrylate (MAPTAC, GMA, N-vinyl pyrrolidone; abstract; C2/L49-53; C7/L 17-20; C9/L4-12; C10/L9-13,35-40; C17/L1-8; C18/L14-19).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify EMD to include layers grafted with copolymer comprising 3-methacrylamidopropyltrimethylammonium chloride, N-vinyl pyrrolidone, and glycidyl methacrylate for the benefit of filtering mammalian cell cultures capable of removing charged contaminants from a cell broth with improved filtration efficiency.
Conclusion
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 9 to 5:30.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Claire Wang can be reached at (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 1774
