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 .
Response to Amendment
The amendment filed March 30, 2026 has been entered.
Claims 1-13 remain pending in the application, with claims 1-5 and 8-13 being examined, and claims 6-7 deemed withdrawn.
Applicant’s amendments to the Claims have overcome some of the objections previously set forth in the Non-Final Office Action mailed January 12, 2026, while some remain outstanding, as detailed below in the Claim Objections section of this instant Office Action.
Based on Applicant’s amendments and remarks, the previous prior art rejection has been modified to address the claim amendments.
Claim Objections
Claims 11-13 are objected to because of the following informalities:
Regarding claim 11, Ln. 5 recites, “and;”. There should be no semicolon after the “and” to be grammatically correct.
Claim 12, Ln. 5, and Claim 13, Ln. 5 contain similar issues regarding reciting the grammatically incorrect, “and;”, and are similarly objected to.
Appropriate correction is required.
Claim Interpretation
The limitation “pleat density” has been interpreted according to the definition as provided in [0037]-[0038] of the instant Specification. That is, the pleat density has been calculated as the total combined pleat thickness (where the total combined pleat thickness is the combined thickness of both legs of each pleat multiplied by the total number of pleats), divided by the width of the internal thickness of the housing, multiplied by 100%.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-3, 5, 8, and 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Strobbe (US Pub. No. 2014/0227769; already of record) in view of Sun et al. (US Pub. No. 2024/0336885; hereinafter Sun).
Regarding claim 1, Strobbe discloses a cell culture arrangement ([0023], see Figs. 1-3). The cell culture arrangement comprises
(a) a housing having a first end and a second end and a longitudinal axis ([0184], [0381], see Fig. 6. See also Figs. 1-3, and [0163]-[0164], which states that the bioreactor can comprise a number of identical stacked matrix sections including an inlet and outlet assembled in a fluid tight housing).
(b) at least one fixed bed arranged in the housing, the at least one fixed bed comprising a continuous pleated porous medium comprising a top end, a bottom end, a front side, a rear side, a right side, and a left side, and a plurality of pleats folded on the right side and the left side, and having vertical fluid flow channels along the longitudinal axis between adjacent pleats ([0184], [0381], see Fig. 6, where the pleated porous medium is continuous and has a top, bottom front, rear, right, and left side, with pleats on the right and left sides, and spaces 63b between the pleats 62, the spacers acting as vertical fluid flow channels. Some of these vertical fluid flow channels are arranged along the longitudinal axis between adjacent pleats).
Strobbe fails to explicitly disclose that the cell culture arrangement is rectangular.
Sun is in the analogous field of bioreactors systems for culturing cells (Sun [0002]). Sun teaches a rectangular cell culture arrangement (Sun; [0092], see Fig. 4 at bioreactor vessel 322, which is rectangular). It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the cell culture arrangement of Strobbe with the teachings of Sun so that the cell culture arrangement is rectangular, since the configuration of the cell culture arrangement is a matter of choice which a person of ordinary skill in the art would have found obvious absent persuasive evidence that the particular configuration of the claimed cell culture arrangement is significant. See MPEP 2144.04(IV)(B), and In re Dailey, 357 F.2d 669, 149 USPQ 47 (CCPA 1966). The motivation for providing a rectangular cell culture arrangement, other than being a routine matter of design choice as demonstrated above, would have been that rectangular arrangements are easy to stack for subsequent transport.
Regarding claim 2, modified Strobbe discloses the cell culture arrangement of claim 1.
Modified Strobbe fails to explicitly disclose that the continuous pleated porous medium has a pleat density in the range of 25% to 95%.
However, Strobbe teaches that the continuous pleated porous medium has a pleat density that is greater than 0% and less than 100% (see Fig. 6. The presence of pleats means that the pleat density must be greater than 0%, while the clear spacing between legs of the pleats means that the pleat density must be less than 100%). Therefore, where 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, and arrive at a pleat density in the range of 25% to 95%. See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955), and MPEP 2144.05(II)(A). The motivation would have been to provide sufficient spacing between the pleats to allow fluid flow through the pleats, while also providing sufficient density of the pleats to provide adequate surface for cells to adhere to, thereby promoting cell culture.
Regarding claim 3, modified Strobbe discloses the cell culture arrangement of claim 1. Strobbe further discloses at least two fixed beds arranged in the housing, each of the at least two fixed beds comprising a continuous pleated porous medium comprising a top end, a bottom end, a front side, a rear side, a right side, and a left side, and a plurality of pleats folded on the right side and the left side, and having vertical fluid flow channels along the longitudinal axis between adjacent pleats (see Claim 1 above at Strobbe teaching fixed beds comprising the claimed arrangement in [0184], [0381], see Fig. 6, and further teaching that the bioreactor can comprise a number of identical stacked matrix sections in [0163]-[0164]).
Further, even if Strobbe is not considered to teach at least two fixed beds arranged in the housing, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to provide at least two fixed beds arranged in the housing, since it has been held that the mere duplication of essential working parts of a device involves only routine skill in the art. (See MPEP 2144.04 Section VI (B) and St. Regis Paper Co. v Bemis Co., 193 USPQ 8). The motivation would have been that increasing the number of fixed beds would improve the throughput of the cell culture arrangement, thereby increasing yield.
Regarding claim 5, modified Strobbe discloses the cell culture arrangement according to claim 1. Strobbe further discloses a cell culture device (Strobbe; [0272], [0313], see Figs. 12-13). The device comprises:
(a) the cell culture arrangement according to claim 1 (Strobbe; [0272], [0313], see Figs. 12-13).
(b) a pump body arranged at the second end of the bed housing, the pump body including a central cavity (Strobbe; [0272], [0313], see Figs. 12-13).
(c) an impeller arranged in the central cavity of the pump body (Strobbe; [0272], [0313], see Figs. 12-13 at impeller 125b, 135b).
(d) a cell culture vessel having a central chamber, wherein the cell culture arrangement is arranged in the central chamber (Strobbe; [0272], [0313], see Figs. 12-13. See also [0184], [0381], Fig. 6, Figs. 1-3, and [0163]-[0164]).
Regarding claim 8, modified Strobbe discloses the cell culture arrangement of claim 2. Strobbe further discloses at least two fixed beds arranged in the housing, each of the at least two fixed beds comprising a continuous pleated porous medium comprising a top end, a bottom end, a front side, a rear side, a right side, and a left side, and a plurality of pleats folded on the right side and the left side, and having vertical fluid flow channels along the longitudinal axis between adjacent pleats (see Claim 1 above at Strobbe teaching fixed beds comprising the claimed arrangement in [0184], [0381], see Fig. 6, and further teaching that the bioreactor can comprise a number of identical stacked matrix sections in [0163]-[0164]).
Further, even if Strobbe is not considered to teach at least two fixed beds arranged in the housing, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to provide at least two fixed beds arranged in the housing, since it has been held that the mere duplication of essential working parts of a device involves only routine skill in the art. (See MPEP 2144.04 Section VI (B) and St. Regis Paper Co. v Bemis Co., 193 USPQ 8). The motivation would have been that increasing the number of fixed beds would improve the throughput of the cell culture arrangement, thereby increasing yield.
Regarding claim 11, modified Strobbe discloses the cell culture arrangement according to claim 2. Strobbe further discloses a cell culture device (Strobbe; [0272], [0313], see Figs. 12-13). The device comprises:
(a) the cell culture arrangement according to claim 2 (Strobbe; [0272], [0313], see Figs. 12-13).
(b) a pump body arranged at the second end of the bed housing, the pump body including a central cavity (Strobbe; [0272], [0313], see Figs. 12-13).
(c) an impeller arranged in the central cavity of the pump body (Strobbe; [0272], [0313], see Figs. 12-13 at impeller 125b, 135b).
(d) a cell culture vessel having a central chamber, wherein the cell culture arrangement is arranged in the central chamber (Strobbe; [0272], [0313], see Figs. 12-13. See also [0184], [0381], Fig. 6, Figs. 1-3, and [0163]-[0164]).
Regarding claim 12, modified Strobbe discloses the cell culture arrangement according to claim 3. Strobbe further discloses a cell culture device (Strobbe; [0272], [0313], see Figs. 12-13). The device comprises:
(a) the cell culture arrangement according to claim 3 (Strobbe; [0272], [0313], see Figs. 12-13).
(b) a pump body arranged at the second end of the bed housing, the pump body including a central cavity (Strobbe; [0272], [0313], see Figs. 12-13).
(c) an impeller arranged in the central cavity of the pump body (Strobbe; [0272], [0313], see Figs. 12-13 at impeller 125b, 135b).
(d) a cell culture vessel having a central chamber, wherein the cell culture arrangement is arranged in the central chamber (Strobbe; [0272], [0313], see Figs. 12-13. See also [0184], [0381], Fig. 6, Figs. 1-3, and [0163]-[0164]).
Claims 4, 9-10, and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Strobbe in view of Sun as applied to claims 1-3, 5, 8, and 11-12 above, and further in view of Castillo et al. (US Pub. No. 2021/0009933; hereinafter Castillo; already of record).
Regarding claim 4, modified Strobbe discloses the cell culture arrangement of claim 1.
Modified Strobbe fails to explicitly disclose a plurality of removable sampling elements comprising porous media inserted in the continuous pleated porous medium.
Castillo is in the analogous field of cell culturing devices (Castillo [0002]). Castillo teaches a plurality of removable sampling elements comprising media inserted in a continuous medium (Castillo; [0057]-[0058], see Fig. 1A at sample portion 16, see also [0101], Fig. 27 at sample portions 516a, 516b). It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the cell culture arrangement of modified Strobbe with the teachings of Castillo to include a plurality of removable sampling elements comprising media inserted in the continuous pleated porous medium, in order to recover a sample of cells from the cell culture arrangement, in order to determine if the cell culture arrangement is operating as desired (Castillo; [0005]-[0006], [0057]-[0058], see Fig. 1A, [0101], see Fig. 27).
Modified Strobbe fails to explicitly disclose that the removable sampling elements comprise porous media.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to have the removable sampling elements in the cell culture arrangement of modified Strobbe comprise porous media, as Castillo teaches that the removable sampling elements should be adapted to promote cell growth or cell immobilization/entrapment (Castillo [0057]-[0058]), and Strobbe teaches that porous materials are suitable for cultivation of microorganisms, as many microorganisms such as stem cells are by nature adherent or semi-adherent to surfaces within permeable bodies (Strobbe [0020]).
Regarding claim 9, modified Strobbe discloses the cell culture arrangement of claim 2.
Modified Strobbe fails to explicitly disclose a plurality of removable sampling elements comprising porous media inserted in the continuous pleated porous medium.
Castillo is in the analogous field of cell culturing devices (Castillo [0002]). Castillo teaches a plurality of removable sampling elements comprising media inserted in a continuous medium (Castillo; [0057]-[0058], see Fig. 1A at sample portion 16, see also [0101], Fig. 27 at sample portions 516a, 516b). It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the cell culture arrangement of modified Strobbe with the teachings of Castillo to include a plurality of removable sampling elements comprising media inserted in the continuous pleated porous medium, in order to recover a sample of cells from the cell culture arrangement, in order to determine if the cell culture arrangement is operating as desired (Castillo; [0005]-[0006], [0057]-[0058], see Fig. 1A, [0101], see Fig. 27).
Modified Strobbe fails to explicitly disclose that the removable sampling elements comprise porous media.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to have the removable sampling elements in the cell culture arrangement of modified Strobbe comprise porous media, as Castillo teaches that the removable sampling elements should be adapted to promote cell growth or cell immobilization/entrapment (Castillo [0057]-[0058]), and Strobbe teaches that porous materials are suitable for cultivation of microorganisms, as many microorganisms such as stem cells are by nature adherent or semi-adherent to surfaces within permeable bodies (Strobbe [0020]).
Regarding claim 10, modified Strobbe discloses the cell culture arrangement of claim 3.
Modified Strobbe fails to explicitly disclose a plurality of removable sampling elements comprising porous media inserted in the continuous pleated porous medium.
Castillo is in the analogous field of cell culturing devices (Castillo [0002]). Castillo teaches a plurality of removable sampling elements comprising media inserted in a continuous medium (Castillo; [0057]-[0058], see Fig. 1A at sample portion 16, see also [0101], Fig. 27 at sample portions 516a, 516b). It would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to modify the cell culture arrangement of modified Strobbe with the teachings of Castillo to include a plurality of removable sampling elements comprising media inserted in the continuous pleated porous medium, in order to recover a sample of cells from the cell culture arrangement, in order to determine if the cell culture arrangement is operating as desired (Castillo; [0005]-[0006], [0057]-[0058], see Fig. 1A, [0101], see Fig. 27).
Modified Strobbe fails to explicitly disclose that the removable sampling elements comprise porous media.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to have the removable sampling elements in the cell culture arrangement of modified Strobbe comprise porous media, as Castillo teaches that the removable sampling elements should be adapted to promote cell growth or cell immobilization/entrapment (Castillo [0057]-[0058]), and Strobbe teaches that porous materials are suitable for cultivation of microorganisms, as many microorganisms such as stem cells are by nature adherent or semi-adherent to surfaces within permeable bodies (Strobbe [0020]).
Regarding claim 13, modified Strobbe discloses the cell culture arrangement according to claim 4. Strobbe further discloses a cell culture device (Strobbe; [0272], [0313], see Figs. 12-13). The device comprises:
(a) the cell culture arrangement according to claim 4 (Strobbe; [0272], [0313], see Figs. 12-13).
(b) a pump body arranged at the second end of the bed housing, the pump body including a central cavity (Strobbe; [0272], [0313], see Figs. 12-13).
(c) an impeller arranged in the central cavity of the pump body (Strobbe; [0272], [0313], see Figs. 12-13 at impeller 125b, 135b).
(d) a cell culture vessel having a central chamber, wherein the cell culture arrangement is arranged in the central chamber (Strobbe; [0272], [0313], see Figs. 12-13. See also [0184], [0381], Fig. 6, Figs. 1-3, and [0163]-[0164]).
Response to Arguments
Applicant's arguments filed March 30, 2026 have been fully considered but they are not persuasive.
Applicant argues on Pgs. 5-6 of their Remarks that Strobbe does not teach a cell culture arrangement having a top end, bottom end, and four sides, with a plurality of pleats folded on the right and left side thereof, as the cylindrical cell culture arrangement of Strobbe does not have sides, except for top and bottom sides thereof. Applicant further argues that as they have amended the claims so that the cell culture arrangement is rectangular, the cylindrical cell culture arrangement of Strobbe does not anticipate the claimed cell culture arrangement. While the Examiner agrees that the cell culture arrangement of Strobbe is not rectangular, the Examiner respectfully disagrees that the cylindrical cell culture arrangement of Strobbe does not have four sides. Under broadest reasonable interpretation, a section of the cylinder can be designated as the front, and then the left, right, and back sides of the cylinder can be extrapolated based on the designated front side. Further, as there are pleats formed on all sides of the cylindrical cell culture arrangement of Strobbe, there will necessarily be pleats on the left and right sides of the cylinder. Further, while the cell culture arrangement of Strobbe is not rectangular, the reference Sun does teach a rectangular cell culture arrangement, in combination with applied precedential case law that holds changes in shape a matter of obvious design choice absent persuasive evidence that the particular configuration of the claimed cell culture arrangement is significant. For a more detailed explanation, please see the rejection of Claim 1 in the Claim Rejections-35 USC 103 section of this instant Office Action.
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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/JOHN MCGUIRK/Examiner, Art Unit 1798
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