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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 7/14/2026 has been entered.
Response to Amendment
The amendment filed June 25, 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Claims 1-13 remain pending in the application, with claims 1-5 and 8-13 being examined, and claims 6-7 deemed withdrawn. Claim 14 is newly added, and is pending and examined.
Applicant’s amendments to the Claims have overcome each and every objection previously set forth in the Final Office Action mailed May 4, 2026.
Based on Applicant’s amendments and remarks, the previous prior art rejection has been modified to address the claim amendments.
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 § 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 3, 8, 10, and 12 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 3, the claim recites that there at least two fixed beds arranged in the housing, each of the fixed beds comprising a plurality of pleats folded on the right side and the left side. However, it is unclear if one of these at least two fixed beds is the same as the fixed bed recited in claim 1, which has a plurality of pleats folded only on the right side and the left side. If one of these fixed beds is the same as the fixed bed recited in claim 1, then the claim improperly broadens the scope of claim 1 by no longer requiring the pleats of the recited fixed bed to be only on the right side and the left side. For purposes of compact prosecution, the above limitation has been examined as reciting that each of the fixed beds comprises a plurality of pleats folded only on the right side and the left side.
Claims 10 and 12 are rejected as depending on a rejected claim.
Claim 8 contains similar issues regarding reciting at least two fixed beds arranged in the housing, each of the fixed beds comprising a plurality of pleats folded on the right side and the left side, and is similarly rejected and examined.
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, 8, and 14 are rejected under 35 U.S.C. 103 as being unpatentable over Tanaka et al. (Translation of WO Pub. No. 2014/148507; hereinafter Tanaka; already of record) in view of Strobbe (US Pub. No. 2014/0227769; already of record) and Martin (US Pub. No. 2008/0003671).
Regarding claim 1, Tanaka discloses a cell culture arrangement (Pg. 2 2nd Para.-Pg. 3 5th to Last Para., see Figs. 3-6). The cell culture arrangement comprises
(a) a housing having a first end and a second end and a longitudinal axis (Pg. 2 2nd Para.-Pg. 3 5th to Last Para., see Figs. 3-6 at container body 10).
(b) at least one fixed bed arranged in the housing, the at least one fixed bed comprising a continuous pleated 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 only on the right side and the left side, and having vertical fluid flow channels along the longitudinal axis between adjacent pleats (Pg. 2 2nd Para.-Pg. 3 5th to Last Para., see Figs. 3-6 at film 30, which is pleated and has spaces between pleats, i.e. vertical fluid flow channels).
Tanaka fails to explicitly disclose that the cell culture arrangement is rectangular; and
that the continuous pleated medium is porous.
Strobbe is in the analogous field of devices for cell cultivation (Strobbe [0001]). Strobbe teaches a continuous pleated medium that is porous (Strobbe; [0020], [0184]). 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 Tanaka with the teachings of Strobbe so that the continuous pleated medium is porous, as Strobbe teaches that porous materials can be used to allow microorganisms to be hosted and cultivated within the pores (Strobbe [0020]), thereby promoting cell culture.
Modified Tanaka fails to explicitly disclose that the cell culture arrangement is rectangular.
Martin is in the analogous field of cell culture vessels (Martin [0001]). Martin teaches a rectangular cell culture arrangement (Martin; [0019], see also Claim 17, Fig. 3). 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 Tanaka with the teachings of Martin so that the 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 and storage.
Regarding claim 2, modified Tanaka discloses the cell culture arrangement of claim 1.
Modified Tanaka fails to explicitly disclose that the continuous pleated porous medium has a pleat density in the range of 25% to 95%.
However, Tanaka teaches that the continuous pleated porous medium has a pleat density that is greater than 0% and less than 100% (see Tanaka Figs. 1-6. 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 Tanaka discloses the cell culture arrangement of claim 1.
Modified Tanaka fails to explicitly disclose 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 only on the right side and the left side, and having vertical fluid flow channels along the longitudinal axis between adjacent pleats.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to include at least two of the fixed beds as claimed 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 8, modified Tanaka discloses the cell culture arrangement of claim 2.
Modified Tanaka fails to explicitly disclose 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 only on the right side and the left side, and having vertical fluid flow channels along the longitudinal axis between adjacent pleats.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to include at least two of the fixed beds as claimed 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 14, modified Tanaka discloses the cell culture arrangement of claim 1. Tanaka further discloses that the vertical fluid flow channels are voids between adjacent pleats of the plurality of pleats (see Tanaka Figs. 3-6. The spaces between the pleats are the vertical fluid flow channels).
Claims 4 and 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Tanaka in view of Strobbe and Martin as applied to claims 1-3, 8, and 14 above, and further in view of Castillo et al. (US Pub. No. 2021/0009933; hereinafter Castillo; already of record).
Regarding claim 4, modified Tanaka discloses the cell culture arrangement of claim 1.
Modified Tanaka 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 Tanaka 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 Tanaka 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 Tanaka 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 Tanaka discloses the cell culture arrangement of claim 2.
Modified Tanaka 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 Tanaka 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 Tanaka 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 Tanaka 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 Tanaka discloses the cell culture arrangement of claim 3.
Modified Tanaka 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 Tanaka 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 Tanaka 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 Tanaka 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]).
Allowable Subject Matter
Claims 5, 11, and 13 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claim 12 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Tanaka, Strobbe, Martin, and Castillo teach a cell culture arrangement similar to that claimed. However, Tanaka, Strobbe, Martin, and Castillo do not teach, either alone or in combination with the prior art of record, a cell culture device comprising a cell culture arrangement as claimed, a pump body arranged at the second end of the bed housing, the pump including a central cavity, and impeller arranged in the central cavity of the pump body, and a cell culture vessel having a central chamber, wherein the cell culture arrangement is arranged in the central chamber. Specifically, Tanaka is drawn to a cell culture container for passive cell culture, and modifying this cell culture container to contain a pump body and impeller would impermissibly change the principle of operation of the container of Tanaka. See MPEP 2143.01(VI). Further, although Strobbe teaches a cell culture arrangement comprising a pump body, an impeller, and a cell culture vessel where the cell culture arrangement is arranged in the central chamber (Strobbe; [0272], [0313], see Figs. 12-13 at impeller 125b, 135, and see also [0184], [0381], Fig. 6, Figs. 1-3, and [0163]-[0164]), Strobbe is drawn to a cell culture arrangement comprising a porous medium that is pleated circumferentially (Strobbe; [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 modifying the cell culture arrangement of Strobbe so that the porous medium is pleated only on the right side and the left side would impermissibly change the principle of operation of the container of Strobbe. See MPEP 2143.01(VI).
Response to Arguments
Applicant's arguments filed June 25, 2026 have been fully considered but they are not persuasive.
Applicant’s arguments filed on 6/25/2026 have been considered but are moot because applicant’s arguments are towards the amended claims and not the current grounds of rejection.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to John McGuirk whose telephone number is (571)272-1949. The examiner can normally be reached M-F 8am-530pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Capozzi can be reached at (571) 270-3638. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/JOHN MCGUIRK/Examiner, Art Unit 1798
Prosecution Insights