DETAILED ACTION
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 .
Notes
All the objections and rejections in the previous Office Action not reiterated herein have been withdrawn. 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.
Claim 4 is 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.
Claim 4 recites the limitation "the retainers" in line 3. However, it is unclear which retainers among the “one or more retainers” the limitation is referring to.
Appropriate correction is required.
Claim Rejections - 35 USC § 103
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 and 3-5 are rejected under 35 U.S.C. 103 as being unpatentable over Castillo et al. (US 2008/0248552; hereinafter “Castillo”) in view of Wang et al. (US 2019/0144353; hereinafter “Wang”).
It is noted that while the invention contains a fixed bed, the fixed bed is not positively recited in the instant claims.
Regarding claims 1 and 3, Castillo discloses an apparatus for culturing cells, comprising: a housing having an inner compartment (FIGS. 1-2 and 4: cylindrical culture vessel (2); [0118]); and a container for removable positioning in the inner compartment of the housing (FIGS. 1-2 and 4: culture modules (e.g., m1,m2); [0155]), the container comprising first and second portions adapted to interlock for containing a fixed bed for culturing cells (FIGS. 1-2 and 4: culture modules (e.g., m1,m2); [0032], [0118], [0155]), the container forming a chamber within the inner compartment for circulating fluid to or from the fixed bed (FIGS. 1-2 and 4: culture modules (e.g., m1,m2); [0032], [0118], [0155]). Castillo does not explicitly disclose wherein the first and second portions include a labyrinth seal forming a tortuous path for fluid flow. Wang discloses a fermentation system comprising a fermentation reactor and a labyrinth seal between components of the fermentation reactor ([0011], [0078]). In view of Wang, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the sealing between the sections of the container of Castillo with the labyrinth seal of Wang to arrive at the claimed invention. One of ordinary skill in the art would have made said modification because said modification would have been the simple substitution of one known sealing means for another for the predictable result of sealing components to one another. Furthermore, it is noted that the recitations of functional language "for culturing cells; for containing a fixed bed" are drawn to intended use of the claimed invention. It is noted that a recitation directed to the manner in which a claimed apparatus is intended to be used does not distinguish the claimed apparatus from the prior art, if the prior art has the capability to so perform. Apparatus claims must distinguish from the prior art in terms of structure rather than function (see MPEP 2114). The prior art discloses all of the structural features of the claimed apparatus and thus since the structure is the same, the claimed functions are apparent.
Regarding claim 4, modified Castillo discloses one or more retainers for retaining the fixed bed within the container (Castillo, FIG. 1: wall (15); [0128]). Modified Castillo does not explicitly disclose wherein the removable container includes one or more internal grooves engaging the retainers. However, modified Castillo does disclose wherein the one or more retainers are coupled to a portion of the container. It would therefore have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the coupling between the one or more retainers and the container of modified Castillo to comprise a groove to arrive at the claimed invention. One of ordinary skill in the art would have made said modification because said modification would have been the substitution of one known means for coupling the one or more retainers to the container for another for the predictable result of retaining an article within the container.
Regarding claim 5, modified Castillo discloses wherein the container comprises a central tube, the retainers adapted for engaging the central tube (Castillo, FIG. 1: wall (15) is coupled to a central tube).
Claim(s) 1-2, 7-10 and 12-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Asgari (already of record, US 2008/0206734) in view of Gantefort et al. (already of record, US 2010/0240094; hereinafter “Gantefort”).
It is noted that while the invention contains a fixed bed, the fixed bed is not positively recited in the instant claims.
Regarding claim 1, Asgari discloses an apparatus for culturing cells, comprising: a housing having an inner compartment (FIG. 28, annotated and reproduced below: vessel (200) having an inner compartment; [0156]); and
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a container for removable positioning in the inner compartment of the housing, the container forming a chamber within the inner compartment for circulating fluid to or from the fixed bed (FIG. 28: container defining compartment (210); [0156]). Asgari discloses wherein the container includes a housing defined by a wall, but does not explicitly disclose the container comprising first and second portions adapted to interlock for containing a fixed bed for culturing cells. Gantefort discloses an apparatus for culturing cells, comprising a container having a housing formed by a first section (first wall) and a second section (second wall) adapted to interlock (FIG. 4: defined having walls (41a,41b)). In view of Gantefort, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the container of Asgari with the container of Gantefort to arrive at the claimed invention with a reasonable expectation of success. One of ordinary skill in the art would have made said modification because said modification would have resulted in an apparatus having the added advantage of ease of arranging materials within the container.
Furthermore, it is noted that the recitation of functional language "for containing a fixed bed for culturing cells, the container forming a chamber within the inner compartment for circulating fluid to or from the fixed bed" is drawn to intended use of the claimed invention. It is noted that a recitation directed to the manner in which a claimed apparatus is intended to be used does not distinguish the claimed apparatus from the prior art, if the prior art has the capability to so perform. Apparatus claims must distinguish from the prior art in terms of structure rather than function (see MPEP 2114). The prior art discloses all of the structural features of the claimed apparatus and thus since the structure is the same, the claimed functions are apparent.
Regarding claim 2, modified Asgari discloses wherein the first and second portions comprise locking means (see FIG. 4 of Gantefort), but does not explicitly disclose wherein the first and second portions comprise interlocking male and female couplers. However, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the locking means of modified Asgari with interlocking male and female couplers to arrive at the claimed invention. One of ordinary skill in the art would have made said modification because said modification would have been the simple substitution of one known locking means for another for the predictable result of coupling a first and second sections.
Regarding claim 7, modified Asgari further discloses wherein the removable container further includes a third portion for receiving an agitator (FIG. 28: compartment (220) adapted to container magnetic stirrer; [0156]).
Regarding claim 8, modified Asgari discloses does not explicitly disclose wherein the third portion includes a door for receiving the agitator. However, modified Asgari does disclose wherein the third portion receives an agitator and thus intrinsically comprises a covered opening (Asgari at [0156]). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the covering of the opening of third portion of modified Asgari with a door to arrive at the claimed invention. One of ordinary skill in the art would have been motivated to make said modification because said modification would have been the simple substitution of one known covering means for another for the predictable result of covering the opening.
Regarding claim 9, modified Asgari further discloses wherein the third portion includes
one or more openings for allowing fluid flow to enter the container (compartment (220) in fluid communication with inner compartment of the housing and thus has at least one opening; [0156]).
Regarding claim 10, modified Asgari does not explicitly disclose wherein the third portion is adapted to releasably connect to the container. However, modified Asgari does disclose, in another embodiment, that the chambers can be separated from each other (Asgari at [0143]). Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the apparatus of modified Asgari such that the third portion is adapted to releasably connect to the container, since it has been held that constructing formerly integral structure in various elements involves only routing skill in art. One of ordinary skill in the art would have made said modification because said modification would have resulted in an apparatus having the added advantage of ease of cleaning and maintenance.
Regarding claims 12-13, modified Asgari further discloses wherein a cap for engaging the container (see Asgari at FIG. 28). Modified Asgari does not explicitly disclose the cap comprising a hinged plate, wherein the hinged plate comprises a releasable lock for locking with the cap in a closed position. However, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the coupling between the cap and container of modified Asgari with a hinged plate to arrive at the claimed invention. One of ordinary skill in the art would have made said modification because said modification would have been the simple substitution of one known coupling means for another for the predictable result of coupling two components.
Regarding claim 14, modified Asgari further discloses wherein the first and second portions comprise halves of the container (see FIG. 4 of Gantefort).
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Asgari in view of Gantefort as applied to claim 7 above, and further in view of Yu (already of record, CN 201080454; with English machine translation).
Regarding claim 11, modified Asgari discloses the apparatus according to claim 7. Modified Asgari does not explicitly disclose a retainer comprising a plate with peripheral notches for allowing fluid to pass to the third portion of the container. However, modified Asgari does disclose wherein the third portion is coupled to the container (FIG. 28 of Asgari). Yu discloses an apparatus comprising a housing (FIG. 1: frame 1) coupled to a base (FIG. 5). The apparatus includes a retainer comprising a plate with peripheral notches for allowing fluid to pass to the third portion of the container (FIG. 1: 53a; [0035]). In view of Yu, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the coupling between the third portion and container of modified Asgari with the coupling as disclosed by Yu to arrive at the claimed invention. One of ordinary skill in the art would have made said modification because said modification would have been the simple substitution of one known coupling means for another for the predictable result of coupling two components.
Allowable Subject Matter
Claim 6 is 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.
Response to Arguments
Applicant’s arguments with respect to claim(s) 34 have been considered but are moot in view of the new ground of rejection.
Applicant's arguments filed on April 14, 2026, with respect to claims 1 and 11 have been fully considered but they are not persuasive.
Applicant argues that: “neither Asgari nor Gantefort is identified as teaching a person of ordinary skill to adopt Gantefort's particular interlocking wall geometry to Asgari's … bioreactor container, and the "ease of arranging" rationale is untethered from any teaching in either reference. The prima facie case is accordingly not established, and the burden has not shifted to Applicant.” See Remarks page 6.
Examiner respectfully disagrees. While the prior art does not explicitly recite the advantage of ease of material arrangement, such advantage necessarily flows naturally from the dual-shell configuration disclosed in FIG. 4 of Gantefort. The separation between the first and second sections creates discrete spatial regions and multiple access interfaces that are structurally absent in a single-shell design. One of ordinary skill in the art would readily recognize that the disclosed first and second sections configuration inherently facilitates material positioning and arrangement by providing accessible entry points and staged placement opportunities that a monolithic single-shell structure cannot offer. Accordingly, the advantage is inherent in the disclosed structure itself.
Applicant further argues that “[t]he mismatch between the cited structures independently defeats the combination. The "first and second portions adapted to interlock" of claim 1 are portions of the container itself -- internal structural elements that together define the chamber within which the fixed bed is contained. The walls 41a/41b of Gantefort, by contrast, are not internal elements of any internal container at all; they are the external walls of Gantefort' s bathing-apparatus housing. A person of ordinary skill looking to Asgari for a bioreactor container and to Gantefort for interlocking container portions would not find in Gantefort a structural analog to what the Examiner proposes to modify in Asgari. The Examiner's proposed modification therefore rests on a structural equivalence that the references themselves do not support, and the motivation offered (i.e. "ease of arranging materials within the container") has no anchor in the actual structures being combined. For this additional reason, the Office Action has not established a prima facie case of obviousness as to claim 1.” See Remarks at page 6.
Examiner respectfully disagrees. The container of Gantefort corresponds to the inner container of Asgari as both containers used for holding materials interacting with fluids therein. The container of Gantefort does not require a second container to be disposed therein, as required by Asgari. As such, Applicant’s argument is not persuasive.
With respect to the Applicant’s argument regarding the rejection of claim 11 (Remarks at page 8), Applicant’s argument is not persuasive. It should be noted that the Yu reference does not need to teach all of the limitations of claims 1 and 7 as contended by the Applicant. Claim 11 requires a retainer comprising a plate with peripheral notches. Asgari is the primary reference and discloses a housing, a container having multiple sections, and a third portion coupled to the container. Yu discloses an apparatus comprising a container having a plurality of sections for holding biological filter media, and a base having a plate with notches coupled to the container (FIG. 1). As discussed in the rejection, the coupling means between the container and third portion of Asgari is modified with the coupling means between the container and the base of Yu. Consequently, it would have been prima facie obvious to one of ordinary skill in the art to substitute the coupling means of Yu with the coupling means in the device of modified Asgari, because it would have resulted in the substitution of art recognized elements for the same intended purpose of coupling components to one another, which is well within the scope of the skilled artisan absent clear evidence otherwise and would yield predictable results. As such, Applicant’s argument is not persuasive.
Conclusion
THIS ACTION IS MADE FINAL. 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. Any inquiry concerning this communication or earlier communications from the examiner should be directed to LIBAN M HASSAN whose telephone number is (571)270-7636. The examiner can normally be reached on 8:30 AM - 5:00 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Marcheschi can be reached on 5712721374. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LIBAN M HASSAN/Primary Examiner, Art Unit 1799
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