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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 2/17/26 has been entered.
Claims 13-28, 30-33 are pending, of which claim 31 was previously withdrawn and claims 32-33 are new.
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 13-28, 30, 32-33 are rejected under 35 U.S.C. 103 as being unpatentable over KENNEY US 2008/0206857) in view of MARTIN (US 2010/0227405).
Regarding claim 13, 30, KENNEY discloses a flask apparatus 100 (culture vessel) comprising a multi-layered growth chamber part (culture vessel part) and a manifold part (reservoir part attached to culture vessel part) (Fig 1, 2) wherein
Disposed within the flask are a bottom tray 120, top plate 110 and individual growth chambers 111 that have a bottom surface, top surface and sidewall attaching surfaces (culture trays) in which the trays are stacked (0029, 0040, Fig 1);
The manifold comprises a barrier plate 106 (surrounding wall) defining a reservoir internal space and a neck opening 121 (port) communicating with the internal space (Fig 1, 2);
The barrier plate has the barrier plate (first wall part) with the opening (port) and a facing second internal surface 128 (second surrounding wall part) (Fig 2, 6, 0047);
The individual growth chambers 111 (each internal space) have apertures 109 in the neck-end 124 of the growth chambers 111 to communicate with the neck opening 121 (culture vessel part has openings communicating individual trays with internal reservoir part) (0035, Fig 2);
The apertures 109 extend toward the neck end of the barrier plate (first abutting portion that the first surrounding wall part abuts on the culture vessel) from the end walls of the internal surface 128 side (second abutting portion that the second surrounding all abuts on the culture vessel part) (Fig 2-3, 0043, 0047);
Wherein the bottom tray 120 (first culture tray), a cell growth chamber section bounded by walls 112, 114 (second culture tray stacked on first), and a top plate 110 stacked on top (cover plate),
The bottom tray 120 (first culture tray) has a surrounding wall (first wall) and bottom wall having a first internal surface,
The cell growth chamber section (second culture tray) has a surrounding wall 112 & 114, a bottom surface 113 (wall) that has a second internal surface filled with chambers 111 and second outer surface that are opposed,
The top plate 110 (cover) has an internal surface facing the second internal surface,
The first internal surface, surrounding wall and second outer surface of the surface 113 define a first internal space (see space between bottom tray and lowest membrane 113),
The second internal surface, second surrounding wall and third internal surface define a second internal space (see space between top plate and lowest membrane 113 surrounded by walls 112, 114) (0029-36, Fig 1, 2).
KENNEY discloses manifold (reservoir part) with the second internal surface facing the port (second surrounding wall part) comprises a first surface facing the internal surface (Figs 7-8), but does not disclose a second surface that is opposite to the first and faces outside.
However, MARTIN discloses a multilayered cell culture apparatus comprising a stack of gas permeable substrates 830 that the cells grow on (culture vessel part with at least two culture trays stacked) and a manifold 864 (reservoir part) that has a surrounding wall defining the internal space and a port 862, in which the port is provided in one wall and there is a second wall (unlabeled bottom wall of 864) facing the first, the second wall part comprises one surface facing the internal space and a second surface on the opposite side that faces outside (Fig 8) as an alternative arrangement to a manifold shaped similarly to KENNEY (see MARTIN Fig 1b, KENNEY Fig 7-8).
It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the manifold reservoir of KENNEY to include the arrangement of walls providing the manifold reservoir shape as taught by Figure 8 of MARTIN because it provides an alternate manifold that allows for manipulation of flask contents that can be used in a vertical orientation without spilling the fluid out of the port. Additionally, it merely represents either a duplication of parts already known in the art or a rearrangement of parts without substantially affecting functionality or operation, and involved only routine skill in the art. See MPEP 2144.04.
Regarding claim 14, KENNEY discloses the neck opening (port) is provided at an angle of 90 degrees (within claimed range of 70-90degrees) between the axis of the opening and a stacking direction (Fig 2).
Regarding claims 15-16, KENNEY discloses the angle of the opening and the surface of the growth chambers (trays) that the manifold (reservoir part) is opposed to is 0 degrees (within claimed range of 0-50 degrees) (Fig 2).
Regarding claim 17, KENNEY discloses the apertures 109 of the growth chambers extend toward the first abutting portion from the second with a length of less than two-thirds of the distance between the portions (Fig 2, 8).
Regarding claims 18-19, KENNEY discloses individual growth chambers 111 that have a bottom surface, top surface and sidewall attaching surfaces (surrounding wall), the sidewalls (surrounding walls) of the at least two trays constitute a sidewall of the culture vessel, the apertures 109 of the growth chambers (culture vessel part) are formed in the sidewalls (surrounding walls) of the individual walls at the top thereof (distally from the bottom wall of the tray) (0029-32, 0040, Fig 2).
Regarding claim 20-21, KENNEY discloses the flask has a top plate 110 (cover plate with cover wall part) stacked on the growth chambers (trays); each growth chamber comprises a bottom surface surrounded by sidewall attaching surfaces (surrounding wall); the aperture 109 (opening) formed in the sidewall is a space formed by a cutout part in the sidewall and the bottom or cover wall (0029, Figure 2).
Regarding claims 22-24, KENNEY discloses the flask with growth chambers 111 (culture vessel part) has a first and second sidewall, opposed to each other along a lengthwise direction (first direction) which is the same direction of opposition as the barrier plate 106 and internal surface 128 (first and second surrounding walls), the neck opening 121 being located between the first and second sidewall positions in the first direction (Fig 2).
Regarding claim 25, KENNEY discloses the flask as stated above, but does not further disclose the distance between the first and second sidewall is not more than 140mm.
However, it would have been an obvious matter of design choice to create the device with the claimed dimensions to have the desired volume capacity for the cells being cultured and since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. MPEP 2144.04
Regarding claim 26-28, KENNEY discloses the manifold (reservoir part) comprises a third and fourth surrounding wall that are opposed to each other along a second direction orthogonal to the first direction and stacking direction with the port located between the third and fourth walls (Fig 2, 8).
Regarding claim 32, the device of KENNEY would have the lowest most bottom surface 113 (second bottom wall) in direct contact with the first internal space (i.e. space between bottom tray and lowest membrane 113) and with the second internal space (i.e. space between top plate and lowest membrane 113 surrounded by walls 112, 114).
Regarding claim 33, each of the first and second internal spaces are capable of accommodating a culture. It is noted this limitation recites an intended use of the vessel spaces but does not add any further structural limitations. 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. For apparatus claims, if the prior art structure is capable of performing the intended use, then it meets the claim. Apparatus claims must be structurally distinguishable from the prior art in terms of structure,
not function. The manner of operating an apparatus does not differentiate an apparatus claim from the prior art, if the prior art apparatus teaches all of the structural limitations of the claim See MPEP 2114-2115, 2173.05(g).
Response to Arguments
Applicant's arguments filed 2/17/26 have been fully considered but they are not persuasive.
In response to applicant’s arguments that the tracheal spaces of secondary reference MARTIN include structures which define said spaces and therefore prevents interpretation as the newly claimed first and second internal space, the examiner respectfully disagrees. Firstly, the combination of the manifold component of MARTIN to the device of KENNEY does NOT necessarily include the tracheal space structures of MARTIN, as argued by applicant. As stated in the above rejection, the reference of MARTIN was relied upon to teach an alternative shape with which to modify the shape of the manifold component of KENNEY, the rejection above did not rely on MARTIN to disclose the growth chambers and therefore does not require the tracheal space structures of said growth chambers of MARTIN as argued by applicant. Secondly, assuming in arguendo applicant intended to refer to the tracheal spaces 118 of primary reference KENNEY as preventing the KENNEY reference being interpreted as the claimed first and second internal spaces, the examiner points out the above rejection. The rejection treats the entirety of the cell growth chambers bounded by walls 112, 114 and bottom surface 113 as a singular tray, which in addition to bottom tray 120 and top plate 110 creates the first and second internal spaces as in the claimed limitations following the term “or”. Therefore even if applicant intended the argument regarding the tracheal space to be directed to KENNEY, the arguments are unpersuasive given this interpretation of the reference. Furthermore, in response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US PG Pubs 2016/0115434, 2016/0137961, 2021/0189314, 2011/0020923 and 2022/0356427 are cited as they all teach systems with at least three identical culture trays stacked as meets the alternative limitation amended into claim 13.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANIELLE B HENKEL whose telephone number is (571)270-5505. The examiner can normally be reached M-Th 11-7 EST, Alt. Fridays.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Marcheschi can be reached at 571-272-1374. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DANIELLE B HENKEL/Examiner, Art Unit 1799
/MICHAEL A MARCHESCHI/Supervisory Patent Examiner, Art Unit 1799
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