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 .
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 08/31/2022, 09/06/2022, 02/8/2023, 09/20/2024, 01/08/2025, 07/2/2025 and 09/02/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-24 and 38-39 in the reply filed on 09/05/2025 is acknowledged. Claims 25-31 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 09/05/2025.
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 1-11, 13 and 18-24 are rejected under 35 U.S.C. 103 as being unpatentable over Tuan et al. (Hereinafter Tuan) US 2016/0201037.
Regarding claim 1, Tuan discloses a bioreactor [100], the bioreactor comprising: a vessel comprising: a first end (bottom end 112) and a second end (top end 114) which define a central axis of the vessel extending along a first direction of the vessel from said first to said second end as shown in Fig. 1, at least one wall (shell 102) running along the first direction of the vessel, at least one media conduit defining a volume for receiving fresh or spent media (upper inlet 104, lower inlet 106, upper outlet 108, and lower outlet 110); an inner chamber defined by at least a part of a space confined within said at least one wall and comprising a fresh media chamber and a spent media chamber (outer lower chamber 130/outer upper chamber 134); a cell culture chamber (inner lower chamber 128), in fluid communication with said at least one media conduit and said fresh and/or spent media chamber; and a movable wall as shown in Fig. 1 reproduced below configured, within said inner chamber, to separate said fresh media chamber from said spent media chamber within said inner chamber as discussed in at least paragraphs 47-48.
While Tuan does not explicitly disclose the bioreactor is adapted for rotation, given the generally cylindrical shape of the bioreactor (see paragraph 47), it would have been prima facie obvious to one of ordinary skill in the art, that the device of Tuan would be capable of rotation.
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Regarding claim 2, Tuan discloses wherein the at least one wall (shell 102) comprises an inner wall and an outer wall, the inner and outer wall defining an annular compartment in between said walls as shown in Fig. 2 reproduced below, the at least one media conduit (lower inlet 106 and lower outlet 110) is the annular compartment, and the inner chamber is defined by at least a part of the space confined within said inner wall.
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Regarding claim 3, Tuan discloses wherein the at least one wall (shell 102) is a single wall, and the at least one media conduit is at least one conduit arranged inside or outside the single wall as shown in Fig. 2 reproduced above.
Regarding claim 4, Tuan discloses wherein said cell culture chamber (inner lower chamber 128) is arranged separately at said first end of the vessel and is provided with an inlet orifice (a lower porous screen 124) for allowing media from said at least one media conduit, to enter into the cell culture chamber, and an outlet orifice (a lower porous screen 124) for allowing media from said culture chamber to enter into said spent media chamber as shown in Fig. 1.
Regarding claim 5, Tuan discloses wherein said at least one media conduit, is provided with an inlet orifice for allowing media from said fresh media chamber to enter into the at least one media conduit, and an outlet orifice for allowing media from the at least one media conduit to enter into the cell culture chamber, and wherein said outlet orifice of the annular compartment corresponds to said inlet orifice of the cell culture chamber as shown in Fig. 1 and discussed in at least paragraphs 47-50.
Regarding claim 6, Tuan does not explicitly disclose wherein at least part of said at least one wall is detachable, for providing access to the cell culture chamber.
However, absent unexpected results, it would have been prima facie obvious to provide a detachable sealing element for providing access to the cell culture chamber, since it has been held that constructing a formerly integral structure in various elements involves only routine skill in the art. See MPEP §2144.04 (V-C).
Regarding claim 7, Tuan discloses wherein at least part of said at least one wall is transparent glass or plastic configured to permit observation of the media, cells and spheroids contained therein (In some embodiments, bioreactors and associate components, as described herein, can comprise materials that are transparent to X rays so that it is possible to image by microCT the construct within the bioreactor.) as discussed in at least paragraph 86.
Regarding claim 8, Tuan does not explicitly discloses wherein said inner wall has a plurality of raised ridges (protruding ring 118 ) extending along the first direction of the vessel, and extending vertically outwards until contacting said outer wall, and wherein a space between said raised ridges define one or more sub-compartments within said annular compartment as shown in Fig. 1 and discussed in at least paragraph 47.
Regarding claim 9, Tuan discloses wherein the vessel (bioreactor 100/552) has a cylindrical or generally cylindrical shape (FIG. 1 shows a cross-sectional view of an exemplary bioreactor 100. Bioreactor 100 includes a shell 102 having a generally cylindrical inner space…) as discussed in at least paragraph 47. Also see paragraphs 61 and 64. Given the cylindrical or generally cylindrical shape bioreactor 100/552 is capable of being adapted for rotation around a rotational, axis by one or more associated rotation elements, said rotational axis being said central axis running along the first direction of the vessel.
Regarding claim 10, Tuan discloses wherein said movable wall is connected to a displacement element (piston 138) for displacing the movable wall axially along the first direction of the vessel as shown in Fig. 1 and discussed in at least paragraph 48.
Regarding claim 11, Tuan discloses wherein said displacement element is a piston, said movable wall being connected to said piston through a piston shaft which is coincident with said central axis running along the first direction of the vessel as shown in Fig. 1 and discussed in at least paragraph 48.
Regarding claim 13, Tuan discloses wherein the vessel includes a gas permeable membrane for the exchange of gasses, (In certain embodiments, a bioreactor can include an upper chamber having inlet and outlet ports and a lower chamber having inlet and outlet ports. The inlet ports can be fed by the same or independent sources of biological nutrients, such as liquid cell growth medium, that is perfused through each chamber from the inlet port to the outlet port. A first tissue can be situated in the upper chamber so as to be exposed to the biological nutrients fed through the upper inlet port, and a second tissue can be situated in the lower chamber so as to be exposed to the biological nutrients fed through the lower inlet port… Examples of other types of nutrients are various carbohydrates, fats, proteins, amino acids, minerals, water, oxygen…) as discussed in at least paragraphs 10 and 43, said gas permeable membrane being arranged along the circumferential part of the cell culture chamber and shown in Fig. 1.
Regarding claim 18, Tuan discloses wherein the cell culture chamber includes at least one access port (inlet 106) as shown in Fig. 1 and discussed in at least paragraph 48.
The optional claim limitations, namely a sensor, said sensor being removably mounted in said access port, are not required by the instant claim and therefore have not been treated on the merits. optionally.
Regarding claim 19, Tuan discloses wherein said at least one wall includes an access port (inlet 106) as shown in Fig. 1 and discussed in at least paragraph 48 to said fresh media chamber.
Regarding claim 20, Tuan discloses wherein an additional cell culture chamber is adapted in series connection with said cell culture chamber, said additional cell culture chamber having a conduit to transfer said fresh media and having an orifice for allowing the media to flow from the cell culture chamber to said additional cell culture chamber (The well plate 602 comprises twenty four wells, within each of which a bioreactor (e.g., bioreactor 100) can be situated. An inner body (e.g., an inner body similar to inner body 116) having a protruding ring and being configured to be situated within a well of the well plate 602 can have at least one vertical channel formed in its protruding ring, which channel can be configured to accommodate a pipe or tube which can carry fluid from the lower chamber of a first bioreactor, over the wall between adjacent wells of the well plate 602, and to the lower chamber of a second bioreactor adjacent to the first bioreactor.) as discussed in at least paragraph 65.
Regarding claim 21, Tuan discloses wherein the bioreactor includes at least one membrane (lower porous screen 124) for preventing at least part of the cell culture in the cell culture chamber (inner lower chamber 128) from exiting said cell culture chamber as discussed in at least paragraph 47.
Regarding claim 22, Tuan discloses wherein the at least one membrane is arranged over one or more of the outlet (lower outlet 110) orifices of the cell culture chamber as shown in Fig. 1.
Regarding claim 23, Tuan discloses wherein one or more additional cell culture chambers (container 554) are assembled on or in the vessel (bioreactors 552) by inserting extra additional cell culture chambers as discussed in at least paragraphs 61 and 64.
Regarding claim 24, Tuan discloses wherein at least one sensor is mounted (force sensors 566) on the one or more additional cell culture chambers as shown in Fig. 9 in such a way that the contents of each chamber can be monitored independently as discussed in at least paragraphs 61 and 64.
Claim Objections
Claims 12, 14-17 and 38-39 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.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LYDIA EDWARDS whose telephone number is (571)270-3242. The examiner can normally be reached on Monday-Thursday 6:30-5:30 EST.
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/LYDIA EDWARDS/Primary Examiner, Art Unit 1796