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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 06/01/2023, 07/03/2024, 08/27/2025, and 09/25/225 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim 1-18 and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2021/0130760 A1-Castillo et al (hereinafter “Castillo”, has an earlier effective filing date as of the provisional application).
Regarding claim 1, Castillo discloses an apparatus for culturing cells (cell culturing arts and, more particularly, to a bioreactor, para. [0002]; and Castillo discloses an apparatus for culturing cells in a bioreactor, abstract, line 1), comprising: a bioreactor vessel (bioreactor 100, para. [0077], line 1, Fig. 1); and a monolithic structured cell culture bed disposed in a portion of the vessel (the monolithic nature of the structured fixed beds in the bioreactor 100 help to promote consistency of the cell culturing operation throughout, and thus homogeneity, para. [0150], lines 1-5).
Regarding claim 2, Castillo discloses further including an agitator for flowing fluid through the monolithic structured cell culture bed (the first chamber 116 may include an agitator for causing fluid flow within the bioreactor 100, para. [0078], lines 7-8, Fig. 3. Further, Castillo discloses the monolithic nature of the structured fixed beds in the bioreactor 100 help to promote consistency of the cell culturing operation throughout, and thus homogeneity, para. [0150], lines 1-5).
Regarding claim 3, Castillo discloses wherein the monolithic structured cell culture bed is annular (a bioreactor including a structured fixed bed forming a central column of the bioreactor; the structured fixed bed may comprise a spiral bed, para. [0032], lines 1-3).
Regarding claim 4, Castillo discloses wherein the monolithic structured cell culture bed is cuboid (the fixed bed is a structured fixed bed could take a variety of sizes or shapes, para. [0075], lines 3, and 6-7).
Regarding claim 5, Castillo discloses wherein the monolithic structured cell culture bed (the monolithic nature of the structured fixed beds in the bioreactor 100 help to promote consistency of the cell culturing operation throughout, and thus homogeneity, para. [0150], lines 1-5) comprises a sheet (matrix material of structured fixed bed, para. [0080], lines 1-2, Fig. 3A shows at least one sheet of the fixed bed) of interconnected objects (one or more immobilization layers 122a, Fig. 3A) having a partially curved or rounded shape (Fig. 3A shows a partially curved or rounded shape sheet of the structured fixed bed in the bioreactor; Castillo discloses the structured fixed bed can be subsequently spirally or concentrically rolled along an axis or core, para. [0080], lines 18-19, Fig. 3A).
Regarding claim 6, Castillo discloses wherein the monolithic structured cell culture bed (the monolithic nature of the structured fixed beds in the bioreactor 100 help to promote consistency of the cell culturing operation throughout, and thus homogeneity, para. [0150], lines 1-5) comprises a three-dimensional matrix of objects (the spacer layer can be a mesh or comprises a mesh structure. Also, the mesh structure or mesh can be a structure comprising a network or web-like pattern of filament, wire or thread, para. [0076], lines 1-5, Fig. 3B).
Regarding claim 7, Castillo discloses wherein the objects in the three- dimensional matrix are directly connected (the spacer layer can be a mesh or comprises a mesh structure. Also, the mesh structure or mesh can be a structure comprising a network or web-like pattern of filament, wire or thread, para. [0076], lines 1-5, Fig. 3B; further, Fig. 3B shows the matrix is directly connected).
Regarding claim 8, Castillo discloses wherein the objects in the three-dimensional matrix are connected by connectors forming a space between the objects (the spacer layer can be a mesh or comprises a mesh structure. Also, the mesh structure or mesh can be a structure comprising a network or web-like pattern of filament, wire or thread, para. [0076], lines 1-5, Fig. 3B; further, Fig. 3B shows the matrix is connected filament-like structures to cells).
Regarding claim 9, Castillo discloses wherein the bioreactor vessel includes an annular chamber for receiving the monolithic structured cell culture bed (annular chamber 120, para. [0078], line 16, Fig. 3).
Regarding claim 10, Castillo discloses wherein the bioreactor vessel (bioreactor 100, Figs. 1-3) and the monolithic structured cell culture bed comprise a unitary structure (spiral bed 122 in Fig. 3 is shown comprising a unitary structure).
Regarding claim 11, Castillo discloses wherein the monolithic structured cell culture bed (previously discussed above) comprises one or more pathways for unobstructed fluid flow (spacer layers 122b forms a tortuous path for cells and fluid to flow between the immobilization layers 122a, para. [0080], lines 9-14, Fig. 3A).
Regarding claim 12, Castillo discloses wherein the one or more pathways are linear (fluid may then flow radially inwardly to a central return chamber 126, Fig. 3).
Regarding claim 13, Castillo discloses wherein the one or more pathways are non-linear (spacer layers 122b forms a tortuous path for cells and fluid to flow between the immobilization layers 122a, para. [0080], lines 9-14, Fig. 3A, shows non-linear pathways).
Regarding claim 14, Castillo discloses wherein the monolithic structured cell culture bed (the monolithic nature of the structured fixed beds in the bioreactor 100 help to promote consistency of the cell culturing operation throughout, and thus homogeneity, para. [0150], lines 1-5) comprises randomly arranged objects (Fig. 3B shows randomly arranged objects L on matrix formed by immobilization layers 122a and spacer layers 122b).
Regarding claim 15, Castillo discloses wherein the monolithic structured cell culture bed (the monolithic nature of the structured fixed beds in the bioreactor 100 help to promote consistency of the cell culturing operation throughout, and thus homogeneity, para. [0150], lines 1-5) comprises a first zone having a greater density of objects than a second zone (the modules of the bioreactor 100 interact to create a place for growing cells, such as in a high-density manner using a fixed bed, para. [0081], lines 25-27; further, Castillo discloses via Fig. 3B, cells are disposed at various densities).
Regarding claim 16, Castillo discloses wherein the monolithic structured cell culture bed is adapted to create a fluid flow gradient (the first chamber 116 may include an agitator for causing fluid flow within the bioreactor 100, para. [0078], lines 7-8, Fig. 3. Further, Castillo discloses the monolithic nature of the structured fixed beds in the bioreactor 100 help to promote consistency of the cell culturing operation throughout, and thus homogeneity, para. [0150], lines 1-5, that is, a fluid flow gradient is created via the agitator in the chamber. Additionally, Castillo discloses an impeller speed may be adjusted to compensate for an increase in pressure drop so as to maintain consistent linear velocity from bottom of reactor to top of reactor, para. [0119], lines 19-22).
Regarding claim 17, Castillo discloses wherein the monolithic structured cell culture bed is 3D printed (Castillo discloses it may be possible to 3D print the embodiment, para. [0116], line 14-15).
Regarding claim 18, Castillo discloses wherein the monolithic structured cell culture bed is compressible (the spacer layer can be a mesh or comprises a mesh structure. Also, the mesh 122b structure or mesh can be a structure comprising a network or web-like pattern of filament, wire or thread, para. [0076], lines 1-5, Fig. 3B).
Regarding claim 19, Castillo discloses wherein the monolithic structured cell culture bed includes regions of varying porosity (the network can define pores , openings or perforations formed of a three-dimensional weave, para. [0076], lines 5-6; that is, the mesh structure previously discussed above).
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.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over US 2021/0130760 A1-Castillo as applied to claim 18 above, and further in view of US 2018/0282678 A1-Castillo et al (hereinafter “Castillo ‘678”).
Regarding claim 19, Castillo teaches the invention discussed above in claim 18. Further, Castillo teaches a monolithic cell culture bed, also discussed above. However, Castillo does not explicitly teach a compressor.
For claim 19, Castillo ‘678 teaches a cell growth matrix assembly or structured cell growth matrix (para. [0007]) and Castillo teaches the matrix of the device can be compressed by any method known to the person skilled in the art (para. [0057], lines 2-5), which reads on the instant claim limitation of a compressor.
It would have been obvious to one of ordinary skill, in the art at the time, to further include a compressor, as taught by Castillo ‘678, because Castillo ‘678 suggests compression of the matrix allow for improving overall performance of the matrix, which includes the spacer layers of the device (para. [0057]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LENORA A. ABEL whose telephone number is (571)272-8270. The examiner can normally be reached Monday-Friday 7:00am-4:00pm.
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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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/L.A.A./Examiner, Art Unit 1799
/MICHAEL L HOBBS/Primary Examiner, Art Unit 1799
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