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 statement (IDS) submitted on 3/29/2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claim 1 is objected to because of the following informalities:
I. Appropriate correction is required.
It is recommended that “a substrate comprises a polymer base” in line 5 read “a substrate comprising a polymer base”. Appropriate correction is required.
Claim 6 is objected to because of the following informalities:
It is recommended that “and synthetic peptides” in line 2 read “or synthetic peptides”. Appropriate correction is required.
Claim 8 is objected to because of the following informalities:
It is recommended that “and polyvinylidene fluoride” in line 5 read “or polyvinylidene fluoride”. Appropriate correction is required.
Claim 13 is objected to because of the following informalities:
It is recommended that “comprising fiber diameter of from about 10 micrometers” in line 2 read “comprising a fiber diameter of about 10 micrometers”. Appropriate correction is required.
Claim 16 is objected to because of the following informalities:
It is recommended that “and extracellular vesicle production” in line 4 read “or extracellular vesicle production”. Appropriate correction is required.
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.
Claims 1-5, 7-9, and 16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rimsa et al. (WO 2016/014915 A1) (already of record).
Regarding claim 1, Rimsa et al. discloses a bioreactor system for culturing cells, the system comprising: a cell culture vessel comprising at least one interior reservoir (tissue culture plate 600) configured for flowing liquid media therethrough; and a cell culture matrix disposed in the at least one interior reservoir, the cell culture matrix comprising a substrate comprising a polymer base (abstract “polyethylene terephthalate (PET)… polymer”) and a polystyrene coating disposed on the polymer base (polystyrene coating 610).
Regarding claim 2, Rimsa et al. discloses a bioreactor system wherein the polystyrene coating is functionalized to enhance cell attachment and/or growth thereto (para. 0003).
Regarding claim 3, Rimsa et al. discloses a bioreactor system wherein the polystyrene coating is plasma treated (para. 0041).
Regarding claim 4, Rimsa et al. discloses a bioreactor system further comprising a cell attachment treatment on the polystyrene coating (para. 0056).
Regarding claim 5, Rimsa et al. discloses a bioreactor system wherein the cell attachment treatment comprises at least one of an oxygen plasma (para. 0047 “oxygen… plasma”), an allylamine coating, a carboxylic acid group, or a biologics coating.
Regarding claim 7, Rimsa et al. discloses a bioreactor system wherein the polymer base comprises a thermopolymer (abstract “polyethylene terephthalate (PET)… polymer”).
Regarding claim 8, Rimsa et al. discloses a bioreactor system wherein the polymer base comprises at least one of polyethylene terephthalate (abstract “polyethylene terephthalate (PET)… polymer”), polypropylene, nylon, polylactic acid, polybenzimidazole, polycarbonate, polyether sulfone, polyoxymethylene, polyetherether ketone, polyethylene, polyphenylene oxide, polyphenylene sulfide, polyvinyl chloride, or polyvinylidene fluoride.
Regarding claim 9, Rimsa et al. discloses a bioreactor system wherein the substrate comprises woven or non-woven fibers (para. 0032 “fiber reinforced”).
Regarding claim 16, Rimsa et al. discloses a bioreactor system wherein the substrate is capable of at least one of viral vector production, induced pluripotent stem cells (iPSCs), mesenchymal stem cells (MSCs), protein production, antibody production, or extracellular vesicle production. It has been held that the inclusion of the material or article worked upon by a structure being claimed does not impart patentability to the claims (MPEP § 2115). Therefore, the apparatus disclosed by Rimsa et al. would be fully capable of achieving every claimed intended use because the prior art apparatus is disclosed to be for cell growth/culture (para. 0005) and would be structurally capable of at least one of viral vector production, induced pluripotent stem cells (iPSCs), mesenchymal stem cells (MSCs), protein production, antibody production, or extracellular vesicle production absent clear evidence otherwise.
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.
Claims 6 and 10-15 are rejected under 35 U.S.C. 103 as being unpatentable over Rimsa et al. (WO 2016/014915 A1) (already of record) in view of Ferrie et al. (US 2020/0248120 A1).
Regarding claim 6, Rimsa et al. discloses a bioreactor system comprising a coated substrate (polystyrene coating 610), but does not disclose wherein the coating is a biologics coating comprising at least one of laminin, fibronectin, extracellular proteins, or synthetic peptides. However, Ferrie et al. teaches a synthetic peptide coating (paras. 0195-0196) which promotes cell adherence (para. 0193). It would have been obvious to a person of ordinary skill in the art to use the Ferrie et al. configuration of a synthetic peptide coating in Rimsa et al.’s device with a reasonable expectation that it would promote cell adherence. This method for improving Rimsa et al.’s device was within the ability of one of ordinary skill in the art based on the teachings of Ferrie et al. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Rimsa et al. and Ferrie et al. to obtain the invention as specified in claim 6.
Regarding claim 10, Rimsa et al. discloses a bioreactor system wherein the cell culture matrix comprises a single layer (para. 0027), but does not disclose a plurality of layers of substrate. However, Ferrie et al. teaches a multilayer substrate (200) which allows efficient and uniform flow through one or multiple substrate layers (para. 0095). It would have been obvious to a person of ordinary skill in the art to use the Ferrie et al. configuration of multiple substrate layers in Rimsa et al.’s device with a reasonable expectation that it would allow efficient and uniform flow through one or multiple substrate layers. This method for improving Rimsa et al.’s device was within the ability of one of ordinary skill in the art based on the teachings of Ferrie et al. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Rimsa et al. and Ferrie et al. to obtain the invention as specified in claim 10.
Regarding claim 11, Rimsa et al. discloses a bioreactor system comprising a single substrate layer (para. 0027), but does not disclose wherein the plurality of layers is in a stacked arrangement. However, Ferrie et al. teaches stack of substrate layers (308) which allows the system to be easily scaled up without negative impacts on cell attachment and proliferation (para. 0097). It would have been obvious to a person of ordinary skill in the art to use the Ferrie et al. configuration of stacked substrate layers in Rimsa et al.’s device with a reasonable expectation that it would allow the system to be easily scaled up without negative impacts on cell attachment and proliferation. This method for improving Rimsa et al.’s device was within the ability of one of ordinary skill in the art based on the teachings of Ferrie et al. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Rimsa et al. and Ferrie et al. to obtain the invention as specified in claim 11.
Regarding claim 12, Rimsa et al. discloses a bioreactor system comprising a single substrate layer (para. 0027), but does not disclose wherein the substrate comprises a rolled substrate. However, Ferrie et al. teaches a rolled substrate (350) which allows the substrate to expand to the shape of a culture chamber within a bioreactor vessel (para. 0182). It would have been obvious to a person of ordinary skill in the art to use the Ferrie et al. configuration of a rolled substrate in Rimsa et al.’s device with a reasonable expectation that it would allow the substrate to expand to the shape of a culture chamber within a bioreactor vessel. This method for improving Rimsa et al.’s device was within the ability of one of ordinary skill in the art based on the teachings of Ferrie et al. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Rimsa et al. and Ferrie et al. to obtain the invention as specified in claim 12.
Regarding claim 13, Rimsa et al. discloses a bioreactor system wherein the substrate comprises fibers (para. 0032 “fiber reinforced”), but does not disclose fibers comprising a fiber diameter of about 10 micrometers to about 500 micrometers. However, Ferrie et al. teaches a fiber diameter of about 50 micrometers to about 400 micrometers (para. 0161) which controls flow resistance and volumetric density (para. 0098). It would have been obvious to a person of ordinary skill in the art to overlap the Ferrie et al. configuration of fiber diameter in the range of about 50 micrometers to about 400 micrometers in Rimsa et al.’s device with a reasonable expectation that it would control flow resistance and volumetric density. This method for improving Rimsa et al.’s device was within the ability of one of ordinary skill in the art based on the teachings of Ferrie et al. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Rimsa et al. and Ferrie et al. to obtain the invention as specified in claim 13.
Regarding claim 14, Rimsa et al. discloses a bioreactor system comprising a substrate, but does not disclose a regular array of openings between fibers of the substrate. However, Ferrie et al. teaches an array of openings between fibers in a substrate (para. 0155) which allows flow of culture media, cells, or cell products through the thickness of the substrate (para. 0155). It would have been obvious to a person of ordinary skill in the art to use the Ferrie et al. configuration of openings between fibers in Rimsa et al.’s device with a reasonable expectation that it would allow flow of culture media, cells, or cell products through the thickness of the substrate. This method for improving Rimsa et al.’s device was within the ability of one of ordinary skill in the art based on the teachings of Ferrie et al. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Rimsa et al. and Ferrie et al. to obtain the invention as specified in claim 14.
Regarding claim 15, Rimsa et al. discloses a bioreactor system comprising a substrate, but does not disclose an effective porosity of about 10% to about 80%. However, Ferrie et al. teaches a porosity of about 40.8% to 61.4% (para. 0132) which allows flow uniformity and permeability through the substrate (para. 0132). It would have been obvious to a person of ordinary skill in the art to overlap the Ferrie et al. configuration of a porosity of about 40.8% to 61.4% in Rimsa et al.’s device with a reasonable expectation that it would allow flow uniformity and permeability through the substrate. This method for improving Rimsa et al.’s device was within the ability of one of ordinary skill in the art based on the teachings of Ferrie et al. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Rimsa et al. and Ferrie et al. to obtain the invention as specified in claim 15.
Citation of Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Kwak et al. (US 2018/0362913 A1) (already of record) discloses a nanofiber structure for cell culture.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ASHLEY LOPEZLIRA whose telephone number is (703)756-5517. The examiner can normally be reached Mon - Fri: 8:30-5:00.
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/ASHLEY LOPEZLIRA/Examiner, Art Unit 1799
/MICHAEL A MARCHESCHI/Supervisory Patent Examiner, Art Unit 1799
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