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 .
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.
Claims 91, 93, 94 and 98 are 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 91 recites the limitation "the second cell culture device" in line 2. There is insufficient antecedent basis for this limitation in the claim.
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, 10, 17, 88, 89, 91, 93, 185, 186, 191, 196, 197, and 261 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mason et al. (US 2018/0142200). The embodiments of the device most relevant to the instant claims are shown in Figures 1-8 and 12-16; and described in Paragraphs 0007-0046, 0088-0098, and claims 6-18.
Regarding claims 1, 17, 88, 185, 191 and 261 – As shown in the cited Figures, Mason teaches a collapsible cell culture container (10) comprising a base region (12), a top region (14) and a plurality of wall elements (8). The wall elements each comprise annular rigid sections (18, 20, 22, 24, 26, 28, 30) interweaved with a deformable region (32, 34, 36, 38) and are arranged parallel with the base region (12). Mason teaches the container may be made of gas permeable material in Paragraphs 0026 and 0046, and also in claim 16. Mason also teaches a membrane or filter disposed within the container located at the deformable regions to partition the lumen of the container into a plurality of segments. The Examiner considers any grouping of a pair of the plurality of segments (18, 20, 22, 24, 26, 28, 30) separated by the membrane or filter to meet the limitation of a first and second compartment by a sieve element as recited in claim 1. Mason teaches the plurality of chambers in the lumen of the container (10) may have different widths and a larger second chamber (i.e. greater cross sectional area as recited in claim 1) in Paragraphs 0022-0023 and Figures 8(a)-8(b). Mason further teaches grouping multiple sections together to form a first compartment (chamber 1) and second compartment (chamber 2) in Figures 3(a)-3(c). Figure 3(b) shows the container (10) in a configuration wherein the cross sectional area of the second gas permeable surface is at least 2 times greater than the cross sectional area of the first gas permeable surface and wherein the ratio of the volume of the second compartment to the first compartment is at least 2:1 (claims 17 and 88).
Regarding claims 185, 186, 196 and 197 – Mason teaches diaphragm structures (perforated plated and baffles) in Figure 16 and Paragraph 0087 such that a first section extending from a distal end of the interior space to a boundary, the first section being liquid-impermeable to prevent liquid from passing from the first chamber to the second chamber through the first section; and a second section that extends from the boundary towards a proximal end of the interior space, the second section being liquid-permeable to allow liquid to pass from the first chamber to the second chamber through the second section, wherein the first section of the diaphragm and the first wall define a well in the first chamber that is configured to retain up to a predetermined volume of liquid when the cell culture device is in a vertical orientation, the predetermined volume being less than a maximum fill volume of the first chamber.
Regarding claims 10, 89 and 261 – Mason discloses outlet ports in the base region or wall in Paragraphs 0019, 0028, 0041, 0043, and 0051.
Regarding claims 91, 93, 94 and 98 – Mason teaches the use of a restriction means in the form of a clamp or clamps coupled to the container in Paragraphs 0033 and 0095; and also in Figure 12.
Inventorship
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 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.
Claims 2, 8, and 9 are rejected under 35 U.S.C. 103 as being unpatentable over Mason et al. (US 2018/0142200) in view of Rhodes (US 2018/0154289).
Regarding claims 2 and 9 – Mason teaches every element of claims 2, 8 and 9 except for the support frame recited in claim 2. Rhodes teaches a cell culturing system including a bioreactor and flexible filter bag (22) with stand (20). The bag (22) and stand (20) are best shown in Figures 2-8 and 12-14. The stand (20) includes a tray (24) and support (26) upstanding on tray for supporting the filter bag (22) at various angles while processing material in the filter bag. The Examiner submits is would have been obvious to one of ordinary skill in the art at the time of the effective date of the invention to combine the support frame from Rhodes with the device of Mason. One of ordinary skill in the art at the time would add the support frame to Mason in order to support the filter bag at different angles while processing material in the filter bag as taught by Mason.
Regarding claim 8 – Mason discloses outlet ports in the base region or wall in Paragraphs 0019, 0028, 0041, 0043, and 0051.
Claims 179 and 180 are rejected under 35 U.S.C. 103 as being unpatentable over Mason et al. (US 2018/0142200) in view of Singh (US 2003/0036192). Mason teaches every element of claims 179 and 180 except for the fresh media container, collection container, and pumps recited in claims 179 and 180. Singh teaches a bioreactor assembly. The embodiments of the device most relevant to the instant claims are shown in Figures 1 and 4; and described in Paragraphs 0020-0025. As shown in Figure 4, the bioreactor assembly includes a fresh media container (feed container 32) and feed pump (33) connected to the inlet port (30) of the bag (10) for adding media, and also a collection container (35) and harvest pump (34) connected to the outlet of the bag (10) for removing media from the bag (10). The feed pump (33) and harvest pump (34) are operated intermittently by a controller (50) which provides a substantially constant volume of liquid media in the bag (10). See Paragraph 0025 and claim 14. The Examiner submits is would have been obvious to one of ordinary skill in the art at the time of the effective date of the invention to combine the fresh media container, collection container, and pumps from Singh with the device of Mason. One of ordinary skill in the art at the time would add the fresh media container, collection container, and pumps to Mason in order to provide a substantially constant volume of liquid media in the container as taught by Singh.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DWAYNE K HANDY whose telephone number is (571)272-1259. The examiner can normally be reached M-F 10AM-7PM.
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/DWAYNE K HANDY/Examiner, Art Unit 1798 June 12, 2026
/BRIAN R GORDON/Primary Examiner, Art Unit 1798
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