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 .
Election/Restrictions
Applicant's election with traverse of Group I in the reply filed on 6/29/2026 is acknowledged. The traversal is on the ground(s) that the technical feature of a backward operation of the centrifuge is not taught in Tijsterman. This is not found persuasive because a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Furthermore, as discussed below, claim 1 is found as obvious over Tijsterman and Wang
The requirement is still deemed proper and is therefore made FINAL.
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.
Claim 16 is 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 16 recites the limitation "the sensor arrangement" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 16 recites the limitation "the waste receptacle " in line 4. There is insufficient antecedent basis for this limitation in the claim.
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(s) 1-3, 5, 6 and 10-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over United States Application Publication No. 2015/0299644, hereinafter Tijsterman in view of United States Application Publication No. 2016/0187330, hereinafter Wang.
Regarding claim 1, Tijsterman teaches a method for operating a bioprocess installation (paragraphs [0051]-0054]) with an electronic process control (paragraph [0031]) and at least one bioprocess unit (item 100), wherein the bioprocess unit comprises a cell broth source (item 16 and “seed culture”) with a first receptacle (item 10) for cell broth including cultivation media and cells (paragraph [0029]), establishing a culture environment for cell cultivation and/or bioproduction (paragraph [0029]), wherein the bioprocess unit comprises a clarification setup (item 40) with a centrifuge (item 35) for the clarification of the cell broth by centrifugation (paragraph [0032]), with a liquid pumping arrangement (bidirectional pump) assigned to the centrifuge (figure 1) and with a liquid network with a number of liquid lines (the lines connecting item 10 to the pump to item 35) communicating with the liquid pumping arrangement (figure 1), wherein out of a first culture environment established by the first receptacle, the cell broth is transferred to the centrifuge via the liquid network (figure 1 and paragraph [0032]), which centrifuge is operated in a forward operation for cell separation and/or cell washing (paragraph [0032]) and the direction of the cell broth is reversed (paragraph [0035]), wherein the liquid network comprises a recycling line (the line that connects the pump to item 15) and that in the backward operation, at least part of the discharged cells is being transferred into a second culture environment different from the first culture environment via the recycling line for subsequent cell cultivation and/or bioproduction (paragraph [0035]).
Tijsterman fails to teach the centrifuge is operated in a backward operation for cell discharging.
Wang teaches a centrifuge for a reaction vessel unit in which the rotational direction of the centrifuge is reversed to drain all the fluid out of the centrifuge (Wang, paragraph [0127]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have operated the centrifuge in the backward operation because it would drain all the fluid (cell broth) out of the centrifuge (Wang, paragraph [0127]).
Regarding claim 2, Tijsterman teaches the second culture environment differs from the first culture environment with respect to the structural entity establishing the respective culture environment (items 10 and 15), and/or, that the second culture environment differs from the first culture environment with respect to liquid properties, and/or, that the second culture environment differs from the first culture environment with respect to culture environment conditions (paragraph [0045]).
Regarding claim 3, Tijsterman teaches the second culture environment provides culture environment conditions thereby favouring cell growth and/or bioproduction (paragraph [0029]), and/or, that the second culture environment is the first culture environment, after having exchanged the cultivation media (optional).
Regarding claim 5, Tijsterman teaches the second culture environment is provided by a second receptacle, which is separate from the first receptacle (items 10 and 15, figure 1).
Regarding claim 6, Tijsterman teaches the first receptacle and/or the second receptacle comprise(s) a feed line (the line connecting to item 16) for a controlled feeding of media during cultivation according to a predefined feeding profile (paragraph [0032]), and/or, that the second receptacle is a passive receptacle without a feed line and/or without electronic process control (optional).
Regarding claim 10, Tijsterman teaches in the backward operation, after transferring at least part of the discharged cells into the second culture environment, a startup phase is initiated in the second culture environment to establish conditions for cell cultivation and/or bioproduction (paragraph [0035]).
Regarding claim 11, Tijsterman teaches in forward operation for cell washing, washing liquid is transferred to the centrifuge via the liquid network (paragraph [0032]).
Regarding claim 12, Tijsterman teaches in backward operation for cell discharging, discharging liquid is transferred to the centrifuge via the liquid network (paragraph [0032]).
Regarding claim 13, Tijsterman teaches the bioprocess installation comprises a valve arrangement (item 40), which allows to deactivate and activate at least one of the liquid lines (paragraph [0034]).
Regarding claim 14, Tijsterman teaches the centrifuge and/or the liquid pumping arrangement and/or the valve arrangement are controlled by the electronic process control (paragraph [0031]).
Regarding claim 15, Tijsterman teaches the first receptacle and/or the second receptacle is/are provided as a bioreactor (figure 1), and/or, that a bioreactor process control serves for monitoring and/or controlling at least one parameter in the first receptacle and/or the second receptacle out of the group of carbon-source concentration, nitrogen-source concentration, amino acid concentration, growth factor concentration, oxygen concentration, carbon dioxide concentration, pH, temperature, conductivity, pressure, biomass concentration (paragraph [0031]), biomass production rate, product concentration, productivity, oxygen uptake rate and/or stirring speed.
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tijsterman and Wang as applied to claim 1 above, and further in view of United States Application Publication No. 2011/0207225, hereinafter Mehta.
Regarding claim 4, Tijsterman and Wang teach all limitations of claim 1; however, they fail to teach the second culture environment is provided by the first receptacle, which, for establishing the second culture environment, is being brought to a cell-free and/or a liquid-free state in a preparation phase.
Mehta teaches a bioreactor device which has a bioreactor and centrifuge in which the fluid flow is reversed and returned to the same receptacle for further processing (Mehta, paragraph [0114]).
Examiner further finds that the prior art contained a device/method/product (i.e., utilizing one receptacle) which differed from the claimed device by the substitution of component(s) (i.e., utilizing two receptacles) with other component(s) (i.e., using one receptacle), and the substituted components and their functions were known in the art as above set forth. An ordinarily skilled artisan at the time of invention could have substituted one known element with another (i.e., utilizing two receptacles with one), and the results of the substitution (i.e., bioprocessing) would have been predictable.
Therefore, pursuant to MPEP §2143 (I), Examiner concludes that it would have been obvious to an ordinarily skilled artisan at the time of invention to substitute the two receptacles of reference Tijsterman with the singular receptacle of reference Mehta, since the result would have been predictable.
Claim(s) 7 and 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tijsterman and Wang as applied to claim 5 above, and further in view of Mehta.
Regarding claim 7, Tijsterman teaches all limitations of claim 5; however, they fail to teach the cell broth in the second receptacle is transferred into the first receptacle after an intermediate phase.
Mehta teaches that a perfusion cycle may be repeated 3 or more times depending on the needs of the cells (Mehta, paragraph [0114]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to determine, through routine experimentation, the optimum number of cycles to a range of 3 or more which would allow which would allow for the needs of the cells to be met (MPEP § 2144.05 (II)). Each cycle would transfer the cells to the first receptacles and then the second and then back to the first.
Regarding claim 8, Tijsterman teaches all limitations of claim 5; however, they fail to teach the cell broth in the second receptacle is transferred into the first receptacle not before a termination condition has been fulfilled with respect to the liquid level in the first receptacle.
Mehta teaches that a perfusion cycle may be repeated 3 or more times depending on the needs of the cells (Mehta, paragraph [0114]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to determine, through routine experimentation, the optimum number of cycles to a range of 3 or more which would allow which would allow for the needs of the cells to be met (MPEP § 2144.05 (II)). Each cycle would transfer the cells to the first receptacles and then the second and then back to the first.
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tijsterman and Wang as applied to claim 1 above, and further in view of United States Application Publication No. 2008/0057553, hereinafter Cadwalader.
Regarding claim 9, Tijsterman and Wang teach all limitations of claim 1; however, they fail to teach the bioprocess installation comprises two or more bioprocess units and that the second receptacle of each bioprocess unit is the first receptacle of a subsequent bioprocess unit such that the bioprocess units are cascaded.
Cadwalader teaches a process in which multiple reactors and centrifuges are connected in series such the substrate is moved from one reactor to the next and the target product increases to form a continuous process (Cadwalader, paragraphs [0097] and [0103] and figure 1).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have utilized two or more bioprocess units with the second receptacle of each bioprocess unit the first receptacle of the subsequent bioprocess unit because it would allow for the substrate to be moved from one reactor to the next and the target product increases to form a continuous process (Cadwalader, paragraphs [0097] and [0103] and figure 1).
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tijsterman and Wang as applied to claim 1 above, and further in view of CN 105861364, hereinafter Li.
Regarding claim 16, Tijsterman and Wang teach all limitations of claim 1; however, they fail to teach the sensor arrangement comprises a biomass sensor in the recycling line, and that, in the backward operation of the centrifuge, depending on the sensor data of the biomass sensor, the liquid is transferred to the second culture environment or the waste receptacle by the electronic process control switching the valve arrangement accordingly.
Li teaches a biomass system in which biomass sensors are utilized to controlled the pipeline solenoid valves with the microcomputer controlling the valves based upon if the current biomass meets the pre-set detection range (Li, page 8, paragraphs 3-4).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have added a biomass sensor on the recycling line and controlled the flow utilizing the valves based upon the sensor because it would allow for the biomass to meet the pre-set detection range (Li, page 8, paragraphs 3-4).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW D KRCHA whose telephone number is (571)270-0386. The examiner can normally be reached M-Th 7am-5pm.
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/MATTHEW D KRCHA/Primary Examiner, Art Unit 1796
