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.
Claim 5 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 5 recites the limitation "the medium supply system". There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 102
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 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Shevitz (US 2013/0059371).
Regarding claim 1 Shevitz discloses a perfusion module, wherein the perfusion module comprises at least one perfusion chamber, wherein each perfusion chamber is connected to a pressure regulating pipe for inflow or outflow of an airflow, and the pressure regulating pipe is provided with a pump that enables the pressure regulating pipe to be opened and closed and changes a delivery direction of the airflow; (See Shevitz Abstract Figs. 1A and 1i and wherein a perfusion module comprises a perfusion chamber42 connected to a pressure regulating pipe 21 for inflow/outflow of air with pipe 21 provided with pump 4/54 that enables the pressure regulating pipe to be opened and closed and changes airflow deliver direction.)
Regarding claim 2 Shevitz discloses perfusion culture system, comprising: a bioreaction module, comprising at least one bioreactor; (See Shevitz Abstract Fig. 1a and [0152] wherein a perfusion system comprises a bioreaction module 2)
a perfusion module, comprising at least one perfusion chamber, wherein each perfusion chamber is connected to a pressure regulating pipe for inflow or outflow of an airflow, and the pressure regulating pipe is provided with a pump that enables the pressure regulating pipe to be opened and closed and changes a delivery direction of the airflow; (See Shevitz Figs. 1a and 1i wherein a perfusion module comprises a chamber 42 and a pressure regulating pipe 21 provided with a pump 4/ 54 to be opened and closed that changes airflow direction from inflow to outflow.)
a filtration module, comprising at least one filter, wherein each filter has an inlet end and an outlet end opposite to the inlet end, the inlet end is provided with a cell culture fluid inlet, and the outlet end is provided with a permeate outlet and a cell culture fluid outlet; (See Shevitz wherein a filtration module comprises a filter 5 with an inlet end with a cell culture fluid inlet, i.e. lumens 17 connected to chamber 42 , and outlet end with a permeate outlet and cell culture fluid outlet, i.e. end connected to pump 40 outer wall 19.)
wherein the at least one bioreactor, the perfusion module, and the filtration module are communicated in sequence; wherein a cell culture fluid in the at least one bioreactor flows into the at least one perfusion chamber in the perfusion module, and then flows out from the at least one perfusion chamber into the at least one filter for filtration, (See Shevitz Figs. 1a and 1i wherein bioreactor 2, perfusion module 42, and filtration module are fluidically communicated in series such that fluid flows from bioreactor 2 into perfusion module 42 and into filter 5.)
and a permeate from the at least one filter flows into a harvesting device through the permeate outlet. (See Shevitz Figs. 1a and 1i wherein the permeate from the filter flows into a harvesting device, i.e. tube and pump 13-14, from outlet 12.)
Regarding claim 3 Shevitz discloses all the claim limitations as set forth above as well as the device wherein the inlet end of each filter is further provided with a medium inlet, and the medium inlet is connected to a medium supply system. (See Shevitz [0161]-[0162] and Fig.4a wherein an inlet end of each filter is provided with a medium inlet, i.e. ports 216,238 connected to a medium supply system 281)
Regarding claim 4 Shevitz discloses all the claim limitations as set forth above as well as the device, wherein the cell culture fluid outlet of each filter is connected to the at least one bioreactor through a return pipe, and the cell culture fluid filtered by each filter is returned to the at least one bioreactor through the return pipe. (See Shevitz Fig. 1a and 1i wherein a return pipe 71 or 73 to return filtered cell culture fluid to the bioreactor.)
Regarding claim 5 Shevitz discloses all the claim limitations as set forth above as well as the device wherein the medium supply system is connected to the at least one bioreactor through a medium delivery pipe.(See Shevitz Fig. 1a wherein a medium supply system is connected to the bioreactor 2 through a delivery pipe 39 or 36)
Regarding claim 6 Shevitz discloses all the claim limitations as set forth above as well as the device wherein when the perfusion module comprises only one perfusion chamber, a top of the perfusion chamber is communicated with a top of the at least one bioreactor through the pressure regulating pipe. (See Shevitz Figs. 1A and 1i wherein a top of perfusion module is fluidically connected, i.e. communicated, with a top of the bioreactor through pressure regulating pipe 21.)
Regarding claim 7 Shevitz discloses all the claim limitations as set forth above as well as the device wherein the pump is a diaphragm pump. (See Shevitz Figs. 1A and 1i and [0097] wherein the pump 4 is a diaphragm pump)
Regarding claim 8 Shevitz discloses all the claim limitations as set forth above as well as the device wherein each perfusion chamber is connected to an airflow mass flow controller through an airflow delivery pipe. (See Shevitz Figs. 1A wherein the perfusion chamber is connected to an airmass flow controller 54 through a delivery pipe21)
Regarding claim 9 Shevitz discloses all the claim limitations as set forth above as well as the device wherein the airflow delivery pipe is provided with a gas filter or/and a switching valve. (See Shevitz Figs. 1A and 1i and [0097] wherein there is a gas filter 22 in the airflow delivery pipe.)
Regarding claim 10 Shevitz discloses all the claim limitations as set forth above as well as the device wherein the at least one bioreactor is connected to the at least one perfusion chamber through an infusion pipe, and the infusion pipe is provided with an on-off valve to enable the infusion pipe to be opened and closed. (See Shevitz Figs. 1A and 1i and [0121] wherein an infusion pipe 71 is connected to the bioreactor and perfusion chamber via an on-off valve 72 to allow pipe to be opened or closed.)
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.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Shevitz (US 2013/0059371) as applied to claims above, and further in view of Dam (US 2022/0372422).
Regarding claim 11 Shevitz discloses all the claim limitations as set forth above but does not disclose the use of two filtration modules side by side which work alternately.
Dam et al. discloses providing two filtration modules which work alternately provided side by side in a bioreactor device in order to prolong filter life and allow servicing thereof. (See Fig. 2 and 4a wherein a bioreactor is provided with two filters side by side which are used alternately.)
It would have been obvious to one of ordinary skill in the art at the time of filing to provide two side by side filters used alternately because doing so is known in bioreactor systems to allow continuous filtration and filter servicing as would be desirable in the device of Shevitz.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JONATHAN M HURST whose telephone number is (571)270-7065. The examiner can normally be reached on M-F 7AM-4PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Marcheschi can be reached on 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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/JONATHAN M HURST/ Primary Examiner, Art Unit 1799