Prosecution Insights
Last updated: August 14, 2026
Application No. 18/602,016

BIOLOGICAL FILTRATION SYSTEMS AND CONTROLLING METHODS THEREOF

Non-Final OA §103§112
Filed
Mar 11, 2024
Priority
Oct 21, 2021 — CN 202122544497.1 +7 more
Examiner
MCCULLOUGH, ERIC J.
Art Unit
Tech Center
Assignee
Alit Biotech (Shanghai) Co. Ltd.
OA Round
1 (Non-Final)
32%
Grant Probability
At Risk
1-2
OA Rounds
1y 5m
Est. Remaining
76%
With Interview

Examiner Intelligence

Grants only 32% of cases
32%
Career Allowance Rate
130 granted / 405 resolved
-27.9% vs TC avg
Strong +44% interview lift
Without
With
+44.1%
Interview Lift
resolved cases with interview
Typical timeline
3y 10m
Avg Prosecution
31 currently pending
Career history
445
Total Applications
across all art units

Statute-Specific Performance

§101
0.7%
-39.3% vs TC avg
§103
57.7%
+17.7% vs TC avg
§102
10.5%
-29.5% vs TC avg
§112
24.8%
-15.2% vs TC avg
Black line = Tech Center average estimate • Based on career data from 405 resolved cases

Office Action

§103 §112
DETAILED ACTION This action is in response to an application filed with the US on 03/11/2024 and having an Effective Filing Date of 10/21/2021, in which claims 1-18, 20 and 24 are pending and ready for examination. 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(s) (IDS) submitted on 07 JUNE 2024 is/are in compliance with the provisions of 37 CFR 1.97 and has/have been considered. An initialed copy of Form 1449 is enclosed herewith. 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 8, 12 and 14 are rejected under 35 U.S.C. 112(b) 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 8 recites the limitation “the chamber”, repeatedly. There is insufficient antecedent basis for this limitation in the claim. It will be interpreted to refer to “the liquid chamber”. Claim 12 recites the limitation “disposed for the liquid chamber and is used to cool air entering the gas purifier”. It is not clear if “disposed for the liquid chamber” is to mean that the cooling device is part of the liquid chamber or merely used in the process along with it. Claim 14 recites the limitation “the condensed water”. 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 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. Claims 1, 4, 6, 9, 11, 15-16, 20 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over US 2014/0342446 Al (hereinafter “Pralong”) in view of US 11,459,535 B1 (hereinafter “Yeh”). Regarding Claim 1 Pralong discloses a biological filtration system for filtering a solution in a bioreactor 1, comprising: a filter device 6/8 having a top end and a bottom end, the top end being in fluid communication with the bioreactor 1 for filtering the solution in the bioreactor; a liquid chamber 17 in fluid communication with the bottom end for storing a solution in the filter device; a positive pressure source (which may be compressed air [0066]), in fluid communication with the liquid chamber 17, for driving the solution to flow from the liquid chamber to the bioreactor; and a negative pressure source/vacuum injector 36 (can be generated by vacuum pump [0072]), in fluid communication with the liquid chamber 17, for driving the solution to flow from the bioreactor to the liquid chamber; Fig. 1, [0059]-[0075]. The compressed air positive pressure source is not specifically disclosed to be a pump, however Yeh discloses a gas compressor or pump is a known source of compressed air (C5/L41-45). Therefore, before the effective filing date, it would have been prima facie obvious to one of ordinary skill in the art to modify the filter system of Pralong by using for the compressed air pressure source a gas compressor or pump as disclosed by Yeh because this is a known source of compressed air, and thus involves the simple substitution of known compressed air pressure sources to obtain the predictable result of forming a successful biological filtration system. Regarding Claim 4 Pralong in view of Yeh discloses the biological filtration system of claim 1, wherein the liquid chamber comprises a single chamber connected to the top end of the filter device by a conduit (Pralong Fig. 1). Regarding Claim 9 Pralong in view of Yeh discloses the biological filtration system of claim 1, wherein the biological filtration system further comprises a first sensor LSH 26, wherein the first sensor is configured to detect liquid level information in the liquid chamber 17 and is disposed on a top portion of the liquid chamber at a preset interval, a second sensor LSL 25, configured to detect the liquid level information in the liquid chamber and disposed on a bottom portion of the liquid chamber; Pralong Fig. 1, [0069]. Regarding Claim 11 Pralong in view of Yeh discloses the biological filtration system of claim 1, the biological filtration system further comprises a gas purifier (sterile filter 21) disposed on a flow path connecting the positive pressure pump and the negative pressure pump in the liquid chamber; Pralong [0026]. Regarding Claim 15 Pralong in view of Yeh discloses the biological filtration system of claim 11, wherein the biological filtration system further comprises a heating device, and the heating device is disposed for the gas purifier; Pralong [0026]. Regarding Claim 16 Pralong in view of Yeh discloses the biological filtration system of claim 1, wherein the biological filtration system further comprises a first pressure regulating device 44 and a second pressure regulating device 42, wherein the first pressure 44 regulating device is disposed at an outlet of the positive pressure pump and is used to adjust a pumping gas pressure of the positive pressure pump, and the second pressure regulating device 42 is disposed at an outlet of the negative pressure pump and is used to adjust a suction gas pressure of the negative pressure pump; Pralong [0074]. Regarding Claim 20 Pralong in view of Yeh discloses the biological filtration system of claim 1, further comprising a gas flow controller 28 configured to: obtain a first liquid level signal (i.e. from the LSH 26) in the liquid chamber 17; control the positive pressure source/pump to drive the solution in the filter device to flow to the bioreactor based on the first liquid level signal (i.e. backflushing the filter); obtain a second liquid level signal (i.e. from LSL 25) in the liquid chamber 17; and control the negative pressure source/pump to drive the solution in the bioreactor 1 to flow to the filter device based on the second liquid level signal; Pralong Fig. 1, [0069]-[0075], particularly [0073]. The flow controller is not specifically disclosed to comprise a processor, however a processor must be inherent in order to achieve the actions disclosed to be accomplished by the gas flow controller 28. See MPE 2112 with regard to inherency. Alternatively, before the effective filing date, it would have been prima facie obvious to one of ordinary skill in the art to modify the filter system of Pralong in view of Yeh by using a processor in order to achieve the actions disclosed to be accomplished by the gas flow controller 28. Regarding Claim 24 Pralong discloses a controlling method for a biological filtration system, wherein the biological filtration system comprises a filter device 6/8 having a top end and a bottom end, the top end being in fluid communication with the bioreactor 1 for filtering the solution in the bioreactor; a liquid chamber 17 in fluid communication with the bottom end for storing a solution in the filter device; a positive pressure source (which may be compressed air [0066]), in fluid communication with the liquid chamber 17, for driving the solution to flow from the liquid chamber to the bioreactor; and a negative pressure source/vacuum injector 36 (can be generated by vacuum pump [0072]), in fluid communication with the liquid chamber 17, for driving the solution to flow from the bioreactor to the liquid chamber; Fig. 1, [0059]-[0075]. the controlling method comprises: obtaining a first liquid level signal i.e. from the LSH 26) in the liquid chamber; controlling the positive pressure source to drive the solution in the filter device 6 to flow to the bioreactor 1 based on the first liquid level signal (i.e. backflushing the filter); obtaining a second liquid level signal (i.e. from LSL 25) in the liquid chamber 17; and controlling the negative pressure source/pump to drive the solution in the bioreactor 1 to flow to the filter device 6 based on the second liquid level signal; Fig. 1, [0069]-[0075], particularly [0073]. The compressed air positive pressure source is not specifically disclosed to be a pump, however Yeh discloses a gas compressor or pump is a known source of compressed air (C5/L41-45). Therefore, before the effective filing date, it would have been prima facie obvious to one of ordinary skill in the art to modify the filter system of Pralong by using for the compressed air pressure source a gas compressor or pump as disclosed by Yeh because this is a known source of compressed air, and thus involves the simple substitution of known compressed air pressure sources to obtain the predictable result of forming a successful biological filtration system. Claims 2-3 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Pralong in view of Yeh further in view of US 20100078395 A1 (hereinafter “Shevitz”). Regarding Claims 2-3 Pralong in view of Yeh discloses the biological filtration system of claim 1, but does not disclose (claim 2) wherein the filter device comprises a filter portion and a storage portion, wherein the filter portion is disposed close to the bottom end of the filter device, the storage portion is disposed close to the top end of the filter device, the storage portion is configured as a hollow chamber to form the liquid chamber, and the storage portion is in direct communication with the filter portion., or (claim 3) wherein the liquid chamber comprises a single chamber that directly interfaces with the top end of the filter device. However Shevitz discloses a similar filter for alternating flow filtration of living cell solutions, wherein gas positive or negative pressure applied to a liquid chamber causes liquid to flow in and out of the filter for tangential flow filtration, wherein the filter device comprises a filter portion 17 and a storage portion 7/8, wherein the filter portion is disposed close to the bottom end of the filter device, the storage portion is disposed close to the top end of the filter device, the storage portion is configured as a hollow chamber to form the liquid chamber 7, and the storage portion is in direct communication with the filter portion (as they are attached/integral), wherein the liquid chamber comprises a single chamber that directly interfaces with the top end of the filter device (as they are attached/integral), see Fig. 1, 2, Abstract, [0114], and discloses this arrangement as an alternative to one where the liquid chamber is separate from the filter and connected by a conduit, see Fig. 16. Therefore, before the effective filing date, it would have been prima facie obvious to one of ordinary skill in the art to modify the filter system of Pralong in view of Yeh by integrating the liquid chamber with the filter device by incorporating it into the filter as disclosed by Shevitz because this is a known alternative arrangement to a separate liquid chamber connected by a conduit. While it is noted that in Pralong the liquid chamber is connected to the bottom of the filter, as Shevitz shows the liquid chamber which drives fluid flow is on the top, and supplying fluid to the top, it would have been obvious to arrange the filter so that the liquid chamber is incorporated into the top of the filter, i.e. inverting the filter of Pralong because this is a known alternative arrangement of such filters, and because there is no criticality placed on the orientation of the filter of Pralong. Thus resulting in wherein the liquid chamber comprises a single chamber that directly interfaces with the top end of the filter device. Regarding Claim 6 Pralong in view of Yeh and Shevitz discloses the biological filtration system of claim 2, wherein the biological filtration system comprises a first conduit, wherein the bottom end of the filter device (i.e. because it is inverted from as shown in the figure, see rejection of claim 2 supra) is connected to the bioreactor through the first conduit, the positive pressure pump is used to drive the solution in the filter device to flow to the bioreactor along the first conduit, and the negative pressure pump is used to drive the solution in the bioreactor to flow to the filter device along the first conduit (Pralong Fig. 1). Regarding Claim 10 Pralong in view of Yeh discloses the biological filtration system of claim 1, but does not disclose wherein the biological filtration system further comprises a third sensor and a fourth sensor for detecting liquid level information in the filter device, and the filter device includes a reaction liquid port and a retentate liquid port, wherein the third sensor is disposed at the reaction liquid port, and the fourth sensor is disposed at the retentate liquid port. However Shevitz discloses a similar filter for alternating flow filtration of living cell solutions, wherein gas positive or negative pressure applied to a liquid chamber causes liquid to flow in and out of the filter for tangential flow filtration, wherein the filter device comprises a filter portion 17 and a storage portion 7/8, wherein the filter portion is disposed close to the bottom end of the filter device, the storage portion is disposed close to the top end of the filter device, the storage portion is configured as a hollow chamber to form the liquid chamber 7, and the storage portion is in direct communication with the filter portion (as they are attached/integral), wherein the liquid chamber comprises a single chamber that directly interfaces with the top end of the filter device (as they are attached/integral), see Fig. 1, 2, Abstract, [0114], and discloses this arrangement as an alternative to one where the liquid chamber is separate from the filter and connected by a conduit, see Fig. 16. Therefore, before the effective filing date, it would have been prima facie obvious to one of ordinary skill in the art to modify the filter system of Pralong in view of Yeh by integrating the liquid chamber with the filter device by incorporating it into the filter as disclosed by Shevitz because this is a known alternative arrangement to a separate liquid chamber connected by a conduit. While it is noted that in Pralong the liquid chamber is connected to the bottom of the filter, as Shevitz shows the liquid chamber which drives fluid flow is on the top, and supplying fluid to the top, it would have been obvious to arrange the filter so that the liquid chamber is incorporated into the top of the filter, i.e. inverting the filter of Pralong because this is a known alternative arrangement of such filters, and because there is no criticality placed on the orientation of the filter of Pralong. Pralong discloses wherein the biological filtration system further comprises the liquid chamber, which in the combination of Pralong in view of Yeh and Shevitz is integral with the top of the filter, a third sensor LSH 26, and a further sensor LSL 25 for detecting liquid level information in the top and bottom of the liquid chamber (i.e. thus part of the filter device), Fig. 1, [0069]. Wherein the top of the liquid chamber may be considered a reaction liquid port and the bottom of the liquid chamber a retentate liquid port, thus the third sensor is disposed at the reaction liquid port, and the fourth sensor is disposed at the retentate liquid port. Claims 5 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Pralong in view of Yeh further in view of US 20190185803 A1 (hereinafter “Grant”). Regarding Claim 5 Pralong in view of Yeh discloses the biological filtration system of claim 1, but does not disclose wherein the liquid chamber comprises a plurality of chambers, each of the plurality of chambers being connected to the top end or the bottom end of the filter device through a conduit. However Grant discloses a similar system for filtering cell cultures from a bioreactor using alternating tangential flow, wherein a liquid chamber 120 is attached to a positive/negative pressure pump to push fluid in and out of a filter, wherein the liquid chamber may comprise a plurality of chambers (Fig. 4), each of the plurality of chambers being connected to the top end or the bottom end of the filter device through a conduit, (Fig. 1, 3A-B). Therefore, before the effective filing date, it would have been prima facie obvious to one of ordinary skill in the art to modify the filter system of Pralong in view of Yeh by using a plurality of liquid chambers as disclosed by Grant because this is a known alternative arrangement of liquid chambers. Further this is mere duplication of the single liquid chamber, where mere duplication has been held obvious. See MPEP 2144.04. Regarding Claim 8 Pralong in view of Yeh discloses the biological filtration system of claim 4, but does not disclose wherein the biological filtration system comprises a fourth conduit, a fifth conduit and a sixth conduit, wherein one of the top end and the bottom end of the filter device is connected to the chamber through the fourth conduit, the other one of the top end and the bottom end of the filter device is connected to the bioreactor through the fifth conduit, the chamber is connected to the bioreactor through the sixth conduit, the positive pressure pump is used to drive the solution in the chamber to flow to the bioreactor through the filter device, and the negative pressure pump is used to drive the solution in the bioreactor to flow to the chamber; or the positive pressure pump is used to drive the solution in the chamber to flow to the bioreactor, and the negative pressure pump is used to drive the solution in the bioreactor to flow to the chamber through the filter device. However Grant discloses a similar system for filtering cell cultures from a bioreactor using alternating tangential flow, wherein a liquid chamber 120 is attached to a positive/negative pressure pump to push fluid in and out of a filter, wherein the system comprises a fourth conduit 153 or 253, a fifth conduit 151 and a sixth conduit 152, wherein one of the top end and the bottom end of the filter device 140 is connected to the chamber 120 or 220 through the fourth conduit, the other one of the top end and the bottom end of the filter device 140 is connected to the bioreactor through the fifth conduit, the chamber 120 or 220 is connected to the bioreactor through the sixth conduit (Fig. 4, [0047]-[0050]). Therefore, before the effective filing date, it would have been prima facie obvious to one of ordinary skill in the art to modify the filter system of Pralong in view of Yeh by using a fourth conduit, a fifth conduit and a sixth conduit to connect the liquid chamber, filter and bioreactor such that the bottom end of the filter device is connected to the liquid chamber through the fourth conduit, the top end of the filter device 140 is connected to the bioreactor through the fifth conduit, the liquid chamber is connected to the bioreactor through the sixth conduit as disclosed by Grant because this is disclosed as an alternative flow arrangement for the connection of the liquid chamber, filter and bioreactor, to a single pipe connecting the liquid chamber to the filter and another connecting the filter to the bioreactor (Grant Fig. 1 and Pralong Fig. 1), and would thus have been obvious to substitute the flow arrangement of Grant for the flow arrangement disclosed by Pralong to obtain the predictable result of a successful filtration system. Thus in combination, the positive pressure pump is used to drive the solution in the chamber to flow to the bioreactor through the filter device, and the negative pressure pump is used to drive the solution in the bioreactor to flow to the chamber; or the positive pressure pump is used to drive the solution in the chamber to flow to the bioreactor, and the negative pressure pump is used to drive the solution in the bioreactor to flow to the chamber through the filter device. Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Pralong in view of Yeh and Shevitz further in view of US 20150247114 A1 (hereinafter “Gebauer”). Regarding Claim 7 Pralong in view of Yeh and Shevitz discloses the biological filtration system of claim 2, but does not disclose wherein the biological filtration system comprises a second conduit and a third conduit, wherein the bottom end of the filter device is connected to the bioreactor through the second conduit and the third conduit, the second conduit is disposed with a first one-way valve, so that the solution in the filter device flows to the bioreactor in one direction, and the third conduit is disposed with a second one-way valve, so that the solution in the bioreactor flows to the filter device in one direction. However Gebauer discloses a similar the biological filtration system wherein two conduits (i.e. a second conduit and a third conduit) are used to transfer fluid back and forth between a filter and bioreactor, wherein the filter device is fluidly connected to the bioreactor through the second conduit 9 and the third conduit 8, the second conduit is disposed with a first one-way valve 9, so that the solution in the filter device flows to the bioreactor in one direction, and the third conduit is disposed with a second one-way valve 8, so that the solution in the bioreactor flows to the filter device in one direction; (Fig. 1, [0020]-[0023]). Therefore, before the effective filing date, it would have been prima facie obvious to one of ordinary skill in the art to modify the filter system of Pralong in view of Yeh and Shevitz by fluidly connecting the bottom of the filter device and the bioreactor through a second conduit and the third conduit, where the second conduit is disposed with a first one-way valve, so that the solution in the filter device flows to the bioreactor in one direction, and the third conduit is disposed with a second one-way valve, so that the solution in the bioreactor flows to the filter device in one direction as disclosed by Gebauer because this involves the simple substitution of known arrangements of conduits used for controlling flow between a bioreactor and a filter to provide tangential flow perfusion to obtain the predictable result of forming a successful filter system. Claims 12-13 are rejected under 35 U.S.C. 103 as being unpatentable over Pralong in view of Yeh further in view of US 2014/0120609 A1 (hereinafter “Goh”). Regarding Claim 12 Pralong in view of Yeh discloses the biological filtration system of claim 11, but does not disclose wherein the biological filtration system further comprises a cooling device, wherein the cooling device is disposed for the liquid chamber and is used to cool air entering the gas purifier. However Goh discloses control of gas supplied to a bioreactor, wherein it is disclosed that in the gas outlet, the gas in cooled by a liquid trap to remove humidity/condensation in the gas before it flows to a control mechanism, to prevent the fluid from condensing in the flow control mechanism to prevent and potential for clogging; Fig. 1, [0035]-[0036], [0064]. Therefore, before the effective filing date, it would have been prima facie obvious to one of ordinary skill in the art to modify the filter system of Pralong in view of Yeh by placing a cold liquid trap (i.e. a cooler) in the gas line between the liquid chamber 17 gas outlet and of the gas flow controller 28 of Pralong, in order to prevent the fluid from condensing in the flow control mechanism to prevent and potential for clogging as in Goh. As the sterile filter/gas purifier 21 is the only other item on the flow path between the liquid chamber gas outlet and the gas flow controller 28, and therefore it would have been obvious to place the cooling device/liquid trap on either the upstream or downstream side of the gas purifier, because this involves the choice between two finite options, either of which would have been obvious. Regarding Claim 13 Pralong in view of Yeh discloses the biological filtration system of claim 11, but does not disclose wherein the biological filtration system further comprises a liquid storage box, wherein the liquid storage box is disposed on a flow path between the gas purifier and the negative pressure pump, and the liquid storage box is used to collect condensed water. However Goh discloses control of gas supplied to a bioreactor, wherein it is disclosed that in the gas outlet, the gas in cooled by a liquid trap (i.e. liquid storage box) to remove humidity/condensation in the gas before it flows to a control mechanism, to prevent the fluid from condensing in the flow control mechanism to prevent and potential for clogging; Fig. 1, [0035]-[0036], [0064]. Therefore, before the effective filing date, it would have been prima facie obvious to one of ordinary skill in the art to modify the filter system of Pralong in view of Yeh by placing a cold liquid trap (i.e. a liquid storage box) in the gas line between the liquid chamber 17 gas outlet and of the gas flow controller 28 of Pralong, in order to prevent the fluid from condensing in the flow control mechanism to prevent and potential for clogging as in Goh. As the sterile filter/gas purifier 21 is the only other item on the flow path between the liquid chamber gas outlet and the gas flow controller 28, and therefore it would have been obvious to place the cooling device/liquid trap on either the upstream or downstream side of the gas purifier, because this involves the choice between two finite options, either of which would have been obvious. Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Pralong in view of Yeh further in view of US 20150247114 A1 (hereinafter “Gebauer”). Regarding Claim 14 Pralong in view of Yeh discloses the biological filtration system of claim 11, but does not disclose wherein the biological filtration system further comprises a check valve, wherein the check valve is disposed on a flow path between the gas purifier and the negative pressure pump, and is used to prevent the condensed water from flowing back into the gas purifier. However, Gebauer discloses a similar the biological filtration system for tangential flow filtration and perfusion of cell cultures, wherein it is disclosed check vales may be used to control in a conduit to its intended direction (Fig. 1, [0020]-[0023]). Therefore, before the effective filing date, it would have been prima facie obvious to one of ordinary skill in the art to modify the filter system of Pralong in view of Yeh by including check valves in fluid lines intended for one way fluid flow as disclosed by Gebauer because this will prevent fluid (including condensed water if present) flow flowing in a direction that is not intended. This is seen to include the conduit/flow path between the gas purifier and the negative pressure pump to prevent fluid from flowing back into the gas purifier, i.e. a direction not as intended. Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Pralong in view of Yeh further in view of US 2014/0377739 A1 (hereinafter “Welch”). Regarding Claim 17 Pralong in view of Yeh discloses the biological filtration system of claim 1, but does not disclose wherein the biological filtration system further comprises a pressure relief bypass, wherein the pressure relief bypass is disposed on a flow path between the liquid chamber and the positive pressure pump and/or the negative pressure pump for releasing gas pressure in the biological filtration system. However Welch discloses similar methods and apparatus are disclosed for cell culture and cell recovery, wherein a gas source 6038 is used to supply gas to media 6020 in vessel 6000 and a pressure relief valve 6056 (i.e. bypass) is included on the gas source line 6052 in order to minimize pressure buildup in the device 6000 [0067]. Therefore, before the effective filing date, it would have been prima facie obvious to one of ordinary skill in the art to modify the filter system of Pralong in view of Yeh by including pressure relief valve (i.e. bypass) on the gas source line between the liquid chamber and the gas source as disclosed by Welch in order to minimize pressure buildup in the system. The combination thus results in a pressure relief bypass, wherein the pressure relief bypass is disposed on a flow path between the liquid chamber and the positive pressure pump for releasing gas pressure in the biological filtration system as claimed. Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Pralong in view of Yeh further in view of US 20210269477 A1 (hereinafter “Konstantinov”). Regarding Claim 18 Pralong in view of Yeh discloses the biological filtration system of claim 1, wherein the filter device is disposed with a penetrating liquid port 10, and the biological filtration system further comprises permeate exit (arrow to “Permeate” after item 12) to be recovered or harvested and a flow controlling device (pump 12), wherein the penetrating liquid port is connected to the permeate exit, the flow controlling device is disposed between the permeate exit and the filter device, and is used to control a flow rate of the solution in the filter device to the permeate exit, Pralong Fig. 1, [0062]. The permeate exit is not specifically disclosed to comprise a collection container. However Konstantinov discloses a similar system for filtering cell cultures from a bioreactor, wherein the permeate/filtrate is collected into a holding tank 10, Fig. 1, [0067]-[0068]. Therefore, before the effective filing date, it would have been prima facie obvious to one of ordinary skill in the art to modify the filter system of Pralong in view of Yeh by including a holding tank for collecting permeate from the filter as disclosed by Konstantinov in order to collect the permeate for harvesting or recovery. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to Eric J. McCullough whose telephone number is (571)272-8885. The examiner can normally be reached Monday-Friday 10:00-6:00. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Benjamin L Lebron can be reached at 571-272-0475. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /ERIC J MCCULLOUGH/ Examiner, Art Unit 1773 /BENJAMIN L LEBRON/ Supervisory Patent Examiner, Art Unit 1773
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Prosecution Timeline

Mar 11, 2024
Application Filed
Jul 16, 2026
Non-Final Rejection mailed — §103, §112 (current)

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