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 . 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.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Drawing
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the cavity and cell based drug production device must be shown or the feature(s) canceled from the claims such as claim 1. No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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.
Claims 1-7, 10-17, 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over ZHAO1, CN202837029U in view of Griffin2 ,US 20160123848 A1.
Claim 1
ZHAO teaches: A quantitative, sterile and disposable automatic cell sampling device3, comprising a sampling container 1, a pump 7, a sterile filter (6: ¶0002¶0003¶0021), a control valve 3, a first conduit 2 , and a second conduit (C2 connected to 7,6 and F2);
a receiving cavity 41,42 being formed in an interior of the sampling container 1 for receiving a sample (cell: bioreactor for cell sampler, e.g., ¶0001) , and a first interface (inlet, outlet F1) and a second interface (inlet, outlet F2) being formed in a top portion 12 of the sampling container 1 communicating with the receiving cavity 41,42 for achieving a maximum sampling capacity (function can met by 41,42,12,1 see also e.g. , ¶0004) of the sampling container 1;
one end of the first conduit 2 being connected to the first interface (F1), and the other end of the first conduit 2 being connected to a cell based drug production device (e.g., ¶0020¶0021);
the control valve 3 being installed in a middle of the first conduit 2 for controlling on and off (function met by valve 3, also ¶0004¶0020¶0021) of the first conduit 2;
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the second conduit (C2) being connected between the second interface (F2) and the sterile filter 6 for discharging and supplementing sterile air (e.g., ¶0004 ¶0020¶0021)4 in the sampling container 1;
the sterile filter 6 being configured to filter air passing therethrough into the sterile air (¶0020¶0021);
the control valve 3 having an open state and a closed state, wherein when the control valve 3 is in the open state, a communication is formed between two ends of the first conduit 2; when the control valve 3 is in the closed state, the communication between the two ends of the first conduit 2 is interrupted (any valve , including valve 3 reads on this limitation, see also ¶0020¶0021).
ZHAO does not specifically teach the other end of the first conduit being connected to a cell based drug production device through the pump.
In the similar field of endeavor, Griffin in e.g., figs. 1 and 3 teaches a pump (160, 318), and the other end of the first conduit (102,306) being connected to a cell based drug production device (e.g.,130,132,304) through the pump 160,318.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use Griffin‘s pump for ZHAO‘s cell sampling device and the other end of the modified ZHAO’s first conduit being connected to a cell based drug production device through the modified ZHAO’s pump. One of ordinary skill in the art knows pumps are assisting the fluid movement when necessary and would have been motivated to make this modification in order to facilitate and mange proper movement of fluid or for example assist in purging at least a portion of the tubing of the sampling assembly(e.g., Griffin ¶0047) .
Claim 2
ZHAO in view of Griffin teaches the automatic cell sampling device according to claim 1, Griffin teaches wherein the pump 160 is a peristaltic pump (e.g., ¶0047).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use Griffin‘s peristaltic pump for the modified ZHAO‘s system. One of ordinary skill in the art know peristaltic pumps and their usage for sterilized systems since no touching fluid and mechanical components would have been motivated to make this modification in order to use them in a sterilized system.
Claim 3
ZHAO in view of Griffin teaches the automatic cell sampling device according to claim 1, ZHAO teaches wherein the sampling container 1 is a transparent container provided with a scale (0009¶0020).
Claim 4
ZHAO in view of Griffin teaches the automatic cell sampling device according to claim 1, ZHAO teaches wherein the control valve is a tube clamp (¶0013).
Claim 5
ZHAO in view of Griffin teaches the automatic cell sampling device according to claim 1, ZHAO teaches wherein the sampling container is made of flexible material (¶0020).
Claim 6
ZHAO in view of Griffin teaches a cell sampling method using the automatic cell sampling device according to claim 1, wherein cell fluid is introduced into the sampling container 1 by generating a fluid driving force (¶0004¶0020¶0021: by negative and positive pressure created by 7 the fluid flow to and from sampling device is managed), and the cell sampling method comprises:
closing the control valve 3 of the cell sampling device 1 such that the control valve 3 is in the closed state, and allowing both the first interface F1 and the second interface F2 to be located at highest positions of the sampling container (see at least figure 1);
opening the control valve 3, and quantitatively transferring the cell fluid from the cell based drug production device to the receiving cavity of the sampling container through the force by gradient pressure created by 7 (¶0020¶0021);
closing the control valve (3)5, and closing the first conduit 2 between the sampling container 1 and the control valve 3 to achieve a quantitative, sterile and disposable cell sampling (¶0004¶0020¶0021).
ZHAO modified by Griffin as cited above does not specifically teach wherein cell fluid is introduced into the sampling container by generating a fluid driving force through the pump, the automatic cell sampling device, opening the control valve and the pump of the automatic cell sampling device, connecting the pump of the automatic cell sampling device to the cell based drug production device, and quantitatively transferring the cell fluid from the cell based drug production device to the receiving cavity of the sampling container through the pump, and sealing the first conduit between the sampling container and the control valve to achieve a quantitative, sterile and disposable cell sampling.
But Griffin teaches pump 160 and teaches the sampling is automatic (fig.2 and ¶0059) and also teaches sealing (e.g., via 126) the first conduit 102 between the sampling container 140 and the control valve ( valve to e.g., 132 e.g., ¶0038¶0040¶0041).
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use Griffin‘s pump and sealing for the modified ZHAO‘s method wherein cell fluid is introduced into the modified ZHAO’s sampling container by generating a fluid driving force through the modified ZHAO’s pump, the modified ZHAO’s automatic cell sampling device, opening the control valve and modified ZHAO’s pump of the automatic cell sampling device, connecting modified ZHAO’s pump of the automatic cell sampling device to the cell based drug production device, and quantitatively transferring the cell fluid from the cell based drug production device to the receiving cavity of the sampling container through modified ZHAO’s pump, and sealing modified ZHAO’s first conduit between the sampling container and the control valve to achieve a quantitative, sterile and disposable cell sampling. One of ordinary skill in the art knows aseptic sealing (e.g., ¶0038 of Griffin) would have been motivated to make this modification in order to facilitate managing different cell fluids for different kits and prevent samples mixing or contamination (¶0038¶0039).
Furthermore, Examiner holds claim is not further limited to any structural limitation for claimed automatic sampling device and the courts have held that broadly providing an automatic or mechanical means to replace a manual activity which accomplished the same result is not sufficient to distinguish over the prior art. See MPEP 2144.04 III (“Automating A Manual Activity”) and based on MPEP 2114.IV, broadly claiming an automated means to replace a manual function to accomplish the same result does not distinguish over the prior art. See Leapfrog Enters., Inc. v. Fisher-Price, Inc., 485 F.3d 1157, 1161, 82 USPQ2d 1687, 1691 (Fed. Cir. 2007). Therefore, the combination of ZHAO and Griffin teaches the broad limitation the automatic cell sampling device.
Claim 7
ZHAO in view of Griffin teaches the cell sampling method according to claim 6, ZHAO further teaches further comprising following steps between the opening the control valve 3 and of the cell sampling device 1 and the closing the control valve 3 of the automatic cell sampling device 1:
allowing the air in the sampling container 1 and the air filtered by the sterile filter 6 to be introduced into the first conduit 2, and allowing the cell fluid in the first conduit 2 to flow back into the cell based drug production device (ZHAO manage and allowing the air ,via gradient of pressure, in the sampling container 1 and the air filtered by the sterile filter to be introduced into the first conduit 2, and allowing the cell fluid in the first conduit 2 to flow back into the cell based drug production device (see e.g., ¶0004¶0020¶0021)6. But, ZHAO does not specifically teach controlling the pump to rotate reversely.
Griffin in figs. 4-6 teaches pump 318 rotate reversely (reverse directions 321,343) allowing the fluid in the 319 and the fluid to be introduced into the 306, and allowing the cell fluid in the 306 to flow back into the 319. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use Griffin‘s pump for the modified ZHAO‘s method of fluid movement and controlling the modified ZHAO’s pump to rotate reversely, allowing the air in the modified ZHAO’s sampling container and the air filtered by the sterile filter to be introduced into the modified ZHAO’s first conduit, and allowing the cell fluid in the first conduit to flow back into the cell based drug production device. One of ordinary skill in the art knows peristaltic pumps (e.g., Griffin ¶0083) and knows these pumps creating a vacuum that draws liquid through and pushes it forward without the fluid touching mechanical parts, ideal for sterile or corrosive applications, would have been motivated to make this modification in order to cause fluid be introduced back to the line in sterilized systems with reversing rotation direction of pump (e.g., Griffin ¶0083) to manage fluid movement in a sterilized system. Furthermore, based on MPEP 2143(D), courts have ruled that Simple applying a known technique (Griffin’s controlling the pump to rotate reversely) to a known product (the ZHAO’s method of generating gradient air pressure) to yield predictable results (to move fluid between sampling device and cell production device of ZHAO and Griffin), is within the purview of a skilled artisan. See KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421,82 USPQ2d 1385, 1395-97 (2007).
Claim 9
ZHAO in view of Griffin teaches the cell sampling method according to claim 6, the combination does not specifically teach wherein after the sealing the first conduit between the sampling container and the control valve, the method further comprises: sterilely connecting another automatic cell sampling device to the sealed first conduit, and repeating the above steps to achieve multiple times of sterile sampling. However, It would have been obvious to one of ordinary skill in the art at the time the invention was made to repeating the above steps to achieve multiple times of sterile sampling, since it has been held that mere duplication of the essential working parts and method of use steps of a device involves only routine skill in the art. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8 (1977).
Claim 10
ZHAO in view of Griffin teaches the cell sampling method according to claim 9, Griffin teaches wherein in the sterilely connecting another automatic cell sampling device (any of 132,130, 140) to the sealed first conduit 102, a first conduit 120,124 of another automatic cell sampling device 132,130 is connected to the sealed first conduit 102 through a sterile conduit adapter 126, and, It would have been obvious to one of ordinary skill in the art at the time the invention was made to sterilely connecting another automatic cell sampling device to the sealed first conduit, a first conduit of another automatic cell sampling device is connected to the sealed first conduit through a sterile conduit adapter, to do this for different cell types (e.g., ¶0039¶0041 Griffin ).
Claim 11
ZHAO in view of Griffin teaches the automatic cell sampling device according to claim 2, wherein the control valve is a tube clamp (¶0013).
Claim 12
ZHAO in view of Griffin teaches the automatic cell sampling device according to claim 2, wherein the sampling container is made of flexible material (¶0020).
Claim 13
ZHAO in view of Griffin teaches the automatic cell sampling device according to claim 3, wherein the control valve is a tube clamp (¶0013).
Claim 14
ZHAO in view of Griffin teaches the automatic cell sampling device according to claim 3, wherein the sampling container is made of flexible material (¶0020).
Claim 15
ZHAO in view of Griffin teaches the cell sampling method according to claim 7, Griffin teaches wherein in the sterilely connecting another automatic cell sampling device (any of 132,130, 140) to the sealed first conduit 102, a first conduit 120,124 of another automatic cell sampling device 132,130 is connected to the sealed first conduit 102 through a sterile conduit adapter 126, and, It would have been obvious to one of ordinary skill in the art at the time the invention was made to sterilely connecting another automatic cell sampling device to the sealed first conduit, a first conduit of another automatic cell sampling device is connected to the sealed first conduit through a sterile conduit adapter, to do this for different cell types (e.g., ¶0039¶0041 Griffin ).
Claim 16
ZHAO in view of Griffin teaches a cell sampling method using the automatic cell sampling device according to claim 2, wherein cell fluid is introduced into the sampling container1 by generating a fluid driving force (¶0004¶0020¶0021: by negative and positive pressure created by 7 the fluid flow to and from sampling device is managed), and the cell sampling method comprises:
closing the control valve 3 of the cell sampling device 1 such that the control valve 3 is in the closed state, and allowing both the first interface F1 and the second interface F2 to be located at highest positions of the sampling container (see figure 1);
opening the control valve 3, and quantitatively transferring the cell fluid from the cell based drug production device to the receiving cavity of the sampling container through the force by negative pressure (¶0020¶0021);
closing the control valve7 and the pump of the automatic cell sampling device, and closing the first conduit 2 between the sampling container 1 and the control valve 3 to achieve a quantitative, sterile and disposable cell sampling (¶0004¶0020¶0021).
ZHAO modified by Griffin as cited above does not specifically teach wherein cell fluid is introduced into the sampling container by generating a fluid driving force through the pump, the automatic cell sampling device, opening the control valve and the pump of the automatic cell sampling device, connecting the pump of the automatic cell sampling device to the cell based drug production device, and quantitatively transferring the cell fluid from the cell based drug production device to the receiving cavity of the sampling container through the pump, and sealing the first conduit between the sampling container and the control valve to achieve a quantitative, sterile and disposable cell sampling.
But Griffin teaches pump 160 and teaches the sampling is automatic (fig.2 and ¶0059) and also teaches sealing (e.g., via 126) the first conduit 102 between the sampling container 140 and the control valve ( valve to e.g., 132 e.g., ¶0038¶0040¶0041).
Therefore, It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use Griffin‘s pump and sealing for the modified ZHAO‘s method wherein cell fluid is introduced into the modified ZHAO’s sampling container by generating a fluid driving force through the modified ZHAO’s pump, the modified ZHAO’s automatic cell sampling device, opening the control valve and modified ZHAO’s pump of the automatic cell sampling device, connecting modified ZHAO’s pump of the automatic cell sampling device to the cell based drug production device, and quantitatively transferring the cell fluid from the cell based drug production device to the receiving cavity of the sampling container through modified ZHAO’s pump, and sealing modified ZHAO’s first conduit between the sampling container and the control valve to achieve a quantitative, sterile and disposable cell sampling. One of ordinary skill in the art knows aseptic sealing (e.g., ¶0038 of Griffin) would have been motivated to make this modification in order to facilitate managing different cell fluids for different kits and prevent samples mixing or contamination (¶0038¶0039).
Furthermore, Examiner holds claim is not limited to any structural limitation for automatic sampling device and the courts have held that broadly providing an automatic or mechanical means to replace a manual activity which accomplished the same result is not sufficient to distinguish over the prior art. See MPEP 2144.04 III (“Automating A Manual Activity”) and based on MPEP 2114.IV, broadly claiming an automated means to replace a manual function to accomplish the same result does not distinguish over the prior art. See Leapfrog Enters., Inc. v. Fisher-Price, Inc., 485 F.3d 1157, 1161, 82 USPQ2d 1687, 1691 (Fed. Cir. 2007). Therefore, the combination of ZHAO and Griffin teaches the broad limitation the automatic cell sampling device.
Claim 17
ZHAO in view of Griffin teaches the cell sampling method according to claim 16, ZHAO further teaches further comprising following steps between the opening the control valve 3 and of the cell sampling device 1 and the closing the control valve 3 of the automatic cell sampling device 1:
allowing the air in the sampling container 1 and the air filtered by the sterile filter 6 to be introduced into the first conduit 2, and allowing the cell fluid in the first conduit 2 to flow back into the cell based drug production device (ZHAO manage and allowing the air (via gradian of pressure) in the sampling container 1 and the air filtered by the sterile filter to be introduced into the first conduit 2, and allowing the cell fluid in the first conduit 2 to flow back into the cell based drug production device (see e.g., ¶0004¶0020¶0021)8. ZHAO does not specifically teach controlling the pump to rotate reversely.
Griffin in figs. 4-6 teaches pump 318 rotate reversely (reverse directions 321,343) allowing the fluid in the 319 and the fluid to be introduced into the 306, and allowing the cell fluid in the 306 to flow back into the 319. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use Griffin‘s pump for the modified ZHAO‘s method of fluid movement and controlling the modified ZHAO’s pump to rotate reversely, allowing the air in the modified ZHAO’s sampling container and the air filtered by the sterile filter to be introduced into the modified ZHAO’s first conduit, and allowing the cell fluid in the first conduit to flow back into the cell based drug production device. One of ordinary skill in the art knows peristaltic pumps (e.g., Griffin ¶0083) and knows these pumps creating a vacuum that draws liquid through and pushes it forward without the fluid touching mechanical parts, ideal for sterile or corrosive applications, would have been motivated to make this modification in order to cause fluid be introduced back to the line in sterilized systems with reversing rotation direction of pump (e.g., Griffin ¶0083) to manage fluid movement in a sterilized system. Furthermore, based on MPEP 2143(D), courts have ruled that Simple applying a known technique (Griffin’s controlling the pump to rotate reversely) to a known product (the ZHAO’s method of generating gradian air pressure) to yield predictable results (to move fluid between sampling device and cell production device of ZHAO and Griffin), is within the purview of a skilled artisan. See KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421,82 USPQ2d 1385, 1395-97 (2007).
Claim 19
ZHAO in view of Griffin teaches the cell sampling method according to any one of claim 18, Griffin teaches wherein in the sterilely connecting another automatic cell sampling device (any of 132,130, 140) to the sealed first conduit 102, a first conduit 120,124 of another automatic cell sampling device 132,130 is connected to the sealed first conduit 102 through a sterile conduit adapter 126, and, It would have been obvious to one of ordinary skill in the art at the time the invention was made to sterilely connecting another automatic cell sampling device to the sealed first conduit, a first conduit of another automatic cell sampling device is connected to the sealed first conduit through a sterile conduit adapter, to do this for different cell types (e.g., ¶0039¶0041 Griffin ).
Claim 20
ZHAO in view of Griffin teaches the cell sampling method according to claim 19, Griffin teaches wherein in the sterilely connecting another automatic cell sampling device (any of 132,130, 140) to the sealed first conduit 102, a first conduit 120,124 of another automatic cell sampling device 132,130 is connected to the sealed first conduit 102 through a sterile conduit adapter 126, and, It would have been obvious to one of ordinary skill in the art at the time the invention was made to sterilely connecting another automatic cell sampling device to the sealed first conduit, a first conduit of another automatic cell sampling device is connected to the sealed first conduit through a sterile conduit adapter, to do this for different cell types (e.g., ¶0039¶0041 Griffin ).
Claims 8 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over ZHAO, CN202837029U in view of Griffin ,US 20160123848 A1, and YU9 , CN212674526U.
Claim 8
ZHAO in view of Griffin teaches the cell sampling method according to claim 6, Griffin teaches wherein in the sealing the first conduit between the sampling container and the control valve (e.g., ¶0038¶0041) for the same reason and motivation cited above, but the combination does not specifically teach a hot-melt device is used to perform a hot-melt sealing process on the first conduit.
In the similar field of endeavor, YU teaches, a hot-melt device is used to perform a hot-melt sealing process on the first conduit (see underlined portions on English translation provided by the office)10.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use YU‘s hot-melt device for the modified ZHAO‘s sealing the conduits. One of ordinary skill in the art would have been motivated to make this modification in order to use known methods of sealing (Griffin ¶0054), based on MPEP 2143 (C), courts have ruled that Use of known technique to improve similar devices (methods, or products) in the same way is within the purview of a skilled artisan. See KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421,82 USPQ2d 1385, 1395-97 (2007).
Claim 18
ZHAO in view of Griffin teaches the cell sampling method according to claim 16, Griffin teaches wherein in the sealing the first conduit between the sampling container and the control valve (e.g., ¶0038¶0041) for the same reason and motivation cited above, but the combination does not specifically teach a hot-melt device is used to perform a hot-melt sealing process on the first conduit.
In the similar field of endeavor, YU teaches, a hot-melt device is used to perform a hot-melt sealing process on the first conduit (see underlined portions on English translation provided by the office)11.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use YU‘s hot-melt device for the modified ZHAO‘s sealing the conduits. One of ordinary skill in the art would have been motivated to make this modification in order to use known methods of sealing (Griffin ¶0054), based on MPEP 2143 (C), courts have ruled that Use of known technique to improve similar devices (methods, or products) in the same way is within the purview of a skilled artisan. See KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421,82 USPQ2d 1385, 1395-97 (2007).
Conclusion
Prior art of record considered as relevant but not used in the action:
Ho, (Lewis Ho, PhD, BIOREACTOR SCIENCES™, BioReactor Sciences LLC
, Improving Quality of Life by Helping Manufacturers with Collaborative Development and High Quality, Value-Priced Bioreactors, “Continuous Mass Production of Epithelial Cells Using a Bioreactor System for Regenerative Medicine” Nov. 2020: https://www.bioreactorsciences.com/landing-page-nov2020)
Ho teaches:
. A quantitative, sterile and disposable automatic cell sampling device, comprising a sampling container (21,8), a pump 16, a sterile filter (“exit from port 13 through the dispensing system 14 comprising several pinch valves to external designated containers 19, 20 with outlet air filters inside of a CO2 incubator or a refrigerator 15”) , a control valve (“exit from port 13 through the dispensing system 14 comprising several pinch valves to external designated containers 19, 20 with outlet air filters inside of a CO2 incubator or a refrigerator 15”), a first conduit (conduit connecting 13 to cell culture devices 19,20 in 15 via pump 16), and a second conduit ( from gas mixture system 11 to feed the gas mixture through inlet port 12);
a receiving cavity 10 being formed in an interior of the sampling container 21,8 for receiving a sample (at least title: epithelial cells using a bioreactor system for regenerative medicine or description footnote of figs.1-2), and a first interface and a second interface (integrated rocker 8,9) being formed [mounted with ] the sampling container 21,8 communicating with the receiving cavity 10 for achieving a maximum sampling capacity of the sampling container (function met by rocker 8,digital 9);
one end of the first conduit (to 13) being connected to the first interface (8,9), and the other end of the first conduit (13) being connected to a cell based drug production device (19,20 inside 15) through the pump (16);
the control valve ((“exit from port 13 through the dispensing system 14 comprising several pinch valves to external designated containers 19, 20 with outlet air filters inside of a CO2 incubator or a refrigerator 15”) being installed in a middle of the first conduit (to 13) for controlling on and off of the first conduit (inherent by valve and automatic system);
the second conduit (to 12) being connected between the second interface (8,9);
the sterile filter being configured to filter air passing therethrough into the sterile air;
the control valve ((“exit from port 13 through the dispensing system 14 comprising several pinch valves to external designated containers 19, 20 with outlet air filters inside of a CO2 incubator or a refrigerator 15”) having an open state and a closed state, wherein when the control valve is in the open state, a communication is formed between two ends of the first conduit; when the control valve is in the closed state, the communication between the two ends of the first conduit is interrupted (any valve , including valve 14 reads on this limitation).
US 20190358633 A1
Teaches automatic cell sampling device and method. The automatic cell sampling device includes a sampling container, a pump, a sterile filter, a control valve, a first conduit, and a second conduit.
US 20080114290 A1
Teaching pumping system which reverse the rotation of direction of pump 54 to move fluid and air to and back from eyes.
US 20190033176 A1
Teaches quantitative, sterile and disposable automatic cell sampling device and the device is designed such that a pressure difference between the first and the second ends of the first liquid line is greater than a predetermined minimum value when the first liquid line is connected with the process tank and the process tank is to be protected from contamination.
US 20220154127 A1
Teaches quantitative, sterile and disposable automatic cell sampling device and the sampling system includes a graduated sampling chamber configured for fluid connection to a sample source, a pump device configured for fluid connection with the sampling chamber, and a sterile air filter intermediate the pump device and the sampling chamber, wherein the pump device is selectively actuatable to draw a volume of fluid from the sample source into the sampling chamber.
US 20240009400 A1
Teaches quantitative, sterile and disposable automatic cell sampling device , the device and methods for sterile sampling from automated cell engineering systems are configured to maintain sterility of a sample reservoir during intake and expulsion of fluids or other material to the sterile sampling devices.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Fatemeh E. Nia whose telephone number is (469)295-9187. The examiner can normally be reached 9:00 am to 4:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kristina DeHerrera can be reached at (303) 297-4237. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/FATEMEH ESFANDIARI NIA/Examiner, Art Unit 2855
1 Prior art of record
2 Prior art of record
3 See e.g., ¶0009 or¶0003, however, where a patentee defines a structurally complete invention in the claim body and uses the preamble only to state a purpose or intended use for the invention, the preamble is not a claim limitation: see MPEP 2111.02 “Rowe v. Dror, 112 F.3d 473, 478, 42 USPQ2d 1550, 1553 (Fed. Cir. 1997).
4 ¶0020:“air pump 7 through an air filter 6 connected with the air inlet on the top cover 12, through air pump 7 of the air and gas operable to change the pressure sampling pipe I is to realize sampling of culture liquid and culture liquid sample discharge.” ¶0021: air pump 7 pumping, the sampling pipe 7 to form negative pressure, then the cells in the bioreactor is positive pressure, flows in through the sample inlet tube 2 into sampling tube I from liquid outlet of the bioreactor cell culture liquid. in the sampling pipe I culture amount of liquid reaching the sampling quantity after the air pump 7 to the sampling pipe I, inlet pressure into the sampling pipe I is greater than the pressure in the cell bioreactor, a sampling tube of culture liquid reflux 2 to cell bioreactor, closing the inlet valve 3, the sample inlet tube 2 on clip clamp, closed cell bioreactor with the pipeline between sampling tube I, finishing sampling. sample-inputting, the sampling tube is opened outlet valve 4 down the clip, 5, namely on air pump 7 to the inlet of sampling pipe I, increasing the pressure sampling pipe I in the culture liquid sample enters the out of sample tube 4, parallel to the EP sample tube.
5 ¶0004: after culture amount of liquid reaching the sampling quantity in the sampling tube, air pump pipe to the sampling inlet to the sampling pipe pressure is greater than the pressure in cell bioreactor in the culture liquid in the sampling tube in all return to cell bioreactor. closing the inlet valve off the connecting pipeline to finish the sampling.¶0020-¶0021: the sampling pipe is provided with scales and can perform quantitative sampling.
6 pressure difference between the gas pump 7 adjusts the sampling tube with cell bioreactor, the culture liquid flowing from cell reactor flows into the sampling pipe is through the sampling pipe and the sampling end back to cell bioreactor the culture liquid in the sampling tube. Specifically, opening the inlet valve is connected with the pipeline between the sampling tube and cell bioreactor, air pumping device for liquid pump, a sampling pipe in form negative pressure, then the cells in the bioreactor is positive pressure. culture liquid from the liquid outlet of the cell reactor flows through the sampling pipe sampling pipe, after culture amount of liquid reaching the sampling quantity in the sampling tube, air pump pipe to the sampling inlet to the sampling pipe pressure is greater than the pressure in cell bioreactor in the culture liquid in the sampling tube in all return to cell bioreactor. closing the inlet valve off the connecting pipeline to finish the sampling.
7 ¶0004: after culture amount of liquid reaching the sampling quantity in the sampling tube, air pump pipe to the sampling inlet to the sampling pipe pressure is greater than the pressure in cell bioreactor in the culture liquid in the sampling tube in all return to cell bioreactor. closing the inlet valve off the connecting pipeline to finish the sampling.¶0020-¶0021: the sampling pipe is provided with scales and can perform quantitative sampling.
8 pressure difference between the gas pump 7 adjusts the sampling tube with cell bioreactor, the culture liquid flowing from cell reactor flows into the sampling pipe is through the sampling pipe and the sampling end back to cell bioreactor the culture liquid in the sampling tube. Specifically, opening the inlet valve is connected with the pipeline between the sampling tube and cell bioreactor, air pumping device for liquid pump, a sampling pipe in form negative pressure, then the cells in the bioreactor is positive pressure. culture liquid from the liquid outlet of the cell reactor flows through the sampling pipe sampling pipe, after culture amount of liquid reaching the sampling quantity in the sampling tube, air pump pipe to the sampling inlet to the sampling pipe pressure is greater than the pressure in cell bioreactor in the culture liquid in the sampling tube in all return to cell bioreactor. closing the inlet valve off the connecting pipeline to finish the sampling.
9 Prior art of record
10 the connecting pipe 30 can be hot melt under the welding operation of the welding machine, and form a self-sealing at the welding position; the connecting pipe 30 is fused to form self-sealing to ensure the sealing of the connecting pipe 30; ensure that the connecting tube 30 after fusing the culture medium in the culture pipeline of the cell culture liquid and sampling bottle 10 in the sampling to obtain the cell culture solution will not be polluted.
hot melting the connecting pipe 30, and forming a self-sealing at the welding
position; at last, cutting the connecting pipe 30 at the fuse, taking the sampler, sampling operation is
finished.
11 self-sealing at the welding position, and the fusing of the connection tube 30 forms the self-sealing to ensure the sealing property of the connection tube 30, so as to ensure that neither the cell culture fluid in the culture pipeline nor the cell culture fluid sampled in the sampling bottle 10 after the fusing of the connection tube 30 is polluted.