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.
Response to Amendment / Arguments
The response and amendments, filed 4/29/26, has been entered. Claims 1-6, 8-16, 18-20 are pending upon entry of this Amendment. The previous objections are withdrawn due to amendment. Applicant’s arguments regarding the prior art rejections of claims have been fully considered :
On pages 8-12 Applicant is arguing ZHAO does not teach these limitations of claim 1:
the pump provides a power source to introduce cell fluid in the cell based drug production device into the sampling container, enabling a quantitative, sterile and disposable cell sampling; then the pump being configured to be operated reversely, which can introduce the air in the sampling container and the sterile air filtered by the sterile filter into the first conduit, such that the cell fluid in the first conduit can flow back to the cell based drug production device.
Response:
one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
In this case, the rejection is relying on the combination of ZHAO, Griffin and amended claim relies also on Takeda, US20180298324A1.
ZHAO teaches all limitations of claim 1 except for “other end of the first conduit being connected to a cell based drug production device through the pump, and disposable cell sampling; then the pump being configured to be operated reversely, which can introduce the air in the sampling container and the sterile air filtered by the sterile filter into the first conduit, such that the cell fluid in the first conduit can flow back to the cell based drug production device.”
Griffin teaches semi-automated system for taking sterile samples from a cell culture or similar biological vessel without repeatedly opening the system. The setup uses a main sampling tube, a recovery tube, a pump, and several pre-attached sampling kits. Before each sample is taken, the system can circulate the biological fluid to mix it and then draw a portion into one selected sampling kit. After sampling, the pump can push purging fluid through the tubes to flush out leftover sample. The recovery tube helps return residual fluid back to the source instead of leaving it in the tubing. This reduces the chance that material from one sampling event contaminates the next one. The sampling kits are already connected to the tubing, so a user does not need to attach a new kit each time. The system is intended to make repeated aseptic sampling faster and less labor-intensive. It is especially aimed at cell culture monitoring, where samples may be needed at multiple times during growth. The purging fluid may be growth media, sterile water, buffer, or air, depending on the embodiment (see :¶0008-0010, 0015-0017, 0033-0036).
Therefore, Griffin teaches : other end of the first conduit being connected to a cell based drug production device through the pump, the pump being configured to be operated reversely, which can introduce the air in the sampling container and the sterile air filtered by the sterile filter into the first conduit (see e.g., ¶0034-0036,0047,0072-0074).
And the combination teaches the limitation “other end of the first conduit being connected to a cell based drug production device through the pump; then the pump being configured to be operated reversely, which can introduce the air in the sampling container and the sterile air filtered by the sterile filter into the first conduit, such that the cell fluid in the first conduit can flow back to the cell based drug production device” based on obviousness.
limitation “disposable cell sampling” now cited in the body of claim1 is taught by Takeda, US20180298324A1.
On pages 12-13 Applicant is arguing that there is no motivation to combine ZHAO and Griffin.
Response:
the test for obviousness is not whether the features of a secondary reference may be bodily incorporated into the structure of the primary reference; nor is it that the claimed invention must be expressly suggested in any one or all of the references. Rather, the test is what the combined teachings of the references would have suggested to those of ordinary skill in the art. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981).
In this case, a reason and motivation for the combination was cited from Griffin, although based on GUIDELINES in MPEP 2141.II and III : Prior art is not limited just to the references being applied, but includes the understanding of one of ordinary skill in the art, furthermore, in this case, neither reference provides any indication that their combination would not have yielded a predictable result, and the combination of arts meet the claimed limitations.
Therefore, the arguments are not persuasive.
Claim Objections
Claim 1 is objected. Term can in claim 1 makes the claim language optional. Therefore, claim should be amended to for example read as “which
Appropriate action is required.
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 1-6, 10-16 are rejected under 35 U.S.C. 103 as being unpatentable over ZHAO, CN202837029U in view of Griffin ,US 20160123848 A1 and Takeda, US20180298324A1.
Claim 1
ZHAO1 teaches: A quantitative, sterile and automatic cell sampling device2, 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)3 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), and the pump 7 provides a power source to introduce cell fluid in the cell based drug production device into the sampling container 1, enabling a quantitative, sterile cell sampling (pump 7 through creating pressure gradient does these function);
ZHAO does not specifically teach the other end of the first conduit being connected to a cell based drug production device through the pump, and disposable cell sampling; then the pump being configured to be operated reversely, which can introduce the air in the sampling container and the sterile air filtered by the sterile filter into the first conduit, such that the cell fluid in the first conduit can flow back to the cell based drug production device.
In the similar field of endeavor, Griffin4 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 that receiving from cell production device e.g., ¶0033,0034) through the pump 160,318, also teaches the pump (160,318) being configured to be operated reversely (¶0017, 0047, 0048, 0072-0074 also after sampling, the pump circulates purging fluid through the sampling conduit and recovery conduit to flush residual sample back to the source ¶0035-0036,0047,0072-0074).
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 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 then the pump being configured to be operated reversely, which can introduce the air in the modified ZHAO’s sampling container and the sterile air filtered by the sterile filter into the modified ZHAO’s first conduit, such that the modified ZHAO’s cell fluid in the modified ZHAO’s first conduit can flow back to the modified ZHAO’s cell based drug production device. 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 ¶0047,0048) Griffin also suggests using this reversable pumping to solve the contamination and carryover problem (¶0008,0010,0015-0017).
The modified ZHAO in view of Griffin does not specifically teach a disposable cell sampling.
In the similar field of endeavor, Takeda teaches a disposable microfluidic system for analyzing, sorting, and dispensing tiny particles such as cells, cell clusters, and emulsion droplets. It uses a transparent cartridge with flow paths, reservoirs, light illumination, and detectors to find particles of interest by scattered light or fluorescence, and teaches a disposable cell sampling (e.g., ¶0094).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use Takeda‘s disposable cell sampling for the modified ZHAO‘s sampling to have a quantitative, sterile and automatic disposable cell sampling device. One of ordinary skill in the art knows disposable units (single-use systems) are ideal for cell sampling because they completely eliminate the risk of cross-contamination between batches. They remove the need for labor-intensive cleaning validation, steam sterilization (CIP/SIP), and reduce turnaround time, ensuring maximum sterility and sample integrity for sensitive application would have been motivated to make this modification in order to have a sealed disposable flow-path cartridge without outside contamination (e.g., ¶0057,0113,0114 of Takeda).
Claim 2
ZHAO in view of Griffin and Takeda 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 and Takeda 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 and Takeda 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 and Takeda 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 and Takeda teaches a cell sampling method using the cell sampling device according to claim 1, wherein cell fluid is introduced into the sampling container 1 by generating a fluid driving force through the pump 7 (¶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, connecting the pump 7 of the cell sampling device 1 to the cell based drug production device (function met via pump 7 driving sample to the container) , 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 the pump 7 of the cell sampling device 1, and quantitatively transferring the cell fluid from the cell based drug production device to the receiving cavity of the sampling container 1 through the pump 7; 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).
The modified ZHAO combined with Griffin and Takeda teaches the limitation “to achieve a quantitative, sterile and disposable cell sampling; further comprising following steps between the opening the control valve and the pump of the automatic cell sampling device and the closing the control valve and the pump of the automatic cell sampling device: controlling the pump to rotate reversely, allowing the air in the sampling container and the air filtered by the sterile filter to be introduced into the first conduit, and allowing the cell fluid in the first conduit to flow back into the cell based drug production device.” based on obviousness.
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 that receiving from cell production device e.g., ¶0033,0034) through the pump 160,318, also teaches the pump (160,318) being configured to be operated reversely (¶0017, 0047, 0048, 0072-0074 also after sampling, the pump circulates purging fluid through the sampling conduit and recovery conduit to flush residual sample back to the source ¶0035-0036,0047,0072-0074). Griffin also in e.g., ¶0015,0017,0049 teaches the system is automated cell sampling.
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 for the modified ZHAO‘s method following steps between the opening the modified ZHAO‘s control valve and the modified ZHAO‘s pump of the automatic cell sampling device and the closing the control valve and the modified ZHAO‘s pump of the automatic cell sampling device: 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 modified ZHAO‘s sterile filter to be introduced into the modified ZHAO‘s first conduit, and allowing the modified ZHAO‘s cell fluid in the modified ZHAO‘s first conduit to flow back into the modified ZHAO‘s cell based drug production device. 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 ¶0047,0048) Griffin also suggests using this reversable pumping to solve the contamination and carryover problem (¶0008,0010,0015-0017). The modified ZHAO as cited above does not specifically teach and sealing the first conduit between the sampling container and the control valve to achieve a quantitative, sterile and disposable cell sampling. Tackeda in figs.1-2 teaches sealing (sealing is requirement for disposability, element 11 MUST be sealed6) the first conduit 11 between the sampling container (cartridge including 2A,2B,4 or22) and a quantitative, sterile and disposable cell sampling (e.g., ¶0094), 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 Tackeda‘s disposable automatic cell sampling for the modified ZHAO‘s cell sampling method and sealing the modified ZHAO‘s first conduit between the modified ZHAO‘s sampling container and the modified ZHAO‘s control valve to achieve a quantitative, sterile and disposable cell sampling. One of ordinary skill in the art knows disposable units (single-use systems) are ideal for cell sampling because they completely eliminate the risk of cross-contamination between batches. They remove the need for labor-intensive cleaning validation, steam sterilization (CIP/SIP), and reduce turnaround time, ensuring maximum sterility and sample integrity for sensitive application would have been motivated to make this modification in order to have a sealed disposable flow-path cartridge without outside contamination (e.g., ¶0057,0113,0114 of Takeda).
Claim 9
ZHAO in view of Griffin and Takeda 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 and Takeda 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 and Takeda 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 and Takeda 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 and Takeda 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 and Takeda 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 and Takeda teaches the cell sampling method according to claim 6, 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 Takeda teaches a cell sampling method using the automatic cell sampling device according to claim 2, wherein cell fluid is introduced into the sampling container 1 by generating a fluid driving force through the pump 7 (¶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, connecting the pump 7 of the cell sampling device 1 to the cell based drug production device (function met via pump 7 driving sample to the container) , 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)7 and the pump 7 of the cell sampling device 1, and quantitatively transferring the cell fluid from the cell based drug production device to the receiving cavity of the sampling container 1 through the pump 7; 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).
The modified ZHAO combined with Griffin and Takeda teaches the limitation “to achieve a quantitative, sterile and disposable cell sampling; further comprising following steps between the opening the control valve and the pump of the automatic cell sampling device and the closing the control valve and the pump of the automatic cell sampling device: controlling the pump to rotate reversely, allowing the air in the sampling container and the air filtered by the sterile filter to be introduced into the first conduit, and allowing the cell fluid in the first conduit to flow back into the cell based drug production device.” based on obviousness.
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 that receiving from cell production device e.g., ¶0033,0034) through the pump 160,318, also teaches the pump (160,318) being configured to be operated reversely (¶0017, 0047, 0048, 0072-0074 also after sampling, the pump circulates purging fluid through the sampling conduit and recovery conduit to flush residual sample back to the source ¶0035-0036,0047,0072-0074). Griffin also in e.g., ¶0015,0017,0049 teaches the system is automated cell sampling.
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 for the modified ZHAO‘s method following steps between the opening the modified ZHAO‘s control valve and the modified ZHAO‘s pump of the automatic cell sampling device and the closing the control valve and the modified ZHAO‘s pump of the automatic cell sampling device: 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 modified ZHAO‘s sterile filter to be introduced into the modified ZHAO‘s first conduit, and allowing the modified ZHAO‘s cell fluid in the modified ZHAO‘s first conduit to flow back into the modified ZHAO‘s cell based drug production device. 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 ¶0047,0048) Griffin also suggests using this reversable pumping to solve the contamination and carryover problem (¶0008,0010,0015-0017). The modified ZHAO as cited above does not specifically teach and sealing the first conduit between the sampling container and the control valve to achieve a quantitative, sterile and disposable cell sampling. Tackeda in figs.1-2 teaches sealing (sealing is requirement for disposability, element 11 MUST be sealed8) the first conduit 11 between the sampling container (cartridge including 2A,2B,4 or22) and a quantitative, sterile and disposable cell sampling (e.g., ¶0094), 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 Tackeda‘s disposable automatic cell sampling for the modified ZHAO‘s cell sampling method and sealing the modified ZHAO‘s first conduit between the modified ZHAO‘s sampling container and the modified ZHAO‘s control valve to achieve a quantitative, sterile and disposable cell sampling. One of ordinary skill in the art knows disposable units (single-use systems) are ideal for cell sampling because they completely eliminate the risk of cross-contamination between batches. They remove the need for labor-intensive cleaning validation, steam sterilization (CIP/SIP), and reduce turnaround time, ensuring maximum sterility and sample integrity for sensitive application would have been motivated to make this modification in order to have a sealed disposable flow-path cartridge without outside contamination (e.g., ¶0057,0113,0114 of Takeda).
Claims 8 and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over ZHAO, CN202837029U in view of Griffin ,US 20160123848 A1, Takeda, US20180298324A1, 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).
Claim 19
ZHAO in view of Griffin and Takeda and YU 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 and Takeda and Yu 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 ).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
MA, CN 105890923 B
MA in fig.1 teaches biochemical analysis is adaptable to a sterile micro-liquid sampling device and method of microbial fermentation, cell culture bioreactor on-line detection system, sterile micro-sampling probe anticlogging back flushing flow sampling rate lower than the set limit, closing the valve (6), opening the valve (3), starting the peristaltic pump (4) from (5) is suction reverse washing blowing sterile air or sterile water, finishing the recoil when repeating the above step a) - e) sampling.
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 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).
3 ¶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.
4 Prior art of record
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 See for example ¶0061: each reservoir is covered by a seal cover so that the inside of the each reservoir is sealed from the outside and ¶0128: the hollow needle 30 penetrates through the cover of the reservoir 11
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 See for example ¶0061: each reservoir is covered by a seal cover so that the inside of the each reservoir is sealed from the outside and ¶0128: the hollow needle 30 penetrates through the cover of the reservoir 11
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.
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