DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1, 3, 5-10, 12-14, 16-18, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Biksacky (US20140033834A1) in view of Castillo et al. (WO 2019072584A1).
Regarding Claim 1, Biksacky teaches the following:
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A sampling apparatus comprised of three system (para 28) and the sample delivery system includes a sample manifold to which multiple withdrawal systems are connected so that a single flow system may be used to deliver a sample from multiple sources (para 30)(a sampling device that receives two or more samples from a cell culturing device)
A pump (first pump disposed between the cell culturing device and the temporary storage unit) draws the sample from the manifold through a channel (sample introduction channel) and into the sample collector system (sampling channel)(para 30 and Fig. 3, above)
The channel includes a temporary storage unit and the pump disposed between the cell culturing device and the temporary storage unit (see Fig. 3, above). The temporary storage unit configured to receive a first sample of the two or more samples from a first reactor of a plurality of reactors of the cell culturing device and a second sample of the two or more samples from a second reactor of the plurality of reactors, to form a combined sample including at least a portion of each of the two or more samples, and to store the first sample, the second sample, or the combined sample and the sampling channel configured to receive the combined sample from the temporary storage unit is an intended use of the device. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim (see MPEP 2114). The device of Biksacky would be capable of operating in the above manner and therefore meets the claim.
Biksacky does not teach a second pump disposed between the temporary storage unit and the sampling channel.
Castillo teaches a bioreactor system comprising a conduit suitable for collecting a retenate which allows recirculating to an input of the bioreactor or an intermediate vessel positioned therebetween (page 1, lines 34 – page 2, line 2). Castillo further teaches the conduits of the system are fitted with one or more pumps (page 9, line 30).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Biksacky and add a pump to the conduit between the “temporary storage unit” (as seen above in Fig. 3) and the sample collector system. One would have been motivated to make this modification as it would allow control or induce differential pressure between different parts of the system (page 9, lines 31-32).
Regarding Claim 3, Biksacky in view of Castillo teaches all of the limitations of Claim 1 (see above). Biksacky further teaches the sample to be delivered to an analyzer (detection unit) for analysis (para 50)(the sampling device includes a detection unit provided in the sampling channel for measuring properties of the combined sample, the sample introduction channel connected to the sampling channel upstream of the detection unit). Note: examiner is interpreting the link from the delivery system to the collector system, collector system, and analyzer of Biksacky to all be the sampling channel as claimed.
Regarding Claim 5, Biksacky in view of Castillo teaches all of the limitations of Claim 1 (see above). Biksacky further teaches a controller then determines how long the pump should run (para 48)(a control unit that is configured to operate at least one of the first pump and the second pump).
Regarding Claim 6, Biksacky in view of Castillo teaches all of the limitations of Claim 5 (see above). Biksacky further teaches the sample is withdrawn by activating the pump until detected by the sample indicator which then indicates to the controller and the controller determines how long the pump should run to draw the desired amount of sample from the source and then valve V1 (supply clamp) is closed and valve 3 is opened and the pump is pumped at a faster rate (para 48)(the control unit is configured to receive information from the cell culturing device regarding the openings and closings of the different supply clamps of the plurality of supply clamps, and the control unit operates at least one of the first pump and the second pump in response to the information).
The cell culturing device is not a positively recited limitation of the claim and therefore the structural limitations of the cell culturing device are not required and the teachings of Biksacky anticipate the claim.
Regarding Claim 7, Biksacky in view of Castillo teaches all of the limitations of Claim 6 (see above). Biksacky further teaches the pump rate is defined by the type of sample (predetermined)(para 48) and given the sample is withdrawn into a fixed volume, the control unit would operate the pump for a predetermined period.
Regarding Claim 8, Biksacky in view of Castillo teaches all of the limitations of Claim 6 (see above). Biksacky further teaches the controller determines how long the pump should run at the desired pump rate with different valves (supply clamps) opening and closing (para 32)(the control unit operates at least one of the first pump and the second pump for one cycle period determined by adding together opening periods of each of the plurality of supply clamps).
Regarding Claim 9, Biksacky in view of Castillo teaches all of the limitations of Claim 1 (see above). Biksacky further teaches the pump 22 draws the test sample from the manifold 20, with valve V4 opened and valve V5 closed. However, when the sample reaches the sample indicator 24, valve V4 is closed and valve V5 opened and with valve V4 closed and valve V5 open, the test sample is delivered to the collector system 16 for collection, storage, analysis (para 34)(the control unit has a first phase that causes the first pump to run moving the two or more samples from the plurality of reactors to the temporary storage unit and a second phase that causes the first pump to stop the operation to move the combined sample from the temporary storage unit to the sampling channel).
Regarding Claim 10, Biksacky in view of Castillo teaches all of the limitations of Claim 9 (see above). Biksacky further teaches the pump 22 draws the test sample from the manifold 20, with valve V4 opened and valve V5 (clamp, located between the temporary storage unit and the sampling channel) closed. However, when the sample reaches the sample indicator 24, valve V4 is closed and valve V5 opened and with valve V4 closed and valve V5 open, the test sample is delivered to the collector system 16 for collection, storage, analysis (para 34)(the sample introduction channel further includes a downstream clamp between the temporary storage unit and the sampling channel that is configured to open and close the sample introduction channel, the control unit configured to cause the downstream clamp to close in the first phase and open in the second).
Regarding Claim 12, Biksacky in view Castillo teaches all of the limitations of Claim 9 (see above). Biksacky further teaches the pump 22 draws the test sample from the manifold 20, with valve V4 opened and valve V5 closed. However, when the sample reaches the sample indicator 24, valve V4 is closed and valve V5 opened and with valve V4 closed and valve V5 open, the test sample is delivered to the collector system 16 for collection, storage, analysis (para 34)(the control unit is configured to cause operation of the second pump to stop in the first phase and run in the second phase). Note: Given the modification of Castillo adding a second pump to the system, the control unit would control the second pump as well as the first pump.
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Regarding Claim 13, Biksacky in view of Castillo teaches all of the limitations of Claim 9 (see above). Biksacky further teaches an upstream clamp between the culturing device and the temporary storage unit that is configured to open and close the sample introduction channel (see Fig. 5, below).
Biksacky further teaches with valve one (upstream clamp) open, a test sample is withdrawn by activating the pump (the pump is controlled by the controller (para 32) (a control unit configured to cause the clamp to open). The clamp is open when the sample is moving along the system and therefor would be open during the first and second phases.
Regarding Claim 14, Biksacky teaches the following:
A sampling apparatus composed of three system (para 28) and the sample delivery system includes a sample manifold to which multiple withdrawal systems are connected so that a single flow system may be used to deliver a sample from multiple sources (para 30)(a cell culture device with a plurality of reactors and a sampling device)
The sample to be delivered to an analyzer (detection unit) for analysis (para 50)(the sampling device having a sampling channel that includes a detection unit for measuring properties of a sample as received from the cell culturing device) Note: examiner is interpreting the link from the delivery system to the collector system, collector system, and analyzer of Biksacky to all be the sampling channel as claimed. The sample including at least portions of subsamples from two or more reactors of the plurality of reactors is an intended use of the device and the device of Biksacky would be capable of including subsamples from two or more reactors and therefore meets the claim
The collector system 16 is linked (by a channel) to receive samples from a delivery system (the sample introduction channel and temporary storage unit)(para 31)(a sample introduction channel fluidically connecting the cell culturing device and the sampling device, the sample introduction channel fluidically connected to the sampling device upstream of the detection unit). Also see Fig. 3, below.
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A pump (first pump) draws the sample from the manifold through a channel and into the sample collector system (para 30 and Fig. 3, below)
A temporary storage unit (see Fig. 3, above). The temporary storage unit configured to receive the subsamples from the two or more reactors of the plurality of reactors, to form the sample by combining the portions of the subsamples from the two or more reactors, and to temporarily store the subsamples or sample before movement of the sample to the sampling device is an intended use of the device. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim (see MPEP 2114). The device of Biksacky would be capable of operating in the above manner and therefore meets the claim.
Biksacky does not teach a second pump disposed between the temporary storage unit and the sampling channel.
Castillo teaches a bioreactor system comprising a conduit suitable for collecting a retenate which allows recirculating to an input of the bioreactor or an intermediate vessel positioned therebetween (page 1, lines 34 – page 2, line 2). Castillo further teaches the conduits of the system are fitted with one or more pumps (page 9, line 30).
It would have been obvious to one or ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Biksacky and add a pump to the conduit between the “temporary storage unit” (as seen above in Fig. 3) and the sample collector system. One would have been motivated to make this modification as it would allow control or induce differential pressure between different parts of the system (page 9, lines 31-32).
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Regarding Claim 16, Biksacky in view of Castillo teaches all of the limitations of Claim 14 (see above). Biksacky further teaches a valve (clamp) between the cell culturing device and the temporary storage unit (see Fig. 3, below).
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Regarding Claim 17, Biksacky in view of Castillo teaches all of the limitations of Claim 16 (see above). Biksacky further teaches the sample introduction channel to further include a second clamp between the temporary storage unit and the sampling device (see Fig. 3, below).
Regarding Claim 18, Biksacky in view of Castillo teaches all of the limitations of Claim 14 (see above). Biksacky further teaches a controller then determines how long the pump should run (para 48)(a control unit that is configured to operate at least one of the first pump and the second pump).
Regarding Claim 20, Biksacky teaches the following:
A sampling apparatus comprised of three system (para 28) and the sample delivery system includes a sample manifold to which multiple withdrawal systems are connected to that a single flow system may be used to deliver a sample from multiple sources (para 30)(a sampling device that receives a sample from a cell culturing device)
The sample to be delivered to an analyzer (detection unit) for analysis (para 50)(the sampling device having a sampling channel that includes a detection unit for measuring properties of a sample as received from the cell culturing device) Note: examiner is interpreting the link from the delivery system to the collector system, collector system, and analyzer of Biksacky to all be the sampling channel as claimed. The sample including at least portions of subsamples from two or more reactors of the plurality of reactors is an intended use of the device and the device of Biksacky would be capable of including subsamples from two or more reactors and therefore meets the claim
The collector system 16 is linked (by a channel) to receive samples from a delivery system (the sample introduction channel and temporary storage unit)(para 31)(a sample introduction channel fluidically connecting the cell culturing device and the sampling device, the sample introduction channel fluidically connected to the sampling device upstream of the detection unit). Also see Fig. 3, below)
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A pump (first pump) draws the sample from the manifold through a channel and into the sample collector system (para 30 and Fig. 3, below)
A temporary storage unit (see Fig. 3, above). The temporary storage unit configured to receive the subsamples from the two or more reactors of the plurality of reactors, to form the sample by combining the portions of the subsamples from the two or more reactors, and to temporarily store the subsamples or sample before movement of the sample to the sampling device is an intended use of the device. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim (see MPEP 2114). The device of Biksacky would be capable of operating in the above manner and therefore meets the claim.
Biksacky does not teach a second pump disposed between the temporary storage unit and the sampling channel.
Castillo teaches a bioreactor system comprising a conduit suitable for collecting a retenate which allows recirculating to an input of the bioreactor or an intermediate vessel positioned therebetween (page 1, lines 34 – page 2, line 2). Castillo further teaches the conduits of the system are fitted with one or more pumps (page 9, line 30).
It would have been obvious to one or ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Biksacky and add a pump to the conduit between the “temporary storage unit” (as seen above in Fig. 3) and the sample collector system. One would have been motivated to make this modification as it would allow control or induce differential pressure between different parts of the system (page 9, lines 31-32).
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Biksacky (US20140033834A1) in view of Castillo et al. (WO 2019072584A1) and further in view of Kudugunti et al. (WO2018022661A1).
Biksacky in view of Castillo teaches all of the limitations of Claim 18 (see above). Biksacky in view of Castillo does not explicitly teach the cell culturing device to include a plurality of supply channels for supplying a culture medium to the plurality of reactors, and a plurality of supply clamps for opening and closing the plurality of supply channels, and wherein the control unit is configured to receive information from the cell culturing device regarding the openings and closing of the different supply clamps of the plurality of supply clamps, and the control unit operates the pump in response to the information.
Kudugunti teaches harvesting a cell product from a cell culture by culturing cells in a fluid medium (Abstract). Kudugunti further teaches medium and additives are introduced into the bioreactor (reactor) via a feed line (supply channel) which is controlled by a valve and/or a pump (supply clamp for opening and closing the supply channel)(page 11, para 3). Kudugunti further teaches a controller arranged and programed to carry out one or more methods (including the pumping of culture medium into the reactor)(page 5, para 1).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to attach feed lines (controlled by valves) and a controller for carrying out the process which introduces medium into the reactors as Kudugunti teaches it to be an effective method for culturing cells and it would have yielded a predictable result of a cell culturing device.
Further, while Kudugunti does not explicitly teach multiple supply channels for a plurality of reactors, given the device of Biksacky in view of Castillo teaches multiple cell culturing vessels, it would have been obvious to add a feed line and valve to each cell culturing vessel as a mere duplication of parts holds no patentable significance unless a new and unexpected result is produced. See MPEP 2144.04(VI)(B).
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Biksacky (US20140033834A1) in view of Castillo et al. (WO 2019072584A1) and further in view of Wang et al. (WO2019051486A1).
Biksacky in view of Castillo teaches all of the limitations of Claim 1 (see above). Biksacky in view of Castillo does not teach the temporary storage unit to include a medical bag.
Wang teaches a bioreactor having culture medium passed through with multiple culture chambers and reservoirs (Abstract). Wang further teaches fluids could be stored either in rigid containers or bags and thew flexible bags are widely used in medical applications (page 16, lines 5-7).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use a medical bag for the storage of fluids in the device of Biksacky in view of Castillo. One would have been motivated to make this modification as flexible bags are widely used in medical applications and are inexpensive (page 16, lines 5-7).
Response to Arguments
Applicant’s arguments with respect to claims 1 and 14 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Newly cited Castillo and Wang have been used to address the new and amended claims.
The applicants amendments to address the 112(b) rejections from the 03/18/2026 Office Action have been accepted and the 112(b) rejections from the 03/18/2026 Office Action have been withdrawn.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JONATHAN E LEPAGE whose telephone number is (571)270-3971. The examiner can normally be reached 8:30-5:30 ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Marcheschi can be reached at 571-272-1374. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/J.E.L./Examiner, Art Unit 1796
/MICHAEL A MARCHESCHI/Supervisory Patent Examiner, Art Unit 1799
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