DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 9-13 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 9 recites the limitation "the control unit" in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. For examination purposes, it is interpreted as the same control unit as claimed in Claim 5.
Claims 10-13 are further rejected as they depend from Claim 9.
Claim 9 recites the limitation “the sampling channel” in line 6. There is insufficient antecedent basis for this limitation in the claim. For examination purposes, it is interpreted as the same sampling channel as claimed in Claim 2.
Claims 10-13 are further rejected as they depend from Claim 9.
Claim 10 recites the limitations “the downstream clamp” in line 5. It is unclear whether it is intended for this downstream clamp to be the clamp referred to in line 2, or one of the plurality of supply clamps from Claim 6. Further clarification is requested. For examination purposes, it is being interpreted as the clamp from Claim 10, line 2.
Claims 11-13 are further rejected as they depend from Claim 10.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-10, 13, 14, 16-18, and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Biksacky (US20140033834A1).
Regarding Claim 1, 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 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 draws the sample from the manifold through a channel and into the sample collector system (para 30 and Fig. 3, below)
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A 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 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.
Regarding Claim 2, Biksacky teaches all of the limitations of Claim 1 (see above). Biksacky further teaches 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)(the sampling device includes a sampling channel, the sample introduction channel connecting the sampling channel and the cell culturing device, the sampling channel receiving the combined sample from the temporary storage unit).
Regarding Claim 3, Biksacky teaches all of the limitations of Claim 2 (see above). Biksacky further teaches the sample to be delivered to an analyzer (detection unit) for analysis (para 50)(the sampling device included a detection unit provided in the sampling channel for measuring properties of the combined sample, the 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 4, Biksacky teaches all of the limitations of Claim 1 (see above). Biksacky further teaches the pump is provided between the culturing device and the temporary storage unit (see Fig. 3, above). Note: the vessels in Fig. 3 are the culturing devices.
Regarding Claim 5, Biksacky 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 the pump).
Regarding Claim 6, Biksacky 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 the 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 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 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 the pump for one cycle period determined by adding together opening periods of each of the plurality of supply clamps).
Regarding Claim 9, Biksacky 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 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 pump to stop the operation to move the combined sample from the temporary storage to the sampling channel).
Regarding Claim 10, Biksacky 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 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).
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Regarding Claim 13, Biksacky 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)
A pump draws the sample from the manifold through a channel and into the sample collector system (para 30 and Fig. 3, below)
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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.
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Regarding Claim 16, Biksacky 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 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 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 the 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 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.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 11, 12, 15 are rejected under 35 U.S.C. 103 as being unpatentable over Biksacky (US20140033834A1) in view of Jones et al. (EP3656842A1).
Regarding Claim 11, Biksacky teaches all of the limitations of Claim 9 (see above). Biksacky further teaches the first pump between the culturing device and the temporary storage unit (see Fig. 3, below). Biksacky does not explicitly teach the sample introduction channel to further include a second pump between the temporary storage unit and the sample channel.
Jones teaches a cell growth system with bioreactors, fluid flow paths, and pumps (para 29). Jones further teaches one or more pumps may be used to circulate a fluid at a flow rate within a circulation path (para 29).
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It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to add a second pump to the device of Biksacky as taught by Jones. One would have been motivated to make this modification as Jones teaches it as a viable method for moving fluid through a flow path and it would have provided an effective method of doing so.
In the alternative, assuming arguendo, a mere duplication of parts holds no patentable significance unless a new and unexpected result is produced. See MPEP 2144.04(VI)(B). A duplication of a pump within the sample introduction channel to move liquid would provide and expected result of continuing to move the liquid along the flow path.
Regarding Claim 12, Biksacky in view of Jones teaches all of the limitations of Claim 11 (see above). Jones does teach a controller for controlling the operation of the pump (para 29) and given the modification above with the teachings of Biksacky with the different phases of operations, the control unit would cause the operations of the second pump to stop in the first phase and run in the second phase.
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Regarding Claim 15, Biksacky teaches all of the limitations of Claim 14 (see above). Biksacky further teaches the first pump between the culturing device and the temporary storage unit (see Fig. 3, below). Biksacky does not explicitly teach the sample introduction channel to further include a second pump between the temporary storage unit and the sampling device.
Jones teaches a cell growth system with bioreactors, fluid flow paths, and pumps (para 29). Jones further teaches one or more pumps may be used to circulate a fluid at a flow rate within a circulation path (para 29).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to add a second pump to the device of Biksacky as taught by Jones. One would have been motivated to make this modification as Jones teaches it as a viable method for moving fluid through a flow path and it would have provided an effective method of doing so.
In the alternative, assuming arguendo, a mere duplication of parts holds no patentable significance unless a new and unexpected result is produced. See MPEP 2144.04(VI)(B). A duplication of a pump within the sample introduction channel to move liquid would provide and expected result of continuing to move the liquid along the flow path.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Biksacky (US20140033834A1) in view of Kudugunti et al. (WO2018022661A1).
Biksacky teaches all of the limitations of Claim 18 (see above). Biksacky 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 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).
Conclusion
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