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 Status
Claims 1-20 are pending and are examined.
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 1, 2, 3, 4, 5, 6, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Hitachi Ltd. (JP-6429765), in view of Biksacky (US Pub 2014/0033834), and further in view of Proulx (US Pub 2011/020110).
Regarding Claim 1, Hitachi Ltd. teaches a sampling device for receiving a sample from a cell culturing device (suspension 11 in cultivation tank (culture vessel) 10, see Abstract), the sampling device (Fig. 1) comprising:
a sampling channel through which the sample flows (Fig. 1, sampling pipe 21, see page 2/14, see halfway down the page);
a detection unit disposed in the sampling channel so as to come into contact with the sample (image magnifying device 42 and television camera 44. See page 2/14, see 1/3 from the bottom of the page);
a first pump disposed in the sampling channel between the cleaning solution storage unit and the sample introduction channel and configured to allow the cleaning solution to flow from the cleaning solution storage unit to the detection unit; and a second pump disposed in the sample introduction channel and configured to allow the sample to flow from the sample introduction channel to the detection unit (sampling pump 22, stain solution supply pump 32, cleaning fluid supply pump 34, transportation pump 35, see page 2/14, see 2/3 down the page).
a cleaning solution storage unit in fluid communication with the sampling channel upstream of the detection unit and configured to store a cleaning solution (In order to wash flow cell 41 periodically, cleaning fluid supply pump 34 drives according to instructions of pair 1-evening 100, and cleaning fluid 33 is poured in just before flow cell 41. See page 2/14, 1/3 from the bottom of the page).
Hitachi Ltd. is silent to a sample introduction channel in fluid communication with the sampling channel between the detection unit and the cleaning solution storage unit and also in fluid communication with the cell culturing device, the sample introduction channel enabling movement of the sample from the culturing device and into the sampling channel.
Biksacky teaches in the related art of a sampling apparatus in the Abstract. [0060] Multi-channel/lumen tubing could be used for line L. This would allow delivery of two samples to the sample delivery system on one line from the sample withdraw system on one source S.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added a sample introduction channel in fluid communication with the sampling channel between the detection unit and the cleaning solution storage unit and also in fluid communication with the cell culturing device, as taught by Biksacky, to the device of Hitachi Ltd., to allow for extracting a sample from a source and deliver the sample to a collector for storage or analysis, as taught by Biksacky, in the Abstract.
Modified Biksacky is silent to the detection unit including at least one of a pH chip configured to measure pH in the sample, an O2 chip configured to measure O2 concentration in the sample, a CO2 chip configured to measure CO2 concentration in the sample, a glucose chip configured to measure glucose concentration in the sample, and a lactic acid chip that is configured to measure lactic acid concentration in the sample.
Proulx teaches in the related art of a culturing apparatus. The sensor is selected from the group consisting of a pH sensor, temperature sensor, humidity sensor, pressure sensor, glucose sensor, oxygen sensor, carbon dioxide sensor, glutamine sensor, lactic acid sensor. See Claim 8.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added at least one of a pH chip configured to measure pH in the sample, an O2 chip configured to measure O2 concentration in the sample, a CO2 chip configured to measure CO2 concentration in the sample, a glucose chip configured to measure glucose concentration in the sample, and a lactic acid chip that is configured to measure lactic acid concentration in the sample, as taught by Proulx, in the device, as taught by modified Biksacky, simultaneously optimizing multiple parameters significant for cell culturing.
Regarding Claim 2, Hitachi Ltd. teaches the sampling device of claim 1.
Hitachi Ltd. is silent to the sampling device further includes: an aseptic filter disposed between the cell culturing device and the second pump, the aseptic filter configured to prevent entry of bacteria into the cell culturing device.
Biksacky teaches in the related art of sampling apparatus. [0052] FIG. 13 illustrates one alternate embodiment of a sampling apparatus 34(a) in which two air sources AS1 and AS2 are used to inject air into the system. Filters 19(a) and 19(b) function to filter air provided by the air sources AS1 AS2, respectively.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added an aseptic filter, as taught by Biksacky, to the device of Hitachi Ltd., to allow for introducing a filtered sample through the line, as taught by Biksacky, in [0033].
Regarding Claim 3, modified Hitachi Ltd. teaches the sampling device of claim 1, wherein the sampling device further includes: a control unit configured to control operation of the first pump and the second pump (controlled by computer 100, see page 2/14, see 1/3 from the bottom of the page).
Regarding Claim 4, modified Hitachi Ltd. teaches the sampling device of claim 3, wherein the control unit is configured to initiate the first pump and the second pump at different times (This directions result is transmitted to computer 100. Computer lOO performs control of oxygen supply, churning, and substrate exchange based on this directions result. Next, the example of a sequence which makes sampling pump 22, stain solution supply pump 32, cleaning fluid supply pump 34, transportation pump 35, XY stage 43, and A/D conversion machine 51 drive is shown in Drawing 2. These drive sequences are controlled by computer 100. Since this drive frequency is also controlled by computer 100, it can do in 1 time or 2 hours even once in 30 minutes, but it drives once in 1 hour and sampling pump 22 supplies suspension 11 to mixer 23. Stain solution supply pump 32 drives synchronizing with this, and it supplies stain solution 31 to mixer 23. See page 3/14, see lines 5-8.).
Regarding Claim 5, modified Hitachi Ltd. teaches the sampling device of claim 3, wherein the sampling device further includes: a standard solution storage unit in fluid communication with the sampling channel upstream of the first pump and configured to store a standard solution for calibrating the detection unit (In order to wash flow cell 41 periodically, cleaning fluid supply pump 34 drives according to instructions of pair 1-evening 100, and cleaning fluid 33 is poured in just before flow cell 41. See page 2/14, 1/3 from the bottom of the page).
Regarding Claim 6, modified Hitachi Ltd. teaches the sampling device of claim 5, wherein the sampling channel is in fluid communication with a cleaning solution branch path that is in fluid communication with the cleaning solution storage unit, the sampling channel is also in fluid communication with a standard solution branch path that is in fluid communication with the standard solution storage unit ([0042] The dispensing cup 46 is fluidly connected to a number of reservoirs and output streams 39. More particularly, a distilled water reservoir 48, a sterilizing solution reservoir 50, a detergent reservoir 52, a waste reservoir 54, an air source 56, and multiple delivery systems are capable of either supplying fluid to the dispensing cup 46 or receiving fluid from the dispensing cup 46. For instance, opening valves V1 and closing valves V2 through V10, dilutent can be drawn into the pump 32, then opening valve V10 and closing valves V1 through V9 allows the fluid from the reservoir 48 to be pumped into the dispensing cup 46. Similarly, sterilizing solution, detergent, and air may be pumped to the dispensing cup 46 by opening valves V2, V3, and V5.).
Regarding Claim 9, modified Hitachi Ltd. teaches the sampling device of claim 1, wherein at least a part of the sampling channel and also the first pump are formed as a main unit that is configured to be integrally handled ([0042] The dispensing cup 46 is fluidly connected to a number of reservoirs and output streams 39. More particularly, a distilled water reservoir 48, a sterilizing solution reservoir 50, a detergent reservoir 52, a waste reservoir 54, an air source 56, and multiple delivery systems are capable of either supplying fluid to the dispensing cup 46 or receiving fluid from the dispensing cup 46. For instance, opening valves V1 and closing valves V2 through V10, dilutent can be drawn into the pump 32, then opening valve V10 and closing valves V1 through V9 allows the fluid from the reservoir 48 to be pumped into the dispensing cup 46. Similarly, sterilizing solution, detergent, and air may be pumped to the dispensing cup 46 by opening valves V2, V3, and V5, respectively.).
Regarding Claim 10, modified Hitachi Ltd. teaches the sampling device of claim 9, wherein the part of the sampling channel includes a region of the sampling channel between the cleaning solution storage unit and the first pump ([0042] The dispensing cup 46 is fluidly connected to a number of reservoirs and output streams 39. More particularly, a distilled water reservoir 48, a sterilizing solution reservoir 50, a detergent reservoir 52, a waste reservoir 54, an air source 56, and multiple delivery systems are capable of either supplying fluid to the dispensing cup 46 or receiving fluid from the dispensing cup 46. For instance, opening valves V1 and closing valves V2 through V10, dilutent can be drawn into the pump 32, then opening valve V10 and closing valves V1 through V9 allows the fluid from the reservoir 48 to be pumped into the dispensing cup 46. Similarly, sterilizing solution, detergent, and air may be pumped to the dispensing cup 46 by opening valves V2, V3, and V5.).
Regarding Claim 11, modified Hitachi Ltd. teaches the sampling device of claim 9, wherein the sampling channel includes a connection part configured to receive at least a portion of the sample introduction channel, wherein the connection part is provided on a portion exposed from the main unit downstream of the first pump (Sampling pipe 21 draws out suspension 11, sampling pump 22 drives in response to instructions of computer 100, and it conveys suspension 11 to mixer 23. See page 2/14, 1/3 of the way down the page).
Regarding Claim 12, modified Hitachi Ltd. teaches the sampling device of claim 9, wherein the detection unit includes one or more elements, and the one or more elements are integrally mounted in a measuring instrument that is provided separately from the main unit (A substrate and the physicochemical quality of suspension 11 containing an animal cell are measured by various kinds of sensors. That is, they are the temperature of suspension, pH, DP (dissolved oxygen concentration), and DCO with temperature sensor 16, pH sensor 17, DO sensor 18, and DCO2 sensor 19 (dissolved carbon dioxide concentration). It is measured respectively. These measurement signals are transmitted to inferencer 95. See page 2/14, 2/3 of the way down the page).
Regarding Claim 13, modified Hitachi Ltd. teaches the sampling device of claim 1, wherein at least a part of the sample introduction channel and also the second pump are formed as an introduction unit that is configured to be integrally handled (Transportation pump 35 conveys the liquid with which suspension 11 and stain solution 31 were mixed in response to instructions of computer 100 to flow cell 41. In order to wash flow cell 41 periodically, cleaning fluid supply pump 34 drives according to instructions of pair 1-evening 100, and cleaning fluid 33 is poured in just before flow cell 41. See page 2/14, 2/3 of the way down the page).
Regarding Claim 14, modified Hitachi Ltd. teaches the sampling device of claim 13, wherein the introduction unit includes at least one of: a pressure sensor that is configured to detect an internal pressure of the sample introduction channel (DP (dissolved oxygen concentration), and DCO with temperature sensor 16, pH sensor 17, DO sensor 18, and DCO2 sensor 19 (dissolved carbon dioxide concentration). It is measured respectively. See page 2/14, 2/3 of the way down the page).
Hitachi Ltd. is silent to a bubble sensor that is configured to detect an air bubble in the sample introduction channel.
Biksacky teaches [0029] In Fig. 2, The sample withdrawal system 12 further has an inline sample indicator 18, such as a bubble detector, that indicates when a sample has been extracted from the source S. [0030] A bubble detector 24, or similar indicator, is located downstream of the pump and is used to indicate when the sample has been withdrawn from the manifold 20.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added a bubble detector, as taught by Biksacky, to the device of modified Hitachi Ltd., to allow for detecting bubbles in the fluid flow.
Regarding Claim 15, modified Hitachi Ltd. teaches the sampling device of claim 14, wherein the pressure sensor is disposed in the sample introduction channel upstream of the second pump (DP (dissolved oxygen concentration), and DCO with temperature sensor 16, pH sensor 17, DO sensor 18, and DCO2 sensor 19 (dissolved carbon dioxide concentration). It is measured respectively. See page 2/14, at ~2/3 of the page).
Regarding Claim 16, modified Hitachi Ltd. teaches the sampling device of claim 14.
Hitachi Ltd. is silent to the bubble sensor is disposed in the sample introduction channel downstream of the second pump.
Biksacky teaches [0029] In Fig. 2, The sample withdrawal system 12 further has an inline sample indicator 18, such as a bubble detector, that indicates when a sample has been extracted from the source S. [0030] A bubble detector 24, or similar indicator, is located downstream of the pump and is used to indicate when the sample has been withdrawn from the manifold 20.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added a bubble detector, as taught by Biksacky, in the sample introduction channel downstream of the second pump in the device of modified Hitachi Ltd., to allow for detecting bubbles in the fluid flow.
Regarding Claim 17, Hitachi Ltd. teaches a cell culturing system (Fig. 1) comprising:
a culturing unit configured to culture cells (suspension 11 in cultivation tank 10 see Abstract);
a sampling channel configured to receive a sample from the culturing unit (Fig.1, sampling pipe 21, see page 2/14, see halfway down the page);
a detection unit disposed in the sampling channel so as to come into contact with the sample (image magnifying device 42 and television camera 44. See page 2/14, see 1/3 from the bottom of the page);
a cleaning solution storage unit in fluid communication with the sampling channel upstream of the detection unit and configured to store a cleaning solution (In order to wash flow cell 41 periodically, cleaning fluid supply pump 34 drives according to instructions of pair 1-evening 100, and cleaning fluid 33 is poured in just before flow cell 41. See page 2/14, 1/3 from the bottom of the page).
a first pump disposed in the sampling channel between the cleaning solution storage unit and the sample introduction channel and configured to allow the cleaning solution to flow from the cleaning solution storage unit to the detection unit; and a second pump disposed in the sample introduction channel and configured to allow the sample to flow to the detection unit from the sample introduction channel (sampling pump 22, stain solution supply pump 32, cleaning fluid supply pump 34, transportation pump 35. see page 2/14, see 2/3 down the page).
Hitachi Ltd. is silent to a sample introduction channel in fluid communication with the sampling channel between the detection unit and the cleaning solution storage unit and also in fluid communication with the culturing unit, the sample introduction channel enabling movement of the sample from the culturing unit and into the sampling channel.
Biksacky teaches in the related art of a sampling apparatus in the Abstract. [0060] Multi-channel/lumen tubing could be used for line L. This would allow delivery of two samples to the sample delivery system on one line from the sample withdraw system on one source S.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added a sample introduction channel in fluid communication with the sampling channel between the detection unit and the cleaning solution storage unit and also in fluid communication with the cell culturing device, as taught by Biksacky, to the device of Hitachi Ltd., to allow for extracting a sample from a source and deliver the sample to a collector for storage or analysis, as taught by Biksacky, in the Abstract.
Modified Biksacky is silent to the detection unit including at least one of a pH chip configured to measure pH in the sample, an O2 chip configured to measure O2 concentration in the sample, a CO2 chip configured to measure CO2 concentration in the sample, a glucose chip configured to measure glucose concentration in the sample, and a lactic acid chip that is configured to measure lactic acid concentration in the sample.
Proulx teaches in the related art of a culturing apparatus. The sensor is selected from the group consisting of a pH sensor, temperature sensor, humidity sensor, pressure sensor, glucose sensor, oxygen sensor, carbon dioxide sensor, glutamine sensor, lactic acid sensor. See Claim 8.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added at least one of a pH chip configured to measure pH in the sample, an O2 chip configured to measure O2 concentration in the sample, a CO2 chip configured to measure CO2 concentration in the sample, a glucose chip configured to measure glucose concentration in the sample, and a lactic acid chip that is configured to measure lactic acid concentration in the sample, as taught by Proulx, in the device, as taught by modified Biksacky, allowing for simultaneously optimizing multiple parameters significant for cell culturing.
Regarding Claim 18, modified Hitachi Ltd. teaches the cell culturing system of claim 17.
Hitachi Ltd. teaches the cell culturing system further includes: an aseptic filter disposed between the cell culturing device and the second pump, the aseptic filter configured to prevent entry of bacteria into the cell culturing device.
Biksacky teaches in the related art of sampling apparatus. [0052] FIG. 13 illustrates one alternate embodiment of a sampling apparatus 34(a) in which two air sources AS1 and AS2 are used to inject air into the system. Filters 19(a) and 19(b) function to filter air provided by the air sources AS1 AS2, respectively.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added an aseptic filter, as taught by Biksacky, to the device of modified Hitachi Ltd., to allow for introducing a filtered sample through the line, as taught by Biksacky, in [0033].
Regarding Claim 19, modified Hitachi Ltd. teaches the cell culturing system of claim 17, wherein the sampling device further includes: a control unit configured to control operation of the first pump and the second pump including initiating the first pump and the second pump at different times; a standard solution storage unit in fluid communication with the sampling channel upstream of the first pump and configured to store a standard solution for calibrating the detection unit ([0061] The controller (not shown) would check the sample indicators before a sample is drawn out of source S to verify that the system is ready to operate properly.).
Claims 7, 8, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Hitachi Ltd. (JP-6429765), in view of Biksacky (US Pub 2014/0033834), Proulx (US Pub 2011/0201100)and further in view of Shuhei (WO 2015/012174).
Regarding Claim 7, modified Hitachi Ltd. teaches the sampling device of claim 6.
Hitachi Ltd. is silent to the sampling device further includes: a cleaning solution clamp that is configured to open and close the cleaning solution branch path; and a standard solution clamp that is configured to open and close the standard solution branch path.
Shuhei teaches in the related art of a solution treatment system. In FIG. 2, when priming is performed before the step a), first, the priming solution bag is connected to the priming solution bag connecting portion 26 and the clamps 21 and 25 are opened.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added clamps, as taught by Shuhei, to open and close the cleaning solution branch path in the device of modified Hitachi Ltd., to allow for controlling the flow of a solution.
Regarding Claim 8, modified Hitachi Ltd. teaches the sampling device of claim 7.
Hitachi Ltd. is silent to the control unit is configured to open one of the cleaning solution clamp and the standard solution clamp and to close the other of the cleaning solution clamp and the standard solution clamp as the first pump operates.
Shuhei teaches in the related art of a solution treatment system. In FIG. 2, when priming is performed before the step a), first, the priming solution bag is connected to the priming solution bag connecting portion 26 and the clamps 21 and 25 are opened.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added clamps, as taught by Shuhei, to open and close the cleaning solution branch path in the device of modified Hitachi Ltd., to allow for controlling the flow of a solution.
Regarding Claim 20, modified Hitachi Ltd. teaches the cell culturing system of claim 19, wherein the sampling channel is in fluid communication with a cleaning solution branch path that is in fluid communication with the cleaning solution storage unit, the sampling channel is also in fluid communication with a standard solution branch path that is in fluid communication with the standard solution storage unit ([0042] The dispensing cup 46 is fluidly connected to a number of reservoirs and output streams 39. More particularly, a distilled water reservoir 48, a sterilizing solution reservoir 50, a detergent reservoir 52, a waste reservoir 54, an air source 56, and multiple delivery systems are capable of either supplying fluid to the dispensing cup 46 or receiving fluid from the dispensing cup 46. For instance, opening valves V1 and closing valves V2 through V10, dilutent can be drawn into the pump 32, then opening valve V10 and closing valves V1 through V9 allows the fluid from the reservoir 48 to be pumped into the dispensing cup 46. Similarly, sterilizing solution, detergent, and air may be pumped to the dispensing cup 46 by opening valves V2, V3, and V5.).
Hitachi Ltd. is silent to the sampling device further includes a cleaning solution clamp that is configured to open and close the cleaning solution branch path, and a standard solution clamp that is configured to open and close the standard solution branch path, wherein the control unit is configured to open one of the cleaning solution clamp and the standard solution clamp and to close the other of the cleaning solution clamp and the standard solution clamp as the first pump operates.
Shuhei teaches in the related art of a solution treatment system. In FIG. 2, when priming is performed before the step a), first, the priming solution bag is connected to the priming solution bag connecting portion 26 and the clamps 21 and 25 are opened.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have added clamps, as taught by Shuhei, such that the control unit is configured to open and close the cleaning solution branch path in the device of modified Hitachi Ltd., to allow for controlling the flow of a solution.
Response to Arguments
Applicant’s arguments with respect to claims 1 and 17 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.
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 JACQUELINE BRAZIN whose telephone number is (571)270-1457. The examiner can normally be reached M-F 8-5.
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/JB/
/CHARLES CAPOZZI/Supervisory Patent Examiner, Art Unit 1798
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