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 .
Priority
Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e).
Failure to provide a certified translation may result in no benefit being accorded for the non-English application.
Claim Rejections - 35 USC § 103
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 (i.e., changing from AIA to pre-AIA ) 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.
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 1-3, 11-14 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Nobuhiro (JP 5239552 B2), in view of O'Brien et al. (US PAT 9151709 B2).
Regarding claim 1, Nobuhiro teaches a reaction vessel that is sealed, containing a reactor channel flow path, and a separate sealed container containing a container flow path, containing the liquid sample within. The channel housing, the reactor channels, and the sealed containers are in a closed system (see Nobuhiro, [0004]-[0005]).
Nobuhiro fails to teach a detection member provided inside the housing container and configured to detect a liquid present in a space inside the housing container.
However, in the analogous art of multiple phase flow systems for detecting and isolating substances, O'Brien et al. teaches a substance detector 32 comprising flow chamber 33 within a detection chamber 38 being made on an acoustic impedance material close to the acoustic impedance of water, such as acrylamide gel, shaped around a wire or other tube. The acrylamide gel is allowed to harden or solidify, and the wire is removed to create a channel, such as flow chamber 33 defined by an internal wall, for fluid to flow through when it is within the detection chamber 38. The substance detector is configured to identify a first signal corresponding to detection of the first type of analyte and a second signal corresponding to the second type of analyte (see O'Brien et al., col. 3/lines 37-51, Fig. 4, Claim 1).
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 closed flow channel held in a vessel holding a sample liquid of Nobuhiro to incorporate a substance detector comprising a flow chamber having a inner wall configured to detect a analyte in a liquid (as taught by O'Brien et al), for the benefit of being sensitive to single metastatic cell and isolation, allowing for earlier detection of diseases like cancer (see O'Brien et al., col. 5/lines 37-56).
Regarding claim 2, Nobuhiro fails to teach wherein the detection member is provided to an inner wall face of the housing container.
However, O'Brien et al. teaches a substance detector comprising a flow chamber having an interior wall, wherein the internal wall is made of acrylamide gel that provides an acoustic path from an excited cell to an acoustic sensor (see O'Brien et al., Claim 1).
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 closed flow channel and container of Nobuhiro to incorporate an internal wall in the flow chamber comprising acrylamide gel (as taught by O'Brien et al), for the benefit of being sensitive to single metastatic cell and isolation, allowing for earlier detection of diseases like cancer (see O'Brien et al., col. 5/lines 37-56).
Regarding claim 3, Nobuhiro fails to teach the detection member is filled in the space inside the housing container.
However, O'Brien et al. teaches preparing the flow chamber by holding it together with an acrylic ring that has three holes drilled 90° from each other. Masterflex tubing was fed through the holes and a wire with the same outer diameter as the tubing's inner diameter was suspended through the two opposing holes while a second wire was fed through the third hole to prevent acrylamide from entering the tubing hole. Once the acrylic ring was prepared, Parafilm was stretched across the bottom of the ring and clear acrylamide was poured into the ring, gelling around the tubing and wire (see O'Brien et al., col. 8/lines 36-54).
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 closed flow channel and container of Nobuhiro to incorporate an internal wall in the flow chamber comprising acrylamide gel being filled in the chamber (as taught by O'Brien et al), for the benefit of being sensitive to single metastatic cell and isolation, allowing for earlier detection of diseases like cancer (see O'Brien et al., col. 5/lines 37-56).
Regarding claim 11, the combination of Nobuhiro and O'Brien et al. teaches the exact limitations of claim 11. Specifically, Nobuhiro teaches the sample processing apparatus according to claim 1, wherein a gas non-reacting with the detection member is filled in a detection space that is a space between an inner wall face of the housing container and the flow channel (see Nobuhiro, [0018], disclosing that gases can be circulated between the reaction vessel and the reaction vessel air vent channel when injecting liquid into the reaction vessel via the injection channel, allowing for smooth injection of liquid into the reaction vessel.).
Regarding claim 12, Nobuhiro fails to teach wherein the detection member is a gas, small-particle, or gel-like substance, and the detection member is filled in the detection space.
However, O'Brien et al. teaches that the flow chamber 33 within the detector chamber 38 is made from acrylamide gel shaped around a wire or other tube. The acrylamide gel is allowed to harden or solidify, and the wire is removed to create a channel, such as flow chamber 33 defined by an internal wall, for fluid to flow through when it is within the detection chamber 38 (see O'Brien et al., col. 3, lines 37-51).
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 closed flow channel held in a vessel holding a sample liquid of Nobuhiro to incorporate acrylamide gel as a detection member within the detection chamber (as taught by O'Brien et al), for the benefit of being sensitive to single metastatic cell and isolation, allowing for earlier detection of diseases like cancer (see O'Brien et al., col. 5/lines 37-56).
Regarding claim 13, Nobuhiro fails to teach wherein the detection member is filled in the detection space with no gap.
However, O'Brien et al. teaches preparing the flow chamber by holding it together with an acrylic ring that has three holes drilled 90° from each other. Masterflex tubing was fed through the holes and a wire with the same outer diameter as the tubing's inner diameter was suspended through the two opposing holes while a second wire was fed through the third hole to prevent acrylamide from entering the tubing hole. Once the acrylic ring was prepared, Parafilm was stretched across the bottom of the ring and clear acrylamide was poured into the ring, gelling around the tubing and wire (see O'Brien et al., col. 8/lines 36-54).
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 closed flow channel held in a vessel holding a sample liquid of Nobuhiro to incorporate pouring the liquid acrylamide gel around a tubing and wire (which would fill any gaps) prior to it gelling (as taught by O’Brien et al., for the benefit of being sensitive to single metastatic cell and isolation, allowing for earlier detection of diseases like cancer (see O'Brien et al., col. 5/lines 37-56).
Regarding claim 14, Nobuhiro fails to teach wherein the detection member is a small-particle or gel-like substance, and the detection member is filled in the detection space to cover at least the flow channel.
However, O'Brien et al. teaches that the flow chamber 33 within the detector chamber 38 is made from acrylamide gel shaped around a wire or other tube. The acrylamide gel is allowed to harden or solidify, and the wire is removed to create a channel, such as flow chamber 33 defined by an internal wall, for fluid to flow through when it is within the detection chamber 38 (see O'Brien et al., col. 3, lines 37-51).
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 closed flow channel held in a vessel holding a sample liquid of Nobuhiro to incorporate acrylamide gel as a detection member as part of the flow channel within the detection chamber (as taught by O'Brien et al), for the benefit of being sensitive to single metastatic cell and isolation, allowing for earlier detection of diseases like cancer (see O'Brien et al., col. 5/lines 37-56).
Regarding claim 20, Nobuhiro teaches a reaction vessel that is sealed, containing a reactor channel flow path, and a separate sealed container containing a container flow path, containing the liquid sample within. The channel housing, the reactor channels, and the sealed containers is in a closed system (see Nobuhiro, [0004]-[0005]).
However, Nobuhiro fails to teach a detection member provided inside the housing part and configured to detect a liquid present in a space inside the housing part.
However, O'Brien et al. teaches a substance detector 32 comprising flow chamber 33 within a detection chamber 38 being made of an acoustic impedance material close to the acoustic impedance of water, such as acrylamide gel, shaped around a wire or other tube. The acrylamide gel is allowed to harden or solidify, and the wire is removed to create a channel, such as flow chamber 33 defined by an internal wall, for fluid to flow through when it is within the detection chamber 38. The substance detector is configured to identify a first signal corresponding to detection of the first type of analyte and a second signal corresponding to the second type of analyte (see O'Brien et al., col. 3/lines 37-51, Fig. 4, Claim 1).
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 closed flow channel held in a vessel holding a sample liquid of Nobuhiro to incorporate a substance detector comprising a flow chamber having a inner wall configured to detect a analyte in a liquid (as taught by O'Brien et al), for the benefit of being sensitive to single metastatic cell and isolation, allowing for earlier detection of diseases like cancer (see O'Brien et al., col. 5/lines 37-56).
Claims 4-6 are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Nobuhiro and O'Brien et al. as applied to claim 1 above, and further in view of Aouad (US PG 20120241045 A1).
Regarding claim 4, the combination of Nobuhiro and O'Brien et al. fails to teach wherein the detection member is a member changing in chemical or physical properties on contact with liquid, the sample processing apparatus further comprising; a sensor configured to sense a state of the detection member inside the housing container; and processing circuitry configured to detect the liquid present in the space inside the housing container based on a sensing result of the sensor and, when the liquid is detected, provide notification of the being detected.
However, in the analogous art of automated high precision solution preparation apparatus, Aouad teaches an automated solution preparation apparatus comprising a container can have devices such as probes, stirrers, detectors or analyzers 110 for monitoring the chemical and physical properties of the solution being prepared. The probes, sensors and detectors monitor physical properties of the solution such as temperature, amount of suspended particles, viscosity and density and send signals to a processor for adjusting the properties to a predetermined value by heating, cooling, or adding additional liquid reagents. The processor additionally can send control signals to valves, pumps, heating or cooling devices, stirrers or other actuators to adjust the concentration or properties of the solution (see Aouad, Abstract, [0011], [0045], Fig. 1).
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 closed flow channel and container of the combination of Nobuhiro and O'Brien et al. to incorporate probes, detectors, or analyzers that monitors a solution's chemical and physical properties, and a processor that receives signals from sensors and detectors, for the processor to then send control signals to other parts of the apparatus (as taught by Aouad), for the benefit of automating detection and data collection of a liquid (see Aouad, [0011]).
Regarding claim 5, the combination of Nobuhiro and O'Brien et al. fails to teach wherein the sensor is provided inside the housing container.
However, Aouad teaches that a chamber 70 can contain devices such as probes, detectors, or analyzers 110 for monitoring the chemical and physical properties of the solution being prepared. Such components are found internally in the chamber 70 (see Aouad, [0045], Fig. 1).
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 closed flow channel and container of the combination of Nobuhiro and O'Brien et al. to incorporate probes, detectors, or analyzers within the housing container, or chamber (as taught by Aouad), for the benefit of automating detection and data collection of a liquid (see Aouad, [0011]).
Regarding claim 6, the combination of Nobuhiro and O'Brien et al. fails to teach wherein the sensor is a camera configured to photograph the detection member inside the housing container.
However, Aouad teaches that a camera associated with the chamber 70 can also be used to observe the solution during preparation to detect undissolved solids or other visual abnormalities in the solution (see Aouad, [0045]).
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 closed flow channel and container of the combination of Nobuhiro and O'Brien et al. to incorporate a camera within the housing, or chamber (as taught by Aouad), for the benefit of visual imaging of physical or chemical changes.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over the combination of Nobuhiro, O'Brien et al., and Aouad as applied to claim 4 above, and further in view of Kudo et al. (US PAT 5546790 A).
Regarding claim 7, while the combination of Nobuhiro, O'Brien et al. and Aouad teaches a processing circuitry that detects a liquid present in the space in space inside the housing container (see claim 4 rejection), the combination fails to teach wherein the detection member is a lead wire, the sensor is a current sensor configured to measure a current passing through the detection member; and the processing circuitry detects the liquid present in the space inside the housing container based on a measured value of the current.
However, in the analogous art of low molecular weight organic liquid leakage detection system, Kudo et al. teaches a low molecular weight organic liquid leakage detection system that is mounted on a pipeline. A plurality of sensors shows electric variation upon contact with a low molecular weight organic liquid, are electrically connected in series by lead wires L1 and L2, and the sensor S1 which is located at a first end of the connected sensors is connected, with a lead wire L3, to an electric resistance detector having a current-feeding function and electric resistance measuring function, and the sensor S3 which is located at a second end of the connected sensors is connected to the electric resistance detector with a return wire R (see Kudo et al., col. 3/lines 1-17, Fig. 1).
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 closed flow channel, container, and processor of the combination of Nobuhiro, O'Brien et al., and Aouad to incorporate lead wires that contact the liquid to measure current (as taught by Kudo et al.), for the benefit of precise and efficient detection of liquid leakage without providing a long sensor over an entire detection area (see Kudo et al., Abstract).
Claims 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Nobuhiro and O'Brien et al. as applied to claim 1 above, and further in view of Fish (US PAT 5389338 A).
Regarding claim 8, the combination of Nobuhiro and O'Brien et al. fails to teach wherein the detection member contains a substance changing in chemical properties on contact with liquid.
However, in the analogous art of apparatus for dry chemicals analysis of fluids, Fish teaches reagent matrix areas that detect chemical components of sample liquids by a color reaction formed when the reagent contacts the liquid sample. In the case of the invention, when a liquid blood sample contacts a nylon membrane, chemical components of the blood react with reagents in the nylon membrane to cause a color change in the reagents thus detecting the presence and/or concentration of these chemical components (see col. 1/lines 12-18, col. 4/lines 58-68).
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 closed flow channel and container of the combination of Nobuhiro and O'Brien et al. to incorporate a reagent that changes chemical properties (such as color) when it contacts a sample liquid (as taught by Fish), for the benefit of a visual identification to be used with light or photo imaging.
Regarding claim 9, the combination of Nobuhiro and O'Brien et al. fails to teach wherein the detection member contains a substance changing in chemical properties on contact with liquid.
However, Fish teaches reagent matrix areas that detect chemical components of sample liquids by a color reaction formed when the reagent contacts the liquid sample. In the case of the invention, when a liquid blood sample contacts a nylon membrane, chemical components of the blood react with reagents in the nylon membrane to cause a color change in the reagents thus detecting the presence and/or concentration of these chemical components (see col. 1/lines 12-18, col. 4/lines 58-68).
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 closed flow channel and container of the combination of Nobuhiro and O'Brien et al. to incorporate a reagent that changes chemical properties (such as color) when it contacts a sample liquid (as taught by Fish), for the benefit of a visual identification to be used with light or photo imaging.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over the combination of Nobuhiro and O'Brien et al. as applied to claim 1 above, and further in view of Vilkov et al.
Regarding claim 10, the combination of Nobuhiro and O'Brien et al. fails to teach wherein the detection member is a liquid member, the sample processing apparatus further comprising a spray configured to spray and apply the detection member to an inner wall face of the housing container.
However, in the analogous art of temperature influenced chemical vaporization and detection of compounds having low volatility, Vilkov et al. teaches methods and systems for detecting a chemical substance of interest. It comprises collecting a sample of a substantially non-volatile substance of interest on a sampling trap, where the sampling trap has a reagent deposited onto it, such as sprayed onto it, which desorbs the substance of interest and increases the volatility of the substance of interest. Such reagents deposits are liquid deposits or liquid spray and may be sprayed within a housing (see Vilkov et al., [0004], [0025], [0050]).
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 closed flow channel and container of the combination of Nobuhiro and O'Brien to incorporate a sprayable detecting reagent that can be applied to a surface (as taught by Vilkov et al.), for the benefit of re-using substance detectors or traps, and to minimize outgassing of the reagent into a detector of a detection system (see Vilkov et al., [0025]).
Claims 15-18 are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Nobuhiro and O'Brien et al. as applied to claim 1 above, and further in view of Karasawa (US PG-Pub 20150062263 A1).
Regarding claim 15, the combination of Nobuhiro and O'Brien et al. fails to teach wherein the housing container is formed of a rigid body.
However, in the analogous art of liquid containing body, Karasawa teaches a housing 270 containing a flexible member 210, the housing comprising a synthetic resin polypropylene (PP) (see Karasawa, [0045]).
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 container of the combination of Nobuhiro and O'Brien et al. to incorporate the housing consisting of polypropylene material, a rigid to semi-rigid material (as taught by Karasawa), for the benefit of maintaining the shape of the housing when holding components and liquids.
Regarding claim 16, the combination of Nobuhiro and O'Brien et al. fails to teach wherein the housing container is formed of a resin or a metal.
However, Karasawa teaches a housing 270 containing a flexible member 210, the housing comprising a synthetic resin polypropylene (PP) (see Karasawa, [0045]).
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 container of the combination of Nobuhiro and O'Brien et al. to incorporate the housing consisting of synthetic resin, polypropylene (as taught by Karasawa), for the benefit of maintaining the shape of the housing when holding components and liquids.
Regarding claim 17, the combination of Nobuhiro and O'Brien et al. fails to teach wherein the housing container is at least partially formed of a transparent member.
However, Karasawa teaches a housing 270 containing a flexible member 210, the housing comprising a synthetic resin polypropylene (PP) which can be colored in black and block ultraviolet light and visible light. In another embodiment, the housing 270 can be a part which lets ultraviolet and visible light pass (see Karasawa, [0045]).
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 container of the combination of Nobuhiro and O'Brien et al. to incorporate the housing having a transparent surface to allow visible and ultraviolet light to pass (as taught by Karasawa), for the benefit of allowing an outside view of the state of the apparatus, such as seeing visible color change of detection member.
Regarding claim 18, the combination of Nobuhiro and O'Brien et al. fails to teach wherein the housing container has a light-blocker configured to block the part formed of the transparent member from light.
However, Karasawa teaches a housing 270 containing a flexible member 210, the housing comprising a synthetic resin polypropylene (PP) which can be colored in black (a black master batch of 4 weight %) and block ultraviolet light and visible light (see Karasawa, [0045]).
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 container of the combination of Nobuhiro and O'Brien et al. to incorporate the housing having a transparent surface to allow visible and ultraviolet light to pass (as taught by Karasawa), for the benefit of preventing external interference from liquid/sample detection.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over the combination of Nobuhiro and O'Brien et al. as applied to claim 1 above, and further in view of Collins (US PG-Pub 20190358633 A1).
Regarding claim 19, the combination of Nobuhiro and O'Brien et al. fails to teach wherein the flow channel includes a reagent container configured to store a reagent used in a cell culture process, and a culture container configured to culture a cell.
However, in the analogous art of fluidic devices for closed cell culture applications under current good manufacturing practice, Collins teaches a system and method for automated and closed cell culture system, including a drug or reagents containers and cell culture flask/containers. Reagents are stored to be provided into a cell culture container by pumping from reagent containers (see Collins, Abstract, [0015]).
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 closed flow channel and container of the combination of Nobuhiro and O'Brien et al. to incorporate a reagent container holding reagents to be transferred to a cell culture container, and a cell culture container that cultures (as taught by Collins), for the benefit of automation of continuous cell culturing (see Collins, [0164]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Tracy C Colena whose telephone number is (571)272-1625. The examiner can normally be reached Mon-Thus 8:00am-5:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Lyle Alexander can be reached at (571) 272-1254. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TRACY CHING-TIAN COLENA/ Examiner, Art Unit 1797
/JENNIFER WECKER/Primary Examiner, Art Unit 1797
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