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 .
Response to Amendment
The amendment filed 7/22/25 has been entered and fully considered.
Claims 1-4, 6-21 are pending, of which claim 21 is new.
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.
Claim(s) 1-4, 6, 9-15, 18-21 are rejected under 35 U.S.C. 103 as being unpatentable over TABOAS (US 2009/0215104) in view of LO (US 2007/0278155).
Regarding claim 1-2, TABOAS discloses a bioreactor device mounted on a plate (biological component cassette, main body formed in sheet shape) having a fluid circuit with flow paths (flow path through which a liquid for culturing cells is allowed to flow) (0034-35), the device can flexibly accommodate a plurality of different types of loadings (possesses flexibility) (0030, 0054, 0065), in the fluid circuit flow channels there is a section having sensors (target parameter detection part) used to measure system parameters such as pH and oxygen concentration (configured to detect pH, oxygen amount), the sensor section including a encapsulated coated glass slides (a chip) configured to be read optically by fluorescence or spectrophotomer (configured to undergo coloring) in the presence of the parameter (0033, 0058-59), four total pipe openings, any of which can be used as the claimed fluid inlet and outlet, all located at a bottom (first) edge of the main body through which fluid flows in and out of the flow path to a reservoir (bioreactor) (0036-38, 0049, Fig 1a) with the section having sensors (target parameter detection part) being in the flow path between inlet and outlet (0036-38, Fig 1a).
TABOAS discloses the device includes a Part B comprising a plurality of layers 60 (first and second sheets) (0042) which can be made of polyethylene, polyvinyl chloride etc. or silicone (resin) (0042, 0067) clamped together (joined) (0049) and that the flow paths and sensor section are defined by recesses (raised in opposite perpendicular directions) made in the walls of these layers (Figs 2B, 3A).
TABOAS discloses the sensors (parameter detection parts) are encapsulated in a space that extends in a perpendicular direction to the main body (portion configured to accommodate chip) (Fig 3a), and that chambers could bulge beyond their layer, i.e. larger than the flow paths (Fig 4) but does not explicitly disclose this portion includes a first and second part bulging in opposite directions and forming a single space through from a first section of flow path to a second, with a cross-sectional area of the bulging portion being larger than that of the flow paths.
However, LO discloses a flexible sheeting cassette comprising sheets 74a, 74b (first, second sheet) forming opposite sides of a cavity (bulging portion) separating a first part of the flow path 66b and a second part of the flow path 68b on either side, in which the cavity is formed by a first portion of each sheet bulging in opposite directions and forming a single space through which liquid can flow through the flow path sections, the cavity further having a larger cross sectional area than that of the adjacent flow paths (fig 9B, 0139, 0162). It would have been obvious to one of ordinary skill in the art to modify the device of TABOAS to include the cavity (bulging portion) with sheets bulging in opposite directions, the cavity having a larger cross sectional area than the flow path as taught by LO because it allows for space to accommodate the desired volume of liquid and move it through the cassette in a controlled manner (0120). and the cross sectional area being larger than that of the flow paths to ensure that there was adequate height to properly accommodate the contents .
b. Regarding claim 3, TABOAS discloses the device can include one or more plurality of chemical and pH sensors (target parameter detection parts configured to detect different types of parameters) (0058-59, Fig 3A).
c. Regarding claim 4, TABOAS discloses that two of the fluid pipe openings (first inlet/outlet) are adjacent each other at the edge of the main body (Fig. 1A, 2A).
d. Regarding claim 6, TABOAS disclose the device includes a plurality of layers (pair of sheets) (0042) which can be made of polyethylene, polyvinyl chloride etc. (resin) (0067) clamped together (joined) (0049) and the sensor parts are embedded and encapsulated (adhered) and mounted on the lower plate within the fluid circuit (chip is adhered to one of the pair of sheets and protrudes inside the flow path perpendicular to the direction it extends) (0043-45, Fig 3A), the sensors being doped sol-gels or doped membranes coated on glass slides and encapsulated with silicone, the membranes capable of being read optically using fluorescence (sensor chip being configured as laminated structure comprising detection layer containing fluorescent substance) (0059).
e. Regarding claim 9, TABOAS a bioreactor device mounted on a plate (biological component cassette, main body formed in sheet shape) comprising a fluid pipe (tube) for exchanging fluid medium (liquid for culturing cells is allowed to flow) connected to the plate (cassette) which has a fluid circuit with flow paths (flow path through which a liquid for culturing cells is allowed to flow) (0034-35), the device can flexibly accommodate a plurality of different types of loadings (possesses flexibility) (0030, 0054, 0065), in the fluid circuit flow channels there is a section having sensors (target parameter detection part) used to measure system parameters such as pH and oxygen concentration (configured to detect pH, oxygen amount), the sensor section including a encapsulated coated glass slides (a chip) configured to be read optically by fluorescence or spectrophotomer (configured to undergo coloring) in the presence of the parameter (0033, 0058-59), four total pipe openings, any of which can be used as the claimed fluid inlet and outlet, all located at a bottom (first) edge of the main body through which fluid flows in and out of the flow path to a reservoir (bioreactor) (0036-38, 0049, Fig 1a) with the section having sensors (target parameter detection part) being in the flow path between inlet and outlet (0036-38, Fig 1a).
TABOAS discloses the device includes a Part B comprising a plurality of layers 60 (pair of sheets) (0042) which can be made of polyethylene, polyvinyl chloride etc. or silicone (resin) (0042, 0067) clamped together (joined) (0049) and that the flow paths and sensor section are defined by recesses (raised in opposite perpendicular directions) made in the walls of these layers (Figs 2B, 3A).
TABOAS discloses the sensors (parameter detection parts) are encapsulated in a space that extends in a perpendicular direction to the main body (portion configured to accommodate chip) (Fig 3a), and that chambers could bulge beyond their layer, i.e. larger than the flow paths (Fig 4) but does not explicitly disclose this portion includes a first and second part bulging in opposite directions and forming a single space through from a first section of flow path to a second, with a cross-sectional area of the bulging portion being larger than that of the flow paths.
However, LO discloses a flexible sheeting cassette comprising sheets 74a, 74b (first, second sheet) forming opposite sides of a cavity (bulging portion) separating a first part of the flow path 66b and a second part of the flow path 68b on either side, in which the cavity is formed by a first portion of each sheet bulging in opposite directions and forming a single space through which liquid can flow through the flow path sections, the cavity further having a larger cross sectional area than that of the adjacent flow paths (fig 9B, 0139, 0162). It would have been obvious to one of ordinary skill in the art to modify the device of TABOAS to include the cavity (bulging portion) with sheets bulging in opposite directions, the cavity having a larger cross sectional area than the flow path as taught by LO because it allows for space to accommodate the desired volume of liquid and move it through the cassette in a controlled manner (0120). and the cross sectional area being larger than that of the flow paths to ensure that there was adequate height to properly accommodate the contents .
f. Regarding claim 10, TABOAS a bioreactor device mounted on a plate (biological component cassette, main body formed in sheet shape) comprising a fluid pipe (tube) for exchanging fluid medium (liquid for culturing cells is allowed to flow) connected to the plate (cassette) which has a fluid circuit with flow paths (flow path through which a liquid for culturing cells is allowed to flow) (0034-35), the device can flexibly accommodate a plurality of different types of loadings (possesses flexibility) (0030, 0054, 0065), in the fluid circuit flow channels there is a section having sensors (target parameter detection part) used to measure system parameters such as pH and oxygen concentration (configured to detect pH, oxygen amount), the sensor section including a encapsulated coated glass slides (a chip) configured to be read optically by fluorescence or spectrophotomer (configured to undergo coloring) in the presence of the parameter (0033, 0058-59), and an imaging device (biological component treatment devices includes optical sensor) with objective lens on which the device is set with the objective arranged in an optical port of the device (Fig 3, 0066) configured to detect the parameter related to cell culturing, by illuminated a light source towards the sensors (chip) and receiving light from the sensors (0056-57, 0066, Fig 5), four total pipe openings, any of which can be used as the claimed fluid inlet and outlet, all located at a bottom (first) edge of the main body through which fluid flows in and out of the flow path to a reservoir (bioreactor) (0036-38, 0049, Fig 1a) with the section having sensors (target parameter detection part) being in the flow path between inlet and outlet (0036-38, Fig 1a).
TABOAS discloses the device includes a Part B comprising a plurality of layers 60 (pair of sheets) (0042) which can be made of polyethylene, polyvinyl chloride etc. or silicone (resin) (0042, 0067) clamped together (joined) (0049) and that the flow paths and sensor section are defined by recesses (raised in opposite perpendicular directions) made in the walls of these layers (Figs 2B, 3A).
TABOAS discloses the sensors (parameter detection parts) are encapsulated in a space that extends in a perpendicular direction to the main body (portion configured to accommodate chip) (Fig 3a), and that chambers could bulge beyond their layer, i.e. larger than the flow paths (Fig 4) but does not explicitly disclose this portion includes a first and second part bulging in opposite directions and forming a single space through from a first section of flow path to a second, with a cross-sectional area of the bulging portion being larger than that of the flow paths.
However, LO discloses a flexible sheeting cassette comprising sheets 74a, 74b (first, second sheet) forming opposite sides of a cavity (bulging portion) separating a first part of the flow path 66b and a second part of the flow path 68b on either side, in which the cavity is formed by a first portion of each sheet bulging in opposite directions and forming a single space through which liquid can flow through the flow path sections, the cavity further having a larger cross sectional area than that of the adjacent flow paths (fig 9B, 0139, 0162). It would have been obvious to one of ordinary skill in the art to modify the device of TABOAS to include the cavity (bulging portion) with sheets bulging in opposite directions, the cavity having a larger cross sectional area than the flow path as taught by LO because it allows for space to accommodate the desired volume of liquid and move it through the cassette in a controlled manner (0120). and the cross sectional area being larger than that of the flow paths to ensure that there was adequate height to properly accommodate the contents .
g. Regarding claim 11, TABOAS in view of DOYLE discloses the sensor recess as discussed in the above rejection of claim 10. TABOAS further discloses the sensors (parameter detection parts) are encapsulated in a space that extends in a perpendicular direction to the main body (portion configured to accommodate chip) (Fig 3a), and an optical port (placement recess) aligned with the sensor part and an objective lens arranged in a bottom part of the recess (optical sensor) (Fig 2A, 3A).
h. Regarding claims 12, 18, TABOAS discloses the section having sensors (target parameter detection part) used to measure system parameters such as pH and oxygen concentration (configured to detect pH, oxygen amount), the sensor section including an encapsulated coated glass slides (a chip) configured to be read optically by fluorescence or spectrophotomer (configured to undergo coloring) in the presence of the parameter (0033, 0058-59).
i. Regarding claim 13, 19, TABOAS discloses the device can include one or more plurality of chemical and pH sensors (target parameter detection parts configured to detect different types of parameters) (0058-59, Fig 3A).
j. Regarding claim 14, TABOAS discloses that two of the fluid pipe openings (first inlet/outlet) are adjacent each other at the edge of the main body (Fig. 1A, 2A).
k. Regarding claim 15, 20, TABOAS discloses the sensor parts are embedded and encapsulated (adhered) and mounted on the lower plate within the fluid circuit (chip is adhered to one of the pair of sheets and protrudes inside the flow path perpendicular to the direction it extends) (0043-45, Fig 3A), the sensors being doped sol-gels or doped membranes coated on glass slides and encapsulated with silicone, the membranes capable of being read optically using fluorescence (sensor chip being configured as laminated structure comprising detection layer containing fluorescent substance) (0059).
l. Regarding claim 21, as discussed in the above rejection of claim 1, TABOAS discloses four total pipe openings, any of which can be used as the claimed first and second inlets and outlets, two of which fluid flows in and out of the flow path to a pump (0036-38, 0049, Fig 1a) with the section having sensors (target parameter detection part) being in the flow path between an inlet and an outlet (0036-38, Fig 1a). TABOAS discloses all of the pipe openings are located at a bottom (first) edge of the main body, and does not disclose the second inlet and outlet at a second edge of the main body. However, it would have been obvious to one of ordinary skill in the art to modify the location of the second set of pipe openings of TABOAS to be along a different edge of the body in order to shorten the flow paths or reduce the overall size of the body. Additionally, it would have been obvious to one having ordinary skill in the art at the time the invention was filed to move two of the openings to a different edge as it has been held that rearranging parts of an invention involves only routine skill in the art. MPEP 2144.04.
Claim(s) 7-8, 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over TABOAS (US 2009/0215104) in view of LO (US 2007/0278155) as applied above, and further in view of WON (US 2018/0156731).
Regarding claim 7-8, 16-17, TABOAS discloses the imaging technique utilizing light (0066) but does not explicitly disclose the sensor (chip) has a light shielding layer or light blocking coating to block leakage of light from the sensor (chip).
However, WON discloses an optical sensor assembly comprising a sensor (chip) with an optical sensor substrate (configured to undergo coloring) (0091) having a filter integrally formed on the optical sensor substrate (provided on a side or end of chip) that blocks a light (light shielding layer, light blocking coating) to filter incident light (configured to block leakage of light) (0070, 0078). It would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify the sensors of TABOAS to include the filter for blocking light as taught by WON because it provides for excellent filtering characteristics in various incident angles and improving sensing accuracy (0033-34).
Response to Arguments
Applicant's arguments filed 7/22/25 have been fully considered but they are not persuasive.
In response to applicant's argument that TABOAS does not disclose the amended features because it does not provide detail about the sensors being located in a flow path that carries liquid for culturing cells, 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. As stated in TABOAS para. (0049) the pipes with openings at the edge of the body (Fig 1B) are used in medium exchange, which meets the limitation regarding a flow path that carries liquid. The flow paths being specifically for liquid for culturing cells and connected to a bioreactor are considered intended use recitations, which do not carry patentable weight. As stated in the above rejection, the device of TABOAS discloses all the positively recited structural components of the device and therefore meets the amended claim limitations.
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 DANIELLE B HENKEL whose telephone number is (571)270-5505. The examiner can normally be reached M-Th 11-7 EST, Alt. Fridays.
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/DANIELLE B HENKEL/Examiner, Art Unit 1799
/William H. Beisner/Primary Examiner, Art Unit 1799