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 .
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.
Status of Claims
In the amendment filed on March 6th, 2026, claims 1, 10, 13, 18, 19 and 20 have been amended, claim 21 has been cancelled and no new claim has been added. Therefore, claims 1-21 are pending for examination.
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.
Claim(s) 1-4, 6-14, 17-21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Voute et al. (US 20100072216 A1) in view of Voute et al. (US 20120017609 A1) and Gay et al. (WO 2009086136 A2).
In regards to claim 1, Voute’2216 teaches a storage container for aseptically storing and freezing a biopharmaceutical composition, the storage container comprising a frame an expandable bladder supported within the frame, the expandable bladder having a filled state in which the expandable bladder is configured to hold the biopharmaceutical composition(Paragraphs 18, 19, 21)
In an exemplary embodiment depicted in FIGS. 1-4, a system 5 for cooling, freezing, preserving, processing and thawing biopharmaceutical materials is shown. The system may include a sterile container, such as a flexible container 10, configured to contain the biopharmaceutical materials and configured to be supported by a supporting and/or protective structure, such as a holder 15.[P-18]
Flexible container 10 may be formed of a laminated film which includes a plurality of layers and may have an interior volume ranging from 0.01-100 liters, (e.g., 0.1-20 L) as depicted in FIG. 2 for example. Further, flexible container 10 could be available in a variety of sizes to accommodate different uses, for example, 5-10 liter flexible containers, such as 8-liter containers, may be utilized. Also a biocompatible product-contacting layer of the interior of flexible container 10 may be formed of a low density polyethylene, very low density polyethylene, ethylene vinyl acetate copolymer, polyester, polyamide, polyvinylchloride, polypropylene, polyfluoroethylene, polyvinylidenefluoride, polyurethane or fluoroethylenepropylene, for example. A gas and water vapor barrier layer may also be formed of an ethylene/vinyl alcohol copolymer mixture within a polyamide or an ethylene vinyl acetate copolymer. Further, flexible container 10 may include a layer with high mechanical strength (e.g. a polyamide), and an external layer with insulating effect to heat welding, for example, polyester. The layers may be compatible with warm and cold conditions and may be able to withstand ionizing and gamma irradiation for sterilization purposes. Also, flexible container 10 may have a large surface area to volume ratio, and a relatively thin wall thus promoting heat transfer therethrough when received in a temperature control unit such as an interior 500 of a walk-in or blast freezer (FIG. 1).[P-19]
Container 10 may be configured (e.g., shaped and dimensioned) to be received in, and connected to holder 15, which acts as a protector, supporting structure or frame for supporting flexible container 10, as depicted in FIGS. 1-2. In one example, container 10 may have a pillow-shape. Holder 15 may be configured to protect a container held therein during filling, transport, storage, and/or freezing of biopharmaceutical materials. For example, holder 15 may hold and protect container 10 during freezing of biopharmaceutical materials in interior 500 of a walk-in or blast freezer (FIG. 1). Further, holder 15 may protect container 10 when holder 15 is stacked on or under another holder similar to holder 15.[P-21]
Here, Voute ‘2216 teaches a storage container for storing and freezing a biopharmaceutical composition, the storage container having a frame and an expandable bladder (flexible container) supported within the frame, the flexible container configured to hold the biopharmaceutical composition.
Voute’2216 also a sensor system secured to the bladder, the sensor system configured to transmit a signal indicative of a temperature of the surface of the bladder which is correlated to a temperature of biopharmaceutical composition at a desired location within the expandable bladder in the filled state thereof (Paragraphs 39, 41)
The outer rims (e.g., outer rim 40 and outer rim 80) and the inner rims (e.g., inner rim 30 and inner rim 70) may include apertures such as a first aperture 420 and a second aperture 410 depicted in FIG. 2. to allow conduits (e.g., a conduit 13) connected to container 10 to pass therethrough. Such conduits may allow filling or draining of biopharmaceutical materials or other solids, liquids, or gases into and/or out of the interior (not shown) of container 10. Conduit 13 may also be used to insert a measurement probe (not shown) inside container 10 (e.g., a pH electrode, a conductivity sensor, temperature probe, an ion selective electrode, a spectrophotometric probe, an ultrasound sensor, an optic fiber.)[P-39]
In another example depicted in FIGS. 3-4, holder 15 receives a second container 910 having a monitoring device 920 (e.g., (e.g., a pH electrode, a conductivity sensor, temperature probe, an ion selective electrode, a spectrophotometric probe, an ultrasound sensor, an optic fiber) extending from an interior of container 910 through connecting portion 750 to sample cavity 740 where said monitoring device 920 may couple to a connecting cable 930 or other means of coupling the monitoring device to a computing unit or controller for processing data received from the monitoring device. The monitoring device may also include data logging and wireless communication (e.g., RFID) capability. For example, an identification signal may be transferred into a RFID tag at a product filling step. Such signal may be utilized to track the product during storage and distribution phases. The monitoring device (e.g., monitoring device 920) may record the physical parameters of the biopharmaceutical materials during the processing thereof and such data may be communicated to a computing unit at the conclusion of the processing via the coupling of the data logging system to a computing logging system or via wireless transmission during the processing thereof.[P-41]
Voute ’2216 fails to teach the exterior surface of the bladder, being the sensor system configured to transmit a signal indicative of a temperature of the exterior surface of the bladder.
Voute ‘7609 on the other hand teaches the exterior surface of the bladder, being the sensor system configured to transmit a signal indicative of a temperature of the exterior surface of the bladder(Paragraphs 57-59)
One or more plates 28 may also include temperature sensor 18 mounted on an interior portion or exterior portion of plates 28 or it may be integral thereto. Temperature sensor 18 may detect a temperature of one or more of plates 28 and one or more locations thereon. Controller portion 21 of temperature control unit 20 may be coupled to temperature sensor 18 and to a heat transfer fluid control portion 22 of temperature control unit 20. Such heat transfer fluids may be circulated through plates 28 by heat transfer fluid control portion 22 controlled by controller portion 21 in response to temperatures detected by temperature sensor 18. [P-57]
In another example, a temperature sensor (not shown) could be located in a heat transfer fluid input (not shown) of a plate and/or a heat transfer output (not shown) of such a plate. A difference between the temperatures determined at such points could be utilized to determine the temperature of the biopharmaceutical materials held in a container (e.g., containers 10 and 410). Thus, controller 21 may regulate a flow of heat transfer fluid to one or more of plates 28 to regulate a temperature of the biopharmaceutical materials held in such a container in slot 25 of cavity 26 of temperature control unit 20. More specifically, controller 21 may cause a heat transfer fluid control portion 22 to circulate heat transfer fluids in plate(s) 28 to raise or lower a temperature of plate(s) 28, thereby lowering or raising the temperature of a container (e.g., containers 10 and 410) which is in contact with plate 28. In this manner, the biopharmaceutical material may have its temperature controlled (i.e., it may be thawed or frozen). Alternatively, such control of heat transfer plates 28 may be performed by controller portion 21 controlling flow of heat transfer fluid to plates 28 in a predetermined manner without feedback from a sensor coupled to plates 28 or the heat transfer fluid. In a further example, a temperature sensor (not shown) could extend through a port or conduit of a container (e.g., container 10) to allow a determination of a temperature of biopharmaceutical materials held therein. A flow of heat transfer fluid or other temperature regulation may be based on such determination.[P-58]
Also, one or more of plates 28 may be moveable to contact container 10, container 410 and/or any other container when the containers are received in holders (e.g., holders 15 and 415) and the holders are connected to plate 500 and received in slot 25 of cavity 26 of temperature control unit 20, as depicted in FIG. 8. Further, plates 28 could be stationary and temperature control unit 20 may include one or more non-temperature controlled moveable plates, surfaces, or walls (not shown) configured to contact the container(s), when the container(s) and holder(s) are received in slot 25. Alternatively, plates 28 may be movable along with such additional movable plates, surfaces, or walls. For example, temperature control units useful with the containers (e.g., containers 10, 410, 610 and 710) and plates (e.g., plates 500 and 800) of the present application.[P-59]
Here, we see Voute ‘7609 illustrate a sensory system that measure and controls the temperature of the exterior surface of the flexible container , as well as capturing the temperature of the interior of the container to account for the temperature of the biopharmaceutical substance, such that the temperature may further be measurable and regulated accordingly.
Thereby, it would be obvious to one of ordinary skill in the art to combine Voute ‘7609 with Voute ‘2216 teaching in order to enable as capturing the temperature of the interior of the container to account for the temperature of the biopharmaceutical substance, such that the temperature may further be measurable and regulated during storage accordingly.
Voutte ’2216 modified fails to teach the sensor system to measure/probe a temperature of biopharmaceutical composition at a desired location within the expandable bladder in the filled state thereof, the desired location being a location within the bladder spaced apart from an interior surface of the bladder.
Gay on the other hand teaches the sensor system to measure/probe a temperature of biopharmaceutical composition at a desired location within the expandable bladder in the filled state thereof, the desired location being a location within the bladder spaced apart from an interior surface of the bladder. (Paragraph 91; Figure 19)
In another example depicted in FIGS. 18-19, holder 1015 receives a second container 1910 having a monitoring device 1920 (e.g., (e.g., a pH electrode, a conductivity sensor, temperature probe, an ion selective electrode, a spectophotometric probe, an ultrasound sensor, an optic fiber) extending from an interior of container 1910 through connecting portion 1750 to sample cavity 1740 where said monitoring device 1920 may couple to a connecting cable 930 or other means of coupling the monitoring device to a computing unit or controller for processing data received from the monitoring device. The monitoring device may also include data logging and wireless communication (e.g., RFID) capability. For example, an identification signal may be transferred into a RFID tag at a product filling step. Such signal may be utilized to track the product during storage and distribution phases. The monitoring device (e.g., monitoring device 1920) may record the physical parameters of the biopharmaceutical materials during the processing thereof and such data may be communicated to a computing unit at the conclusion of the processing via the coupling of the data logging system to a computing logging system or via wireless transmission during the processing thereof.[P-91]
Here, we see Gay’s positioning of the sensor system placed at the desired location being a location within the bladder spaced apart from an interior surface of the bladder.
Thereby, it would be obvious to one of ordinary skill in the art to combine Gay’s teaching with Voute ‘2216 modified’s teaching in order to enable as capturing the temperature at a specific location of the interior of the container to account for the temperature of the biopharmaceutical substance, such that the temperature may further be measurable and regulated during storage accordingly.
In regards to claim 2, Voute ‘2216 modified via teaches the sensor system is within the envelope of the container and its supporting structure when the expandable bladder is in the filled state thereof (Paragraph 10; Figure 2).
The present invention provides, in a second aspect, a system for use in freezing, storing and thawing biopharmaceutical materials which includes a container for holding biopharmaceutical materials therein. A sensor is coupled to the container for monitoring a physical parameter of the biopharmaceutical materials in the container. A holder has a storage cavity receiving the container and a sampling cavity receiving the sensor. The holder includes a first portion and a second portion. The container is received between the first portion and the second portion to connect the container to the holder. The holder includes an interior storage cradle bounding the storage cavity. The holder includes an interior sampling cradle bounding the sampling cavity. The sampling cradle is separated from the storage cradle and connected to the storage cradle by a passage of the holder. The holder includes an outer rim connected to the storage cradle and separated from the storage cavity.[P-10]
Voute ‘7609 also teaches the sensor system is within the envelope of the container and its supporting structure when the expandable bladder is in the filled state thereof (Paragraph 59).
Also, one or more of plates 28 may be moveable to contact container 10, container 410 and/or any other container when the containers are received in holders (e.g., holders 15 and 415) and the holders are connected to plate 500 and received in slot 25 of cavity 26 of temperature control unit 20, as depicted in FIG. 8. Further, plates 28 could be stationary and temperature control unit 20 may include one or more non-temperature controlled moveable plates, surfaces, or walls (not shown) configured to contact the container(s), when the container(s) and holder(s) are received in slot 25. Alternatively, plates 28 may be movable along with such additional movable plates, surfaces, or walls. For example, temperature control units useful with the containers (e.g., containers 10, 410, 610 and 710) and plates (e.g., plates 500 and 800) of the present application.[P-59]
In regards to claim 3, Voute ‘2216 modified teaches the sensor system is configured to remain secured to the expandable bladder during a freezing process, shipping, storage, and a thawing process of the expandable bladder (Paragraphs 10, 11).
The present invention provides, in a second aspect, a system for use in freezing, storing and thawing biopharmaceutical materials which includes a container for holding biopharmaceutical materials therein. A sensor is coupled to the container for monitoring a physical parameter of the biopharmaceutical materials in the container. A holder has a storage cavity receiving the container and a sampling cavity receiving the sensor. The holder includes a first portion and a second portion. The container is received between the first portion and the second portion to connect the container to the holder. The holder includes an interior storage cradle bounding the storage cavity. The holder includes an interior sampling cradle bounding the sampling cavity. The sampling cradle is separated from the storage cradle and connected to the storage cradle by a passage of the holder. The holder includes an outer rim connected to the storage cradle and separated from the storage cavity.[P-10]
The present invention provides, in a third aspect, a method for use in freezing, storing or thawing biopharmaceutical materials which includes receiving a container holding biopharmaceutical materials in a holder having a storage cavity and a sampling cavity. The container is connected to the holder by receiving the container between a first portion and the second portion of the holder. An interior storage cradle of the holder bounds the storage cavity. An interior sample cradle of the holder bounds the sampling cavity. The sampling cradle is separated from the storage cavity. The sample cavity is connected to the storage cavity by a connecting passage of the holder. An outer rim of the holder is connected to the storage cradle and separated from the storage cavity.[P-11]
In regards to claim 4, Voute ‘2216 modified via Voute ‘7609 the sensor system comprises a body secured to the exterior of the storage container; and a sensor disposed between the body and the exterior surface of the bladder with the sensor in contact with the exterior surface of the bladder, the sensor configured to determine a temperature of the exterior surface of the bladder to generate the signal indicative of the temperature of the exterior surface of the bladder. (Paragraphs 57-59, Voute ‘7609)
One or more plates 28 may also include temperature sensor 18 mounted on an interior portion or exterior portion of plates 28 or it may be integral thereto. Temperature sensor 18 may detect a temperature of one or more of plates 28 and one or more locations thereon. Controller portion 21 of temperature control unit 20 may be coupled to temperature sensor 18 and to a heat transfer fluid control portion 22 of temperature control unit 20. Such heat transfer fluids may be circulated through plates 28 by heat transfer fluid control portion 22 controlled by controller portion 21 in response to temperatures detected by temperature sensor 18. [P-57]
In another example, a temperature sensor (not shown) could be located in a heat transfer fluid input (not shown) of a plate and/or a heat transfer output (not shown) of such a plate. A difference between the temperatures determined at such points could be utilized to determine the temperature of the biopharmaceutical materials held in a container (e.g., containers 10 and 410). Thus, controller 21 may regulate a flow of heat transfer fluid to one or more of plates 28 to regulate a temperature of the biopharmaceutical materials held in such a container in slot 25 of cavity 26 of temperature control unit 20. More specifically, controller 21 may cause a heat transfer fluid control portion 22 to circulate heat transfer fluids in plate(s) 28 to raise or lower a temperature of plate(s) 28, thereby lowering or raising the temperature of a container (e.g., containers 10 and 410) which is in contact with plate 28. In this manner, the biopharmaceutical material may have its temperature controlled (i.e., it may be thawed or frozen). Alternatively, such control of heat transfer plates 28 may be performed by controller portion 21 controlling flow of heat transfer fluid to plates 28 in a predetermined manner without feedback from a sensor coupled to plates 28 or the heat transfer fluid. In a further example, a temperature sensor (not shown) could extend through a port or conduit of a container (e.g., container 10) to allow a determination of a temperature of biopharmaceutical materials held therein. A flow of heat transfer fluid or other temperature regulation may be based on such determination.[P-58]
Also, one or more of plates 28 may be moveable to contact container 10, container 410 and/or any other container when the containers are received in holders (e.g., holders 15 and 415) and the holders are connected to plate 500 and received in slot 25 of cavity 26 of temperature control unit 20, as depicted in FIG. 8. Further, plates 28 could be stationary and temperature control unit 20 may include one or more non-temperature controlled moveable plates, surfaces, or walls (not shown) configured to contact the container(s), when the container(s) and holder(s) are received in slot 25. Alternatively, plates 28 may be movable along with such additional movable plates, surfaces, or walls. For example, temperature control units useful with the containers (e.g., containers 10, 410, 610 and 710) and plates (e.g., plates 500 and 800) of the present application.[P-59]
Here, Voute ‘7609 illustrates the sensor system where a body secured to the exterior such as holders of the storage container plates with a sensor disposed between the body and the exterior surface of the flexible container/bladder with the sensor in contact with the exterior surface of the flexible container/bladder and the interior of the plate, such that the sensor is configured to determine a temperature of the exterior surface of the bladder to generate the signal indicative of the temperature of the exterior surface of the bladder.
In regards to claim 6, Voute ‘2216 modified via Voute ‘7609 teaches the sensor includes a thermally conductive housing in contact with the exterior surface of the bladder/ flexible container (Paragraph 55, Voute ‘7609).
In one embodiment, temperature control unit 20 includes a heat exchanger having one or more heat transfer or conduction plates for heating and/or cooling one or more containers and biopharmaceutical materials contained therein, as best depicted in FIGS. 7-8. For example, temperature control unit 20 may include heat transfer plates 28 for contacting the containers (e.g., container 10 and/or 410) to cool or heat the contents thereof. For example, first side 12 of container 10 may contact a heat transfer surface (e.g., one of plates 28) of interior 26 of temperature control unit 20 through opening 210 or opening 211 to control the temperature of the biopharmaceutical material in container 10. Alternatively, side 12 of flexible container 10 may be exposed to a still or circulating air within temperature control unit 20, a blast freezer or other means of controlling a temperature of an outer surface of a container (e.g., container 10) or immediate ambient surroundings thereof.[P-55]
In regards to claim 7, Voute ‘2216 modified teaches the sensor system further comprises a sensor cable that extends from the sensor and terminates in a connector (Paragraph 41).
In another example depicted in FIGS. 3-4, holder 15 receives a second container 910 having a monitoring device 920 (e.g., (e.g., a pH electrode, a conductivity sensor, temperature probe, an ion selective electrode, a spectrophotometric probe, an ultrasound sensor, an optic fiber) extending from an interior of container 910 through connecting portion 750 to sample cavity 740 where said monitoring device 920 may couple to a connecting cable 930 or other means of coupling the monitoring device to a computing unit or controller for processing data received from the monitoring device. The monitoring device may also include data logging and wireless communication (e.g., RFID) capability. For example, an identification signal may be transferred into a RFID tag at a product filling step. Such signal may be utilized to track the product during storage and distribution phases. The monitoring device (e.g., monitoring device 920) may record the physical parameters of the biopharmaceutical materials during the processing thereof and such data may be communicated to a computing unit at the conclusion of the processing via the coupling of the data logging system to a computing logging system or via wireless transmission during the processing thereof.[P-41]
In regards to claim 8, Voute ‘2216 modified teaches the body of the sensor system includes a connector holder and a cable guide, the sensor cable received within cable guide to secure the sensor cable relative to the body, the connector received within the connector holder to secure the connector relative to the body(Paragraph 41).
In another example depicted in FIGS. 3-4, holder 15 receives a second container 910 having a monitoring device 920 (e.g., (e.g., a pH electrode, a conductivity sensor, temperature probe, an ion selective electrode, a spectrophotometric probe, an ultrasound sensor, an optic fiber) extending from an interior of container 910 through connecting portion 750 to sample cavity 740 where said monitoring device 920 may couple to a connecting cable 930 or other means of coupling the monitoring device to a computing unit or controller for processing data received from the monitoring device. The monitoring device may also include data logging and wireless communication (e.g., RFID) capability. For example, an identification signal may be transferred into a RFID tag at a product filling step. Such signal may be utilized to track the product during storage and distribution phases. The monitoring device (e.g., monitoring device 920) may record the physical parameters of the biopharmaceutical materials during the processing thereof and such data may be communicated to a computing unit at the conclusion of the processing via the coupling of the data logging system to a computing logging system or via wireless transmission during the processing thereof.[P-41]
In regards to claim 9, Voute ‘2216 modified teaches the body includes attachment features that engage the bladder to releasably secure the body to the bladder (Paragraph 9; Figures 1 & 2).
The present invention provides, in a first aspect, a system for use in freezing, storing and thawing biopharmaceutical materials which includes a holder and a container for holding biopharmaceutical materials therein. The container includes a storage portion and a sampling portion connected to each other by a connecting portion. The holder has a storage cavity receiving the storage portion and a sampling cavity receiving the sampling portion. The holder includes a first portion and second portion. The container is received between the first portion and the second portion to connect the container to the holder. The holder includes an interior storage cradle bounding the storage cavity of the holder. The holder includes an interior sampling cradle bounding the sampling cavity. The sampling cradle is separated from the storage cradle and connected to the storage cradle by a passage receiving the connecting portion connecting the storage portion to the sampling portion. An outer rim is connected to the cradle and separated from the cavity.[P-9]
In regards to claim 10, Voute ‘2216 teaches a system for determining a temperature of a biopharmaceutical composition during a freezing process, the system comprising a storage container for aseptically storing and freezing a biopharmaceutical composition, the storage container comprising: a frame; and an expandable bladder supported within the frame, the expandable bladder having a filled state in which the expandable bladder is configured to hold the biopharmaceutical composition therein(Paragraphs 18, 19, 21)
In an exemplary embodiment depicted in FIGS. 1-4, a system 5 for cooling, freezing, preserving, processing and thawing biopharmaceutical materials is shown. The system may include a sterile container, such as a flexible container 10, configured to contain the biopharmaceutical materials and configured to be supported by a supporting and/or protective structure, such as a holder 15.[P-18]
Flexible container 10 may be formed of a laminated film which includes a plurality of layers and may have an interior volume ranging from 0.01-100 liters, (e.g., 0.1-20 L) as depicted in FIG. 2 for example. Further, flexible container 10 could be available in a variety of sizes to accommodate different uses, for example, 5-10 liter flexible containers, such as 8-liter containers, may be utilized. Also a biocompatible product-contacting layer of the interior of flexible container 10 may be formed of a low density polyethylene, very low density polyethylene, ethylene vinyl acetate copolymer, polyester, polyamide, polyvinylchloride, polypropylene, polyfluoroethylene, polyvinylidenefluoride, polyurethane or fluoroethylenepropylene, for example. A gas and water vapor barrier layer may also be formed of an ethylene/vinyl alcohol copolymer mixture within a polyamide or an ethylene vinyl acetate copolymer. Further, flexible container 10 may include a layer with high mechanical strength (e.g. a polyamide), and an external layer with insulating effect to heat welding, for example, polyester. The layers may be compatible with warm and cold conditions and may be able to withstand ionizing and gamma irradiation for sterilization purposes. Also, flexible container 10 may have a large surface area to volume ratio, and a relatively thin wall thus promoting heat transfer therethrough when received in a temperature control unit such as an interior 500 of a walk-in or blast freezer (FIG. 1).[P-19]
Container 10 may be configured (e.g., shaped and dimensioned) to be received in, and connected to holder 15, which acts as a protector, supporting structure or frame for supporting flexible container 10, as depicted in FIGS. 1-2. In one example, container 10 may have a pillow-shape. Holder 15 may be configured to protect a container held therein during filling, transport, storage, and/or freezing of biopharmaceutical materials. For example, holder 15 may hold and protect container 10 during freezing of biopharmaceutical materials in interior 500 of a walk-in or blast freezer (FIG. 1). Further, holder 15 may protect container 10 when holder 15 is stacked on or under another holder similar to holder 15.[P-21]
Here, Voute ‘2216 teaches a storage container for storing and freezing a biopharmaceutical composition, the storage container having a frame and an expandable bladder (flexible container) supported within the frame, the flexible container configured to hold the biopharmaceutical composition.
Voute ‘2216 teaches a sensor system secured to the bladder, the sensor system configured to transmit a signal indicative of a temperature of the bladder; and a processing device configured to receive the signal from the sensor system, the processing device providing a temperature of the biopharmaceutical composition at a desired location within the bladder based on the temperature of the exterior surface of the bladder(Paragraphs 39, 41)
The outer rims (e.g., outer rim 40 and outer rim 80) and the inner rims (e.g., inner rim 30 and inner rim 70) may include apertures such as a first aperture 420 and a second aperture 410 depicted in FIG. 2. to allow conduits (e.g., a conduit 13) connected to container 10 to pass therethrough. Such conduits may allow filling or draining of biopharmaceutical materials or other solids, liquids, or gases into and/or out of the interior (not shown) of container 10. Conduit 13 may also be used to insert a measurement probe (not shown) inside container 10 (e.g., a pH electrode, a conductivity sensor, temperature probe, an ion selective electrode, a spectrophotometric probe, an ultrasound sensor, an optic fiber.)[P-39]
In another example depicted in FIGS. 3-4, holder 15 receives a second container 910 having a monitoring device 920 (e.g., (e.g., a pH electrode, a conductivity sensor, temperature probe, an ion selective electrode, a spectrophotometric probe, an ultrasound sensor, an optic fiber) extending from an interior of container 910 through connecting portion 750 to sample cavity 740 where said monitoring device 920 may couple to a connecting cable 930 or other means of coupling the monitoring device to a computing unit or controller for processing data received from the monitoring device. The monitoring device may also include data logging and wireless communication (e.g., RFID) capability. For example, an identification signal may be transferred into a RFID tag at a product filling step. Such signal may be utilized to track the product during storage and distribution phases. The monitoring device (e.g., monitoring device 920) may record the physical parameters of the biopharmaceutical materials during the processing thereof and such data may be communicated to a computing unit at the conclusion of the processing via the coupling of the data logging system to a computing logging system or via wireless transmission during the processing thereof.[P-41]
Voute ‘2216 fails to teach the exterior surface of the bladder, being the sensor system configured to transmit a signal indicative of a temperature of the exterior surface of the bladder
Voute ‘7609 on the other hand teaches the exterior surface of the bladder, being the sensor system configured to measure and transmit a signal indicative of a temperature of the exterior surface of the bladder (Paragraphs 57-59)
One or more plates 28 may also include temperature sensor 18 mounted on an interior portion or exterior portion of plates 28 or it may be integral thereto. Temperature sensor 18 may detect a temperature of one or more of plates 28 and one or more locations thereon. Controller portion 21 of temperature control unit 20 may be coupled to temperature sensor 18 and to a heat transfer fluid control portion 22 of temperature control unit 20. Such heat transfer fluids may be circulated through plates 28 by heat transfer fluid control portion 22 controlled by controller portion 21 in response to temperatures detected by temperature sensor 18. [P-57]
In another example, a temperature sensor (not shown) could be located in a heat transfer fluid input (not shown) of a plate and/or a heat transfer output (not shown) of such a plate. A difference between the temperatures determined at such points could be utilized to determine the temperature of the biopharmaceutical materials held in a container (e.g., containers 10 and 410). Thus, controller 21 may regulate a flow of heat transfer fluid to one or more of plates 28 to regulate a temperature of the biopharmaceutical materials held in such a container in slot 25 of cavity 26 of temperature control unit 20. More specifically, controller 21 may cause a heat transfer fluid control portion 22 to circulate heat transfer fluids in plate(s) 28 to raise or lower a temperature of plate(s) 28, thereby lowering or raising the temperature of a container (e.g., containers 10 and 410) which is in contact with plate 28. In this manner, the biopharmaceutical material may have its temperature controlled (i.e., it may be thawed or frozen). Alternatively, such control of heat transfer plates 28 may be performed by controller portion 21 controlling flow of heat transfer fluid to plates 28 in a predetermined manner without feedback from a sensor coupled to plates 28 or the heat transfer fluid. In a further example, a temperature sensor (not shown) could extend through a port or conduit of a container (e.g., container 10) to allow a determination of a temperature of biopharmaceutical materials held therein. A flow of heat transfer fluid or other temperature regulation may be based on such determination.[P-58]
Also, one or more of plates 28 may be moveable to contact container 10, container 410 and/or any other container when the containers are received in holders (e.g., holders 15 and 415) and the holders are connected to plate 500 and received in slot 25 of cavity 26 of temperature control unit 20, as depicted in FIG. 8. Further, plates 28 could be stationary and temperature control unit 20 may include one or more non-temperature controlled moveable plates, surfaces, or walls (not shown) configured to contact the container(s), when the container(s) and holder(s) are received in slot 25. Alternatively, plates 28 may be movable along with such additional movable plates, surfaces, or walls. For example, temperature control units useful with the containers (e.g., containers 10, 410, 610 and 710) and plates (e.g., plates 500 and 800) of the present application.[P-59]
Here, we see Voute ‘7609 illustrate a sensory system that measure and controls the temperature of the exterior surface of the flexible container , as well as capturing the temperature of the interior of the container to account for the temperature of the biopharmaceutical substance, such that the temperature may further be measurable and regulated accordingly.
Thereby, it would be obvious to one of ordinary skill in the art to combine Voute ‘7609 with Voute ‘2216 teaching in order to enable as capturing the temperature of the interior of the container to account for the temperature of the biopharmaceutical substance, such that the temperature may further be measurable and regulated during storage accordingly.
Voutte ’2216 modified fails to teach the sensor system to measure/probe a temperature of biopharmaceutical composition at a desired location within the expandable bladder in the filled state thereof, the desired location being a location within the bladder spaced apart from an interior surface of the bladder.
Gay on the other hand teaches the sensor system to measure/probe a temperature of biopharmaceutical composition at a desired location within the expandable bladder in the filled state thereof, the desired location being a location within the bladder spaced apart from an interior surface of the bladder. (Paragraph 91; Figure 19)
In another example depicted in FIGS. 18-19, holder 1015 receives a second container 1910 having a monitoring device 1920 (e.g., (e.g., a pH electrode, a conductivity sensor, temperature probe, an ion selective electrode, a spectophotometric probe, an ultrasound sensor, an optic fiber) extending from an interior of container 1910 through connecting portion 1750 to sample cavity 1740 where said monitoring device 1920 may couple to a connecting cable 930 or other means of coupling the monitoring device to a computing unit or controller for processing data received from the monitoring device. The monitoring device may also include data logging and wireless communication (e.g., RFID) capability. For example, an identification signal may be transferred into a RFID tag at a product filling step. Such signal may be utilized to track the product during storage and distribution phases. The monitoring device (e.g., monitoring device 1920) may record the physical parameters of the biopharmaceutical materials during the processing thereof and such data may be communicated to a computing unit at the conclusion of the processing via the coupling of the data logging system to a computing logging system or via wireless transmission during the processing thereof.[P-91]
Here, we see Gay’s positioning of the sensor system placed at the desired location being a location within the bladder spaced apart from an interior surface of the bladder.
Thereby, it would be obvious to one of ordinary skill in the art to combine Gay’s teaching with Voute ‘2216 modified’s teaching in order to enable as capturing the temperature at a specific location of the interior of the container to account for the temperature of the biopharmaceutical substance, such that the temperature may further be measurable and regulated during storage accordingly.
In regards to claim 11, Voute ‘2216 modified teaches a probe system including a probe disposed within an interior of the expandable bladder, the probe configured to directly measure and transmit a signal indicative of a temperature at the desired location within the bladder (Paragraphs 39, 41).
The outer rims (e.g., outer rim 40 and outer rim 80) and the inner rims (e.g., inner rim 30 and inner rim 70) may include apertures such as a first aperture 420 and a second aperture 410 depicted in FIG. 2. to allow conduits (e.g., a conduit 13) connected to container 10 to pass therethrough. Such conduits may allow filling or draining of biopharmaceutical materials or other solids, liquids, or gases into and/or out of the interior (not shown) of container 10. Conduit 13 may also be used to insert a measurement probe (not shown) inside container 10 (e.g., a pH electrode, a conductivity sensor, temperature probe, an ion selective electrode, a spectrophotometric probe, an ultrasound sensor, an optic fiber.)[P-39]
In another example depicted in FIGS. 3-4, holder 15 receives a second container 910 having a monitoring device 920 (e.g., (e.g., a pH electrode, a conductivity sensor, temperature probe, an ion selective electrode, a spectrophotometric probe, an ultrasound sensor, an optic fiber) extending from an interior of container 910 through connecting portion 750 to sample cavity 740 where said monitoring device 920 may couple to a connecting cable 930 or other means of coupling the monitoring device to a computing unit or controller for processing data received from the monitoring device. The monitoring device may also include data logging and wireless communication (e.g., RFID) capability. For example, an identification signal may be transferred into a RFID tag at a product filling step. Such signal may be utilized to track the product during storage and distribution phases. The monitoring device (e.g., monitoring device 920) may record the physical parameters of the biopharmaceutical materials during the processing thereof and such data may be communicated to a computing unit at the conclusion of the processing via the coupling of the data logging system to a computing logging system or via wireless transmission during the processing thereof.[P-41]
In regards to claim 12, Voute ‘2216 modified teaches the processing device is configured to correlate the signal provided by the sensor system to the temperature of the biopharmaceutical composition at the desired location within the bladder based on the signal of the probe (Paragraph 41).
In another example depicted in FIGS. 3-4, holder 15 receives a second container 910 having a monitoring device 920 (e.g., (e.g., a pH electrode, a conductivity sensor, temperature probe, an ion selective electrode, a spectrophotometric probe, an ultrasound sensor, an optic fiber) extending from an interior of container 910 through connecting portion 750 to sample cavity 740 where said monitoring device 920 may couple to a connecting cable 930 or other means of coupling the monitoring device to a computing unit or controller for processing data received from the monitoring device. The monitoring device may also include data logging and wireless communication (e.g., RFID) capability. For example, an identification signal may be transferred into a RFID tag at a product filling step. Such signal may be utilized to track the product during storage and distribution phases. The monitoring device (e.g., monitoring device 920) may record the physical parameters of the biopharmaceutical materials during the processing thereof and such data may be communicated to a computing unit at the conclusion of the processing via the coupling of the data logging system to a computing logging system or via wireless transmission during the processing thereof.[P-41]
In regards claim 13, Voute ‘2216 teaches a method of correlating an external sensor system for a storage container filled with a biopharmaceutical composition, the method comprising freezing the storage container filled with the biopharmaceutical composition(Paragraphs 18, 19, 21)
In an exemplary embodiment depicted in FIGS. 1-4, a system 5 for cooling, freezing, preserving, processing and thawing biopharmaceutical materials is shown. The system may include a sterile container, such as a flexible container 10, configured to contain the biopharmaceutical materials and configured to be supported by a supporting and/or protective structure, such as a holder 15.[P-18]
Flexible container 10 may be formed of a laminated film which includes a plurality of layers and may have an interior volume ranging from 0.01-100 liters, (e.g., 0.1-20 L) as depicted in FIG. 2 for example. Further, flexible container 10 could be available in a variety of sizes to accommodate different uses, for example, 5-10 liter flexible containers, such as 8-liter containers, may be utilized. Also a biocompatible product-contacting layer of the interior of flexible container 10 may be formed of a low density polyethylene, very low density polyethylene, ethylene vinyl acetate copolymer, polyester, polyamide, polyvinylchloride, polypropylene, polyfluoroethylene, polyvinylidenefluoride, polyurethane or fluoroethylenepropylene, for example. A gas and water vapor barrier layer may also be formed of an ethylene/vinyl alcohol copolymer mixture within a polyamide or an ethylene vinyl acetate copolymer. Further, flexible container 10 may include a layer with high mechanical strength (e.g. a polyamide), and an external layer with insulating effect to heat welding, for example, polyester. The layers may be compatible with warm and cold conditions and may be able to withstand ionizing and gamma irradiation for sterilization purposes. Also, flexible container 10 may have a large surface area to volume ratio, and a relatively thin wall thus promoting heat transfer therethrough when received in a temperature control unit such as an interior 500 of a walk-in or blast freezer (FIG. 1).[P-19]
Container 10 may be configured (e.g., shaped and dimensioned) to be received in, and connected to holder 15, which acts as a protector, supporting structure or frame for supporting flexible container 10, as depicted in FIGS. 1-2. In one example, container 10 may have a pillow-shape. Holder 15 may be configured to protect a container held therein during filling, transport, storage, and/or freezing of biopharmaceutical materials. For example, holder 15 may hold and protect container 10 during freezing of biopharmaceutical materials in interior 500 of a walk-in or blast freezer (FIG. 1). Further, holder 15 may protect container 10 when holder 15 is stacked on or under another holder similar to holder 15.[P-21]
Here, Voute ‘2216 teaches a storage container for storing and freezing a biopharmaceutical composition, the storage container having a frame and an expandable bladder (flexible container) supported within the frame, the flexible container configured to hold the biopharmaceutical composition
Voute ‘2216 further teaches generating a second temperature signal indicative of a temperature of the biopharmaceutical composition within the storage container with an internal probe system disposed within an interior of the storage container in direct contact with the biopharmaceutical composition during freezing of the storage container(Paragraphs 39, 41)
The outer rims (e.g., outer rim 40 and outer rim 80) and the inner rims (e.g., inner rim 30 and inner rim 70) may include apertures such as a first aperture 420 and a second aperture 410 depicted in FIG. 2. to allow conduits (e.g., a conduit 13) connected to container 10 to pass therethrough. Such conduits may allow filling or draining of biopharmaceutical materials or other solids, liquids, or gases into and/or out of the interior (not shown) of container 10. Conduit 13 may also be used to insert a measurement probe (not shown) inside container 10 (e.g., a pH electrode, a conductivity sensor, temperature probe, an ion selective electrode, a spectrophotometric probe, an ultrasound sensor, an optic fiber.)[P-39]
In another example depicted in FIGS. 3-4, holder 15 receives a second container 910 having a monitoring device 920 (e.g., (e.g., a pH electrode, a conductivity sensor, temperature probe, an ion selective electrode, a spectrophotometric probe, an ultrasound sensor, an optic fiber) extending from an interior of container 910 through connecting portion 750 to sample cavity 740 where said monitoring device 920 may couple to a connecting cable 930 or other means of coupling the monitoring device to a computing unit or controller for processing data received from the monitoring device. The monitoring device may also include data logging and wireless communication (e.g., RFID) capability. For example, an identification signal may be transferred into a RFID tag at a product filling step. Such signal may be utilized to track the product during storage and distribution phases. The monitoring device (e.g., monitoring device 920) may record the physical parameters of the biopharmaceutical materials during the processing thereof and such data may be communicated to a computing unit at the conclusion of the processing via the coupling of the data logging system to a computing logging system or via wireless transmission during the processing thereof.[P-41]
Voute ‘2216 fails to teach generating a first temperature signal indicative of a temperature of an exterior surface of the storage container with the external sensor system secured to the exterior surface of the storage container during freezing of the storage container
Voute ‘7609 on the other hand teaches the measuring and the generating a first temperature signal indicative of a temperature of an exterior surface of the storage container with the external sensor system secured to the exterior surface of the storage container during freezing of the storage container (Paragraphs 57-59)
One or more plates 28 may also include temperature sensor 18 mounted on an interior portion or exterior portion of plates 28 or it may be integral thereto. Temperature sensor 18 may detect a temperature of one or more of plates 28 and one or more locations thereon. Controller portion 21 of temperature control unit 20 may be coupled to temperature sensor 18 and to a heat transfer fluid control portion 22 of temperature control unit 20. Such heat transfer fluids may be circulated through plates 28 by heat transfer fluid control portion 22 controlled by controller portion 21 in response to temperatures detected by temperature sensor 18. [P-57]
In another example, a temperature sensor (not shown) could be located in a heat transfer fluid input (not shown) of a plate and/or a heat transfer output (not shown) of such a plate. A difference between the temperatures determined at such points could be utilized to determine the temperature of the biopharmaceutical materials held in a container (e.g., containers 10 and 410). Thus, controller 21 may regulate a flow of heat transfer fluid to one or more of plates 28 to regulate a temperature of the biopharmaceutical materials held in such a container in slot 25 of cavity 26 of temperature control unit 20. More specifically, controller 21 may cause a heat transfer fluid control portion 22 to circulate heat transfer fluids in plate(s) 28 to raise or lower a temperature of plate(s) 28, thereby lowering or raising the temperature of a container (e.g., containers 10 and 410) which is in contact with plate 28. In this manner, the biopharmaceutical material may have its temperature controlled (i.e., it may be thawed or frozen). Alternatively, such control of heat transfer plates 28 may be performed by controller portion 21 controlling flow of heat transfer fluid to plates 28 in a predetermined manner without feedback from a sensor coupled to plates 28 or the heat transfer fluid. In a further example, a temperature sensor (not shown) could extend through a port or conduit of a container (e.g., container 10) to allow a determination of a temperature of biopharmaceutical materials held therein. A flow of heat transfer fluid or other temperature regulation may be based on such determination.[P-58]
Also, one or more of plates 28 may be moveable to contact container 10, container 410 and/or any other container when the containers are received in holders (e.g., holders 15 and 415) and the holders are connected to plate 500 and received in slot 25 of cavity 26 of temperature control unit 20, as depicted in FIG. 8. Further, plates 28 could be stationary and temperature control unit 20 may include one or more non-temperature controlled moveable plates, surfaces, or walls (not shown) configured to contact the container(s), when the container(s) and holder(s) are received in slot 25. Alternatively, plates 28 may be movable along with such additional movable plates, surfaces, or walls. For example, temperature control units useful with the containers (e.g., containers 10, 410, 610 and 710) and plates (e.g., plates 500 and 800) of the present application.[P-59]
Here, we see Voute ‘7609 illustrate a sensory system that measure and controls the temperature of the exterior surface of the flexible container , as well as capturing the temperature of the interior of the container to account for the temperature of the biopharmaceutical substance, such that the temperature may further be measurable and regulated accordingly.
Voute ‘7609 teaches receiving the first temperature signal and the second temperature signal with a processing device; and generating correlated external temperature data to correlate the temperature of the exterior surface of the storage container to a temperature of the biopharmaceutical composition within the interior of the storage container based on the first temperature signal and the second temperature signal (Paragraph 58)
In another example, a temperature sensor (not shown) could be located in a heat transfer fluid input (not shown) of a plate and/or a heat transfer output (not shown) of such a plate. A difference between the temperatures determined at such points could be utilized to determine the temperature of the biopharmaceutical materials held in a container (e.g., containers 10 and 410). Thus, controller 21 may regulate a flow of heat transfer fluid to one or more of plates 28 to regulate a temperature of the biopharmaceutical materials held in such a container in slot 25 of cavity 26 of temperature control unit 20. More specifically, controller 21 may cause a heat transfer fluid control portion 22 to circulate heat transfer fluids in plate(s) 28 to raise or lower a temperature of plate(s) 28, thereby lowering or raising the temperature of a container (e.g., containers 10 and 410) which is in contact with plate 28. In this manner, the biopharmaceutical material may have its temperature controlled (i.e., it may be thawed or frozen). Alternatively, such control of heat transfer plates 28 may be performed by controller portion 21 controlling flow of heat transfer fluid to plates 28 in a predetermined manner without feedback from a sensor coupled to plates 28 or the heat transfer fluid. In a further example, a temperature sensor (not shown) could extend through a port or conduit of a container (e.g., container 10) to allow a determination of a temperature of biopharmaceutical materials held therein. A flow of heat transfer fluid or other temperature regulation may be based on such determination.[P-58]
Thereby, it would be obvious to one of ordinary skill in the art to combine Voute ‘7609 with Voute’2216 teaching in order to enable as capturing the temperature of the interior of the container to account for the temperature of the biopharmaceutical substance, such that the temperature may further be measurable and regulated during storage accordingly.
Voute ‘2216 modified fails to teach measuring a temperature of the biopharmaceutical composition within the storage container with an internal probe system disposed within an interior of the storage container at a desired location within the storage container and spaced apart from an interior surface of the storage container, the internal probe system in direct contact with the biopharmaceutical composition during freezing of the storage container.
Gay on the other hand teaches measuring a temperature of the biopharmaceutical composition within the storage container with an internal probe system disposed within an interior of the storage container at a desired location within the storage container and spaced apart from an interior surface of the storage container, the internal probe system in direct contact with the biopharmaceutical composition during freezing of the storage container(Paragraph 91; Figure 19)
In another example depicted in FIGS. 18-19, holder 1015 receives a second container 1910 having a monitoring device 1920 (e.g., (e.g., a pH electrode, a conductivity sensor, temperature probe, an ion selective electrode, a spectophotometric probe, an ultrasound sensor, an optic fiber) extending from an interior of container 1910 through connecting portion 1750 to sample cavity 1740 where said monitoring device 1920 may couple to a connecting cable 930 or other means of coupling the monitoring device to a computing unit or controller for processing data received from the monitoring device. The monitoring device may also include data logging and wireless communication (e.g., RFID) capability. For example, an identification signal may be transferred into a RFID tag at a product filling step. Such signal may be utilized to track the product during storage and distribution phases. The monitoring device (e.g., monitoring device 1920) may record the physical parameters of the biopharmaceutical materials during the processing thereof and such data may be communicated to a computing unit at the conclusion of the processing via the coupling of the data logging system to a computing logging system or via wireless transmission during the processing thereof.[P-91]
Here, we see Gay’s positioning of the sensor system placed at the desired location being a location within the bladder spaced apart from an interior surface of the bladder, where the pharmaceutical substance/material is being monitored accordingly.
Thereby, it would be obvious to one of ordinary skill in the art to combine Gay’s teaching with Voute ‘2216 modified’s teaching in order to enable as capturing the temperature at a specific location of the interior of the container to account for the temperature of the biopharmaceutical substance, such that the temperature may further be measurable and regulated during storage accordingly.
In regards to claim 14, Voute ‘2216 modified via Voute ‘7609 teaches a freezing another storage container filled with the biopharmaceutical composition and determining a temperature of the biopharmaceutical composition within the other storage container with only an external sensor system using the correlated external temperature data (Paragraphs 57, 58, 75, Voute ‘7609)
One or more plates 28 may also include temperature sensor 18 mounted on an interior portion or exterior portion of plates 28 or it may be integral thereto. Temperature sensor 18 may detect a temperature of one or more of plates 28 and one or more locations thereon. Controller portion 21 of temperature control unit 20 may be coupled to temperature sensor 18 and to a heat transfer fluid control portion 22 of temperature control unit 20. Such heat transfer fluids may be circulated through plates 28 by heat transfer fluid control portion 22 controlled by controller portion 21 in response to temperatures detected by temperature sensor 18.[P-57]
In another example, a temperature sensor (not shown) could be located in a heat transfer fluid input (not shown) of a plate and/or a heat transfer output (not shown) of such a plate. A difference between the temperatures determined at such points could be utilized to determine the temperature of the biopharmaceutical materials held in a container (e.g., containers 10 and 410). Thus, controller 21 may regulate a flow of heat transfer fluid to one or more of plates 28 to regulate a temperature of the biopharmaceutical materials held in such a container in slot 25 of cavity 26 of temperature control unit 20. More specifically, controller 21 may cause a heat transfer fluid control portion 22 to circulate heat transfer fluids in plate(s) 28 to raise or lower a temperature of plate(s) 28, thereby lowering or raising the temperature of a container (e.g., containers 10 and 410) which is in contact with plate 28. In this manner, the biopharmaceutical material may have its temperature controlled (i.e., it may be thawed or frozen). Alternatively, such control of heat transfer plates 28 may be performed by controller portion 21 controlling flow of heat transfer fluid to plates 28 in a predetermined manner without feedback from a sensor coupled to plates 28 or the heat transfer fluid. In a further example, a temperature sensor (not shown) could extend through a port or conduit of a container (e.g., container 10) to allow a determination of a temperature of biopharmaceutical materials held therein. A flow of heat transfer fluid or other temperature regulation may be based on such determination.[P-58]
Further, the above-described containers may be removed from a freezer or other system for storage of the flexible containers and contents thereof at a controlled temperature. These containers having biopharmaceutical material therein may then be received in a temperature control unit for heating, melting, agitating, mixing and/or thawing the biopharmaceutical material contained in the containers. For example, holder 15 supporting container 10 having frozen biopharmaceutical material therein may be placed in temperature control unit 20 where its temperature may be controlled (e.g. thawed) by heat transfer plate(s) 28. In addition, holder 15 or supporting plate 500 on which holders 15 are secured may be submitted to gentle mixing inside temperature control unit 20 to accelerate the thawing kinetics and to minimize any solute concentration gradient in the thawed liquid. Also, when use of the biopharmaceutical materials held in the container (e.g., containers 10, 410, 610 or 710) is desired, and if the conduit is previously at least partially removed and sealed, the remaining portion of the conduit or other portion of the container may be pierced or otherwise opened to allow fluid communication between an interior or an exterior thereof such that biopharmaceutical materials may be removed.[P-75]
Here, we see multiple containers being filled with biopharmaceutical materials with the external sensor system.
In regards to claim 17, Voute ‘2216 modified via Voute ‘7609 teaches shipping the other storage container with the external sensor system secured to the storage container, the external sensor system disposed within extremities of a frame of the other storage container (Paragraphs 48, 57; Figures 7-8, 19, Voute ‘7609)
As depicted in FIG. 2, first portion 115 and second portion 117 of holder 15 may be at least partially separated by a space 119 therebetween. Such space allows the deformation of first portion 115 and/or second portion 117 toward one another (i.e., into space 119) in response to an impact (such as the impact from a person dropping the holder 15 when the container 10 is filled with biopharmaceutical materials) or other stress placed thereon thereby avoiding such stress being applied to container 10. Any damage to container 10 resulting from such impact or stress is therefore reduced or inhibited. Damage may also be reduced or inhibited due to the perimeter of container 10 being surrounded by holder 15 connected thereto, which may be formed of molded plastic, stainless steel, or another material configured to support a weight of container 10 and protect container 10 from being punctured or damaged due to an impact or stress on holder 15. In addition, a container surface (e.g., a first side 12 of container 10) exposed to the exterior through openings 210 and 211 may be protected by additional covers 850 and 851 (FIG. 19) during the storage and or shipment of the holder 15. Such semi-rigid covers 850 and 851 may be releasably connected (e.g., snapped) onto rim 246 of the holder 15 following the freezing and/or thawing of the biopharmaceutical material in temperature control unit 20 of FIG. 8, or in a chest or walk in freezer. Also, the use of covers (e.g., covers 850 and 851) may allow multiple holders (e.g., holders 15) to be horizontally aligned and stacked on each other. For example, holder 15 having covers 850 and 851 attached thereto may be stacked with a second holder (e.g., holder 15) such that one of covers 850 and 851 may abut a cover on the second holder (e.g., holder 15) located above or below holder 15 in a vertical stack of holders arranged horizontally. The covers may inhibit damage to containers held in the holders while providing structural support to the vertically stacked horizontally aligned holders.[P-48]
One or exterior portion of plates 28 or it may be integral thereto. Temperature sensor 18 may detect a temperature of one or more of plates 28 and one or more locations thereon. Controller portion 21 of temperature control unit 20 may be coupled to temperature sensor 18 and to a heat transfer fluid control portion 22 of temperature control unit 20. Such heat transfer fluids may be circulated through plates 28 by heat transfer fluid control portion 22 controlled by controller portion 21 in response to temperatures detected by temperature sensor 18.[P-57]
In regards to claim 18, Voute ‘2216 modified teaches generating the second temperature signal includes the internal probe system disposed at a desired location within the interior of the storage container (Paragraphs 39, 41)
The outer rims (e.g., outer rim 40 and outer rim 80) and the inner rims (e.g., inner rim 30 and inner rim 70) may include apertures such as a first aperture 420 and a second aperture 410 depicted in FIG. 2. to allow conduits (e.g., a conduit 13) connected to container 10 to pass therethrough. Such conduits may allow filling or draining of biopharmaceutical materials or other solids, liquids, or gases into and/or out of the interior (not shown) of container 10. Conduit 13 may also be used to insert a measurement probe (not shown) inside container 10 (e.g., a pH electrode, a conductivity sensor, temperature probe, an ion selective electrode, a spectrophotometric probe, an ultrasound sensor, an optic fiber.)[P-39]
In another example depicted in FIGS. 3-4, holder 15 receives a second container 910 having a monitoring device 920 (e.g., (e.g., a pH electrode, a conductivity sensor, temperature probe, an ion selective electrode, a spectrophotometric probe, an ultrasound sensor, an optic fiber) extending from an interior of container 910 through connecting portion 750 to sample cavity 740 where said monitoring device 920 may couple to a connecting cable 930 or other means of coupling the monitoring device to a computing unit or controller for processing data received from the monitoring device. The monitoring device may also include data logging and wireless communication (e.g., RFID) capability. For example, an identification signal may be transferred into a RFID tag at a product filling step. Such signal may be utilized to track the product during storage and distribution phases. The monitoring device (e.g., monitoring device 920) may record the physical parameters of the biopharmaceutical materials during the processing thereof and such data may be communicated to a computing unit at the conclusion of the processing via the coupling of the data logging system to a computing logging system or via wireless transmission during the processing thereof.[P-41]
Furthermore, Gay teaches measuring the temperature of the biopharmaceutical composition (Paragraph 91; Figure 19)
In another example depicted in FIGS. 18-19, holder 1015 receives a second container 1910 having a monitoring device 1920 (e.g., (e.g., a pH electrode, a conductivity sensor, temperature probe, an ion selective electrode, a spectophotometric probe, an ultrasound sensor, an optic fiber) extending from an interior of container 1910 through connecting portion 1750 to sample cavity 1740 where said monitoring device 1920 may couple to a connecting cable 930 or other means of coupling the monitoring device to a computing unit or controller for processing data received from the monitoring device. The monitoring device may also include data logging and wireless communication (e.g., RFID) capability. For example, an identification signal may be transferred into a RFID tag at a product filling step. Such signal may be utilized to track the product during storage and distribution phases. The monitoring device (e.g., monitoring device 1920) may record the physical parameters of the biopharmaceutical materials during the processing thereof and such data may be communicated to a computing unit at the conclusion of the processing via the coupling of the data logging system to a computing logging system or via wireless transmission during the processing thereof.[P-91]
In regards to claim 19, Voute ‘2216 modified teaches further comprising inserting a probe of the probe system into an interior of the storage container such that a tip of the probe is positioned at a desired location within the interior of the storage container(Paragraphs 39, 41)
The outer rims (e.g., outer rim 40 and outer rim 80) and the inner rims (e.g., inner rim 30 and inner rim 70) may include apertures such as a first aperture 420 and a second aperture 410 depicted in FIG. 2. to allow conduits (e.g., a conduit 13) connected to container 10 to pass therethrough. Such conduits may allow filling or draining of biopharmaceutical materials or other solids, liquids, or gases into and/or out of the interior (not shown) of container 10. Conduit 13 may also be used to insert a measurement probe (not shown) inside container 10 (e.g., a pH electrode, a conductivity sensor, temperature probe, an ion selective electrode, a spectrophotometric probe, an ultrasound sensor, an optic fiber.)[P-39]
In another example depicted in FIGS. 3-4, holder 15 receives a second container 910 having a monitoring device 920 (e.g., (e.g., a pH electrode, a conductivity sensor, temperature probe, an ion selective electrode, a spectrophotometric probe, an ultrasound sensor, an optic fiber) extending from an interior of container 910 through connecting portion 750 to sample cavity 740 where said monitoring device 920 may couple to a connecting cable 930 or other means of coupling the monitoring device to a computing unit or controller for processing data received from the monitoring device. The monitoring device may also include data logging and wireless communication (e.g., RFID) capability. For example, an identification signal may be transferred into a RFID tag at a product filling step. Such signal may be utilized to track the product during storage and distribution phases. The monitoring device (e.g., monitoring device 920) may record the physical parameters of the biopharmaceutical materials during the processing thereof and such data may be communicated to a computing unit at the conclusion of the processing via the coupling of the data logging system to a computing logging system or via wireless transmission during the processing thereof.[P-41]
In regards to claim 20, Voute ‘2216 teaches a method of correlating an external sensor system for a storage container filled with a biopharmaceutical composition, the method comprising: freezing the storage container filled with the biopharmaceutical composition(Paragraphs 18, 19, 21)
In an exemplary embodiment depicted in FIGS. 1-4, a system 5 for cooling, freezing, preserving, processing and thawing biopharmaceutical materials is shown. The system may include a sterile container, such as a flexible container 10, configured to contain the biopharmaceutical materials and configured to be supported by a supporting and/or protective structure, such as a holder 15.[P-18]
Flexible container 10 may be formed of a laminated film which includes a plurality of layers and may have an interior volume ranging from 0.01-100 liters, (e.g., 0.1-20 L) as depicted in FIG. 2 for example. Further, flexible container 10 could be available in a variety of sizes to accommodate different uses, for example, 5-10 liter flexible containers, such as 8-liter containers, may be utilized. Also a biocompatible product-contacting layer of the interior of flexible container 10 may be formed of a low density polyethylene, very low density polyethylene, ethylene vinyl acetate copolymer, polyester, polyamide, polyvinylchloride, polypropylene, polyfluoroethylene, polyvinylidenefluoride, polyurethane or fluoroethylenepropylene, for example. A gas and water vapor barrier layer may also be formed of an ethylene/vinyl alcohol copolymer mixture within a polyamide or an ethylene vinyl acetate copolymer. Further, flexible container 10 may include a layer with high mechanical strength (e.g. a polyamide), and an external layer with insulating effect to heat welding, for example, polyester. The layers may be compatible with warm and cold conditions and may be able to withstand ionizing and gamma irradiation for sterilization purposes. Also, flexible container 10 may have a large surface area to volume ratio, and a relatively thin wall thus promoting heat transfer therethrough when received in a temperature control unit such as an interior 500 of a walk-in or blast freezer (FIG. 1).[P-19]
Container 10 may be configured (e.g., shaped and dimensioned) to be received in, and connected to holder 15, which acts as a protector, supporting structure or frame for supporting flexible container 10, as depicted in FIGS. 1-2. In one example, container 10 may have a pillow-shape. Holder 15 may be configured to protect a container held therein during filling, transport, storage, and/or freezing of biopharmaceutical materials. For example, holder 15 may hold and protect container 10 during freezing of biopharmaceutical materials in interior 500 of a walk-in or blast freezer (FIG. 1). Further, holder 15 may protect container 10 when holder 15 is stacked on or under another holder similar to holder 15.[P-21]
Here, Voute ‘2216 teaches a storage container for storing and freezing a biopharmaceutical composition, the storage container having a frame and an expandable bladder (flexible container) supported within the frame, the flexible container configured to hold the biopharmaceutical composition
Voute ‘2216 teaches measuring and generating a temperature signal indicative of a temperature of the storage container with the external sensor system secured to the storage container during freezing of the storage container(Paragraphs 39, 41)
The outer rims (e.g., outer rim 40 and outer rim 80) and the inner rims (e.g., inner rim 30 and inner rim 70) may include apertures such as a first aperture 420 and a second aperture 410 depicted in FIG. 2. to allow conduits (e.g., a conduit 13) connected to container 10 to pass therethrough. Such conduits may allow filling or draining of biopharmaceutical materials or other solids, liquids, or gases into and/or out of the interior (not shown) of container 10. Conduit 13 may also be used to insert a measurement probe (not shown) inside container 10 (e.g., a pH electrode, a conductivity sensor, temperature probe, an ion selective electrode, a spectrophotometric probe, an ultrasound sensor, an optic fiber.)[P-39]
In another example depicted in FIGS. 3-4, holder 15 receives a second container 910 having a monitoring device 920 (e.g., (e.g., a pH electrode, a conductivity sensor, temperature probe, an ion selective electrode, a spectrophotometric probe, an ultrasound sensor, an optic fiber) extending from an interior of container 910 through connecting portion 750 to sample cavity 740 where said monitoring device 920 may couple to a connecting cable 930 or other means of coupling the monitoring device to a computing unit or controller for processing data received from the monitoring device. The monitoring device may also include data logging and wireless communication (e.g., RFID) capability. For example, an identification signal may be transferred into a RFID tag at a product filling step. Such signal may be utilized to track the product during storage and distribution phases. The monitoring device (e.g., monitoring device 920) may record the physical parameters of the biopharmaceutical materials during the processing thereof and such data may be communicated to a computing unit at the conclusion of the processing via the coupling of the data logging system to a computing logging system or via wireless transmission during the processing thereof.[P-41]
Voute’ 2216 fails to teach the exterior surface of the bladder, being the sensor system configured to transmit a signal indicative of a temperature of the exterior surface of the bladder
Voute ‘7609 on the other hand teaches the exterior surface of the bladder, being the sensor system configured to transmit a signal indicative of a temperature of the exterior surface of the bladder(Paragraphs 57-59)
One or more plates 28 may also include temperature sensor 18 mounted on an interior portion or exterior portion of plates 28 or it may be integral thereto. Temperature sensor 18 may detect a temperature of one or more of plates 28 and one or more locations thereon. Controller portion 21 of temperature control unit 20 may be coupled to temperature sensor 18 and to a heat transfer fluid control portion 22 of temperature control unit 20. Such heat transfer fluids may be circulated through plates 28 by heat transfer fluid control portion 22 controlled by controller portion 21 in response to temperatures detected by temperature sensor 18. [P-57]
In another example, a temperature sensor (not shown) could be located in a heat transfer fluid input (not shown) of a plate and/or a heat transfer output (not shown) of such a plate. A difference between the temperatures determined at such points could be utilized to determine the temperature of the biopharmaceutical materials held in a container (e.g., containers 10 and 410). Thus, controller 21 may regulate a flow of heat transfer fluid to one or more of plates 28 to regulate a temperature of the biopharmaceutical materials held in such a container in slot 25 of cavity 26 of temperature control unit 20. More specifically, controller 21 may cause a heat transfer fluid control portion 22 to circulate heat transfer fluids in plate(s) 28 to raise or lower a temperature of plate(s) 28, thereby lowering or raising the temperature of a container (e.g., containers 10 and 410) which is in contact with plate 28. In this manner, the biopharmaceutical material may have its temperature controlled (i.e., it may be thawed or frozen). Alternatively, such control of heat transfer plates 28 may be performed by controller portion 21 controlling flow of heat transfer fluid to plates 28 in a predetermined manner without feedback from a sensor coupled to plates 28 or the heat transfer fluid. In a further example, a temperature sensor (not shown) could extend through a port or conduit of a container (e.g., container 10) to allow a determination of a temperature of biopharmaceutical materials held therein. A flow of heat transfer fluid or other temperature regulation may be based on such determination.[P-58]
Also, one or more of plates 28 may be moveable to contact container 10, container 410 and/or any other container when the containers are received in holders (e.g., holders 15 and 415) and the holders are connected to plate 500 and received in slot 25 of cavity 26 of temperature control unit 20, as depicted in FIG. 8. Further, plates 28 could be stationary and temperature control unit 20 may include one or more non-temperature controlled moveable plates, surfaces, or walls (not shown) configured to contact the container(s), when the container(s) and holder(s) are received in slot 25. Alternatively, plates 28 may be movable along with such additional movable plates, surfaces, or walls. For example, temperature control units useful with the containers (e.g., containers 10, 410, 610 and 710) and plates (e.g., plates 500 and 800) of the present application.[P-59]
Here, we see Voute ‘7609 illustrate a sensory system that measure and controls the temperature of the exterior surface of the flexible container , as well as capturing the temperature of the interior of the container to account for the temperature of the biopharmaceutical substance, thereby determining a temperature of the biopharmaceutical composition at a desired location within the storage container using the temperature signal and the correlated external temperature data. Thereafter, the temperature may further be measurable and regulated accordingly.
Thereby, it would be obvious to one of ordinary skill in the art to combine Voute ‘7609 with Voute ’2216 teaching in order to enable as capturing the temperature of the interior of the container to account for the temperature of the biopharmaceutical substance, such that the temperature may further be measurable and regulated during storage accordingly.
Voute ‘2216 modified fails to teach determining a temperature of the biopharmaceutical composition at a desired location within the storage container using by correlating the temperature signal and the measured temperature of the exterior surface of the storage container with correlated external temperature data, the desired location being a location spaced apart from an interior surface of the storage container.
Gay on the other hand teaches determining a temperature of the biopharmaceutical composition at a desired location within the storage container using by correlating the temperature signal and the measured temperature of the exterior surface of the storage container with correlated external temperature data, the desired location being a location spaced apart from an interior surface of the storage container. (Paragraph 91; Figure 19)
In another example depicted in FIGS. 18-19, holder 1015 receives a second container 1910 having a monitoring device 1920 (e.g., (e.g., a pH electrode, a conductivity sensor, temperature probe, an ion selective electrode, a spectophotometric probe, an ultrasound sensor, an optic fiber) extending from an interior of container 1910 through connecting portion 1750 to sample cavity 1740 where said monitoring device 1920 may couple to a connecting cable 930 or other means of coupling the monitoring device to a computing unit or controller for processing data received from the monitoring device. The monitoring device may also include data logging and wireless communication (e.g., RFID) capability. For example, an identification signal may be transferred into a RFID tag at a product filling step. Such signal may be utilized to track the product during storage and distribution phases. The monitoring device (e.g., monitoring device 1920) may record the physical parameters of the biopharmaceutical materials during the processing thereof and such data may be communicated to a computing unit at the conclusion of the processing via the coupling of the data logging system to a computing logging system or via wireless transmission during the processing thereof.[P-91]
Here, we see Gay’s positioning of the sensor system placed at the desired location being a location within the bladder spaced apart from an interior surface of the bladder, where the pharmaceutical substance/material is being monitored accordingly.
Thereby, it would be obvious to one of ordinary skill in the art to combine Gay’s teaching with Voute ‘2216 modified’s teaching in order to enable as capturing the temperature at a specific location of the interior of the container to account for the temperature of the biopharmaceutical.
In regards to claim 21, Voute ‘ 2216 modified via Gay teaches the desired location is at or adjacent to a center of the expandable bladder (Paragraph 91; Figure 19)
In another example depicted in FIGS. 18-19, holder 1015 receives a second container 1910 having a monitoring device 1920 (e.g., (e.g., a pH electrode, a conductivity sensor, temperature probe, an ion selective electrode, a spectophotometric probe, an ultrasound sensor, an optic fiber) extending from an interior of container 1910 through connecting portion 1750 to sample cavity 1740 where said monitoring device 1920 may couple to a connecting cable 930 or other means of coupling the monitoring device to a computing unit or controller for processing data received from the monitoring device. The monitoring device may also include data logging and wireless communication (e.g., RFID) capability. For example, an identification signal may be transferred into a RFID tag at a product filling step. Such signal may be utilized to track the product during storage and distribution phases. The monitoring device (e.g., monitoring device 1920) may record the physical parameters of the biopharmaceutical materials during the processing thereof and such data may be communicated to a computing unit at the conclusion of the processing via the coupling of the data logging system to a computing logging system or via wireless transmission during the processing thereof.[P-91]
Figure 19 of Gay effectively illustrate the desired location is at or adjacent to a center of the expandable bladder
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Voute et al. (US 20100072216 A1) in view of Voute et al. (US 20120017609 A1) and Gay et al. (WO 2009086136 A2) as applied to claim 4 above, and further in view of Wisniewski et al. (US 20030066295 A1).
In regards to claim 5, Voute ‘2216 modified fails to teach the specific type of temperature sensor used in the storage container
Wisniewski on the other hand teaches a storage container system that stores biopharmaceutical materials with a temperature sensor is a resistance temperature detector (Paragraph 43).
Biopharmaceutical materials 110 comprise solid mass 124, dendritic freezing front 126 and dendrites 128. Temperature sensor 130 may be located at one or more points on an outer surface of tapered slot 108. Further, sensor 130 could be located on an inner surface of tapered slot 108 or could be integral to tapered slot 108. Sensor 130 may provide an indication to control system 112 or cryorefrigeration system 114 of a temperature at a particular location. Through the use of one or more temperature sensors 130 and the principles of thermodynamics, the temperature of biopharmaceutical material 110 may be determined at a given point in time. Accordingly, control system 112 and cryorefrigeration system 114 may regulate a temperature of biopharmaceutical materials 110 to regulate the freezing or thawing thereof. In another embodiment, temperature sensor 130 may be located within hoses 132 which receive the cryocoolant such that the temperature of biopharmaceutical materials 110 may be regulated based on temperature differences detected in the crycoolant. For example, temperature sensor 130 may be placed in crycoolant output flow 120 and crycoolant input flow 118 such that a difference therebetween may be utilized to determine the temperature of biopharmaceutical materials 110 and therefore desired regulation of the flow and/or temperature of the crycoolant. Temperature sensor 130 may comprise a thermocouple, a thermistor, an RTD, or other conventional temperature sensing devices suitable for use in a cryogenic environment. In an alternative embodiment, temperature sensor 130 may be disposed outside flexible sterile container 104 and may be a temperature remote-sensing device such as, for example, an infrared temperature sensing device.[P-43]
Thereby, it would have been obvious to one of ordinary skill in the art during the filing date of the invention to combine Wisniewski’s teaching with Voute ‘2216 modified ‘s teaching in order to enable a more cost effective way to measure the temperature and more effectively regulate the temperature accordingly.
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Voute et al. (US 20100072216 A1) in view of Voute et al. (US 20120017609 A1) and Gay et al. (WO 2009086136 A2) as applied to claim 14 above, and further in view of Shavit et al. (US 10732083 B2)
In regards to claim 15, Voute ‘2216 modified fails to teach determining the temperature of the biopharmaceutical composition within the other storage container includes looking up the temperature of the biopharmaceutical composition in a look up table of the correlated external temperature data.
Shavit on the other hand teaches determining the temperature of the biopharmaceutical composition within the other storage container includes looking up the temperature of the biopharmaceutical composition in a look up table of the correlated external temperature data (Column 14, lines 21-32; Column 38, lines 42-47)
Alternatively or additionally, the controller can be configured to estimate a volume of the enclosed biological substance 602 based upon the determined weight of the enclosed biological substance 602. In one aspect, the controller can use a density of the enclosed biological substance 602 to determine the volume of the enclosed biological substance 602. In another aspect, the controller can use a lookup table to determine the volume of the enclosed biological substance 602. The density and/or lookup table can be obtained by the controller from a data storage device or input by an operator of the dry thawing system using an user interface device.[Col 14, ln 21-32]
In operation 2202, the controller 104 obtains the ice stage parameters T.sub.ci,I, T.sub.i, and PID.sub.i. As an example, Table 1 can be a lookup table stored in memory and the ice stage parameters can be determined by the controller 104 from this lookup table based upon the weight of the enclosed biological substance 122, 602. [Col 38, ln 42-47]
Thereby, it would be obvious to one of ordinary skill in the art to combine Shavit’s teaching with Voute modified’s teaching in order to enable a threshold reference, such that the appropriate temperature conditions may be regulated and met according to the mode of storage.
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Voute et al. (US 20100072216 A1) in view of Voute et al. (US 20120017609 A1) and Gay et al. (WO 2009086136 A2) as applied to claim 14 above, and further in view of Kriss (US 20170206497 A1)
In regards to claim 16, Voute ‘2166 fails to teach determining the temperature of the biopharmaceutical composition within the other storage container specifically including, calculating the temperature of the biopharmaceutical composition using a correlation algorithm of the correlated external temperature data.
Kriss on the other hand teaches determining the temperature of the biopharmaceutical composition within the other storage container specifically including, calculating the temperature of the biopharmaceutical composition using a correlation algorithm of the correlated external temperature data (Paragraph 27)
A data logger provided in the shipping package 100 to monitor and periodically record temperature in the shipping package 100 during transit. The data logger may record other parameters associated with the shipping package 100. The data logger may be accessed physically and/or wirelessly and a data log copied, removed or transferred during shipment of the shipping container and/or once the shipping container is returned to a reprocessing facility. Such information can prove valuable in dealing with issues relating to liability that might arise if a specimen is damaged during shipment, or in settling questions relating to whether any such damage to the contents did in fact occur during shipment and the circumstances of the damage (e.g., location and time damage occurred). A data logger can be included in a smart module. In order to monitor the temperature or any other parameter of the sample chamber of the shipping container the sample chamber itself can be monitored with sensors to measure the status or condition of the chamber contents, for example, the temperature in the sample chamber can be monitored by use of a proxy calculation based upon a temperature reading taken outside of the sample chamber. For example, if the temperature reading is taken in the neck tube, a simple calculation can be used to calculate what the actual temperature in the sample chamber will be based upon the distance between the sample chamber and the location of the temperature sensor in the neck tube.[P-27]
Thereby, it would be obvious to one of ordinary skill in the art to combine Kriss’ teaching with Voute ‘2216 modified’s teaching in order to enable a more precise method of calculation, such that the appropriate temperature conditions may be regulated and met according to the mode of storage.
Response to Arguments
The examiner has acknowledged the applicants amendments, and has addressed them above under new grounds of rejection.
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 ANTHONY D AFRIFA-KYEI whose telephone number is (571)270-7826. The examiner can normally be reached Monday-Friday 10am-7pm.
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/ANTHONY D AFRIFA-KYEI/Examiner, Art Unit 2686
/BRIAN A ZIMMERMAN/Supervisory Patent Examiner, Art Unit 2686
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