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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/18/2025 has been entered.
Response to Amendment
The Amendment filed 12/18/2025 has been entered. Claims 1-6, 10-16 and 18-23 remain pending in the application. Applicant’s amendments to the claims have overcome each and every objection and 112(a) and 112(b) rejections previously set forth in the Final Office Action mailed 10/20/2025. New grounds of rejections necessitated by amendments are discussed below.
Claim Objections
Claims 1, 4 and 20 are objected to because of the following informalities: It is suggested to recite instances of “headplate” as “head-plate” for improved consistency of terminology. Appropriate correction is required.
Claim 10 is objected to because of the following informalities: It is suggested to recite “the condenser mating features” in lines 2-3 as “the mating features” for improved consistency of terminology. Appropriate correction is required.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-6, 10-16, 18-19, and 22-23 are rejected under 35 U.S.C. 103 as being unpatentable over Arnold et al. (US 20150132840 A1; cited in the IDS filed 11/28/2022) in view of Khan (US 20160040110 A1; cited in the IDS filed 08/31/2021).
Regarding claim 1, Arnold teaches a bioreactor (abstract; Figs. 1-2) comprising:
a vessel (Fig. 1C, container 200) defining a hollow enclosure (reaction chamber 400) for receiving a culture medium (interpreted as an intended use of the hollow enclosure, see MPEP 2114; abstract and paragraph [0041] teaches the container is for use in cell culture; paragraph [0060] teaches culture broth in the bioreactor; Fig. 1C, reaction chamber 400 is structurally capable of receiving a culture medium at a later time); and
a head-plate (Fig. 1C, head plate 100) configured to couple a plurality of components to the bioreactor (Fig. 1C shows head plate 100 is configured to couple components to the bioreactor, such as elements 110, 120, 320, 310, 311, 530, 121; note that “plurality of components” is not positively recited structurally and is interpreted as a functional limitation of the head-plate due to the “configured to” limitation; paragraph [0106]), the headplate including
a condenser (Figs. 1A-1B, 1E, 2A-2D and paragraph [0104], exhaust gas cooling element 700 and exhaust gas tube 701 that condenses fluid) fitted into the headplate via mating features that match a shape and geometrics of the condenser (Figs. 1A-1B, 1E, 2A-2D and paragraph [0104] teach connector 123 and connection slot 124 have a shape/geometrics that match with exhaust gas cooling element 700 and exhaust gas tube 701 and connect/fit the exhaust gas tube 701 and exhaust gas cooling element 700 into the head plate 100), the condenser providing cooling of headspace gas within the vessel (interpreted as an intended use, see MPEP 2114; Figs. 1A-1B, 1E, 2A-2D and paragraph [0104] teach the exhaust gas tube 701 and exhaust gas cooling element 700 condenses exhaust gas to be returned to the chamber, therefore the exhaust gas tube 701 and exhaust gas cooling element 700 are capable of cooling the headspace gas within the container 200 since headspace gas within the container includes the exhaust gas in the tube 701; i.e. headspace gas within container 200 is capable of being cooled as it enters the exhaust gas tube 701).
Arnold fails to teach: the vessel having multiple baffles integrally formed with the vessel.
Khan teaches bioreactors having impellers for cultivation of cells (abstract; Fig. 1). Khan teaches the bioreactor comprises multiple baffles (paragraphs [0052]-[0053]) to prevent the formation of a funnel formation (paragraph [0053]). Khan teaches the baffle (Fig. 1, baffle 128) is integrally formed with a vessel of the bioreactor (Fig. 1). Khan teaches providing a homogenous environment to maintain a well mixed cell suspension and blending nutrient feeds within the bioreactor (paragraphs [0004],[0017]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the vessel of Arnold to incorporate the teachings of baffles for bioreactors of Khan (Fig. 1; paragraphs [0052]-[0053]) to provide the vessel having multiple baffles integrally formed with the vessel. Doing so would have a reasonable expectation of successfully improving maintenance of a homogenous environment for cultivation and prevent the formation of a vortex within the bioreactor as taught by Khan (paragraphs [0004],[0017],[0053]).
Note that the “culture medium” and “plurality of components” are not positively recited structurally and are interpreted as an intended use and functional limitation of the claimed bioreactor due to the language of “for receiving…” and “configured to couple…”. A claim is only limited by positively recited elements; thus, inclusion of the material or article (“culture medium”, “plurality of components”) worked upon by a structure (the vessel; the head-plate) being claimed does not impart patentability to the claims (see MPEP 2115). As discussed above, the bioreactor of Arnold is capable of performing the claimed intended use and functional limitation regarding the “culture medium”, and “plurality of components”. It is suggested for the applicant to positively recite the bioreactor comprising the structures of the plurality of components. Note that claims dependent on claim 1 that refer to “plurality of components” is further interpreted as not positively recited structurally, however for compact prosecution purposes, the plurality of components are interpreted as positively recited.
Note that a functional recitation of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the functional limitations, then it meets the claim. MPEP 2114. The apparatus of modified Arnold is identical to the presently claimed structure. Arnold discloses the vessel (Fig. 1C, container 200), head-plate (Fig. 1C shows head plate 100), and condenser (Figs. 1A-1B, 1E, 2A-2B and paragraph [0104], exhaust gas cooling element 700 and exhaust gas tube 701 that condenses fluid) as claimed and therefore, would have the ability to perform the intended use and functional limitation recited in the claim as discussed above in the claim rejection. See MPEP 2112.01.
Regarding claim 2, note that the limitation of “wherein the head-plate is formed using three-dimensional (3D) printing or injection molding” is interpreted as a product-by-process limitation (see MPEP 2113). Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process. As discussed in claim 1, Arnold teaches a head-plate (Fig. 1C, head plate 100), which is the same as the claimed product. Thus, Arnold teaches all of the limitations of claim 2.
However, for compact prosecution purposes, Arnold further teaches wherein the head-plate is formed using three-dimensional (3D) printing or injection molding (paragraphs [0044],[0103]).
Regarding claim 3, Arnold further teaches the bioreactor of claim 1, further comprising an impeller (Fig. 1C, stirring member 320) and sparger (Fig. 1C, dip tube 110; paragraph [0106] teaches dip tubes for submerged gassing to water or media, i.e. a sparger) disposed within the hollow enclosure of the vessel (Fig. 1C).
Regarding claim 4, Arnold further teaches wherein the headplate comprises a sterile interface to the plurality of components (interpreted as an intended use of the coupling features, see MPEP 2114; paragraph [0033] teaches the head plate can be decontaminated by steam sterilization, thus the head plate 100 comprises a sterile interface to the components).
Regarding claim 5, Arnold further teaches wherein the plurality of components further comprise one or more sensor probes selected from the group consisting of: temperature sensor, dissolved oxygen (DO) sensor, pH sensor, carbon dioxide (COs) sensor, biomass concentration sensor, UV Vis/Raman sensor, visible light camera, infrared spectrum camera, reference light emitters and humidity sensor (paragraph [0105], “Sensors for detecting pH, dissolved oxygen (DO) or temperature, for example, or other kinds of sensors”).
Regarding claim 6, Arnold further teaches wherein the plurality of components further comprise one or more gas or fluid channels (Fig. 1C teaches dip tubes 110, i.e. a gas or fluid channel; Fig. 1E teaches a connector 123 and an exhaust gas tube 701, i.e. a gas or fluid channel) providing fluidic communication with the culture medium contained in the vessel (interpreted as a functional limitation, see MPEP 2114; Fig. 1C teaches dip tubes 110 is capable of being in fluidic communication with medium in reaction container 200 at a later time; Fig. 1E teaches a connector 123 and an exhaust gas tube 701, i.e. a gas or fluid channel, which is capable of providing fluidic communication with medium in reaction container 200; paragraph [0046] teaches dip tubes dip into contents within the reaction chamber; paragraph [0091] teaches supplying or removing fluid from the bioreactors; paragraph [0106] teaches gas connectors for submerged gassing via dip tubes).
Regarding claim 10, Arnold further teaches wherein a dimension of the condenser matches the condenser mating features of the head plate (Figs. 1E, 2A-2E and paragraph [0104] teach a dimension of the exhaust gas cooling element 700 and exhaust gas tube 701 matches the connection slot 124 and connector 123 of the head plate 100).
Note that the limitation of “the condenser is formed using 3D printing” is interpreted as a product-by-process limitation (see MPEP 2113). Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production (e.g. 3D printing). If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process. Arnold teaches a condenser (Figs. 1E,2A-2E and paragraph [0104], exhaust gas cooling element 700 and exhaust gas tube 701), which is the same as the claimed product. Thus, Arnold teaches all of the limitations of claim 10.
Regarding claim 11, Arnold further teaches the bioreactor of claim 1, further comprising a sparger (Fig. 1C, dip tube 110; paragraph [0106] teaches dip tubes for submerged gassing to water or media, i.e. a sparger) and an impeller (Fig. 1C, stirring member 320), a distal end of the sparger (Fig. 1C, interpreted as the end towards element 120) being positioned at a pre-determined distance from the impeller via a fixation feature (Fig. 1C and paragraph [0103] teaches the top end of dip tube 110 towards element 120 is positioned at a pre-determined distance from stirring member 320, i.e. coupled impeller, via connector 120, wherein the structure of the connector 120 is interpreted as a fixation feature), and wherein the impeller and the sparger collectively achieve a mixing effect of the culture medium within the vessel (interpreted as a functional limitation, see MPEP 2114; paragraph [0004] teaches stirring members to mix substances in a reaction chamber, wherein Fig. 1C shows a stirring member 320, thus, the impeller and sparger couplings of Fig. 1C are capable of achieving a mixing effect of culture medium as claimed; paragraph [0106] teaches dip tubes for submerged gassing to water or media and paragraph [0014] teaches a rotary drive drives a mixer with a mixer shaft and a stirring member, thus, is capable of performing the claimed functional limitation).
Regarding claim 12, Arnold further teaches the impeller (Fig. 1C, impeller 320) with customized geometrics (Fig. 1C shows impeller 320 with geometrics or shapes, which is interpreted as customized; paragraph [0093] teaches the stirring member has specific vanes that are pitched at 45 degrees, thus the stirring member is interpreted as having customized geometrics).
Note that the limitation of “is 3D printed with customized geometrics” (emphasis added) is interpreted as a product-by-process limitation (see MPEP 2113). Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production (e.g. 3D printed). If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process. Arnold teaches wherein the impeller has customized geometrics (Fig. 1C shows impeller 320 with a shape and structure, i.e. geometrics, which is interpreted as customized; paragraph [0093] teaches the stirring member has specific vanes that are pitched at 45 degrees, thus the stirring member is interpreted as having customized geometrics), which is the same as the claimed product. Thus, Arnold teaches all of the limitations of claim 12.
Regarding claim 13, Arnold further teaches wherein the mixing effect comprises a flow pattern determined based at least in part on the customized geometrics of the impeller (interpreted as a functional limitation, see MPEP 2114; paragraph [0004] teaches stirring members to mix substances in a reaction chamber, wherein Fig. 1C shows a stirring member 320 with a shape, thus, the flow pattern is determined by the customized geometrics or shape of the stirring member since the stirring member is capable of achieving a mixing effect of culture medium in the vessel; paragraph [0093] teaches the stirring member has specific vanes that are pitched at 45 degrees, thus the stirring member is interpreted as having customized geometrics which is capable of producing a flow pattern at a later time; paragraph [0014] teaches a rotary drive drives a mixer with a mixer shaft and a stirring member, thus, the flow pattern is capable of being determined by the shape of the stirring member).
Regarding claim 14, Arnold further teaches wherein the flow pattern is determined based on a location of the impeller coupled to the head-plate relative to the center of the head-plate (interpreted as a functional limitation, see MPEP 2114; paragraph [0004] teaches stirring members to mix substances in a reaction chamber, wherein Fig. 1C shows a stirring member 320, i.e. impeller, at a location relative to a center of head plate 100, thus, the flow pattern is capable of being determined based on the location of the stirring member as claimed; paragraph [0093] teaches the stirring member has specific vanes that are pitched at 45 degrees, thus the stirring member is interpreted as being capable of producing a flow pattern determined by the location of the stirring member as claimed at a later time; paragraph [0014] teaches a rotary drive drives a mixer with a mixer shaft and a stirring member, thus, is capable of producing a flow pattern determined by the location of the stirring member, i.e. impeller, as claimed at a later time).
Regarding claim 15, Arnold further teaches the sparger (Fig. 1C, dip tube 110; paragraph [0106] teaches dip tubes for submerged gassing to water or media, i.e. a sparger) with customized geometrics of an orifice of the sparger (Fig. 1C, dip tube 110; paragraph [0046] teaches dip tubes can allow media or other items to be introduced into or removed from the reaction chamber; paragraph [0106] teaches dip tubes for submerged gassing to water or media, i.e. a sparger; thus, the dip tube that performs submerged gassing to the water or media inherently comprise customized geometrics of an orifice in order for gas to be introduced into the reaction chamber from the dip tube).
Note that the limitation of “is 3D printed…” (emphasis added) is interpreted as a product-by-process limitation (see MPEP 2113). Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production (e.g. 3D printed). If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process. Arnold teaches wherein the sparger with customized geometrics of an orifice of the sparger (Fig. 1C, dip tube 110; paragraph [0046] teaches dip tubes can allow media or other items to be introduced into or removed from the reaction chamber; paragraph [0106] teaches dip tubes for submerged gassing to water or media, i.e. a sparger; thus, the dip tube that performs submerged gassing to the water or media inherently comprise customized geometrics of an orifice in order for gas to be introduced into the reaction chamber from the dip tube), which is the same as the claimed product. Thus, Arnold teaches all of the limitations of claim 15.
Regarding claim 16, Arnold further teaches wherein the mixing effect is achieved by controlling a location of the orifice of the sparger relative to the impeller (interpreted as a functional limitation, see MPEP 2114; Fig. 1C shows dip tube 110, i.e. sparger, and stirring member 320, i.e. impeller, within the reaction chamber 400, wherein the dip tube has a location relative to the stirring member; thus, the structures are capable of achieving the mixing affect due to controlling the locations of the dip tube 110, which inherently comprise the orifice as discussed in claim 15 above, and the stirring member 320).
Regarding claim 18, modified Arnold teaches an arrangement of the multiple baffles, number of the multiple baffles and geometrics of the multiple baffles (see above claim 1 regarding the modification of Arnold with Khan to provide multiple baffles, wherein multiple baffles integrally formed with the vessel is interpreted as comprising an arrangement of the multiple baffles, number of the multiple baffles and geometrics of the multiple baffles).
Note that the limitation of “wherein an arrangement of the multiple baffles, number of the multiple baffles and geometrics of the multiple baffles are selected based on a user determined mixing requirement” (emphasis added) is interpreted as a product-by-process limitation (see MPEP 2113). Even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production (e.g. selected based on a user determined mixing requirement). If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process. As discussed above, Arnold teaches an arrangement of the multiple baffles, number of the multiple baffles and geometrics of the multiple baffles (see above claim 1 regarding the modification of Arnold with Khan to provide multiple baffles, wherein multiple baffles integrally formed with the vessel is interpreted as comprising an arrangement of the multiple baffles, number of the multiple baffles and geometrics of the multiple baffles), which is the same as the claimed product. Thus, Arnold teaches all of the limitations of claim 18.
Regarding claim 19, Arnold further teaches wherein the bioreactor is single-use or disposable (interpreted as a functional limitation of the bioreactor, see MPEP 2114; paragraph [0014], “single-use”).
Regarding claim 22, Arnold further teaches wherein the bioreactor is handled by a robot of an automated fermentation system (interpreted as an intended use of the bioreactor and are not accorded any patentable weight, see MPEP 2114; the structure of the bioreactor 1 in Fig. 1C of Arnold is structurally capable of being handled by a robot of an automated fermentation system at a later time).
Note that the “robot of an automated fermentation system” is not positively recited structurally.
Regarding claim 23, note that the “automated fermentation system” is interpreted as an intended use of the claimed bioreactor as discussed above in claim 22, thus the limitation of “wherein the automated fermentation system comprises a camera configured to capture image data of the culture medium contained in the vessel” is interpreted as an intended use of the bioreactors and are not accorded any patentable weight, see MPEP 2114.
Furthermore, note that the “automated fermentation system” and the limitations regarding the automated fermentation system (e.g. “camera”) are not positively recited structurally.
Claims 20-21 are rejected under 35 U.S.C. 103 as being unpatentable over Arnold et al. (US 20150132840 A1; cited in the IDS filed 11/28/2022) in view of Khan (US 20160040110 A1; cited in the IDS filed 08/31/2021), and Johnson et al. (US 20120256756 A1).
Regarding claim 20, Arnold teaches a bioreactor (abstract; Figs. 1-2) comprising:
a vessel (Fig. 1C, container 200) defining a hollow enclosure (reaction chamber 400) for receiving a culture medium (interpreted as an intended use of the hollow enclosure, see MPEP 2114; abstract and paragraph [0041] teaches the container is for use in cell culture; paragraph [0060] teaches culture broth in the bioreactor; Fig. 1C, reaction chamber 400 is structurally capable of receiving a culture medium at a later time); and
a head-plate (Fig. 1C, head plate 100) configured to couple a plurality of components including at least an impeller and a sparger to the bioreactor (Fig. 1C shows head plate 100 is configured to couple components to the bioreactor, such as elements 110, 120, 320, 310, 311, 530, 121; note that “plurality of components” and “an impeller and a sparger” are not positively recited structurally and is interpreted as a functional limitation of the head-plate due to the “configured to” limitation; paragraph [0106]; Fig. 1C shows head plate 100 coupling stirring member 320 and dip tube 110), the headplate including
a condenser (Figs. 1A-1B, 1E, 2A-2D and paragraph [0104], exhaust gas cooling element 700 and exhaust gas tube 701 that condenses fluid) fitted into the headplate via mating features that match a shape and geometrics of the condenser (Figs. 1A-1B, 1E, 2A-2D and paragraph [0104] teach connector 123 and connection slot 124 have a shape/geometrics that match with exhaust gas cooling element 700 and exhaust gas tube 701 and connect/fit the exhaust gas tube 701 and exhaust gas cooling element 700 into the head plate 100), the condenser providing cooling of headspace gas within the vessel (interpreted as an intended use, see MPEP 2114; Figs. 1A-1B, 1E, 2A-2D and paragraph [0104] teach the exhaust gas tube 701 and exhaust gas cooling element 700 condenses exhaust gas to be returned to the chamber, therefore the exhaust gas tube 701 and exhaust gas cooling element 700 are capable of cooling the headspace gas within the container 200 since headspace gas within the container includes the exhaust gas in the tube 701; i.e. headspace gas within container 200 is capable of being cooled as it enters the exhaust gas tube 701).
While Arnold teaches the headplate has space for arranging instruments and sensors (paragraph [0016]) and the headplate has connectors for instruments and sensors (paragraph [0103]), Arnold fails to teach: the vessel having multiple baffles integrally formed with the vessel; and wherein the head-plate is configured to automatically identify at least one of the impeller or sparger.
Khan teaches bioreactors having impellers for cultivation of cells (abstract; Fig. 1). Khan teaches the bioreactor comprises multiple baffles (paragraphs [0052]-[0053]) to prevent the formation of a funnel formation (paragraph [0053]). Khan teaches the baffle (Fig. 1, baffle 128) is integrally formed with a vessel of the bioreactor (Fig. 1). Khan teaches providing a homogenous environment to maintain a well mixed cell suspension and blending nutrient feeds within the bioreactor (paragraphs [0004],[0017]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the vessel of Arnold to incorporate the teachings of baffles for bioreactors of Khan (Fig. 1; paragraphs [0052]-[0053]) to provide the vessel having multiple baffles integrally formed with the vessel. Doing so would have a reasonable expectation of successfully improving maintenance of a homogenous environment for cultivation and prevent the formation of a vortex within the bioreactor as taught by Khan (paragraphs [0004],[0017],[0053]).
Modified Arnold fails to teach: wherein the head-plate is configured to automatically identify at least one of the impeller or sparger.
Johnson teaches a system for using multiplexed RFID transceivers and RFID tags to verify connections and communicate the connection status to a host system, wherein RFID tags that are programmed with connection specific indicia are attached at or in proximity to various connections in a pharmaceutical or biotech processing system and interrogated by remote antennas driven by a multiplexed RFID transceiver, thus enabling a user to verify the status of each connection and communicate the connection status to a host system (abstract). Johnson teaches a bioreactor/fermentation system (Fig. 1; paragraph [0015]) comprising a multiplexed RFID transceiver and RFID tags to verify connections and communicate the connection status to a host system (paragraph [0015]). Johnson teaches a container with a plurality of sensors (paragraph [0025]; Fig. 4), wherein RFID tags used for sensors can identify the type of sensor, such as oxygen or pH sensors, being sensed (paragraph [0025]). Johnson teaches verification of connection in processing equipment using RFID and an RFID reader is known (paragraph [0005]). Johnson teaches the current invention provides a connectable reader driving low cost and potentially disposable antennas on one side of each connection half, which read the RFID associated with the other side of each connection half, thus, the invention can be used in many areas of a biotech and pharma manufacturing, wherein RFID enabled connections allow for real-time connection status information, thereby providing the current status of the overall system; and additionally, process verification data can be automatically generated and stored by single batch or process run using the invention (paragraph [0013]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the head-plate that has connectors for instruments and sensors of modified Arnold (paragraph [0103]) to incorporate the teachings of RFID tags and readers for identifying the type of sensor attached to a system of Johnson (paragraph [0025]; abstract) to provide wherein the head-plate is configured to automatically identify at least one of the impeller or sparger. Doing so would utilize known structures for verifying and identifying connections of the components to a bioreactor, as taught by Johnson, to improve automation of verifying proper connection of desired components to the overall bioreactor as taught by Johnson (paragraph [0013]) with a reasonable expectation of success.
Regarding claim 21, modified Arnold fails to teach wherein the head-plate comprises a sensor configured to read a serial number of the at least one of the plurality of components.
Johnson teaches a system for using multiplexed RFID transceivers and RFID tags, to verify connections and communicate the connection status to a host system, wherein RFID tags that are programmed with connection specific indicia are attached at or in proximity to various connections in a pharmaceutical or biotech processing system and interrogated by remote antennas driven by a multiplexed RFID transceiver, thus enabling a user to verify the status of each connection and communicate the connection status to a host system (abstract). Johnson teaches a bioreactor/fermentation system (Fig. 1; paragraph [0015]) comprising a multiplexed RFID transceiver and RFID tags to verify connections and communicate the connection status to a host system (paragraph [0015]). Johnson teaches a container with a plurality of sensors (paragraph [0025]; Fig. 4), wherein RFID tags used for sensors can identify the type of sensor, such as oxygen or pH sensors, being sensed (paragraph [0025]). Johnson teaches verification of connection in processing equipment using RFID and an RFID reader is known (paragraph [0005]). Johnson teaches the current invention provides a connectable reader driving low cost and potentially disposable antennas on one side of each connection half, which read the RFID associated with the other side of each connection half, thus, the invention can be used in many areas of a biotech and pharma manufacturing, wherein RFID enabled connections allow for real-time connection status information, thereby providing the current status of the overall system; and additionally, process verification data can be automatically generated and stored by single batch or process run using the invention (paragraph [0013]). Johnson teaches RFID identifier can include lot number, part number, and additional information (paragraph [0012]). Johnson teaches the reader is part of the fixed system and reused, which is an economical and reliable solution for connection verification (paragraph [0042]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the head-plate that has connectors for instruments and sensors of Arnold (paragraph [0103]) to incorporate the teachings of RFID tags and readers for identifying the type of sensor attached to a system of Johnson (paragraph [0025]; abstract) to provide wherein the head-plate comprises a sensor configured to read a serial number of the at least one of the plurality of components. Doing so would utilize known structures for verifying and identifying connections of sensors to bioreactors, as taught by Johnson, to improve automation of verifying proper connection of desired components to the overall bioreactor as taught by Johnson (paragraphs [0013],[0042]) with a reasonable expectation of success.
Response to Arguments
Applicant’s arguments, see pages 6-8, filed 12/18/2025, with respect to the drawing objections, claim objections, and rejections under 35 U.S.C. 112(a) and 112(b) have been fully considered and are persuasive. The drawing objections, claim objections, and rejections under 35 U.S.C. 112(a) and 112(b) of 10/20/2025 have been withdrawn.
Applicant's arguments, see pages 9-18, filed 12/18/2025, with respect to the rejections under 35 U.S.C. 103, specifically regarding claim 1, have been fully considered but they are not persuasive. Note a new grounds of rejection necessitated by amendments is made in view of Arnold et al. (US 20150132840 A1; cited in the IDS filed 11/28/2022) in view of Khan (US 20160040110 A1; cited in the IDS filed 08/31/2021) and Arnold et al. (US 20150132840 A1; cited in the IDS filed 11/28/2022) in view of Khan (US 20160040110 A1; cited in the IDS filed 08/31/2021), and Johnson et al. (US 20120256756 A1).
In response to applicant’s argument that Arnold and Khan fails to teach all of the elements of claim 1, specifically Arnold does not teach or suggest “the headplate including a condenser fitted into the headplate via mating features that match a shape and geometrics of the condenser, such that the condenser provides cooling of headspace gas within the vessel” (Remarks, pages 13-16), the examiner disagrees.
Arnold teaches: a head-plate (Fig. 1C, head plate 100) including a condenser (Figs. 1A-1B, 1E, 2A-2D and paragraph [0104], exhaust gas cooling element 700 and exhaust gas tube 701 that condenses fluid) fitted into the headplate via mating features that match a shape and geometrics of the condenser (Figs. 1A-1B, 1E, 2A-2D and paragraph [0104] teach connector 123 and connection slot 124 have a shape/geometrics that match with exhaust gas cooling element 700 and exhaust gas tube 701 and connect/fit the exhaust gas tube 701 and exhaust gas cooling element 700 into the head plate 100), the condenser providing cooling of headspace gas within the vessel (interpreted as an intended use, see MPEP 2114; Figs. 1A-1B, 1E, 2A-2D and paragraph [0104] teach the exhaust gas tube 701 and exhaust gas cooling element 700 condenses exhaust gas to be returned to the chamber, therefore the exhaust gas tube 701 and exhaust gas cooling element 700 are capable of cooling the headspace gas within the container 200 since headspace gas within the container includes the exhaust gas in the tube 701; i.e. headspace gas within container 200 is capable of being cooled as it enters the exhaust gas tube 701).
In response to applicant’s argument that Arnold does not indicate that head plate 100 includes the exhaust gas cooling element 700 (Remarks, pages 14-15, [0033]-[0034]), the examiner disagrees. Figs. 1E, 2A-2E shows exhaust gas cooling element 700 and exhaust gas tube 701 are attached and therefore included with the head plate 100 via connector 123 and connection slot 124. Applicant discusses exhaust gas cooling element 700 is disposed over the headplate 100 (Remarks, page 15, [0034]). The examiner agrees. However, the BRI of “the headplate including a condenser fitted into the headplate…” includes the interpretation of Arnold’s exhaust gas cooling element 700 and exhaust gas tube 701 are attached into headplate 100 via connector 123 and connection slot 124. The claimed limitations do not exclude portions of the condenser from being disposed over the headplate.
In response to applicant’s argument that Arnold makes no indication that its exhaust gas cooling element provides cooling of headspace gas within the vessel (Remarks, page 15, [0034]) the examiner disagrees. Arnold teaches: the condenser providing cooling of headspace gas within the vessel (interpreted as an intended use, see MPEP 2114; Figs. 1A-1B, 1E, 2A-2D and paragraph [0104] teach the exhaust gas tube 701 and exhaust gas cooling element 700 condenses exhaust gas to be returned to the chamber, therefore the exhaust gas tube 701 and exhaust gas cooling element 700 are capable of cooling the headspace gas within the container 200 since headspace gas within the container includes the exhaust gas in the tube 701; i.e. headspace gas within container 200 is capable of being cooled as it enters the exhaust gas tube 701).
In response to applicant’s arguments regarding claims 2, 5-6, 10-16, 18-19, and 22-23 (Remarks, page 16, [0037]), the examiner notes that the arguments are tantamount to the claims being dependent upon claim 1. The arguments are not persuasive for the same reasons as discussed above regarding claim 1.
In response to applicant’s arguments regarding claims 3-4 (Remarks, pages 16-17), claim 11 (Remarks, page 17), and claims 20-21, (Remarks, pages 17-18) the examiner disagrees. The arguments are not persuasive for the same reasons as discussed above regarding claim 1.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Rudolph et al. (US 20220161220 A1; effectively filed 02/01/2019) teaches a reaction container system providing headspace-based condensation (abstract). Rudolph teaches a condenser directly associated with/in contact with the film forming the headspace (paragraph [0015]).
Arsovic (US 4369194 A) teaches a bioreactor (abstract). Arsovic teaches water vapor produced by the drier is condensed in a coil mounted within the bioreactor; and this water vapor will thus yield the heat necessary for bringing the reactor's content to an optimum temperature for its proper operation (column 3, lines 16-20).
Tipler (US 20170038347 A1; cited in the OA filed 10/20/2025) teaches a gas chromatography system (abstract), where water can be recaptured by condensation and returned to the gas generator for use in generating more hydrogen and oxygen via a condenser (paragraph [0060]). Tipler teaches water vapor can be condensed from the air and used to generate the hydrogen and oxygen; for example, air can be drawn into a condenser (positioned inside the system or positioned external to the system) (paragraph [0068]).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HENRY H NGUYEN whose telephone number is (571)272-2338. The examiner can normally be reached M-F 7:30A-5:00P.
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/HENRY H NGUYEN/Primary Examiner, Art Unit 1758