Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
The Amendment filed 09/01/2026 has been entered. Claims 1-6, 10-16 and 18-23 remain pending in the application. New grounds of rejections necessitated by amendments are discussed below.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “a mating feature that penetrates into the head-plate to mate with a condenser, wherein the condenser is configured to be disposed into the head-plate and at least partially within the vessel” (claims 1 and 20) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered. Note that Figs. 1-4 shows a head plate 101 and condenser 213, but does not show “a mating feature that penetrates into the head-plate to mate with a condenser, wherein the condenser is configured to be disposed into the head-plate and at least partially within the vessel”.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities: In the specification, paragraph [0044] recites “an opening or penetrating feature 213 to mate with a condenser 213”. Both the penetrating feature and condenser uses the same reference number 213. It is suggested to remove “213” from “an opening or penetrating feature”.
Appropriate correction is required.
Claim Objections
Claim 1 is objected to because of the following informalities: It is suggested to recite “headplate” in line 5 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 mating features” in line 3 as “the mating feature” for improved consistency of terminology. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-6, 10-16 and 18-23 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claims 1 and 20, claims 1 and 20 recite the headplate including “a mating feature that penetrates into the head-plate to mate with a condenser, wherein the condenser is configured to be disposed into the head-plate and at least partially within the vessel”. The specification discloses: a “condenser may be built into the head-plate itself and may act upon the headspace gas in the bioreactor or in close proximity to the gas outlet line” and “the head-plate 101 may have an opening or penetrating feature 213 to mate with a condenser 213” (paragraph [0044]); “condenser may be located on the gas exit line (e.g., close to exhaust 211)” (paragraph [0045]); and the “condenser may be pressed into the head-plate via mating features that match the shape and geometrics of the condenser” (paragraph [0046]). Figs. 1-2 show head plate 101 and condenser 213. However, the disclosure fails to clearly describe “a mating feature that penetrates into the head-plate to mate with a condenser, wherein the condenser is configured to be disposed into the head-plate and at least partially within the vessel”. Additionally, applicant has not pointed out where the new claim limitation is supported (Remarks filed 09/01/2026). See MPEP 2163.04 (I). Therefore, the claims contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claims 2-6, 10-16, 18-19, and 21-23 are rejected by virtue of their dependency on claims 1 and 20.
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) and Martens et al. (Martens et al., “Configuration of Bioreactors”, (2014). Configuration of Bioreactors. In: Pörtner, R. (eds) Animal Cell Biotechnology. Methods in Molecular Biology, vol 1104. Humana Press, Totowa, NJ).
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 mating feature (Fig. 1E, connector 123 that includes a through-hole) that penetrates into the head-plate (Fig. 1E teaches the through-hole of connector 123 penetrates into head plate 100 to form a fluid connection between the reaction chamber 400 and exhaust gas tube 701) to mate with a condenser (interpreted as an intended use of the mating feature, see MPEP 2114; Figs. 1E and 2A-2D and paragraph [0104] teaches connector 123 is used for connecting to exhaust gas tube 701 which is used with exhaust gas cooling element 700 to condense fluid transported in the gas tube; the exhaust gas cooling element 700 and exhaust gas tube 701 are interpreted as “a condenser”; note that “condenser” is not positively recited structurally), wherein the condenser (note that “condenser” is not positively recited structurally; Figs. 1A-1B, 1E, 2A-2D and paragraph [0104], exhaust gas cooling element 700 and exhaust gas tube 701 that condenses fluid) is configured to be disposed into the head-plate (Figs. 2A-2D and paragraph [0104] teaches exhaust gas cooling element 700 is configured to be disposed into connection slot 124 of the head plate 100, i.e. disposed into the head-plate), 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; and wherein the mating feature that penetrates into the head-plate to mate with the condenser, wherein the condenser disposed at least partially within 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]).
Arnold fails to teach: wherein the mating feature that penetrates into the head-plate to mate with the condenser, wherein the condenser disposed at least partially within the vessel.
Martens teaches a bioreactor (page 287, Fig. 1a teaches a bioreactor setup) comprising: a vessel defining a hollow enclosure (page 287, Fig. 1a teaches a bioreactor vessel that defines a hollow enclosure that includes at least impeller I) for receiving a culture medium (interpreted as an intended use, MPEP 2114; page 287, Fig. 1a teaches a bioreactor vessel that is structurally capable of receiving a culture medium; page 287, Fig. 1a teaches the bioreactor is coupled to a medium bottle A), and a head-plate configured to couple a plurality of components to the bioreactor (page 287, Fig. 1a teaches the bioreactor including a headplate to couple a plurality of components, such as tubes and probes), the headplate including a mating feature that penetrates into the head-plate to mate with a condenser (page 287, Fig. 1a teaches H, a gas outlet with condenser, i.e. condenser, that has a portion that penetrates into the head plate; therefore, the head plate is implied to include at least an opening or port, i.e. mating feature, that penetrates into the head plate in order to allow for mating with the gas outlet with condenser), wherein the condenser is configured to be disposed into the head-plate and at least partially within the vessel (page 287, Fig. 1a teaches H, a gas outlet with condenser, i.e. condenser, is disposed into the head plate and at least partially in the bioreactor vessel). Martens teaches the outlet gas should first be transported through a condenser to prevent excessive evaporation of the liquid medium (page 293, step 9).
Since Martens teaches a headplate including a mating feature that penetrates into the head-plate to mate with a condenser (page 287, Fig. 1a) is known in the art, 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 mating feature of modified Arnold to provide: wherein the mating feature that penetrates into the head-plate to mate with the condenser, wherein the condenser disposed at least partially within the vessel. I.e., it would have been obvious to have substituted one known element (Arnold’s mating feature) for another (Martens’ mating feature that penetrates into the head-plate to mate with a condenser, the condenser disposed into the head plate and at least partially in the bioreactor), and the results of the substitution would have been predictable (allowing for proper attachment of a condenser to the bioreactor vessel). See MPEP 2143(I)(B).
Furthermore, the claimed limitations are obvious because all of the claimed elements were known in the prior art and one skilled in the art could have combined the elements (i.e. the mating feature that penetrates into the head-plate to mate with the condenser, wherein the condenser disposed at least partially within the vessel) by known methods with no change in their respective functions (i.e. attaching of a condenser to the head plate of a bioreactor vessel), and the combinations yielded nothing more than predictable results (i.e. providing the mating feature that penetrates into the head-plate to mate with the condenser, wherein the condenser disposed at least partially within the vessel would yield nothing more than the obvious and predictable result of proper attachment of a condenser to the bioreactor vessel and allowing for the condenser to prevent excessive evaporation of the liquid medium in the vessel). See MPEP 2143(A).
Note that the “culture medium”, “plurality of components”, and “condenser” 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…”, “configured to couple…”, and “to mate with…”. A claim is only limited by positively recited elements; thus, inclusion of the material or article (“culture medium”, “plurality of components”, “condenser”) worked upon by a structure (the vessel; the head-plate; mating feature) being claimed does not impart patentability to the claims (see MPEP 2115). As discussed above, the bioreactor of modified Arnold is capable of performing the claimed intended use and functional limitation regarding the “culture medium”, and “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 bioreactor of modified Arnold is identical to the presently claimed structure. Modified Arnold discloses the vessel, head-plate, and mating feature 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 head-plate 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 mating features of the head plate (note that “condenser” is not positively recited structurally, and is interpreted as an intended use, see MPEP 2114 and above claim 1; however, see above claim 1, modified Arnold in view of Marten provides wherein the mating feature that penetrates into the head-plate to mate with the condenser, wherein the condenser disposed at least partially within the vessel, and therefore the condenser is implied to have a dimensions that matches the mating feature of the headplate in order to mate and couple to each other).
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 condenser. Thus, modified 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), Johnson et al. (US 20120256756 A1), and Martens et al. (Martens et al., “Configuration of Bioreactors”, (2014). Configuration of Bioreactors. In: Pörtner, R. (eds) Animal Cell Biotechnology. Methods in Molecular Biology, vol 1104. Humana Press, Totowa, NJ).
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 head-plate including a mating feature (Fig. 1E, connector 123 that includes a through-hole) that penetrates into the head-plate (Fig. 1E teaches the through-hole of connector 123 penetrates into head plate 100 to form a fluid connection between the reaction chamber 400 and exhaust gas tube 701) to mate with a condenser (interpreted as an intended use of the mating feature, see MPEP 2114; Figs. 1E and 2A-2D and paragraph [0104] teaches connector 123 is used for connecting to exhaust gas tube 701 which is used with exhaust gas cooling element 700 to condense fluid transported in the gas tube; the exhaust gas cooling element 700 and exhaust gas tube 701 are interpreted as “a condenser”; note that “condenser” is not positively recited structurally), wherein the condenser (note that “condenser” is not positively recited structurally; Figs. 1A-1B, 1E, 2A-2D and paragraph [0104], exhaust gas cooling element 700 and exhaust gas tube 701 that condenses fluid) is configured to be disposed into the head-plate (Figs. 2A-2D and paragraph [0104] teaches exhaust gas cooling element 700 is configured to be disposed into connection slot 124 of the head plate 100, i.e. disposed into the head-plate), 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; wherein the mating feature that penetrates into the head-plate to mate with the condenser, wherein the condenser disposed at least partially within 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 mating feature that penetrates into the head-plate to mate with the condenser, wherein the condenser disposed at least partially within the vessel; and 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.
Modified Arnold fails to teach: wherein the mating feature that penetrates into the head-plate to mate with the condenser, wherein the condenser disposed at least partially within the vessel.
Martens teaches a bioreactor (page 287, Fig. 1a teaches a bioreactor setup) comprising: a vessel defining a hollow enclosure (page 287, Fig. 1a teaches a bioreactor vessel that defines a hollow enclosure that includes at least impeller I) for receiving a culture medium (interpreted as an intended use, MPEP 2114; page 287, Fig. 1a teaches a bioreactor vessel that is structurally capable of receiving a culture medium; page 287, Fig. 1a teaches the bioreactor is coupled to a medium bottle A), and a head-plate configured to couple a plurality of components to the bioreactor (page 287, Fig. 1a teaches the bioreactor including a headplate to couple a plurality of components, such as tubes and probes), the headplate including a mating feature that penetrates into the head-plate to mate with a condenser (page 287, Fig. 1a teaches H, a gas outlet with condenser, i.e. condenser, that has a portion that penetrates into the head plate; therefore, the head plate is implied to include at least an opening or port, i.e. mating feature, that penetrates into the head plate in order to allow for mating with the gas outlet with condenser), wherein the condenser is configured to be disposed into the head-plate and at least partially within the vessel (page 287, Fig. 1a teaches H, a gas outlet with condenser, i.e. condenser, is disposed into the head plate and at least partially in the bioreactor vessel). Martens teaches the outlet gas should first be transported through a condenser to prevent excessive evaporation of the liquid medium (page 293, step 9).
Since Martens teaches a headplate including a mating feature that penetrates into the head-plate to mate with a condenser (page 287, Fig. 1a) is known in the art, 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 mating feature of modified Arnold to provide: wherein the mating feature that penetrates into the head-plate to mate with the condenser, wherein the condenser disposed at least partially within the vessel. I.e., it would have been obvious to have substituted one known element (Arnold’s mating feature) for another (Martens’ mating feature that penetrates into the head-plate to mate with a condenser, the condenser disposed into the head plate and at least partially in the bioreactor), and the results of the substitution would have been predictable (allowing for proper attachment of a condenser to the bioreactor vessel). See MPEP 2143(I)(B).
Furthermore, the claimed limitations are obvious because all of the claimed elements were known in the prior art and one skilled in the art could have combined the elements (i.e. the mating feature that penetrates into the head-plate to mate with the condenser, wherein the condenser disposed at least partially within the vessel) by known methods with no change in their respective functions (i.e. attaching of a condenser to the head plate of a bioreactor vessel), and the combinations yielded nothing more than predictable results (i.e. providing the mating feature that penetrates into the head-plate to mate with the condenser, wherein the condenser disposed at least partially within the vessel would yield nothing more than the obvious and predictable result of proper attachment of a condenser to the bioreactor vessel and allowing for the condenser to prevent excessive evaporation of the liquid medium in the vessel). See MPEP 2143(A).
Note that the “culture medium”, “plurality of components including at least an impeller and a sparger”, and “condenser” 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…”, “configured to couple…”, and “to mate with…”. A claim is only limited by positively recited elements; thus, inclusion of the material or article (“culture medium”, “plurality of components including at least an impeller and a sparger”, “condenser”) worked upon by a structure (the vessel; the head-plate; mating feature) being claimed does not impart patentability to the claims (see MPEP 2115).
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. Modified Arnold discloses the vessel, head-plate, and mating feature 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 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 page 8, filed 09/01/2026, with respect to the claim objections have been fully considered and are persuasive. The claim objections of 03/26/2026 have been withdrawn.
Applicant's arguments, see pages 8-17, filed 09/01/2026, with respect to the rejections under 35 U.S.C. 103, specifically regarding claim 1, have been fully considered but they are not persuasive.
Applicant’s arguments, see pages 8-17, filed 09/01/2026, with respect to the rejections of the claims under 35 U.S.C. 103, specifically regarding amended claim 1 and amended claim 20 that includes the limitation of “a mating feature that penetrates into the head-plate to mate with a condenser, wherein the condenser is configured to be disposed into the head-plate and at least partially within the vessel”, have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection 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 Martens et al. (Martens et al., “Configuration of Bioreactors”, (2014). Configuration of Bioreactors. In: Pörtner, R. (eds) Animal Cell Biotechnology. Methods in Molecular Biology, vol 1104. Humana Press, Totowa, NJ); 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), Johnson et al. (US 20120256756 A1), and Martens et al. (Martens et al., “Configuration of Bioreactors”, (2014). Configuration of Bioreactors. In: Pörtner, R. (eds) Animal Cell Biotechnology. Methods in Molecular Biology, vol 1104. Humana Press, Totowa, NJ).
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]).
Reed et al. (US 20200165733 A1; effectively filed 03/19/2016) teaches microorganism and bioprocesses (abstract). Reed teaches bioreactors (Figs. 10-11) including head plates that provides gas elastomeric seal for all connections and feed-throughs, such as a feed-through for an exhaust vent, sparger, and impeller (Fig. 10). Reed teaches a reactor configuration including gas lines and a condenser that is at least partially disposed in the reactor (Fig. 23). Reed teaches a condenser connected via tubing to an overflow vessel with a 0.2 μm filter on the gas outlet (paragraph [0141]).
Mietzner et al. (US 20170369828 A1) teaches a bioreactor vessel (abstract). Mietzner teaches the bioreactors can have a variety of ports, probes, spargers and other components such as at least one of an agitator shaft, an agitator, such as an impeller, a sparger, a probe port, a fill port, a condenser, a vent filter, a foam breaker plate, a sample port, a level probe, and a load cell (paragraph [0052]). Mietzner teaches the bioreactor includes an impeller (Fig. 10, agitators 1010) and a plurality of baffles (paragraph [0055] and Fig. 10, baffles 1012).
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 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
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