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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 01/21/2026 has been entered.
Response to Amendment
The Amendment filed 01/21/2026 has been entered. Claims 1-13 remain pending in the application. New grounds of rejections necessitated by amendments are discussed below.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 3-5, 7, and 10-13 are rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) as being anticipated by Cutting (US 20150265986 A1).
Regarding claim 1, Cutting teaches a kit (Figs. 1-3 teaches components of a system including a container 20) for a process vessel (Figs. 1-3 teaches components for a system with a container, i.e. for a process vessel), comprising:
a bioreactor bag (Figs. 1-3, container 20; paragraph [0024] teaches the container is a bag; note that “bioreactor” is interpreted as a functional limitation of the bag, the container is structurally capable of being used for a bioreaction at a later time, i.e. bioreactor bag) including a neck (Figs. 1-3, interpreted as the wall 24 at the bottom of container 20, forming an opening of the bag, that is attached to a structure surrounding elements 25, 26, 27; see annotated Fig. 3 below);
a connector (see annotated Fig. 3 below; interpreted as the structure coupled to the wall 24 of container 24 that surrounds elements 25, 26, 27) defining an aperture (Figs. 1-3 shows the structure coupled to the wall 24 of container 24 that surrounds elements 25, 26, 27 having an aperture or hole comprising at least element 21) and including a welding surface surrounding the aperture (interpreted as the surfaces of the connector comprising the surface of the structure coupled to the wall 24 of container 24 that surrounds elements 25, 26, 27 that attaches to element 24), wherein the welding surface is configured to be heat-sealed to the neck of the bioreactor bag (interpreted as a functional limitation; paragraph [0047] teaches welding the connection portion into the wall of the container; thus, the wall 24 is capable of being heat-sealed or welded to the connector at a later time), wherein the connector includes an outwardly extending flange wherein the outwardly extending flange extends away from the aperture (see below annotated Fig. 3 below; interpreted as the flange of the connector that extends away from the aperture and attaches to element 24); and
an impeller assembly (Figs. 1-3, 5A, 5B, interpreted as comprising at least elements 21, 22, 23, 25, 26, 30, 31, 35; see below annotated Fig. 5B) including:
a rotating impeller shaft (Figs. 3 and 5B, teaches discs 23 perform a mixing motion by a rotating shaft that is led through the container wall; Fig. 5B, interpreted as including impeller shaft 22a and rotating shaft 35; see below annotated Fig. 5B) comprising a first end (Figs. 1-3 and 5 teach a top end of element 22a) and a second end (Figs. 1-3 and 5 teach a bottom end of element 35), wherein the first end is configured to be inserted through the aperture of the connector into the bioreactor bag (Figs. 1-3 and 5 teach the top end of element 22a is inserted through the aperture or hole of the structure coupled to the wall 24 of container 24 that surrounds elements 25, 26, 27 and into the container 24, i.e. bioreactor bag) and the second end is configured to remain outside of the bioreactor bag (Figs. 1-3 and 5 teach the bottom end of element 35 remain outside of the bioreactor bag and connects to an external drive system 30);
an impeller blade (Figs. 1-3 and 5, interior mixing element 21; Figs. 4A-4B and paragraph [0028] teaches interior mixing element 21 is a disc 23, which is interpreted as a structural impeller blade; Figs. 5A-5B, alternatively, interpreted as impeller 22, i.e. blades) coupled to the first end of the impeller shaft (Figs. 1-3 and 5 teach blades 21 or 22 coupled to the top end of impeller shaft 22a) and configured to pass through the aperture of the connector (Figs. 1-3, 5A, 5B shows the interior mixing element 21 and shaft 22a is capable of passing through the aperture or hole of the structure coupled to the wall 24 of container 24 that surrounds elements 25, 26, 27).
wherein the impeller assembly and the connector are configured to be mechanically joined to one another (Figs. 1-2 shows elements 27 and 25 are configured to be mechanically joined to the structure coupled to the wall 24 of container 24 that surrounds elements 25, 26, 27; paragraph [0031] teaches the container and exterior bearing of external drive system 30 are fixed via force-fit, form-fit, snap-fit, adhesive bond, and/or screwing together).
PNG
media_image1.png
417
665
media_image1.png
Greyscale
Annotated Fig. 3: Annotated arrows pointing to claimed bag, neck, connector, and impeller assembly.
PNG
media_image2.png
449
720
media_image2.png
Greyscale
Annotated Fig. 3: Annotated arrow and box pointing to claimed aperture. Annotated arrow pointing to an outwardly extending flange of the connector extending away from the aperture.
PNG
media_image3.png
426
532
media_image3.png
Greyscale
Annotated Fig. 5B: Impeller assembly includes at least impeller shaft 22a and rotating shaft 35.
Regarding claim 3, Cutting further teaches wherein the impeller assembly (Figs. 1-3, 5A, 5B, interpreted as comprising at least elements 21, 22, 23, 25, 26, 30, 31, 35) and the connector (see annotated Fig. 3 below; interpreted as the structure coupled to the wall 24 of container 24 that surrounds elements 25, 26, 27) are configured to be mechanically joined to one another by a press-fit between the impeller assembly and a cup formed at an end of the connector (see below Fig. 3 showing the impeller assembly capable of mechanically joining the impeller assembly and a cup formed at a lower end of the connector; paragraph [0031] teaches the container and the exterior bearing of the exterior drive system is adapted to be fixed via force-fit, i.e. press-fit).
PNG
media_image4.png
523
791
media_image4.png
Greyscale
Annotated Fig. 3: Annotated box showing a cup shaped region formed at a lower end of the connector; annotated arrows showing the connector and impeller assembly mechanically joined.
Regarding claim 4, Cutting further teaches wherein the impeller assembly (Figs. 1-3, 5A, 5B, interpreted as comprising at least elements 21, 22, 23, 25, 26, 30, 31, 35) and the connector (see annotated Fig. 3 above; interpreted as the structure coupled to the wall 24 of container 24 that surrounds elements 25, 26, 27) are configured to be mechanically joined to one another by engagement features included on at least one of the impeller assembly or the connector (see above Fig. 3 showing the impeller assembly capable of mechanically joining the impeller assembly and a cup formed at a lower end of the connector via engagement features, e.g. threading, on each of the connector and impeller assembly; paragraph [0031] teaches the container and the exterior bearing of the exterior drive system is adapted to be fixed via snap-fit or screwing together, which implies the presence of engagement features on at least one of the impeller assembly or connector in order to snap-fit or screw together).
Regarding claim 5, Cutting further teaches wherein the impeller assembly (Figs. 1-3, 5A, 5B, interpreted as comprising at least elements 21, 22, 23, 25, 26, 30, 31, 35) and the connector (see annotated Fig. 3 above; interpreted as the structure coupled to the wall 24 of container 24 that surrounds elements 25, 26, 27) are configured to be mechanically joined to one another by engagement of a captive nut disposed on one of the connector or the impeller assembly engaging with threading provided on the other of the connector or the impeller assembly (note that the instant specification does not structurally define “captive nut” and generally discusses that a captive nut is a structure with an internal thread, see paragraphs [0113]-[0117] and Figs. 7A-7B, therefore the BRI “captive nut” includes a structure with an internal screw thread; Cutting, paragraph [0031] teaches the container and exterior bearing of the exterior drive system comprise screwing means adapted to be screwed together, thus, one of ordinary skill in the art would recognize that the screwing means that allow the container and exterior bearing to be screwed together would include at least one captive nut, or a structure with internal threading, and at least one threading on the other element, i.e. an element with an internal female threading and a different element with an external male threading; Figs. 1-3 appears to show the container 20 with a captive nut, i.e. internal female threading, coupled to external threading of the exterior drive system elements 30 and 25).
Regarding claim 7, note that the limitation of “wherein when the impeller assembly and the connector are mechanically joined to one another, a seal is formed between the impeller assembly and the connector” is interpreted as a product-by-process limitation (see MPEP 2113), where 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. Since Cutting teaches the impeller assembly and the connector (see above claim 1), Cutting teaches all of the structural elements of claim 7.
However, for compact prosecution purposes: Cutting further teaches wherein when the impeller assembly and the connector are mechanically joined to one another, a seal is formed between the impeller assembly and the connector (annotated Fig. 3 above shows the connector and impeller assembly mechanically joined to one another forming a seal; paragraph [0028] teaches flexible portion 27 seals the interior mixing element 21 at the wall of the container 21; paragraph [0031] teaches the container and the exterior bearing of the exterior drive system is adapted to be fixed via force-fit, form-fit, snap-fit, adhesive bond, and/or screwing together, thus, the fixing would forming a seal).
Regarding claim 10, Cutting further teaches wherein the welding surface is defined on an inner surface of the connector (see below annotated Fig. 3; the structure coupled to the wall 24 of container 24 that surrounds elements 25, 26, 27 includes a welding surface that comprises interior surfaces of the connector that surrounds the aperture where element 21 and 23 is located; paragraph [0047] teaches welding the connection portion into the wall of the container, thus, the interior surface of the connector is structurally capable of being welded at a later time, and thus is interpreted as a welding surface).
PNG
media_image5.png
523
831
media_image5.png
Greyscale
Annotated Fig. 3: Boxes and arrows pointing to inner surfaces of the connector, which are interpreted as the claimed welding surface.
Regarding claim 11, Cutting further teaches wherein the welding surface is defined on an outer surface of the connector (see below annotated Fig. 3; the structure coupled to the wall 24 of container 24 that surrounds elements 25, 26, 27 includes a welding surface that comprises outer surfaces of the connector that surrounds the aperture where element 21 and 23 is located; paragraph [0047] teaches welding the connection portion into the wall of the container, thus, the outer surface of the connector is structurally capable of being welded at a later time, and thus is interpreted as a welding surface).
PNG
media_image6.png
523
831
media_image6.png
Greyscale
Annotated Fig. 3: Boxes and arrows pointing to outer surfaces of the connector, which are interpreted as the claimed welding surface.
Regarding claim 12, Cutting further teaches wherein the bioreactor bag is a gusseted three dimensional bag (paragraph [0024] teaches the bag is a plastic bag and/or bag assembly, wherein a bag assembly is interpreted as a gusseted three dimensional bag since an assembly implies a combination of elements as a bag, i.e. a gusseted bag; Figs. 1-3 shows container 10 as a bag comprising additional components coupled to the bag wall 24, e.g. the top and bottom structural elements, which results in a bigger space within the bag, i.e. a gusseted three dimensional bag; further, the inward facing side walls in Figs. 1-3 of container 20 are interpreted as gussets, i.e. gusseted three dimensional bag).
Regarding claim 13, Cutting further teaches wherein the process vessel is a bioreactor (note that “process vessel” is not positively recited structurally; Figs. 1-3, the process vessel is interpreted as the combination of the overall components, which form a “bioreactor”; paragraph [0002] teaches the container may be a fluid for bioprocessing, thus is capable of being used as a “bioreactor” at a later time).
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.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Cutting as applied to claim 1 above, and further in view of Brown et al. (US 20150265943 A1).
Regarding claim 2, Cutting further teaches wherein: the impeller assembly includes an impeller flange (see below annotated Fig. 3; the impeller assembly includes stiff portion 26, which comprises a flange) configured to contact the connector (Fig. 3 and paragraph [0031] teaches the container and the exterior bearing of the exterior drive system is adapted to be fixed via force-fit, form-fit, snap-fit, adhesive bond, and/or screwing together, thus the connector is capable of contacting the flange of the impeller assembly), and the impeller assembly and the connector are configured to be mechanically joined to one another (Fig. 3 and paragraph [0031] teaches the container and the exterior bearing of the exterior drive system is adapted to be fixed via force-fit, form-fit, snap-fit, adhesive bond, and/or screwing together, thus the connector is capable of being mechanically joined to the impeller assembly).
PNG
media_image7.png
449
685
media_image7.png
Greyscale
Annotated Fig. 3: Arrows annotating the connector and the impeller flange of the impeller assembly, wherein the impeller flange is configured to contact the connector.
While Cutting teaches the container and the exterior bearing of the exterior drive system is adapted to be fixed via force-fit, form-fit, snap-fit, adhesive bond, and/or screwing together (paragraph [0031]), and the impeller flange configured to contact the connector (see above annotated Fig. 3), Cutting fails to teach: the kit further comprising a clamp, and wherein: the impeller flange is configured to contact the outwardly extending flange (which extends away from the aperture) of the connector, and the impeller assembly and the connector are configured to be mechanically joined to one another by using the clamp to secure the outwardly extending flange of the connector and the impeller flange to one another.
Brown teaches a system comprising a bag (Fig. 2, container 12) and impeller assembly (78). Brown teaches an embodiment where a coupling flange (Fig. 11, element 252) of an intake port (166) of the bag is configured to mate with a coupling flange (99) of an exhaust port (92) of a container (12), so that when a clamp is tightened over the mated flanges, a gas tight seal is formed that will maintain sterility (paragraph [0104]; Fig. 11). Brown teaches the coupling flange of the intake port (Fig. 11, element 252) and the coupling flange of the exhaust port (99) comprise outwardly extending flanges that extends away from a central aperture (Fig. 11). Brown teaches an embodiment of a connector (Fig. 25, element 92) having an outwardly extending flange extending away from an aperture (Fig. 25) used for coupling a flange of an assembly (260) in combination with a clamp (258). Brown teaches in addition to flanges and a clamp, other types of mechanical connections can maintain a sterile connection, such as threaded connections and snap-fit connections (paragraph [0104]).
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 kit and the connector of Cutting to incorporate the teachings of connectors with outwardly extending flanges and clamps to secure flanges of different components of Brown (Figs. 11, 25; paragraph [0104]) to provide: the portion of the connector the contacts the impeller assembly (Cutting, see above annotated Fig. 3) with an outwardly extending flange extending away from the aperture; the kit further comprising a clamp, and wherein: the impeller flange is configured to contact the outwardly extending flange of the connector, and the impeller assembly and the connector are configured to be mechanically joined to one another by using the clamp to secure the outwardly extending flange of the connector and the impeller flange to one another. Doing so would have a reasonable expectation of successfully maintaining a sterile and sealed connection between the impeller assembly and connector (Brown, paragraph [0104]).
Furthermore, since Brown teaches known methods and structures for connecting elements together (Figs. 11, 25; paragraph [0104]), it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the connector with a threaded connection of Cutting (Fig. 3) to incorporate the teachings of alternative mechanical connections such as connectors with outwardly extending flanges and clamps to secure flanges of different components of Brown (Figs. 11, 25; paragraph [0104]) to provide: the portion of the connector the contacts the impeller assembly (Cutting, see above annotated Fig. 3) with an outwardly extending flange extending away from the aperture; the kit further comprising a clamp, and wherein: the impeller flange is configured to contact the outwardly extending flange of the connector, and the impeller assembly and the connector are configured to be mechanically joined to one another by using the clamp to secure the outwardly extending flange of the connector and the impeller flange to one another. The result of the substitution would have been predictable, such as successfully maintaining a sterile and sealed connection between the impeller assembly and connector (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. a connector including an outwardly extending flange that extends away from an aperture and an impeller assembly including an impeller flange configured to contact the outwardly extending flange; and a clamp to join the impeller assembly and the connector) by known methods with no change in their respective functions (i.e. mechanically joining elements), and the combinations yielded nothing more than predictable results (i.e. providing the claimed outwardly extending flange, impeller flange, and clamp would yield nothing more than the obvious and predictable result of maintaining a sterile and sealed connection between the impeller assembly and connector). See MPEP 2143(A).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Cutting as applied to claim 1 above, and further in view of Reeder et al. (US 20020172092 A1).
Regarding claim 6, while Cutting teaches the container and the exterior bearing of the exterior drive system is adapted to be fixed via force-fit, form-fit, snap-fit, adhesive bond, and/or screwing together (paragraph [0031]), Cutting fails to teach wherein the impeller assembly and the connector are configured to be mechanically joined to one another by a plurality rotating bolts and locking nuts included in one of the impeller assembly or the connector, and a plurality of recesses configured to receive the rotating bolts formed in the other of the impeller assembly or the connector.
Reeder teaches a mixing arrangement for a tank mixing system comprising an impeller (abstract). Reeder teaches embodiments that couple an impeller assembly to a connector element (Figs. 2-3 shows plate 70 coupled to the impeller arm 72 is mechanically coupled to flange 66 of container 60 via support rings 78,80; Figs. 4-5 show plate 70 coupled to impeller arm 72 is mechanically coupled to flange 66 of container 66 via a plurality of bolts 95 and nuts 97 through recesses of the flange 66). Reeder teaches a plurality of bot and nuts can be used to secure a plate to a flange and similar bot and nut assemblies may attach plates together (paragraph [0041]; note that “nut” is interpreted as a locking nut since it locks or secures elements together). Reeder teaches other attachment systems could be used (paragraph [0041]). Reeder teaches upper and lower rings 158 and 160 may be connected to the plate member 150 and flange 146 respectively using bolts or other fastening means such as screws or clamps (paragraph [0043]; Fig. 7).
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 impeller assembly and connector of Cutting to incorporate the teachings of nut and bolt assemblies of Reeder (Figs. 2-5, 7; paragraphs [0041],[0043]) to provide: wherein the impeller assembly and the connector are configured to be mechanically joined to one another by a plurality rotating bolts and locking nuts included in one of the impeller assembly or the connector, and a plurality of recesses configured to receive the rotating bolts formed in the other of the impeller assembly or the connector. Doing so would have a reasonable expectation of successfully providing a sealed connection between the impeller assembly and connector as discussed by Reeder (paragraphs [0041],[0043]).
Furthermore, since Reeder teaches known structures for connecting elements together (Figs. 2-5, 7; paragraphs [0041],[0043]), it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the impeller assembly and connector that provides for a threaded connection of Cutting (Fig. 3) nut and bolt assemblies of Reeder (Figs. 2-5, 7; paragraphs [0041],[0043]) to provide: wherein the impeller assembly and the connector are configured to be mechanically joined to one another by a plurality rotating bolts and locking nuts included in one of the impeller assembly or the connector, and a plurality of recesses configured to receive the rotating bolts formed in the other of the impeller assembly or the connector. The result of the substitution would have been predictable, such as successfully providing a sealed connection between the impeller assembly and connector (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 impeller assembly and the connector are configured to be mechanically joined to one another by a plurality rotating bolts and locking nuts included in one of the impeller assembly or the connector, and a plurality of recesses configured to receive the rotating bolts formed in the other of the impeller assembly or the connector) by known methods with no change in their respective functions (i.e. mechanically joining elements), and the combinations yielded nothing more than predictable results (i.e. providing the impeller assembly and connector to be configured to be joined by bolts and nuts as claimed would yield nothing more than the obvious and predictable result of providing a sealed connection between the impeller assembly and connector). See MPEP 2143(A).
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Cutting as applied to claim 1 above, and further in view of Wong (US 20110249526 A1).
Regarding claim 8, while Cutting teaches the bioreactor bag is a plastic bag and the wall of the container may at least in parts be made of flexible plastic (paragraphs [0023]-[0024]), Cutting fails to teach wherein the bioreactor bag and the connector each comprise a polyolefin.
Wong teaches a process bag container (abstract; Fig. 1) comprising an impeller (24). Wong teaches the bag is formed of a flexible polymeric composition such as polyethylene, i.e. a polyolefin (paragraph [0016]). Wong teaches the container comprises a support housing formed of a rigid composition, such as polyethylene to provide support for the bag (paragraph [0019]). Wong teaches a housing may be a separate plastic piece formed of a plastic that can bond to the bag material, such as polyethylene (paragraph [0021]).
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 bioreactor bag and connector of Cutting to incorporate the teachings of specific materials for bags and support housing of Wong (paragraphs [0016],[0019],[0021]) to provide: wherein the bioreactor bag and the connector each comprise a polyolefin (i.e. polyethylene). Doing so would have a reasonable expectation of successfully providing a flexible bag and supportive material that can bond to the bag as discussed by Wong (paragraphs [0016],[0019],[0021]).
Furthermore, since Cutting teaches the container is made of flexible plastic (paragraphs [0023]-[0024]) and Wong teaches a need for polymeric compositions to be flexible for the bag (paragraph [0016]), it would have been obvious to choose wherein the bioreactor bag and the connector each comprise a polyolefin from a finite number of identified, predictable polymeric materials for bags and connectors (Wong, paragraph [0021]), i.e., it would have been obvious to try the specific structure of polyolefin to optimize and provide desired structural properties to the bioreactor bag and connector with a reasonable expectation of success. See MPEP 2143(I)(E).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Cutting as applied to claim 1 above, and further in view of Pethe et al. (US 20130167960 A1).
Regarding claim 9, while Cutting teaches the bag is a plastic bag and the wall of the container may at least in parts be made of flexible plastic (paragraphs [0023]-[0024]), Cutting fails to teach wherein the bioreactor bag and the connector each comprise a fluoropolymer.
Pethe teaches a container (Fig. 1, element 10) and impeller assembly (mixing elements 25 and 24). Pethe teaches a drain connector for mounting a to a container (paragraph [0010]). Pethe teaches the container can be a bag (paragraph [0045]). Pethe teaches the container and components of a drain connector are fabricated from one or more polymeric materials, such as polyethylene and polytetrafluoroethylene, i.e. fluoropolymer (paragraph [0045]).
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 bioreactor bag and connector of Cutting to incorporate the teachings of specific materials for bags and associated components of Pethe (paragraph [0045]) to provide wherein the bioreactor bag and the connector each comprise a fluoropolymer (i.e. polytetrafluoroethylene). Doing so would have a reasonable expectation of successfully providing a bioreactor bag and connector with desired properties (Pethe, paragraph [0045]).
Furthermore, since Cutting teaches the container is made of flexible plastic (paragraphs [0023]-[0024]) and Pethe teaches a need for polymeric materials to form elements of the drain connector and container (paragraph [0045] discusses preferred materials for the containers and components, which is interpreted as a need to select the appropriate materials to form the elements), it would have been obvious to choose wherein the bioreactor bag and the connector each comprise a fluoropolymer from a finite number of identified, predictable polymeric materials for bags and connectors (Pethe, paragraph [0045]), i.e., it would have been obvious to try the specific structure of fluoropolymer to optimize and provide desired structural properties to the bioreactor bag and connector with a reasonable expectation of success. See MPEP 2143(I)(E).
Response to Arguments
Applicant’s arguments, see page 5, filed 08/12/2025, with respect to the claim objections have been fully considered and are persuasive. The claim objections of 05/12/2025 have been withdrawn.
Applicant’s arguments, see pages 5-6, filed 01/21/2026, with respect to the rejection(s) of claims 1, 3-5, 7, and 10-13 under 35 U.S.C. 102(a)(1) 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 Cutting (US 20150265986 A1), with a new interpretation of: the impeller assembly including a rotating impeller shaft (Figs. 3 and 5B, teaches discs 23 perform a mixing motion by a rotating shaft that is led through the container wall; Fig. 5B, interpreted as including impeller shaft 22a and rotating shaft 35) comprising a first end (Figs. 1-3 and 5 teach a top end of element 22a) and a second end (Figs. 1-3 and 5 teach a bottom end of element 35). Note that the BRI of “rotating impeller shaft” includes the interpretation of Cutting’s elements that together function as a rotating impeller shaft to rotate blades (Figs. 1-3, 5A, 5B, interpreted as comprising at least elements 21, 22, 23, 25, 26, 30, 31, 35).
Applicant's arguments, pages 6-8, filed 01/21/2026, with respect to the rejections under 35 U.S.C. 103, have been fully considered but they are not persuasive.
In response to applicant's arguments regarding claim 2, specifically applicant’s arguments that Cutting and Brown fails to teach or suggest the elements of amended claim 1, and that Cutting teaches away from the elements of claim 1 (Remarks, pages 6-7), one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). In view of amended claim 1, a new ground(s) of rejection is made in view of Cutting, wherein Cutting teaches all of the elements of claim 1. Note that applicant does not specifically argue the combination of Cutting and Brown to arrive at the limitations of claim 2, therefore the rejection is maintained.
In response to applicant’s arguments regarding claim 6, specifically applicant’s argument that it is improper to combine references where the references teaches away from their combination (Remarks, pages 7-8), the examiner disagrees. Cutting’s intended purpose of its system is for mixing content of the container with an interior mixing element (abstract; paragraph [0002]). Cutting teaches and suggests that the system provides a robust and simple sealing with zero leakage (paragraph [0054]). The examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, Cutting provides teachings that the container and the exterior bearing of the exterior drive system is adapted to be fixed via force-fit, form-fit, snap-fit, adhesive bond, and/or screwing together (paragraph [0031]). Cutting provides motivation of: wherein the system provides a robust and simple sealing with zero leakage (paragraph [0054]). Reeder teaches a mixing arrangement for a tank mixing system comprising an impeller (abstract), which has the same intended purpose as Cutting. Reeder provides teachings and motivations of: nut and bolt assemblies for attaching a plate to a flange (Figs. 2-5, 7; paragraphs [0041],[0043]).
It would have been obvious to one of ordinary skill in the art to have modified the impeller assembly and connector of Cutting to incorporate the teachings of nut and bolt assemblies of Reeder (Figs. 2-5, 7; paragraphs [0041],[0043]) to provide: wherein the impeller assembly and the connector are configured to be mechanically joined to one another by a plurality rotating bolts and locking nuts included in one of the impeller assembly or the connector, and a plurality of recesses configured to receive the rotating bolts formed in the other of the impeller assembly or the connector. Doing so would have a reasonable expectation of successfully providing a sealed connection between the impeller assembly and connector as discussed by Reeder (paragraphs [0041],[0043]).
Furthermore, since Reeder teaches known structures for connecting elements together (Figs. 2-5, 7; paragraphs [0041],[0043]), it would have been obvious to one of ordinary skill in the art to have substituted the impeller assembly and connector that provides for a threaded connection of Cutting (Fig. 3) nut and bolt assemblies of Reeder (Figs. 2-5, 7; paragraphs [0041],[0043]) to provide: wherein the impeller assembly and the connector are configured to be mechanically joined to one another by a plurality rotating bolts and locking nuts included in one of the impeller assembly or the connector, and a plurality of recesses configured to receive the rotating bolts formed in the other of the impeller assembly or the connector. The result of the substitution would have been predictable, such as successfully providing a sealed connection between the impeller assembly and connector (See MPEP 2143(I)(B)).
Therefore, there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art to have combined Cutting and Reeder to arrive at the claimed bolts and locking nuts arrangement to mechanically join the impeller assembly to the connector without rendering Cutting unsatisfactory for its intended purpose of mixing content of the container with an interior mixing element. Note that applicant fails to specifically argue the combination of Cutting and Reeder in relation to the limitations of claim 6, therefore the rejection is maintained.
In response to applicant’s arguments regarding claims 8 and 9, specifically regarding the prior art failing to teach claim 1 (Remarks, page 8), the examiner notes that upon further consideration, a new ground(s) of rejection of claim 1 is made in view of Cutting (US 20150265986 A1). Additionally, applicant does not argue the specific rejections of claims 8 and 9, therefore the rejections are maintained.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Mattson et al. (US 10105662 B1; effectively filed 12/19/2017) teaches a mixing assembly (abstract) that includes a flexible drum (Fig. 1, element 11; column 4, line 9) and impeller blade (122). Mattson teaches a collapsed position can allow the impeller to fit through the relatively narrow opening, e.g., 2-inch in diameter, of the container, while the extended position allows for effective stirring of the substance of the container (column 1, lines 54-58).
Tang (US 10730025 B2; effectively filed 03/24/2017) teaches a stirring device for treatment of a tank (Figs. 1-4; abstract). Tang teaches the tank includes a round opening (Figs. 1-4; element 21) constructed for entry and exit of the stirring device for the treatment of photoresist settlement (column 4, lines 27-33). Tang teaches the stirring plates 16 can be folded to fit to the inner telescopic shaft 12, such that the inner telescopic shaft 12 can be pulled out directly together with the stirring plates 16 under the circumstance of not pulling out the sleeve shaft 13; and this is convenient for use, maintenance, and storage (column 3, line 65 - column 4, line 3).
Van Den Boogaard et al. (US 20110003374 A1) teaches a bioreactor having a stirrer (abstract; Figs. 1-2), the bioreactor is used as a disposable bag (paragraph [0017]). Van Den Boogaard teaches an impeller assembly (Figs. 1-2) including a rotating shaft (5) having an first end (top end towards element 19) that extends outside of the bioreactor (Figs. 1-2) and second end (27) that extends into the bioreactor (Figs. 1-2), the second end attached to blades (6). Van Den Boogaard teaches a connector (Figs. 1-2; shaft housing 14) including a flange (collar 14) that is bonded or welded to the flexible wall of the container (Fig. 2; paragraph [0024]).
Mott et al. (US 20080175095 A1) teaches a mounting and coupling assembly for a mixer for a container having an impeller connected toa drive shaft, which extends through an opening into the container (abstract; Figs. 1-3). Mott teaches a rotatable shaft (5), a neck of the container (6a), and a connector (cover 2). Mott teaches the rotatable shaft includes a first end that extends outside of the container (the end towards element 1) and a second end that extends into the container (Figs. 1-3).
Yan et al. (CN 111218391 A) teaches a stirring device (Figs. 1-2) having an impeller shaft (13) and blades (12) that are sized to be inserted into an aperture (6) of a connector (11); wherein one end of the impeller shaft is outside of a container and one end is inside of the container (Fig. 2).
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Maris Kessel can be reached at (571) 270-7698. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/HENRY H NGUYEN/Primary Examiner, Art Unit 1758