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 08/19/2026 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 § 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, 3-4, 7, 10-11, and 13 are rejected under 35 U.S.C. 103 as being unpatentable over Van De Boogaard et al. (US 20110003374 A1) in view of Tang (US 10730025 B2; effectively filed 03/24/2017).
Regarding claim 1, Van De Boogaard teaches a kit (Figs. 1-4) for a process vessel (interpreted as an intended use, see MPEP 2114; note that “process vessel” is not positively recited structurally; [0002] teaches the invention relates to a bioreactor, i.e. for a process vessel), comprising:
a bioreactor bag (Figs. 1-2 and [0023]-[0024] teaches bioreactor 1 includes container 2 with flexible wall 7; therefore container 2 with flexible wall 7 is interpreted as a bioreactor bag since it is at least partially flexible and capable of being used as a bioreactor) including a neck (Fig. 2, interpreted as the flexible wall 7 at the top of container 2);
a connector (Fig. 2, shaft housing 3) defining an aperture (Fig. 2, aperture including through-opening 10 through which shaft 5 is located) and including a welding surface surrounding the aperture (Fig. 2, flat collar 14), wherein the welding surface is configured to be heat-sealed to the neck of the bioreactor bag (interpreted as a functional limitation, see MPEP 2114; [0024] teaches flat collar 14 is connected to adjacent flexible wall 7 by ultrasonic welding), wherein the connector (Fig. 2, shaft housing 3) includes an outwardly extending flange (Fig. 2, flange 15) wherein the outwardly extending flange extends away from the aperture (Fig. 15 shows flange 15 extends outward away from the central aperture or opening that includes shaft 5); and
an impeller assembly (Figs. 1-2, interpreted as including at least shaft 5 and stirrer 6) including:
a single rotating impeller shaft (Fig. 2, shaft 5; [0025] teaches a stirrer is driven by the shaft, therefore the shaft is a single rotating impeller shaft) extending through the aperture of the connector (Fig. 2), the rotating impeller shaft comprising a first end (Figs. 1-2, bottom end of shaft 5 towards shank 27) and a second end (Figs. 1-2, top end of shaft 5 towards motor of drive 4), wherein the first end is configured to be inserted from outside the bioreactor bag, through the aperture of the connector, into the bioreactor bag (interpreted as a functional limitation, see MPEP 2114; [0024] teaches the flexible wall 7 is connected to the shaft for passage of the shaft 5 and Figs. 1-2 shows the bottom end of shaft 5 is placed through the aperture of shaft housing 3 and into the container 2; therefore, the bottom end of shaft 5 is structurally capable of being inserted from outside flexible wall 7, through the aperture of shaft housing 3, and into the container 2) and the second end is configured to remain outside of the bioreactor bag (interpreted as a functional limitation, see MPEP 2114; Figs. 1-2 teach the top end of shaft 5 remains outside of the container 2);
an impeller blade (Fig. 1, stirrer 6) coupled to the first end of the impeller shaft (Fig. 1 shows stirrer coupled to the bottom end of shaft 5 via shank 27),
wherein the impeller assembly (Figs. 1-2, interpreted as including at least shaft 5 and stirrer 6) and the connector (Fig. 2, shaft housing 3) are configured to be mechanically joined to one another (Fig. 2).
Van De Boogaard fails to teach: the impeller blade (Fig. 1, stirrer 6) configured to pass through the aperture of the connector.
Tang teaches a stirring device, i.e. impeller assembly, 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, i.e. impeller blade, 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, i.e. aperture of a connector; and this is convenient for use, maintenance, and storage (column 3, line 65 - column 4, line 3). Tang teaches the stirring plates and inner telescopic shaft can be received in the sleeve shaft; and the stirring plates and telescopic shaft is convenient for disassembly and maintenance (column 3, lines 62-65). Tang teaches in use, the round opening is opened, the stirring device is arranged in the tank, and the stirring plates are opened (column 4, lines 34-40); wherein the stirring device is convenient and efficient for use (column 4, lines 44-45).
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 blade and/or aperture of Van De Boogaard to incorporate Tang’s teachings of a stirring device including stirring plates configured to pass through an opening of a tank and through a sleeve shaft (Figs. 1-4; column 3, line 62 - column 4, line 3; column 4, lines 34-45) to provide: the impeller blade configured to pass through the aperture of the connector. Doing so would have a reasonable expectation of successfully improving convenience for assembly, disassembly, maintenance, storage, and efficiency of the impeller blade with the connector as taught by Tang (column 3, line 62 - column 4, line 3; column 4, lines 44-45).
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 claimed connector and the impeller blade configured to pass through the aperture of the connector) by known methods with no change in their respective functions (i.e. assembling an impeller blade with a connector to provide the impeller blade within a bioreactor), and the combinations yielded nothing more than predictable results (i.e. providing the impeller blade configured to pass through the aperture of the connector would yield nothing more than the obvious and predictable result of enabling assembly of the impeller blade through the aperture and therefore improving convenience for assembly, disassembly, maintenance, storage, and efficiency of the kit as taught by Tang (column 3, line 62 - column 4, line 3; column 4, lines 44-45)). See MPEP 2143(A).
Regarding claim 3, Van De Boogaard further teaches wherein the impeller assembly (Figs. 1-2, interpreted as including at least shaft 5, stirrer 6, and flange 18) and the connector (Fig. 2, shaft housing 3 including flange 15) 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 (Fig. 2 and [0025] teaches the flange 18 and flange 15 are configured to be mechanically joined by an apparent press-fit between flange 18 and flange seal 17 and a cup, i.e. annular groove, formed at the end or top of the flange 15).
Regarding claim 4, Van De Boogaard further teaches wherein the impeller assembly (Figs. 1-2, interpreted as including at least shaft 5, stirrer 6, and flange 18) and the connector (Fig. 2, shaft housing 3 including flange 15) are configured to be mechanically joined to one another by engagement features included on at least one of the impeller assembly or the connector (Fig. 2 shows flange 18 and flange 15 are configured to be mechanically joined by grooves on the flange 18 and flange 15, and a flange seal 17 included on the flange 18 and flange 15; therefore, the grooves and flange seal are interpreted as engagement features).
Regarding claim 7, Van De Boogaard further teaches wherein when the impeller assembly (Figs. 1-2, interpreted as including at least shaft 5, stirrer 6, and flange 18) and the connector (Fig. 2, shaft housing 3 including flange 15) are mechanically joined to one another, a seal is formed between the impeller assembly and the connector (Fig. 2 and [0025] teaches flange 17 is mechanically joined to flange 15 via flange seal 17; therefore, a seal is formed between the impeller assembly and connector).
Regarding claim 10, Van De Boogaard further teaches wherein the welding surface is defined on an inner surface of the connector ([0024] teaches flat collar 14 is connected to adjacent flexible wall 7 by ultrasonic welding; Fig. 2, flat collar 14 includes surfaces that ae interpreted as an inner surface of the connector; alternatively, shaft housing 3 includes internal surfaces surrounding aperture where shaft 5 is located, which are capable of being a welding surface and on an inner surface of the shaft housing 3).
Regarding claim 11 , Van De Boogaard further teaches wherein the welding surface is defined on an outer surface of the connector (Fig. 2, flat collar 14 includes surfaces that are interpreted as an outer surface of shaft housing 3).
Regarding claim 13, Van De Boogaard further teaches wherein the process vessel is a bioreactor (note that “process vessel” is not positively recited structurally; [0002] teaches the invention relates to a bioreactor, i.e. for a process vessel).
Claims 2 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Van De Boogaard in view of Tang as applied to claim 1 above, and further in view of Brown et al. (US 20150265943 A1).
Regarding claim 2, Van De Boogaard further teaches wherein:
the impeller assembly (Figs. 1-2, interpreted as including at least shaft 5, stirrer 6, and flange 18) includes an impeller flange (flange 18) configured to contact the outwardly extending flange of the connector (Fig. 2 shows flange 18 contacting flange 15 of shaft housing 3), and
the impeller assembly and the connector are configured to be mechanically joined to one another (Fig. 2 shows flange 18 configured to be mechanically joined to flange 15 via seal flange seal 17).
Modified Van De Boogaard fails to teach: the kit of claim 1, further comprising a clamp, and wherein: 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 modified Van De Boogaard 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 kit of claim 1, further comprising a clamp, and wherein: 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 impeller flange and connector of Van De Boogaard (Fig. 2) 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 kit of claim 1, further comprising a clamp, and wherein: 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 clamp, and wherein: 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) 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).
Regarding claim 5, Van De Boogaard further teaches wherein the impeller assembly (Figs. 1-2, interpreted as including at least shaft 5, stirrer 6, and flange 18)and the connector (Fig. 2, shaft housing 3 including flange 15) are configured to be mechanically joined to one another (Fig. 2 shows flange 18 configured to be mechanically joined to flange 15 via seal flange seal 17).
Modified Van De Boogaard fails to teach: wherein the impeller assembly and the connector 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.
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 types of latches to lock panels together in a closed position includes blots and threaded fasteners (paragraph [0090]). Brown teaches conventional locking techniques includes threaded fasteners (paragraph [0091]). 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 modified Van De Boogaard to incorporate the teachings of connectors with outwardly extending flanges and threaded connections as conventional mechanical connections to couple elements together of Brown (Figs. 11, 25; paragraphs [0090]-[0091],[0104]) to provide: wherein the impeller assembly and the connector 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. Doing so would have a reasonable expectation of successfully maintaining a sterile and sealed connection between the impeller assembly and connector (Brown, paragraphs [0090]-[0091],[0104]).
Furthermore, since Brown teaches known methods and structures for connecting elements together (Figs. 11, 25; paragraphs [0090]-[0091],[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 impeller flange and connector of Van De Boogaard (Fig. 2) to incorporate the teachings of alternative mechanical connections such as connectors with outwardly extending flanges and threaded connections as conventional mechanical connections to couple elements together of Brown (Figs. 11, 25; paragraphs [0090]-[0091],[0104]) to provide: wherein the impeller assembly and the connector 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. 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. wherein the impeller assembly and the connector 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) 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 impeller assembly and connector configured to be mechanically joined by engagement of a captive nut and threading as claimed 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 Van De Boogaard in view of Tang as applied to claim 1 above, and further in view of Reeder et al. (US 20020172092 A1).
Regarding claim 6, Van De Boogaard further teaches wherein the impeller assembly (Figs. 1-2, interpreted as including at least shaft 5, stirrer 6, and flange 18) and the connector (Fig. 2, shaft housing 3 including flange 15) are configured to be mechanically joined to one another (Fig. 2 shows flange 18 configured to be mechanically joined to flange 15 via seal flange seal 17).
Modified Van De Boogaard 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 modified Van De Boogaard 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 of modified Van De Boogaard (Fig. 2) with 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 Van De Boogaard in view of Tang as applied to claim 1 above, and further in view of Wong (US 20110249526 A1).
Regarding claim 8, while Van De Boogaard teaches bioreactors with flexible walls ([0004],[0005], [0007], [0024]), modified Van De Boogaard 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 modified Van De Boogaard 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 Van De Boogaard teaches bioreactors with flexible walls (0004],[0005], [0007], [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 Van De Boogaard in view of Tang as applied to claim 1 above, and further in view of Pethe et al. (US 20130167960 A1).
Regarding claim 9, while Van De Boogaard teaches bioreactors with flexible walls ([0004],[0005], [0007], [0024]), modified Van De Boogaard 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 modified Van De Boogaard 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 Van De Boogaard teaches bioreactors with flexible walls (0004],[0005], [0007], [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).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Van De Boogaard in view of Tang as applied to claim 1 above, and further in view of Jenkins et al. (US 20060246537 A1).
Regarding claim 12, modified Van De Boogaard fails to teach: wherein the bioreactor bag is a gusseted three dimensional bag.
Jenkins teaches vessels, i.e. bioreactors, in which manufacture of therapeutic protein is carried out (abstract; [0002]). Jenkins teaches containers are made of flexible film (paragraph [0006]), wherein the vessels are bioreactors (paragraph [0010]). Jenkins teaches the container is made of flexible film for manufacturing and allows for repeatedly flexing without fracture and enables for collapsing (paragraph [0019]). Jenkins teaches the bioreactor can include a port for introduction of a mixing blade into the interior (paragraph [0023]). Jenkins teaches containers formed of heat sealing flexible films, which form gusseted containers (paragraph [0028]).
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 of modified Van De Boogaard to incorporate Jenkins’s teachings of bioreactors made of flexible films to form gusseted containers (paragraphs [0006],[0010],[0028]) to provide: wherein the bioreactor bag is a gusseted three dimensional bag. Doing so would have a reasonable expectation of successfully allowing for manufacture of flexible containers that allows for improved flexing without fracture and enabling for collapsing as taught by Jenkins.
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 bioreactor bag is a gusseted three dimensional bag) by known methods with no change in their respective functions (i.e. forming a flexible bag for bioreactions), and the combinations yielded nothing more than predictable results (i.e. providing the bioreactor bag as a gusseted three dimensional bag would yield nothing more than the obvious and predictable result of providing manufacture of flexible containers for bioreactions that allows for improved flexing without fracture and enabling for collapsing). See MPEP 2143(A).
Response to Arguments
Applicant’s arguments, see pages 5-8, filed 08/19/2026, with respect to the rejections of under 35 U.S.C. 102 and 103, specifically regarding the limitations of amended claim 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 Van De Boogaard et al. (US 20110003374 A1) in view of Tang (US 10730025 B2; effectively filed 03/24/2017).
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).
Mott et al. (US 20080175095 A1) teaches a mounting and coupling assembly for a mixer for a container having an impeller connected to a 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).
Brown (US 20160095279 A1) teaches a flexible bag for culturing (abstract), the flexible bag includes gussets, i.e. gusseted bag (paragraph [0074]). Brown teaches the container assembly includes mixing elements, such as an impeller (paragraph [0059]).
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.
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
Prosecution Insights