DETAILED ACTION
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 .
Election/Restrictions
Applicant has amended the claims (8-16) to now depend on independent claim 1; where claim 8 was originally an independent claim. Therefore, the restriction mailed on 01/07/2026 is withdrawn, and claims 1-16 have been examined.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 03/09/2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Objections
Claims 12-13 are objected to because of the following informalities: a comma should be inserted after inserted after the dependent claim number, that is, “1,”. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 3-4, 7, and 10-11 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. More specifically, regarding claim 7, the limitation “wherein the baffle is configured so as to project from one end of the receiving space into the receiving space”; it is unclear what applicant is attempting to claim and convey in this limitation. That is, a baffle projects into a one end of the receiving space, but it is unclear as to what applicant is attempting to claim regarding the end of the claim, when an end of a receiving space has been previously claimed. Additionally, for claim 9, it is unclear as to what applicant is attempting to claim by the following claim limitation “wherein the baffle extends in a baffle extension direction…”. Claims 10-11 are rejected under 112(b) since it depends on claim 9.
Regarding claims 3-4, the term "type" renders the claim(s) indefinite because the claim(s) include(s) elements not actually disclosed, thereby rendering the scope of the claim(s) unascertainable. See MPEP § 2173.05(d).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 1-16 are rejected under 35 U.S.C. 103 as being unpatentable over US 2013/0089925 A1-Damren et al (hereinafter “Damren”).
Regarding claim 1, Damren discloses a bioreactor system for receiving a disposable bioreactor bag (systems and methods for containing and manipulating fluids, and for regulating the temperature of fluids associated with a chemical, biological, or pharmaceutical reaction or process, para. [0042], lines 1-4, and lines 7-8; a flexible bioreactor or mixer bag, para. [0009], lines 1-2), the bioreactor system (vessel 10, para. [0064], line 6, Fig. 1) comprising: ‒ a receiving container (support structure 14, para. [0064], line 7, Fig. 1) having a container wall which defines a receiving space in which the disposable bioreactor bag is received in an operating state of the bioreactor system (Fig. 1 shows support structure 14 comprises a container wall for receiving a disposable bag—container 18, para. [0064], line 10);
“‒ a stirring system (mixing system such as an impeller 51, para. [0069], lines 1-2, Fig. 1) which projects at least partially into the receiving space and is designed (Fig. 1 depicts impeller 51 projecting into the receiving space of container 18 and support structure 14) and configured to stir a biomedium present in the disposable bioreactor bag in the operating state of the bioreactor system (mixing system for mixing contents of the vessel, para. [0050], lines 1-3);”
Regarding claim 1, Damren teaches the invention discussed above. Further, Damen teaches a receiving space of container 18, also discussed above. However, Damren does not explicitly teach a at least one baffle and a temperature control medium flows through at least part of the at least one baffle.
For claim 1, a different embodiment of Damren teaches baffles (heat exchange module 304, para. [0100], line 7, Fig. 3) the at least one heat exchange module 304 can be in fluid communication with a heating or cooling fluid source 312, also referred to herein as a temperature control fluid (para. 0100], lines 14-18), further, Fig. 3 of Damren depicts reactor 300 where module 304 makes the receiving space of reactor 300 smaller, which reads on the instant claim limitation of at least one baffle and a temperature control medium flows through at least part of the at least one baffle, wherein a temperature control medium flows through at least part of the at least one baffle, said temperature control medium controlling the temperature of the baffle.
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to take the invention of Damren and further include at least one baffle and a temperature control medium flows through at least part of the at least one baffle, wherein a temperature control medium flows through at least part of the at least one baffle, said temperature control medium controlling the temperature of the baffle, as taught by a different embodiment of Damren, because the different embodiment of Damren teaches module 304 can comprise a thermally conductive surface 310 adapted to contact the inner container to facilitate heat transfer (para. 0100], lines 7-11).
Regarding claim 2, Damren teaches the invention discussed above in claim 1. Further, Damren teaches a container wall of a receiving container, also discussed above. However, Damren does not explicitly teach at least one baffle comprises at least one baffle of a first baffle type, which rests against the container wall of the receiving container in such a way that it protrudes from the container wall and projects into the receiving space.
For claim 2, a different embodiment of Damren teaches a baffle type (heat exchange module 304, para. [0100], line 7), shown in Fig. 3 resting against the container wall of tank or vessel 302 of the receiving container of reactor 300, also shown in Fig. 3, where module is also shown projecting from the container wall of vessel 302 and into the receiving space of reactor 300), which reads on the instant claim limitation of at least one baffle comprises at least one baffle of a first baffle type, which rests against the container wall of the receiving container in such a way that it protrudes from the container wall and projects into the receiving space.
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to take the invention of Damren and further include at least one baffle comprises at least one baffle of a first baffle type, which rests against the container wall of the receiving container in such a way that it protrudes from the container wall and projects into the receiving space as taught by a different embodiment of Damren, because the different embodiment of Damren teaches the module 304 comprises a body 306 which comprises a thermally conductive surface 310 adapted to contact the inner container to facilitate heat transfer (para. 0100], lines 7-11).
Regarding claim 3, Damren teaches the invention discussed above in claim 1. However, Damren does not explicitly teach at least one baffle, which extends at least along a portion spaced apart from the container wall of the receiving container through the receiving space.
For claim 3, a baffle type (heat exchange module 304, para. [0100], line 7), shown in Fig. 3, extending at least along a portion of the container wall 302 of reactor 300, and spaced apart of the container wall 302), which reads on the instant claim limitation of at least one baffle, which extends at least along a portion spaced apart from the container wall of the receiving container through the receiving space.
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to take the invention of Damren and further include at least one baffle, which extends at least along a portion spaced apart from the container wall of the receiving container through the receiving space, as taught by a different embodiment of Damren, because the different embodiment of Damren teaches the module 304 comprises a body 306 which comprises a thermally conductive surface 310 adapted to contact the inner container to facilitate heat transfer (para. 0100], lines 7-11).
Regarding claim 4, Damren teaches the invention discussed above in claim 1. However, Damren does not explicitly teach a baffle comprising a differential temperature control channel, through which the temperature control medium flows through the baffle in two opposite directions.
For claim 4, a different embodiment of Damren teaches module 1002 having an integral baffle 1006 which comprises baffle channels 1006, which direct fluid flow (para. [0115], lines 7-8), and the different embodiment of Damren teaches opposite directions of the fluid as indicated by the flow arrows in Fig. 12), which reads on the instant claim limitation of a baffle comprising a differential temperature control channel, through which the temperature control medium flows through the baffle in two opposite directions.
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to take the invention of Damren and further include a differential temperature control channel, through which the temperature control medium flows through the baffle in two opposite directions, as taught by a different embodiment of Damren, because the different embodiment of Damren teaches the latter allows for temperature control of fluid to module 1002 (para. [0116], lines 5-7).
Regarding claim 5, Damren teaches the invention discussed above in claim 1. Further, Damren teaches a disposable bioreactor bag, also discussed above. However, Damren does not explicitly teach at least one cooling bridge is arranged on at least one baffle wall.
For claim 5, a deferment embodiment of Damren teaches heat exchange module 304, para. [0100], line 7), shown in Fig. 3, extending at least along a portion of the container wall 302 of reactor 300, and spaced apart of the container wall 302, and when a bag is disposed within the receiving space of reactor 300; the bag abuts the bag when disposed in the receiving space of support structure 14—container, that is, the cooling bridge is the apex of module 304, shown in Fig. 3, which reads on the instant claim limitation of at least one cooling bridge is arranged on at least one baffle wall.
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to take the invention of Damren and further include at least one cooling bridge is arranged on at least one baffle wall, as taught by the different embodiment of Damren teaches the module 304 comprises a body 306 which comprises a thermally conductive surface 310 adapted to contact the inner container to facilitate heat transfer (para. 0100], lines 7-11).
Regarding claim 6, Damren teaches the invention discussed above in claim 1. Further, Damren teaches a receiving space of support structure 14, also discussed above. However, Damren does not explicitly teach a baffle penetrating the receiving space approximately completely along an approximately vertical direction.
For claim 6, a different embodiment of Damren teaches a baffle (baffle structure 710, para. [0109], line 12, Fig. 7) penetrating the receiving space approximately completely along an approximately vertical direction (as shown in Fig. 7), which reads on the instant claim limitation of a baffle penetrates the receiving space approximately completely along an approximately vertical direction.
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to take the invention of Damren and further include a baffle penetrating the receiving space approximately completely along an approximately vertical direction, as taught by a different embodiment of Damren, because the different embodiment teaches the body 706 of baffle structure 710 includes a thermally conductive surface 712 that can be disposed on the baffles 710 or the inner surface 720 between each baffle. The body includes a fluid circulation path through the space between the inner surface 720 and the outer support structure 704 (para. [0110], lines 13-18).
Regarding claim 7, Damren teaches the invention discussed above in claim 1 a receiving space of support structure 14, also discussed above. However, Damren does not explicitly teach a baffle is configured so as to project from one end of the receiving space into the receiving space.
For claim 7, a different embodiment of Damren teaches a baffle type (heat exchange module 304, para. [0100], line 7), shown in Fig. 3 resting against the container wall of tank or vessel 302 of the receiving container of reactor 300, also shown in Fig. 3, where module is also shown projecting from the container wall of vessel 302 and into the receiving space of reactor 300), which reads on the instant claim limitation of a baffle is configured so as to project from one end of the receiving space into the receiving space.
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to take the invention of Damren and further include a baffle is configured so as to project from one end of the receiving space into the receiving space, as taught by a different embodiment of Damren, because the different embodiment of Damren teaches the module 304 comprises a body 306 which comprises a thermally conductive surface 310 adapted to contact the inner container to facilitate heat transfer (para. 0100], lines 7-11).
Regarding claim 8, Damren teaches the invention discussed above in claim 1. Further, Damren teaches a receiving space of support structure 14, also discussed above. However, Damren does not explicitly teach wherein the at least one baffle buts the container wall of the receiving container in such a way that it protrudes from the container wall and projects into the receiving space; and wherein the baffle is configured so as to be rounded, such that a wall of the baffle and/or at least a transition from the container wall of the receiving container to the wall of the baffle abutting the former, which wall and/or transition is abutted by disposable bioreactor bag in the operating state, is configured so as to be substantially edgeless. However, Damren does not explicitly teach a baffle abutting a container wall of a receiving container in such a way that protrudes from the container wall and projects into the receiving space and herein the baffle is configured so as to be rounded, such that a wall of the baffle and/or at least a transition from the container wall of the receiving container to the wall of the baffle abutting the former, which wall and/or transition is abutted by disposable bioreactor bag in the operating state, is configured so as to be substantially edgeless.
For claim 8, a different embodiment of Damren teaches a baffle 710, which abuts a container wall (wall of outer support structure 704 , shown in Fig. 7) and protrudes into the receiving space of support structure 704 and the baffle is configured so as to be rounded (baffle 710 is shown in Fig. 7 to be rounded, also the different embodiment of Damren teaches the structure 710 can alternatively be of any geometric shape, for instance, circular (para. [0110], lines 6-7) which also abuts a the wall as shown in Fig. 7 when the disposable bag is disposed into the receiving space of container support structure 704, and is substantially edgeless, shown in Fig. 7), which reads on the instant claim limitation of a baffle abutting a container wall of a receiving container in such a way that protrudes from the container wall and projects into the receiving space and herein the baffle is configured so as to be rounded, such that a wall of the baffle and/or at least a transition from the container wall of the receiving container to the wall of the baffle abutting the former, which wall and/or transition is abutted by disposable bioreactor bag in the operating state, is configured so as to be substantially edgeless.
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to take the invention of Damren and further include a baffle abutting a container wall of a receiving container in such a way that protrudes from the container wall and projects into the receiving space and herein the baffle is configured so as to be rounded, such that a wall of the baffle and/or at least a transition from the container wall of the receiving container to the wall of the baffle abutting the former, which wall and/or transition is abutted by disposable bioreactor bag in the operating state, is configured so as to be substantially edgeless, as taught by a different embodiment of Damren, because the different embodiment of Damren teaches baffle structure 710 comprises a plurality of thermally conductive surfaces 712. The baffle structure 710 is adapted to contact the inner container (not shown) as it is disposed on an interior surface of the support structure 704 (para. [0109], lines 11-14), and the different embodiment of Damren teaches a protrusion can extend into the interior of the support vessel, such that when the flexible container is inserted into the support structure vessel, the fluid inside the flexible container is both baffled and temperature regulated. By baffling the inner container, mixing within the container can be improved. This integral system provides physical support for the flexible container, temperature regulation of the reactor system, and can provide increased mixing (para. [0108], lines 4-12).
Regarding claim 9, Damren teaches the invention discussed above in claim 1. Further, Damren teaches a container wall and a receiving space, also discussed above. However, Damren does not explicitly teach at least one baffle.
For claim 9, a different embodiment of Damren teaches a baffle 710, which abuts a container wall (wall of outer support structure 704 , shown in Fig. 7) and protrudes into the receiving space of support structure 704 (also, shown in Fig. 7), where baffle 710 is shown in Fig. 7 extending along a the housing wall of reactor system 700; further, baffle 710 is arranged along direction of the housing wall at angle (shown in Fig. 7), by baffling the inner container, mixing within the container can be improved (para. [0108], lines 8-9), which reads on the instant claim limitation of at least one baffle.
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to take the invention of Damren and further include at least one baffle buts the container wall of the receiving container in such a way that it protrudes from the container wall and projects into the receiving space; and wherein the baffle extends in a baffle extension direction along the housing wall of the receiving container and the baffle extension direction is arranged at an angle to a stirring shaft extension direction at taught by a different embodiment of Damren, because the different embodiment of Damren teaches baffle structure 710 comprises a plurality of thermally conductive surfaces 712. The baffle structure 710 is adapted to contact the inner container (not shown) as it is disposed on an interior surface of the support structure 704 (para. [0109], lines 11-14) and the different embodiment of Damren teaches a protrusion can extend into the interior of the support vessel, such that when the flexible container is inserted into the support structure vessel, the fluid inside the flexible container is both baffled and temperature regulated. By baffling the inner container, mixing within the container can be improved. This integral system provides physical support for the flexible container, temperature regulation of the reactor system, and can provide increased mixing (para. [0108], lines 4-12).
Regarding claim 10, Damren teaches the invention discussed above in claim 9. Further, Damren teaches receiving space, also discussed above. However, Damren does not explicitly teach at least one baffle.
For claim 10, a different embodiment of Damren teaches a baffle 710, which abuts a container wall (wall of outer support structure 704 , shown in Fig. 7) and protrudes into the receiving space of support structure 704 (also, shown in Fig. 7), where baffle 710 is shown in Fig. 7 extending along a the housing wall of reactor system 700, which reads on the instant claim limitation of at least one baffle of the receiving space of reactor 700.
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to take the invention of Damren and further include at least one baffle buts the container wall of the receiving container as taught by a different embodiment of Damren, because the different embodiment of Damren teaches a protrusion can extend into the interior of the support vessel, such that when the flexible container is inserted into the support structure vessel, the fluid inside the flexible container is both baffled and temperature regulated. By baffling the inner container, mixing within the container can be improved. This integral system provides physical support for the flexible container, temperature regulation of the reactor system, and can provide increased mixing (para. [0108], lines 4-12).
Regarding claim 11, Damren teaches the invention discussed above. However, Damren not explicitly teach a baffle wherein the at least one baffle is formed from a material having a thermal conductivity that is greater than 10W/mK and/or is solid in form.
For claim 11, a different embodiment of Damren teaches a body 706 which includes a thermally conductive surface 712 that can be disposed on baffles 710 (para. [0110], lines 13-15), which reads on the instant claim limitation of at least one baffle is formed from a material having a thermal conductivity that is solid in form.
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to take the invention of Damren and further include a baffle wherein the at least one baffle is formed from a material having a thermal conductivity that is greater than 10W/mK and/or is solid in form as taught by a different embodiment of Damren, because the different embodiment of Damren teaches baffle structure 710 comprises a plurality of thermally conductive surfaces 712. The baffle structure 710 is adapted to contact the inner container (not shown) as it is disposed on an interior surface of the support structure 704 (para. [0109], lines 11-14).
Regarding claim 12, Damren discloses at least one probe window (one or more windows 60, para. [0071], line 6, Fig. 1), which allows a view into the inside of the disposable bioreactor bag in the operating state of the bioreactor system (windows 60 for viewing a level of liquid 22 within the container 18, para. [0071], lines 6-7, Fig. 1); wherein the probe window comprises at least one thermally conductive probe window cover (support 14 is a stainless steel tank or vessel that surrounds container 18, para. [0064], lines 8-9), which is thermally conductively coupled to a cooling system of the bioreactor system (cooling source 312, para. [0100], line 15).
Regarding claim 13, Damren discloses comprising: ‒ a stirring system (mixing system such as an impeller 51, para. [0069], lines 1-2, Fig. 1) which projects at least partially into the receiving space (Fig. 1 depicts impeller 51 projecting into the receiving space of container 18 and support structure 14) and is designed and configured to stir a biomedium (mixing system for mixing contents of the vessel, para. [0050], lines 1-3) present in the disposable bioreactor bag in the operating state of the bioreactor system (a flexible bioreactor or mixer bag, para. [0009], lines 1-2); wherein ‒ the stirring system comprises a stirring shaft (impeller 51 is rotated about an axis, shaft shown as a vertical black line extending from impeller 51 to motor 52, shown in Fig. 1), which completely penetrates the receiving space in the operating state of the bioreactor system from a first stirring shaft end to a second stirring shaft end (direct shaft-drive mixers, para. [0050], line 13); and ‒ at least one stirring drive of the stirring system is configured at both the first stirring shaft end and the second stirring shaft end for driving the stirring shaft (drive shaft allows raising of an impeller above the bottom of the tank and/or allows for multiple impellers to be used, para. [0050], line 7-8; direct shaft-drive mixers, para. [0050], line 13).
Regarding claim 14, Damren discloses wherein the two stirring drives (direct shaft-drive mixers, para. [0050], line 13; drive shaft allows raising of an impeller above the bottom of the tank and/or allows for multiple impellers to be used, para. [0050], line 7-8) arranged at the stirring shaft ends can be operated in such a way that they drive the stirring shaft simultaneously and together in the same direction of rotation.
Regarding claim 15, Damren discloses wherein the two stirring drives arranged at the stirring shaft ends can be operated in such a way that they drive the stirring shaft in opposite directions of rotation (direct shaft-drive mixers, para. [0050], line 13; drive shaft allows raising of an impeller above the bottom of the tank and/or allows for multiple impellers to be used, para. [0050], line 7-8).
Regarding claim 16, Damren teaches the invention discussed above in claim 13. Further, Damren teaches a biomedium of the disposable bioreactor bag. However, Damren does not explicitly teach a precooling apparatus.
For claim 16, a different of Damren teaches an intercooler can be used to provide cooling of the inlet sparge gas and/or head space gas before it enters the bioreactor (para. [0075], lines 1-3), which reads on the instant claim limitation of a precooling apparatus.
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to take the invention of Damren and further include a precooling apparatus as taught by a different embodiment of Damren, because the different embodiment of Damren teaches the use of an intercooler provides additional heat removal from the liquid in the bioreactor as the cooled gas passes through the bioreactor (para. [0075], lines 3-5).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LENORA A. ABEL whose telephone number is (571)272-8270. The examiner can normally be reached Monday-Friday 7:00am-4:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Marcheschi can be reached at (571) 272-1374. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/L.A.A./Examiner, Art Unit 1799
/MICHAEL L HOBBS/Primary Examiner, Art Unit 1799
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