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 .
Preliminary Remarks
The amendment filed on 04/03/2026 has been entered. Claims 1, 3, 7, and 74 have been amended, claims 4, 6, 20-73 have been canceled, and claims 75-77 have been added. Therefore, claims 1-3, 5, 7-19, and 74-77 remain pending in the application.
Claim Objections
Claim 7 is objected to because of the following informalities: an “a” should be inserted after “comprises” and before “magnetic” in lines 1-2 of said claim. 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.
Claim 11 is 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.
Claim 11 recites the limitation "the second conduit" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 17 recites the limitation “the one or more spacer layers” in line 2. There is insufficient antecedent basis for this limitation in the claim.
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 1-3, 5, 7-18, and 75-76 are rejected under 35 U.S.C. 103 as being unpatentable over US4,634,675A-Freedman et al. (hereinafter “Freedman ‘675”), and further in view of US5,501,971A-Freedman et al. (hereinafter “Freedman ‘971”).
Regarding claim 1, Freedman discloses an apparatus for culturing cells, comprising: a bioreactor (abstract, lines 1-3; col. 2, lines 3-5; laboratory fermenter 10, Fig. 2, col. 3, lines 20-21; comprises culturing vessel 14, col. 3, line 26, Fig. 2); an agitator for pumping liquid through the cell culture bed (agitator 30, col. 3, line 59, Fig. 2); a drive for driving the agitator (drive motor assembly 28, col. 3, line 25, Fig. 2); a container within the bioreactor, said container housing the agitator (protective sheath 32b supports and surrounds driven assembly 32, col. 4, lines 33-35); a first conduit connected to the container (hollow body assembly 31, col. 3, line 61, Fig. 2), wherein the first conduit (hollow body assembly 31, Fig. 2) comprises a drain conduit adapted for draining liquid from the bioreactor (hollow body assembly 31 having a first open end 31a and a second closed end 31b. The hollow body assembly incorporates tubulations 33 which project laterally from said hollow body assembly proximate to the second end 31b of said assembly 31. Said tubulations 33 are hollow, and include a first end defining an exit opening 33a and a second end 33b. Said second end 33b of each said tubulation 33 is connected to said hollow body assembly 31 at an opening 27 in the cylindrical wall of the hollow body assembly to that flow through open end 31a of the hollow body assembly exits through openings 27 and continues through the tubulations and out exit openings 33a, col. 3-4, lines 61-68 and 1-5, respectively, Fig. 2); and a tubular post about which the agitator rotates, the first conduit being connected to the tubular post (tubular post—shaft 35; agitator 30 is mounted on shaft 35; shaft 45 is rotatably supported by bearing assembly 37, col. 4, lines 36-39; when magnet 28a of the magnetic drive motor 28 rotates it causes the driven magnet assembly 32 to rotate as well, thereby turning the agitator 30 and shaft 35 on the axis defined by said shaft, col. 4, lines 37-40). However, Freedman ‘675 does not explicitly teach a fixed cell culture bed.
For claim 1, Freedman ‘971 teaches a method and apparatus cultivates anchorage and nonanchorage cell in a reactor; a reactor includes a basket type packed bed (abstract, lines 1-3; col. 2, lines 37-41), and Freedman ‘971 teaches carrier material 16 positioned in reactor 10 (col. 3, lines 33-34, Fig. 1), which reads on the instant claim limitation of a fixed culture bed.
It would have been obvious to one of ordinary skill, in the art at the time, to further include a fixed cell culture bed as taught by Freedman ‘971, because Freedman ‘971 teaches that separation of cells from secreted proteins and waste products is simplified because they remain trapped in carrier material 16 during perfusion (col. 5, lines 12-16) and cells grown in suspension are retained within the packed bed of the carrier material (col. 5, lines 20-21).
Regarding claim 2, Freedman ‘675 teaches the invention discussed above in claim 1. However, Freedman ‘675 does not explicitly teach an injector conduit for delivering gas bubbles into the container.
For claim 2, Freedman ‘971 teaches a method and apparatus cultivates anchorage and nonanchorage cell in a reactor (abstract; col. 2, lines 37-39) and Freedman ‘971 teaches a sparger 139 for introducing air (gas, col. 4, lines 31-32, Fig. 2; and col. 9, line 12), which reads on the instant claim limitation of an injector conduit for delivering gas bubbles into the container.
It would have been obvious to one of ordinary skill, in the art at the time, to further include an injector conduit for delivering gas bubbles into the container as taught by Freedman ‘971, because Freedman ‘971 teaches sparger 139 allows for oxygenated medium and disengaging the bubbles at the upper fluid surface (col. 4, lines 32-34).
Regarding claim 3, Freedman ‘675 teaches the invention discussed above in claim 1. However, Freedman ‘675 does not explicitly teach wherein the injector conduit is connected to the container.
For claim 3, Freedman ‘971 teaches a method and apparatus cultivates anchorage and nonanchorage cell in a reactor (abstract; col. 2, lines 37-39) and Freedman ‘971 teaches a sparger 139 for introducing air (gas, col. 4, lines 31-32, Fig. 2; and col. 9, line 12) connected to the container (shown in Fig. 2), which reads on the instant claim limitation of wherein the injector conduit is connected to the container.
It would have been obvious to one of ordinary skill, in the art at the time, to further include wherein the injector conduit is connected to the container, as taught by Freedman ‘971, because Freedman ‘971 teaches sparger 139 allows for oxygenated medium and disengaging the bubbles at the upper fluid surface (col. 4, lines 32-34).
Regarding claim 5, Freedman ‘675 teaches the invention discussed above in claim 1. Further, Freedman ‘675 teaches a central chamber of fermenter 10, shown in Fig. 2; and a cover (vessel cap 16a, Fig. 2). Also, Freedman ‘675 teaches a first conduit disposed in the central chamber of fermenter 110, also discussed above. However, Freedman ‘675 does not explicitly teach the first conduit extending from the cover.
For claim 5, Freedman ‘971 teaches a method and apparatus cultivates anchorage and nonanchorage cell in a reactor (abstract; col. 2, lines 37-39) and Freedman ‘971 teaches a first conduit tube 130 (col. 4, line 11, Fig. 2), where tube 130 is shown extending from the cover 128 and tube 130 extends through a central chamber of fermenter 10 (col. 4, lines 12-13, Fig. 2), which reads on the instant claim limitation of the first conduit extending from the cover.
It would have been obvious to one of ordinary skill, in the art at the time, to further include a first conduit extending from the cover, as taught by Freedman ‘971, because Freedman ‘971 teaches tube 130 extends through a packed bed to the bottom of the vessel (col. 4, lines 12-13).
Regarding claim 7, Freedman ‘675 discloses wherein the agitator comprises magnetic, impeller rotatably coupled to the tubular post by a bearing (agitator 30 is mounted on shaft 35 by means of set screw 36, shaft 35 in turn is rotatably supported by bearing assembly 34, which includes bearings 37. An annular driven magnet assembly 32 is affixed proximate to the first end 31a of hollow body assembly 31 by means of rods 38, col. 4, lines 28-33, Fig. 2).
Regarding claim 8, Freedman ‘675 teaches the invention discussed above in claim 1. Further, Freedman ‘675 teaches an agitator and an impeller, discussed above. However, Freedman ‘675 does not explicitly teach a plurality of curved vanes.
For claim 8, Freedman ‘971 teaches impeller 28 comprising curved vanes (blade 29, shown in Fig. 1), which reads on the instant claim limitation of a plurality of curved vanes.
It would have been obvious to one of ordinary skill, in the art at the time, to further include a plurality of curved vanes as taught by Freedman ‘971, because Freedman ‘971 teaches blades 29 of impeller 28 allows for the pushing of medium away in a direction that circulates around the interior of reactor 10 (col. 3, lines 43-47, Fig. 1).
Regarding claim 9, Freedman ‘675 teaches the invention discussed above in claim 1. Further, Freedman ‘675 teaches an agitator and an impeller, discussed above. However, Freedman ‘675 does not explicitly a plurality of vanes of variable height.
For claim 9, Freedman ‘971 teaches impeller 28 comprising curved vanes (blade 29, shown in Fig. 1), where blades 29 are shown at different heights in Fig. 2, which reads on the instant claim limitation of a plurality of vanes of variable height.
It would have been obvious to one of ordinary skill, in the art at the time, to further include plurality of vanes of variable height as taught by Freedman ‘971, because Freedman ‘971 teaches blades 29 of impeller 28 allows for the pushing of medium away in a direction that circulates around the interior of reactor 10 (col. 3, lines 43-47, Fig. 1).
Regarding claim 10, Freedman ‘675 teaches the invention discussed above in claim 9. Further, Freedman ‘675 teaches a sloped portion wherein the container comprises a sloped upper portion directly above the agitator (sloped annular driven magnet assembly 32 above agitator 31, shown in Fig. 2), the sloped upper portion adapted to accommodate the variable height agitator. However, Freedman ‘675 does not explicitly teach variable height of an agitator.
For claim 10, Freedman ‘971 teaches impeller 28 comprising curved vanes (blade 29, shown in Fig. 1), where blades 29 are shown at different heights in Fig. 2, which reads on the instant claim limitation of variable height of an agitator.
It would have been obvious to one of ordinary skill, in the art at the time, to further include plurality of vanes of variable height as taught by Freedman ‘971, because Freedman ‘971 teaches blades 29 of impeller 28 allows for the pushing of medium away in a direction that circulates around the interior of reactor 10 (col. 3, lines 43-47, Fig. 1).
Regarding claim 11, Freedman ‘675 teaches the invention discussed above in claim 2. Further, Freedman ‘675 teaches a first conduit and a second conduit (tubulations 33, col. 3, lines 62-63, Fig. 2), also discussed above. However, Freedman ‘675 does not explicitly teach a fitment.
For claim 11, Freedman ‘971 teaches a sparger 139 for introducing air (gas, col. 4, lines 31-32, Fig. 2; and col. 9, line 12), additionally, Fig. 2 of a different embodiment of Freedman includes a fitment (shown below in annotated Fig. 2), which reads on the instant claim limitation of a fitment.
It would have been obvious to one of ordinary skill, in the art at the time, to further include a fitment adapted to form custom-sized bubbles from a gas as taught by Freedman ‘971, because Freedman ‘971 teaches sparger 139 allows for oxygenated medium and disengaging the bubbles at the upper fluid surface (col. 4, lines 32-34).
Regarding claim 12, Freedman ‘675 teaches the invention discussed above in claim 11. However, Freedman ‘675 does not explicitly teach a fitment comprising a perforated portion.
For claim 12, Freedman ‘971 teaches a sparger 139 for introducing air (gas, col. 4, lines 31-32, Fig. 2; and col. 9, line 12), where sparger 139 comprises holes or perforations for introducing air, which reads on the instant claim limitation of a fitment comprising a perforated portion.
It would have been obvious to one of ordinary skill, in the art at the time, to further include a sparger and fitment comprising a perforated portion as taught by Freedman ‘971, because Freedman ‘971 teaches sparger 139 allows for oxygenated medium and disengaging the bubbles at the upper fluid surface (col. 4, lines 32-34).
Regarding claim 13, Freedman ‘675 teaches the invention discussed above in claim 1. However, Freedman ‘675 does not explicitly teach a cell culture bed.
For claim 13, Freedman ‘971 teaches a reactor includes a basket type packed bed (abstract, lines 1-3; col. 2, lines 37-41), and Freedman ‘971 teaches carrier material 16 positioned in reactor 10 (col. 3, lines 33-34, Fig. 1), and Freedman ‘971 teaches air is introduced from sparger 139 at the bottom hollow shaft 126 for providing an oxygenated medium and disengaging the bubbles at the upper fluid surface (col. 4, lines 31-36), which reads on the instant claim limitation of a cell culture bed.
It would have been obvious to one of ordinary skill, in the art at the time, to further include a sparger 139 for introducing bubbles into the apparatus as taught by Freedman ‘971 because Freedman ‘971 teaches a sparger for introducing bubbles at the bottom of the vessel and near the agitator (impeller) of the apparatus for providing an oxygenated medium (col. 4, lines 31-33).
Regarding claim 14, Freedman ‘675 teaches the invention discussed above in claim 1. However, Freedman ‘675 does not explicitly teach a fixed bed.
For claim 14, Freedman ‘971 teaches a method and apparatus cultivates anchorage and nonanchorage cell in a reactor; a reactor includes a basket type packed bed (abstract, lines 1-3; col. 2, lines 37-41), and Freedman ‘971 teaches carrier material 16 positioned in reactor 10 (col. 3, lines 33-34, Fig. 1), which reads on the instant claim limitation of a fixed culture bed.
It would have been obvious to one of ordinary skill, in the art at the time, to further include a fixed cell culture bed as taught by Freedman ‘971, because Freedman ‘971 teaches that separation of cells from secreted proteins and waste products is simplified because they remain trapped in carrier material 16 during perfusion (col. 5, lines 12-16) and cells grown in suspension are retained within the packed bed of the carrier material (col. 5, lines 20-21).
Regarding claim 15, Freedman ‘675 teaches the invention discussed above in claim 1. However, Freedman ‘675 does not explicitly teach a fixed bed comprising a fixed bed.
For claim 15, Freedman ‘971 teaches reactor 10 includes vessel 12 and basket 14 disposed within the vessel. Carrier material 16 is positioned within basket 14. Screens 18 and 20 form the top and bottom portions of basket 14 and allow flow of medium through basket 14, col. 3, lines 32-36; col. 2, lines 37-40), which reads on the instant claim limitation of a fixed bed comprising a structured fixed bed.
It would have been obvious to one of ordinary skill, in the art at the time, to further include a fixed bed comprising a structured fixed bed as taught by Freedman ‘971, because Freedman ‘971 teaches that separation of cells from secreted proteins and waste products is simplified because they remain trapped in carrier material 16 during perfusion (col. 5, lines 12-16) and cells grown in suspension are retained within the packed bed of the carrier material (col. 5, lines 20-21).
Regarding claim 16, Freedman ‘675 teaches the invention discussed above in claim 15. However, Freedman ‘675 does not explicitly teach a structured fixed bed.
For claim 16, Freedman ‘971 teaches a fiber matrix carrier is placed in a basket within a reactor vessel. A top and bottom portion of the basket has holes therethrough for allowing medium to flow uniformly through the basket (col. 2, lines 41-44), which reads on the instant claim limitation of a structured fixed bed comprising alternating layers comprising one or more cell immobilization layers.
It would have been obvious to one of ordinary skill, in the art at the time, to further include a fixed bed comprising a structured fixed bed comprising alternating layers comprising one or more cell immobilization layers as taught by Freedman ‘971, because Freedman ‘971 teaches that separation of cells from secreted proteins and waste products is simplified because they remain trapped in carrier material 16 during perfusion (col. 5, lines 12-16) and cells grown in suspension are retained within the packed bed of the carrier material (col. 5, lines 20-21).
Regarding claim 17, Freedman ‘675 teaches the invention discussed above in claim 16. However, Freedman ‘675 does not teach one or more cell immobilization layers in the fixed bed.
For claim 17, Freedman ‘971 teaches a fiber matrix carrier is placed in a basket within a reactor vessel. A top and bottom portion of the basket has holes therethrough for allowing medium to flow uniformly through the basket (col. 2, lines 41-44), which reads on the instant claim limitation of one or more cell immobilization layers in the fixed bed.
It would have been obvious to one of ordinary skill, in the art at the time, to further include a fixed bed comprising a structured fixed bed comprising alternating layers comprising one or more cell immobilization layers as taught by Freedman ‘971, because Freedman ‘971 teaches that separation of cells from secreted proteins and waste products is simplified because they remain trapped in carrier material 16 during perfusion (col. 5, lines 12-16) and cells grown in suspension are retained within the packed bed of the carrier material (col. 5, lines 20-21).
Regarding claim 18, Freedman ‘675 teaches the invention discussed above in claim 1. However, Freedman ‘675 does not explicitly teach a cell culture bed in an annular chamber of the bioreactor.
For claim 18, Freedman ‘971 teaches a basket 14 and carrier material 16, shown in Fig. 1. col. 3, lines 32-34) is located in an annular outer chamber (carrier material 16 in basket 14, Fig. 1) of the bioreactor (vessel 12, Fig. 1) adapted to receive a flow of liquid (col. 3, lines 33-36) from a pumping action created by rotation of the agitator (impeller, (col. 3, lines 43-44, Fig. 1) in the container (reactor 10, Fig. 1), which reads on the instant claim limitation of a cell culture bed in an annular chamber of the bioreactor.
It would have been obvious to one of ordinary skill, in the art at the time, to further include a cell culture bed in an annular chamber of the bioreactor as taught by Freedman ‘971, because Freedman ‘971 teaches that separation of cells from secreted proteins and waste products is simplified because they remain trapped in carrier material 16 during perfusion (col. 5, lines 12-16) and cells grown in suspension are retained within the packed bed of the carrier material (col. 5, lines 20-21).
Regarding claim 75, Freedman ‘675 discloses wherein the tubular post (tubular post—shaft 35, Fig. 2) is positioned in a stationary position (tubular post—shaft 35, is shown in a stationary position in fermenter 10, Fig. 2) so as to support the agitator (agitator 30, Fig. 2) at a bottom of the reactor and to further locate the drain tube at the bottom of the reactor (hollow body assembly 31 having a first open end 31a and a second closed end 31b. The hollow body assembly incorporates tubulations 33 which project laterally from said hollow body assembly proximate to the second end 31b of said assembly 31. Said tubulations 33 are hollow, and include a first end defining an exit opening 33a and a second end 33b. Said second end 33b of each said tubulation 33 is connected to said hollow body assembly 31 at an opening 27 in the cylindrical wall of the hollow body assembly to that flow through open end 31a of the hollow body assembly exits through openings 27 and continues through the tubulations and out exit openings 33a, col. 3-4, lines 61-68).
Regarding claim 76, Freedman ‘675 discloses wherein the tubular post includes an inlet at a bottom of the tubular post, located at a bottom of the reactor and further includes an outlet at a top of the tubular post connecting to the drain tube (hollow body assembly 31 having a first open end 31a and a second closed end 31b. The hollow body assembly incorporates tubulations 33 which project laterally from said hollow body assembly proximate to the second end 31b of said assembly 31. Said tubulations 33 are hollow, and include a first end defining an exit opening 33a and a second end 33b. Said second end 33b of each said tubulation 33 is connected to said hollow body assembly 31 at an opening 27 in the cylindrical wall of the hollow body assembly to that flow through open end 31a of the hollow body assembly exits through openings 27 and continues through the tubulations and out exit openings 33a, col. 3-4, lines 61-68).
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over US4,634,675A-Freedman et al. (hereinafter “Freedman ‘675”), in view of US5,501,971A-Freedman et al. (hereinafter “Freedman ‘971” as applied to claim 1 above, and further in view of US 2011/0263021 A1-Stobbe.
Regarding claim 19, modified Freedman teaches the invention discussed above in claim 1. Further, modified Freedman teaches a cell culture bed and an annular outer chamber also discussed above. However, modified Freedman does not explicitly teach a plurality of cell culture beds arranged in a stacked configuration.
For claim 19, Stobbe teaches an invention relating to a device such as a bio-reactor or a bio-reactor module, for producing a bio material and/or a therapeutic material, a process for creating a micro-organism friendly environment for use in a bio-reactor and methods for operating said bio-reactor (para. [0001]), and Stobbe teaches s plurality of cell culture beds arranged in a stacked configuration (discs 11, para. [0070], lines 2-4; para. [0350], lines 1-3, Fig. 1; para. [0362], lines ), which reads on the instant claim limitation of a plurality of cell culture beds arranged in a stacked configuration.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to take the modified reactor of Freedman to further include a plurality of cell culture beds arranged in a stacked configuration as taught by Stobbe. Further, Stobbe teaches, the individual matrix sections are stacked on top of each other and separated by spacers on both the inlet side and on the circumferential side. This design creates a symmetrical and parallel arrangement so that the spacers located between different matrix sections correspond with and, under practical circumstances, is in liquid contact with, both one or more inlet port(s) and one or more outlet port(s) which are isolated from the inlet port(s) and/or from the matrix sections by said spacers (para. [0140], lines 2-9).
Claim 74 is rejected under 35 U.S.C. 103 as being unpatentable over US4,634,675A-Freedman et al. (hereinafter “Freedman ‘675”), in view of US5,501,971A-Freedman et al. (hereinafter “Freedman ‘971” as applied to claim 1 above, and further in view of CN205443336U-Xiao (all citations are made to the machine English translation).
Regarding claim 74, modified Freedman teaches the invention discussed above in claim 1. Further, Freedman teaches a tubular post also, discussed above. However, modified Freedman does not explicitly teach a crenulated portion adjacent to a floor of the bioreactor.
For claim 74, Xiao teaches an invention relating to the field of biotechnology, and particularly relating to a bioreactor (page 1, line 1—Technical Field), and Xiao teaches a tube (inlet 312, is formed in a zigzag shape at the bottom of tube 213, and adjacent to a floor of the bioreactor—tank body 1, shown in Fig. 1, page 3, paragraph 2, lines 1-2), which reads on the instant claim limitation of a crenulated portion adjacent to a floor of the bioreactor.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to take the modified reactor of Freedman to further include a crenulated portion adjacent to a floor of the bioreactor as taught by Xiao. Further, Xiao teaches the zigzag shape increases the amount of liquid per unit time and effectively improves the problem of liquid absorption (page 3, paragraph 2, lines 3-4).
Allowable Subject Matter
Claim 77 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: for claim 77, the prior art fails to teach or fairly suggest wherein the bottom of the tubular post comprises crenulations so as to create apertures bounded by the crenulations and the bottom of the reactor, thereby creating at least one aperture to the inlet of the tubular post at a bottommost location in the reactor, where these limitations are in combination with the claim as a whole.
The closest prior art is Freedman et al. US 4,634,675A, US5,501,971A-Freedman et al., and CN205443336U-Xiao. Freedman ‘675 teaches an improved agitator for use with a fermentation and tissue culturing vessel acting as a microcarrier culture vessel is provided. Freedman ‘971 teaches a method and apparatus cultivates anchorage and nonanchorage cell in a reactor. A reactor includes a basket type packed bed and an internal recirculation device. Xiao teaches a bioreactor, which includes a sealed tank body and a three-way connecting pipe, and the three-way connecting pipe is provided with a first connecting part, a second connecting part and a third connecting part. However, Freedman ‘675, Freedman ‘971, and Xiao does not teach or fairly suggest wherein the bottom of the tubular post comprises crenulations so as to create apertures bounded by the crenulations and the bottom of the reactor, thereby creating at least one aperture to the inlet of the tubular post at a bottommost location in the reactor.
Response to Arguments
Applicant's arguments filed 04/03/2026 have been fully considered but they are not persuasive. On the middle of page 5 of applicant’s remarks, the attorney of record asserted the current combination of references used in rejecting claim 1 would no longer render such an amended claim 1 unpatentable. However, the Examiner merely noted that further search and consideration would need to be conducted and that a decision of patentability of the instant application could not be reached during the time of the interview, as noted in the Interview Summary mailed on 02/13/2026.
Conclusion
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 LENORA A. ABEL whose telephone number is (571)272-8270. The examiner can normally be reached Monday-Friday 7:00am-4:00pm.
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, 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.
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.
/L.A.A./Examiner, Art Unit 1799
/MICHAEL L HOBBS/Primary Examiner, Art Unit 1799
Prosecution Insights