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
Claims 1-9 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 06/24/2026.
Applicant’s election with traverse of claims 10-18 in the reply filed on 06/24/2026 is acknowledged. The traversal is on the ground(s) that:
Invention I: this is a support apparatus for a flexible bioprocessing vessel, e.g. a rigid tank, having a hexagonal interior (claims 1-9); and
Invention II: this is a hexagonal flexible bioprocessing vessel (claims 10-18) that may be used with, e.g. the support apparatus of claim 1-9.
The limitation of “[a] liquid level height to width ratio of ≤1” has been recited in both inventions.
Claim groups are believed to be closely related such that there would be no search burden.
This is not found persuasive because:
The inventions are doubly distinct from each other for the reasons set forth in the previous restriction – Invention I is an apparatus holding a vessel; Invention II is a hexagonal vessel. The arguments above do not address these distinctions.
The claim groups are classified under at least two different CPC symbols:
C12M23/48 (Invention I); and/or,
C12M23/26 (Invention II).
The requirement is still deemed proper and is therefore made FINAL.
Information Disclosure Statement
The information disclosure statement(s) (IDS) were submitted on:
03/07/2025
Accordingly, the information disclosure statement(s) are being considered by the examiner.
Claim Objections
Claims 10-11 and 13 are objected to because of the following informalities:
Regarding claim 10, lines 10-11, the terms “removing fluid” could be “removing a fluid”.
Regarding claim 10, line 13, the term “wherein hexagonal flexible bioprocessing vessel” should be “wherein the hexagonal flexible bioprocessing vessel”.
Regarding claim 11, lines 2-3, the phrase “a liquid level height to width ratio” should be “the liquid level height to width ratio”.
Regarding claim 13, lines 2-3, the phrase “a liquid level height to width ratio” should be “the liquid level height to width ratio”.
Appropriate correction is required.
Claim Rejections - 35 USC §§ 102 | 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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
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 10 and 15-16 are rejected under 35 U.S.C. 102(a)(1) as anticipated by Bibbo (US 20030198406) (newly cited) or, in the alternative, under 35 U.S.C. 103 as obvious over Bibbo (US 20030198406) (newly cited).
Regarding claim 10, Bibbo discloses a hexagonal flexible bioprocessing vessel (paragraphs [0120] and [0126]) comprising:
six flexible (paragraph [0126]) panels (paragraph [0120]) forming sides of the hexagonal flexible bioprocessing vessel (paragraphs [0120] and [0126]);
a top panel (paragraph [0115] “top end wall 215” in Figs. 8 and 9) adjoining the six flexible panels, the top panel forming a top of the hexagonal flexible bioprocessing vessel;
a bottom panel adjoining the six flexible panels, the bottom panel located on an opposite end of the hexagonal flexible bioprocessing vessel from the top panel (paragraph [0115] “bottom end wall 217” in Figs. 8 and 9), and forming a bottom of the hexagonal flexible bioprocessing vessel, the six flexible panels, top surface, and bottom panel defining an interior cavity configured for processing a fluid (paragraph [0121]); and
at least one fluid input (paragraph [0168] “Fluid line 440”) and at least one fluid output (paragraph [0168] “air outlet line 446”) for adding and removing fluid to and from the interior cavity of the hexagonal flexible bioprocessing vessel respectively (paragraph [0120]).
Bibbo does not disclose:
wherein hexagonal flexible bioprocessing vessel has a liquid level height to width ratio of ≤1.
Regarding feature 1, regarding the limitation “a liquid level height to width ratio of ≤1” the manner of operating or intended use of a claimed apparatus does not patentably distinguish it from the prior art. MPEP § 2114(II). The device of Bibbo would be fully capable of operating in this manner given the amount of liquid solution pumped into the hexagonal flexible bioprocessing vessel of Bibbo thus the claim is anticipated by Bibbo.
In addition, the claim limitation is obvious under MPEP § 2144.04(IV)(A), which states that “where the only difference between the prior art and the claims was a recitation of relative dimensions … [and the claimed device] would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device”. It would have been obvious to one skilled in the art before the effective filing date to modify Bibbo with the ratio claimed in order to be able to use magnetic stir bars to rotate the solution within the mixing bag (Bibbo, paragraph [0140]).
Additionally, the limitation is obvious as a matter of routine optimization, because a liquid level height to width ratio of ≤1 is a result-effective variable based on the liquid fill level and the width of the hexagonal flexible bioprocessing vessel. The motivation for optimizing this result-effective variable is to have a lower liquid level to be able to use magnetic stir bars to rotate the solution within the mixing bag (Bibbo, paragraph [0140]). MPEP § 2144.05(II).
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Bibbo, Fig. 8
Regarding claim 15, Bibbo discloses the hexagonal flexible bioprocessing vessel of claim 10 wherein the bottom panel and/or the top panel is a separate panel (paragraphs [0117]-[0118]).
Regarding claim 16, Bibbo discloses the hexagonal flexible bioprocessing vessel of claim 10 wherein each of the six flexible panels are thermally welded to adjacent panels (paragraph [0118] “heat energies” forming “seams” around the “perimeter edges of each panel”).
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 11-14 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Bibbo (US 20030198406) (newly cited).
Regarding claim 11, Bibbo discloses the hexagonal flexible bioprocessing vessel of claim 10 wherein the hexagonal flexible bioprocessing vessel (paragraphs [0120] and [0126]) has a 1500L or 3000L capacity, or other desired amounts (paragraph [0120]).
Bibbo does not disclose a 2000L capacity and a liquid level height to width ratio of about .91.
Regarding this limitation, “2000L capacity”, it would have been obvious to one skilled in the art before the effective filing date to modify Bibbo to be 2000L as it is inside the ranges between 1500L and 3000L in order to optimize the volume constraint for the bioprocess being run to be well-mixed given a particular type of stirring mechanism.
Additionally, the limitation “2000L capacity” is obvious as a matter of routine optimization, because a 2000L capacity is a result-effective variable based on the size of the hexagonal flexible bioprocessing vessel. The motivation for optimizing this result-effective variable is to have a lower liquid level to be able to use magnetic stir bars to rotate the solution within the mixing bag (Bibbo, paragraph [0140]) and to optimize the volume constraint for the bioprocess being run to be well-mixed given a particular type of stirring mechanism. MPEP § 2144.05(II).
Regarding this limitation, “a liquid level height to width ratio of 0.91” the manner of operating or intended use of a claimed apparatus does not patentably distinguish it from the prior art. MPEP § 2114(II). The device of Bibbo would be fully capable of operating in this manner given the amount of liquid solution pumped into the hexagonal flexible bioprocessing vessel of Bibbo.
However, the entire claim limitation is obvious under MPEP § 2144.04(IV)(A), which states that “where the only difference between the prior art and the claims was a recitation of relative dimensions … [and the claimed device] would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device”. It would have been obvious to one skilled in the art before the effective filing date to modify Bibbo with the ratio claimed in order to be able to use magnetic stir bars to rotate the solution within the mixing bag (Bibbo, paragraph [0140]).
Additionally, the limitation “a liquid level height to width ratio of 0.91” is obvious as a matter of routine optimization, because a liquid level height to width ratio of 0.91 is a result-effective variable based on the liquid fill level and the width of the hexagonal flexible bioprocessing vessel. The motivation for optimizing this result-effective variable is to have a lower liquid level to be able to use magnetic stir bars to rotate the solution within the mixing bag (Bibbo, paragraph [0140]). MPEP § 2144.05(II).
Regarding claim 12, Bibbo discloses the hexagonal flexible bioprocessing vessel of claim 11 wherein the hexagonal flexible bioprocessing vessel (paragraphs [0120] and [0126]).
Bibbo does not disclose a width of about 150cm, an overall height of about 151cm, and a liquid level height of about 137cm.
Regarding the limitation “a width of about 150cm, an overall height of about 151cm”, the claim limitation is obvious under MPEP § 2144.04(IV)(A), which states that “where the only difference between the prior art and the claims was a recitation of relative dimensions … [and the claimed device] would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device”. It would have been obvious to one skilled in the art before the effective filing date to modify Bibbo with the width and height claimed in order to be able to use magnetic stir bars to rotate the solution within the mixing bag (Bibbo, paragraph [0140]).
Regarding the limitation “a liquid level height of about 137cm”, the manner of operating or intended use of a claimed apparatus does not patentably distinguish it from the prior art. MPEP § 2114(II). The device of Bibbo would be fully capable of operating in this manner given the virtually any desired size, shape, and configuration of the mixing bag (Bibbo, paragraph [0120]).
Regarding claim 13, Bibbo discloses the hexagonal flexible bioprocessing vessel of claim 10 wherein the hexagonal flexible bioprocessing vessel (paragraphs [0120] and [0126]) has a 3000L capacity (paragraph [0120]).
Bibbo does not disclose a liquid level height to width ratio of about .86.
Regarding this limitation, “a liquid level height to width ratio of 0.86” the manner of operating or intended use of a claimed apparatus does not patentably distinguish it from the prior art. MPEP § 2114(II). The device of Bibbo would be fully capable of operating in this manner given the amount of liquid solution pumped into the hexagonal flexible bioprocessing vessel of Bibbo.
However, the claim limitation is obvious under MPEP § 2144.04(IV)(A), which states that “where the only difference between the prior art and the claims was a recitation of relative dimensions … [and the claimed device] would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device”. It would have been obvious to one skilled in the art before the effective filing date to modify Bibbo with the ratio claimed in order to be able to use magnetic stir bars to rotate the solution within the mixing bag (Bibbo, paragraph [0140]).
Additionally, the limitation is obvious as a matter of routine optimization, because a liquid level height to width ratio of 0.86 is a result-effective variable based on the liquid fill level and the width of the hexagonal flexible bioprocessing vessel. The motivation for optimizing this result-effective variable is to have a lower liquid level to be able to use magnetic stir bars to rotate the solution within the mixing bag (Bibbo, paragraph [0140]). MPEP § 2144.05(II).
Regarding claim 14, Bibbo does not disclose the hexagonal flexible bioprocessing vessel of claim 13 wherein the hexagonal flexible bioprocessing vessel has a width of about 175cm, an overall height of about 159cm, and a liquid level height of about 151cm.
Regarding the limitation “a width of about 175cm, an overall height of about 159cm”, the claim limitation is obvious under MPEP § 2144.04(IV)(A), which states that “where the only difference between the prior art and the claims was a recitation of relative dimensions … [and the claimed device] would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device”. It would have been obvious to one skilled in the art before the effective filing date to modify Bibbo with the width and height claimed in order to be able to use magnetic stir bars to rotate the solution within the mixing bag (Bibbo, paragraph [0140]).
Regarding the limitation “a liquid level height of about 151cm”, the manner of operating or intended use of a claimed apparatus does not patentably distinguish it from the prior art. MPEP § 2114(II). The device of Bibbo would be fully capable of operating in this manner given the virtually any desired size, shape, and configuration of the mixing bag (Bibbo, paragraph [0120]).
Regarding claim 18, Bibbo does not disclose the hexagonal flexible bioprocessing vessel of claim 10 wherein the hexagonal flexible bioprocessing vessel may be folded and unfolded.
However, given the flexible material of Bibbo’s vessel (paragraph [0116]), it would have been obvious to one skilled in the art before the effective filing date to modify the vessel to be able to be folded and unfolded in order to put the vessel in a bag to be sterilized by gamma irradiation before use during its manufacture.
Regarding the limitation “folded for storage and/or transportation and unfolded for installation on a bottom surface of a rigid support structure” the manner of operating or intended use of a claimed apparatus does not patentably distinguish it from the prior art. MPEP § 2114(II). The device of Bibbo would be fully capable of operating in this manner given the flexible material of Bibbo.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Bibbo (US 20030198406) (newly cited) as applied to claim 10, in view of Mietzner (US 20170369828) (newly cited).
Regarding claim 17, Bibbo discloses the hexagonal flexible bioprocessing vessel of claim 10 wherein the interior cavity (paragraph [0115]) includes an impeller (paragraphs [0139]-[0140]) and the top panel (paragraph [0115] “top end wall 215” in Figs. 8 and 9).
Bibbo does not disclose [including] a selectively removable impeller cover to protect the impeller during transportation of the hexagonal flexible bioprocessing vessel.
Mietzner discloses an impeller cover (Figs. 1-3 and elements 106, 206, or 306 “manway”).
In the analogous art of bioreactors with liners, it would have been obvious to one skilled in the art before the effective filing date to modify the vessel of Bibbo with the impeller cover of Mietzner in order to remove the top impeller cover for a person to be able to clean and/or sterilize the internal space of the bioreactor (Mietzner, paragraphs [0071] and [0083]).
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Mietzner, Fig. 1
Regarding the limitation “selectively removable”, making parts separable or removable would be obvious. MPEP § 2144.04(V)(C). It would have been obvious to one skilled in the art before the effective filing date to modify the vessel of Bibbo with the impeller cover of Mietzner in order to remove the top impeller cover for a person to be able to clean and/or sterilize the internal space of the bioreactor (Mietzner, paragraphs [0071] and [0083]).
Regarding limitation “to protect the impeller during transportation of the hexagonal flexible bioprocessing vessel”, the manner of operating or intended use of a claimed apparatus does not patentably distinguish it from the prior art. MPEP § 2114(II). The device of modified Bibbo would be fully capable of operating in this manner given the impeller cover of modified Bibbo.
Additional Prior Art References
The prior art made of record and not relied upon is considered pertinent to Applicant’s disclosure.
Bibbo (US 20030226857) (newly cited) – This invention is a culture feed bag with hexagonal sides, see Figs. 6-8.
Bibbo (US 20030231546) (newly cited) – This invention is a culture feed bag with hexagonal sides, see Figs. 6-8.
Bibbo (US 20040027912) (newly cited) – This invention is a culture feed bag with hexagonal sides, see Figs. 6-8.
Bibbo (US 20050073908) (newly cited) – This invention is a culture feed bag with hexagonal sides, see Figs. 6-8.
Gebauer (US 20190015799) (newly cited) – This invention is a rigid housing holding a flexible bag, including a hexagonal shape, see paragraph [0032].
Kim (KR 20230072447) (machine translated) (newly cited) – This invention is a cell culture bag.
Takeuchi (US 20190264158) (newly cited) – This invention is a method for producing liquid medium composition and production device used therefor.
Redford (US 20120329147) (newly cited) – This invention’s photobioreactor bag in the shape of a hexagon may be pertinent to the instant application.
Marshall (US 20160296897) (newly cited) – This invention has a bioprocessing bag with an impeller housing in the bottom of the bag.
Mahajan (US 20160304824) (newly cited) – This invention has a bioreactor bag with an adjustable-position agitator.
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Mahajan, Fig. 2C
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NATHAN G ESPERON whose telephone number is 571-272-9807. The examiner can normally be reached 9 am - 6 pm Monday through Thursday, and 9 am - 6 pm every other Friday.
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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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/N.G.E./Examiner, Art Unit 1799
/MICHAEL A MARCHESCHI/Supervisory Patent Examiner, Art Unit 1799
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