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’s election without traverse of Group I, claims 1-13 and 16 in the reply filed on 12/19/2025 is acknowledged. Please note, claims 14 is being examined, as it appears to be inadvertently not included in the restriction/restriction response.
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 12/15/2023 and 11/03/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Objections
Claim 2 is objected to because of the following informalities: the abbreviations in said claim need to be clearly defined and the abbreviation acronym can be placed in parentheses. Appropriate correction is required.
Claim 5 is objected to because of the following informalities: there appears to be a grammatical error on line 2, in the following limitation: “which stretchable support…”. It is suggested to amend the claim to the following: “where the stretchable support…” or similar, as “which” seems to indicate another stretch support and/or is unclear.
Claim 16 is objected to because of the following informalities: a period, “.”is needed at the end of the claim.
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 1 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. In particular, the following limitation “mitigate forces acting on the filter when filling and/or expanding and/or rocking the bag” is not definite as it appears unclear as to how the effect is obtained in the claim.
Claim 2 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. In particular, the term “preferably” renders the claim indefinite because description of examples or preferences is properly set forth in the specification rather than the claims. Please see MPEP 2173.05(d).
Claim 16 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. In particular, the limitation “variable volume container” is not clear what applicant is attempting to claim or trying to convey by said limitation.
Claim Rejections - 35 USC § 102
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.
Claims 1-2 and 10-16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2014/0287512 A1-Kaisermayer et al. (hereinafter Kaisermayer).
Regarding claim 1, Kaisermayer discloses a cell culture bag for cultivating cells (invention relates to cultivation of cells in bags and in particular to perfusion cultivation of cells, para. [0001], lines 1-2) under rocking conditions (rocking motion, para. [0038], lines 7-8) in a bioreactor system, the bag comprising a deformable flexible wall defining an expandable cell culture chamber for containing the cells in a cell culture medium (flexible bag 1;21, para. [0028], line 1, Fig. 1; introducing cell culture medium, microcarriers and cells to the bag, para. [0030], lines 1-2);
Kaisermayer discloses a filter arranged inside the culture chamber dividing the culture chamber in a chamber top compartment for containing cell-free culture medium and a chamber bottom compartment for maintaining the cells (filter material 2;22 is attached to a wall 3,7 of the culture bag, wherein the filter material 2;22 delimits a chamber 6;26 is fluidically connected to a first port 4;24 in a wall 3, 7;23,27 of the bag (para. [0028], lines 3-7),
Kaisermayer discloses the chamber top compartment provided with an inlet port (port 4; 24, shown in Fig. 1 disposed at a top region of bag 1;21) for filling the cell culture chamber and the chamber bottom compartment provided with an outlet port for draining of the culture chamber (the bag may also comprise further ports in the bag walls, e.g. for the flow of gases into and out of the reactor, for introduction of cell culture medium, and sample removal (para. [0050], lines 22-25),
Kaisermayer discloses wherein the filter comprises a membrane with a pore size configured to allow exchange of nutrients and gasses between the chamber bottom compartment and chamber top compartment while retaining cells in the chamber bottom compartment, characterized in that the filter is connected to the deformable flexible wall via a filter support frame that is configured and arranged to support the filter and mitigate forces acting on the filter when filling and/or expanding and/or rocking the bag (the chamber is sealed so that liquid and smaller particles such as free cells and cell debris can only pass into the chamber via the pores of the filter material 2:22:42, retaining the larger microcarrier particles in the bag outside of the chamber, para. [0034], lines 4-7). Additionally, Kaisermayer discloses an advantage of having the chamber attached to a bag wall is that when the fluid in the bag is agitated, the suspension of microcarriers and cells will flow over the filter material so that particles smaller than the pore openings of the filter material can pass through the openings (para. [0037], lines 1-5).
Regarding claim 2, Kaisermayer discloses characterized in that the flexible wall is made of a polymer material, and preferably comprises one or more of EVE, EVOH, PE and PVC (the bag 1;21 can be prepared from flexible sheets may comprise thermoplastics such as polyethylene, para. [0033], lines 4-6).
Regarding claim 10, Kaisermayer discloses fluid conduit circuit that defines a first culture medium flow path that extends from an outlet of the cell culture chamber to the inlet port of the chamber top compartment, and a second culture medium flow path that extends from the outlet of the cell culture chamber to an inlet port of the chamber bottom compartment (the cell culture medium, the microcarriers and the cells can be introduced to the bag via tubing and suitable ports (not shown) in the bag according to methods known in the art (para. [0035], lines 1-3), thus, the more than one fluid circuit define a first culture medium and a second culture medium, the and Kaisermayer discloses the bag may also comprise further ports in the bag walls, e.g. for the flow of gases into and out of the reactor, for introduction of cell culture medium (para. [0050], lines 22-25).
Regarding claim 12, Kaisermayer discloses an oxygenator arranged in the first culture medium flow path and/or the second culture medium flow path for oxygenating the cell culture medium (the bag may also comprise further ports in the bag walls, e.g. for sample removal and for various sensors and transducers used during cultivation (para. [0050], lines 22-26).
Regarding claim 13, Kaisermayer discloses a gas source fluidly connected to the inlet port of the chamber top compartment arranged for supplying a gaseous fluid to the chamber top compartment of the cell culture bag (the bag may also comprise further ports in the bag walls, e.g. for the flow of gases into and out of the reactor, para. [0050], lines 22-26).
Regarding claim 14, Kaisermayer discloses wherein a gas source fluidly connected to the inlet port of the chamber top compartment is arranged for supplying a gaseous fluid to the chamber top compartment of the cell culture bag, the gas source being provided by the oxygenator (the bag may also comprise further ports in the bag walls, e.g. for the flow of gases into and out of the reactor, for introduction of cell culture medium, cells and microcarriers, for sample removal and for various sensors and transducers used during cultivation, para. [0050], lines 22-26).
Regarding claim 16, Kaisermayer discloses an agitator unit arranged for operative coupling with the cell culture bag to agitate the cell culture and the fluid cell medium in the cell culture chamber and a mechanism for pinching the outer wall of the variable volume container to create a partially flattened section and operable for increasing the cell-culture chamber in volume by decreasing the flattened section (agitation means, para. [0031], lines 1-2). Further, Kaisermayer discloses the agitation means comprises a movable support 5 and step b) comprises mounting the bag 1;21;41 on this movable support; the movable support can e.g. be a plate, trough or container on or in which the bag is placed and, if needed, secured (securing mechanism, para. [0038], lines 2-5).
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 3-9 are rejected under 35 U.S.C. 103 as being unpatentable over US 2014/0287512 A1-Kaisermayer et al. (hereinafter Kaisermayer) as applied to claim 1 above, and further in view of EP0725134A2-van der Heiden.
Regarding claim 3, Kaisermayer teaches the invention discussed above in claim 1. However, Kaisermayer does not explicitly teach a substantially rigid body made of the same material as the flexible wall.
For claim 3, van der Heiden teaches a flexible container for the culture of cells consisting of two compartments being separated by a semipermeable membrane (col. 4, lines 27-30) and van der Heiden teaches net 10 is disposed between the outer wall sheet 35 and the semipermeable membrane 36 can be fused to the semipermeable membrane to provide a support for it (col. 10, lines 3-6, Fig. 6), and van der Heiden teaches the outer all of the bioreactor 1 defining the cell compartment 7 of the present invention is made of a flexible material (col. 7. lines 14-16), such as poly(ethylene-vinyl acetate, col. 7, line 20-24), which read on the instant claim limitation of a substantially rigid body made of the same material as the flexible wall.
It would have been obvious to one of ordinary skill, in the art at the time, to further include a substantially rigid body made of the same material as the flexible wall as taught by van der Heiden, because van der Heiden teaches the nets 10 not only provide support for the semipermeable membrane and limit any danger of rupture in handling, but they also serve to distribute the cell culture along the semipermeable membrane and to distribute the nutrient medium along the semipermeable membrane (col. 10, lines 9-15).
Regarding claim 4, Kaisermayer teaches the invention discussed above in claim 1. However, Kaisermayer does not explicitly teach the support frame comprises an inner edge section that is attached to the filter and an outer edge section that is attached to the flexible wall.
For claim 4, van der Heiden teaches a flexible container for the culture of cells consisting of two compartments being separated by a semipermeable membrane (col. 4, lines 27-30) and van der Heiden teaches a support frame (protective support 10, Fig. 6) comprises an inner edge section that is attached to the filter (semipermeable membrane 36, Fig. 6) the protective support has an outer edge region which is also attached to the flexible wall outer wall sheet 35, shown in Fig. 6, when the layers are fused together (col. 10, lines 3-6, Fig. 6), which reads on the instant claim limitation of an inner edge section that is attached to the filter and an outer edge section that is attached to the flexible wall.
It would have been obvious to one of ordinary skill, in the art at the time, to further include an inner edge section that is attached to the filter and an outer edge section that is attached to the flexible wall as taught by van der Heiden, because van der Heiden teaches the nets 10 not only provide support for the semipermeable membrane and limit any danger of rupture in handling, but they also serve to distribute the cell culture along the semipermeable membrane and to distribute the nutrient medium along the semipermeable membrane (col. 10, lines 9-15).
Regarding claim 5, Kaisermayer teaches the invention discussed above in claim 1. However, Kaisermayer does not explicitly teach the filter comprises a stretchable support layer attached to the membrane, which stretchable support layer is configured to allow stretching of the filter.
For claim 5, van der Heiden teaches a flexible container is essentially manufactured by sealing together three sheets of material: a first sheet (the outer wall of the cell compartment), made from a highly gas permeable material, a second sheet, being the semipermeable membrane, a third sheet (the outer wall of the medium compartment), made from a material having the desired properties for the specific application of the bioreactor (col. 4, lines 43-51), and van der Heiden teaches the sheet scan be fused to the semipermeable membrane to provide support (col. 10, lines 3-6, Fig. 6), which reads on the instant claim limitation of the filter comprises a stretchable support layer attached to the membrane, which stretchable support layer is configured to allow stretching of the filter.
It would have been obvious to one of ordinary skill, in the art at the time, to further include filter comprises a stretchable support layer attached to the membrane, which stretchable support layer is configured to allow stretching of the filter as taught by van der Heiden, because van der Heiden teaches the nets 10 not only provide support for the semipermeable membrane and limit any danger of rupture in handling, but they also serve to distribute the cell culture along the semipermeable membrane and to distribute the nutrient medium along the semipermeable membrane (col. 10, lines 9-15).
Regarding claim 6, Kaisermayer teaches the invention discussed above in claim 5. However, Kaisermayer does not explicitly teach stretchable support layer is made of a woven material.
For claim 6, van der Heiden teaches a stretchable support layer (net or mesh support layer 37, col. 10, 6-7, Fig. 1), where Fig. 6 indicate layer 37 is comprises a mesh or woven material, which reads on the instant claim limitation of stretchable support layer is made of a woven material.
It would have been obvious to one of ordinary skill, in the art at the time, to further include a stretchable support layer is made of a woven material as taught by van der Heiden, because van der Heiden teaches the nets 10 not only provide support for the semipermeable membrane and limit any danger of rupture in handling, but they also serve to distribute the cell culture along the semipermeable membrane and to distribute the nutrient medium along the semipermeable membrane (col. 10, lines 9-15).
Regarding claim 7, Kaisermayer teaches the invention discussed above in claim 5. However, Kaisermayer does not explicitly teach stretchable support layer is attached to the support frame.
For claim 7, the layers, which includes the net 10 disposed between the outer wall sheet 35 and the semipermeable membrane 36 can be fused to the semipermeable membrane to provide a support for it; a further net or mesh support layer can be provided at 37 between the semipermeable membrane 36 can be fused together (col. 10, lines 3-8), thus, the stretchable support layer 37 is attached to the support frame (protective support 10, Fig. 6) when they are fused together, which reads on the instant claim limitation of the stretchable support layer is attached to the support frame.
It would have been obvious to one of ordinary skill, in the art at the time, to further include of the stretchable support layer is attached to the support frame as taught by van der Heiden, because van der Heiden teaches the nets 10 not only provide support for the semipermeable membrane and limit any danger of rupture in handling, but they also serve to distribute the cell culture along the semipermeable membrane and to distribute the nutrient medium along the semipermeable membrane (col. 10, lines 9-15).
Regarding claim 8, Kaisermayer teaches the invention discussed above in claim 1. However, Kaisermayer does not explicitly teach an anti-folding layer attached to the membrane and configured to protect the membrane against folding.
For claim 8, van der Heiden teaches a similar anti-folding layer (sheet 38, col. 10, line 8), which forms an outer wall of the compartment, and provides further support to the layers when fused (col. 10, lines 3-8, Fig. 6), which reads on the instant claim limitation an anti-folding layer attached to the membrane and configured to protect the membrane against folding.
It would have been obvious to one of ordinary skill, in the art at the time, to further include an anti-folding layer attached to the membrane and configured to protect the membrane against folding as taught by van der Heiden. Further, van der Heiden teaches a net or mesh support layer can be provided at 37 between the semipermeable membrane 36 and the sheet 38 forming the outer wall of the medium compartment. The nets 10 and 37 thus not only provide support for the semipermeable membrane and limit any danger of rupture in handling, but they also serve to distribute the cell culture along the semipermeable membrane and to distribute the nutrient medium along the semipermeable membrane (col. 10, lines 6-15).
Regarding claim 9, Kaisermayer teaches the invention discussed above in claim 8. However, Kaisermayer does not explicitly teach an anti-folding layer comprises a rigid mesh structure.
For claim 9, van der Heiden teaches a similar anti-folding layer (sheet 38, col. 10, line 8), which forms an outer wall of the compartment, and provides further support to the layers when fused (col. 10, lines 3-8, Fig. 6), and thus, comprises a mesh structure when fused with nets or mesh 37, shown in Fig. 6), which reads on the instant claim limitation of an anti-folding layer comprises a rigid mesh structure.
It would have been obvious to one of ordinary skill, in the art at the time, to further include an anti-folding layer comprises a rigid mesh structure as taught by van der Heiden, because van der Heiden teaches the nets 10 not only provide support for the semipermeable membrane and limit any danger of rupture in handling, but they also serve to distribute the cell culture along the semipermeable membrane and to distribute the nutrient medium along the semipermeable membrane (col. 10, lines 9-15).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over US 2014/0287512 A1-Kaisermayer et al. (hereinafter Kaisermayer) as applied to claim 10 above, and further in view of KR20150004333A-Shevitz (all citations are drawn to the machine English translation).
Regarding claim 11, Kaisermayer teaches the invention discussed above in claim 10. Further, Kaisermayer teaches flow into and out of various ports of the cell culture bag. However, Kaisermayer does not explicitly teach a one-way valve of the flow path.
For claim 11, Shevitz teaches an invention relating to filtration system and
the invention relates to sampling manifolds, pump systems as well as filtration systems for biological fluids and products, and modification modules useful in such systems (para. [0001]) and Shevitz teaches the system can include connectors which may include check valves (para. [0089], lines 17-18), which reads on the instant claim limitation of one-way valve of the flow path.
It would have been obvious to one of ordinary skill, in the art at the time, to further include a one-way valve of the flow path, as taught by Shevitz, because Shevitz suggest check valves allow for additional protection against contamination and mishandling via the incorporation of connectors such as check valves which serve to supply fluid to a filtration system (para. [0089], lines 1-3; 15-18).
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. 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.
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/L.A.A./Examiner, Art Unit 1799
/MICHAEL L HOBBS/Primary Examiner, Art Unit 1799