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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on February 27, 2026 has been entered. The amendments have been thoroughly reviewed and entered. Any previous objection/ rejection not repeated herein has been withdrawn.
Note: All claims are patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper). The finality of the instant claims is proper since the instant amendments to claims 1, 4, 20, and 23 do not change the scope and/or previous interpretations of the claims. Hence, instant claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114.
As indicated in the previous final rejection filed October 10, 2025, the Office has interpreted claims 1, 4, 7, 20 and 23 as product-by-process claims since the cell culture container is defined at least in part in terms of the method or process by which it is made. The instant amendments include a closed Markush group directed to limiting the processes steps by which the compressible wall element is jointed to the rigid base plate to produce the end product of a cell culture container. However, the process steps do not limit a product claim, for reasons set forth previously and delineated below. Thus, the instant amendments do not change the scope and/or interpretation of the claims.
Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b).
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 1, 4, and 6-18 remain 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.
Independent claim 1 has been amended to include a Markush group listing alternative methods of joining the compressible wall element to the rigid base. In U.S. patent law, a Markush group is a list of alternatives set off by “consisting of” or “selected from the group consisting of” that defines a single claim element. MPEP §2117 explains that such a group is closed — meaning the selection must be made only from the listed members, and unrecited alternatives are excluded. Claim 4 appears to include another method “over-mold” to further modify and/or limit the closed Markush group, which is confusing and indefinite. When a claim element is set off with “a group consisting of”, the USPTO treats it as a closed group. This means the selection must be made only from the listed alternatives and no other process of making outside the group are allowed (i.e., “over molding” in claim 4). This is confusing and indefinite.
Claim 1, last line, recites “and a portion of the compressible wall element [is] molded into the rigid base”, it is not clear how this differs from the “over-mold” recitation in claim 4. The same reasoning extends to claim 7. Again, dependent claims 4 and 7 appear to further limit a closed Markush group in claim 1, which is not proper.
Claim Rejections - 35 USC § 102/103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1, 4, 6-15, 17, 18, 20, 22 and 23 remain rejected under 35 U.S.C. 102(a)(1)/(a)(2) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Veraitch et al., (WO 2018/087558; hereinafter “Veraitch”; see corresponding US 2020/0190457 for citations below).
As to claims 1 and 7, Veraitch teaches a cell culture container comprising:
a base section 12 including a substantially planar rigid base plate (see para [0063] et seq.); and
a compressible wall element 8 extending from the base section in an axial direction and defining an internal volume of the cell culture container, the compressible wall element being compressible in the axial direction. That is, Veraitch teaches the wall element of the container may be compressible with respect to the top and base section. The wall element of the container may be composed of a flexible material. The container may thereby have a ‘concertina’ or ‘bellows’ arrangement, e.g. it may have one or more z-folds (see para [0010] et seq.)
Specifically, Veraitch teaches a cell culture container/bioreactor may be composed of a flexible material (see para [0010], [0033] et seq.) The container is designed to hold at least cells, gases, and a cell culture medium therein (see para [0024]-[0028]). The container may be composed of the same flexible material throughout. Or, the top section and/or the base section may be composed of material which is different from that of the wall element. The material used in the top section and the base section may be less flexible than that of the wall element since these element are not expanded. The material may be a rigid material so that these sections have more structural rigidity, (see para [0062] et seq.)
Veraitch teaches the top section and/or the base section of a container of the invention may be composed from any generally suitable plastic material for use in cell culture, processing and storage (e.g. cryopreservation), such as polyethylene (high-density or low-density polyethylene HDPE or LDPE), polyvinylchloride (PVC), polypropylene (PP), polystyrene (PS) including high impact polystyrene, polyamides (PA), acrylonitrile butadiene styrene (ABS), polycarbonate (PC), polycarbonate/acrylonitrile butadiene styrene (PC/ABS) etc. may be used (see para [0063] et seq.)
Veraitch teaches the flexible material of the compressible wall may be a polyethylene (optionally a low-density polyethylene (LDPE)), cis-1,4-polybutadiene, a methacrylate such as poly (ethyl methacrylate), a phthalate such as poly (ethylene terephthalate), poly (vinylidiene chloride), a cellulose acetate such as cellulose acetate butyrate, a silicone, flouroethylenepolypropylene, polyolefin, or ethylene vinyl acetate copolymer.
Considering embodiments in which Veraitch teaches the base and wall are formed of polymer materials, it is well known in the art that joints between polymers to form a bag are usually formed by adhesive, welding or molding since these joints provide for an improved liquid tight seal and less distortion than mechanical fasteners (see for example, cited for establishing the state of the art, Silva, L.R.R., Marques, E.A.S. & da Silva, L.F.M. Polymer joining techniques state of the art review. Weld World 65, 2023–2045 (2021). https://doi.org/10.1007/s40194-021-01143-x).
Regardless, the method of joining the wall and the base in Veraitch, the Office has interpreted claim 1 as a product-by-process claim. The method of joining the wall and base members to form the claimed cell culture container is alternatively listed in a closed Markush group “chosen from a group consisting of” an adhesive joining, weld joining, and molding. However, as set forth previously these process steps have not received patentable weight since none them limit the structure of the end product (i.e., cell culture container), see MPEP 2113.
As to claims 6, 8 and 9, Veraitch comprising a base sheet (gas permeable sheet or membrane) over the rigid base plate within the internal volume of the cell culture container (see para [0149] et seq.)
As to claim 10, Veraitch teaches the rigid base plate comprises one or more spacers (strips 125) adapted to space the base sheet from the rigid base plate (see para [0149] et seq.).
As to claim 11, Veraitch teaches the compressible wall element comprises an inwardly deformable portion, an outwardly deformable portion, and a leaf portion extending between the inwardly deformable portion and the outwardly deformable portion, and wherein the inwardly deformable portion and the outwardly deformable portion are adapted to deform to cause the compressible wall element to compress (see para [0129] et seq. and Fig. 11).
As to claim 12, Veraitch teaches a portion chosen from the inwardly deformable portion or the outwardly deformable portion is disposed at a position chosen from at a joint between the compressible wall element and the rigid base plate or immediately adjacent to the joint between the compressible wall element and the rigid base plate (see para [0129] et seq.)
As to claim 13, Veraitch teaches the rigid base plate can be made from polycarbonate, which is translucent and transparent, such that the base plate is a sensor window chosen from a transparent sensor window or a translucent sensor window (see par [0063] et seq.)
As to claim 14, Veraitch teaches the compressible wall element comprises a material chosen from a silicone, a low density polyethylene, or a thermoplastic elastomer (see para [0065] et seq.)
As to claim 15, Veraitch teaches the compressible wall element comprises an outer portion (reads on outer surface) and an element chosen from a liner or an insert (insert reads on reinforced section of material within the compressible wall element; see para [0068] et seq.)
As to claim 17, Veraitch teaches at least a part of the compressible wall element comprises a gas impermeable coating (that is, Veraitch teaches the container of the invention may also be expanded by means of introducing a fluid such as a liquid or a gas. Likewise a container of the invention may also be compressed by means of removing a fluid such as a liquid or a gas (see para [0036] and [0078], which would require a gas impermeable coating else the container would be unable to expand/compress by introducing/removing a gas).
As to claim 18, Veraitch teaches the rigid base plate comprises a material chosen from a high density polyethylene or a polycarbonate (see para [0063] et seq.)
As to claim 20, Veraitch teaches a bioreactor for a cell culturing process, the bioreactor comprising:
a cell culture container including a base section 12 including a substantially planar rigid base plate (see para [0063] et seq.); and
a compressible wall element 8 extending from the base section in an axial direction and defining an internal volume of the cell culture container, the wall element being compressible in the axial direction (Veraitch teaches the wall element of the auxiliary container may be compressible with respect to the top and base section. The wall element of the auxiliary container may be composed of a flexible material. The auxiliary container may thereby have a ‘concertina’ or ‘bellows’ arrangement, e.g. it may have one or more z-folds (see para [0033] et seq.)); and
an interface plate (top section 14) attachable to the compressible wall element opposite to the base section to close the cell culture container.
Veraitch teaches a cell culture container/bioreactor may be composed of a flexible material (see para [0010], [0033] et seq.) The container is designed to hold at least cells, gases, and a cell culture medium therein (see para [0024]-[0028]). The container may be composed of the same flexible material throughout. Or, the top section and/or the base section may be composed of material which is different from that of the wall element. The material used in the top section and the base section may be less flexible than that of the wall element since in use it is not required to be compressed or expanded. The material may be a rigid material so that these sections have more structural rigidity, (see para [0062] et seq.)
Veraitch teaches the top section and/or the base section of a container of the invention may be composed from any generally suitable plastic material for use in cell culture, processing and storage (e.g. cryopreservation), such as polyethylene (high-density or low-density polyethylene HDPE or LDPE), polyvinylchloride (PVC), polypropylene (PP), polystyrene (PS) including high impact polystyrene, polyamides (PA), acrylonitrile butadiene styrene (ABS), polycarbonate (PC), polycarbonate/acrylonitrile butadiene styrene (PC/ABS) etc. may be used (see para [0063] et seq.)
Veraitch teaches the flexible material of the compressible wall may be a polyethylene (optionally a low-density polyethylene (LDPE)), cis-1,4-polybutadiene, a methacrylate such as poly (ethyl methacrylate), a phthalate such as poly (ethylene terephthalate), poly (vinylidiene chloride), a cellulose acetate such as cellulose acetate butyrate, a silicone, flouroethylenepolypropylene, polyolefin, or ethylene vinyl acetate copolymer.
Considering embodiments in which Veraitch teaches the base and wall are formed of polymer materials, it is well known in the art that joints between polymers formed by adhesive, welding or molding provide for an improved liquid tight seal and less distortion than mechanical fasteners (see for example cited for establishing the state of the art, Silva, L.R.R., Marques, E.A.S. & da Silva, L.F.M. Polymer joining techniques state of the art review. Weld World 65, 2023–2045 (2021). https://doi.org/10.1007/s40194-021-01143-x).
Regardless, the method of joining the wall and the base in Veraitch, the Office has interpreted claim 20 as a product-by-process claim. The method of joining the wall and base members to form the claimed cell culture container is alternatively listed in a closed Markush group “chosen from a group consisting of” an adhesive joining, weld joining, and molding. However, as set forth previously these process steps have not received patentable weight since none them limit the structure of the end product (i.e., cell culture container), see MPEP 2113.
As to claim 22, Veraitch teaches the interface plate (top section) comprises a connector interface (para [0075] et seq.)
As to claim 23, Veraitch teaches a cell processing system, comprising.
a bioreactor comprising a cell culture container including a base section 12 including a substantially planar rigid base plate (see para [0063] et seq.); and
a compressible wall element 8 extending from the base section in an axial direction and defining an internal volume of the cell culture container, the compressible wall element being compressible in the axial direction (Veraitch teaches the wall element of the auxiliary container may be compressible with respect to the top and base section. The wall element of the auxiliary container may be composed of a flexible material. The auxiliary container may thereby have a ‘concertina’ or ‘bellows’ arrangement, e.g. it may have one or more z-folds (see para [0033] et seq.)); and
an agitator configured to move the base section to agitate the fluid in the cell culture container (the device of Veraitch may comprise a platform which can be vibrated to permit a container stationed thereon to be thus agitated (see para [0028] et seq.)) Veraitch teaches a cell culture container/bioreactor may be composed of a flexible material (see para [0010], [0033] et seq.) The container is designed to hold at least cells, gases, and a cell culture medium therein (see para [0024]-[0028]). The container may be composed of the same flexible material throughout. Or, the top section and/or the base section may be composed of material which is different from that of the wall element. The material used in the top section and the base section may be less flexible than that of the wall element since in use it is not required to be compressed or expanded. The material may be a rigid material so that these sections have more structural rigidity, (see para [0062] et seq.)
Veraitch teaches the top section and/or the base section of a container of the invention may be composed from any generally suitable plastic material for use in cell culture, processing and storage (e.g. cryopreservation), such as polyethylene (high-density or low-density polyethylene HDPE or LDPE), polyvinylchloride (PVC), polypropylene (PP), polystyrene (PS) including high impact polystyrene, polyamides (PA), acrylonitrile butadiene styrene (ABS), polycarbonate (PC), polycarbonate/acrylonitrile butadiene styrene (PC/ABS) etc. may be used (see para [0063] et seq.)
Veraitch teaches the flexible material of the compressible wall may be a polyethylene (optionally a low-density polyethylene (LDPE)), cis-1,4-polybutadiene, a methacrylate such as poly (ethyl methacrylate), a phthalate such as poly (ethylene terephthalate), poly (vinylidiene chloride), a cellulose acetate such as cellulose acetate butyrate, a silicone, flouroethylenepolypropylene, polyolefin, or ethylene vinyl acetate copolymer.
Considering embodiments in which Veraitch teaches the base and wall are formed of polymer materials, it is well known in the art that joints between polymers formed by adhesive, welding or molding provide for an improved liquid tight seal and less distortion than mechanical fasteners (see for example, Silva, L.R.R., Marques, E.A.S. & da Silva, L.F.M. Polymer joining techniques state of the art review. Weld World 65, 2023–2045 (2021). https://doi.org/10.1007/s40194-021-01143-x).
Regardless, the method of joining the wall and the base in Veraitch, the Office has interpreted claim 23 as a product-by-process claim. The method of joining the wall and base members to form the claimed cell culture container is alternatively listed in a closed Markush group “chosen from a group consisting of” an adhesive joining, weld joining, and molding. However, as set forth previously these process steps have not received patentable weight since none them limit the structure of the end product (i.e., cell culture container), see MPEP 2113.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found above.
Claim 16 remains rejected under 35 U.S.C. 103 as being unpatentable over Veraitch in view of Chang (US 2003/0143727).
As to claim 16, Veraitch does not explicitly disclose the compressible wall element comprises an inner portion and a jacket. In the related art of cell cultivating devices, Chang teaches a first chamber 110 is connected to a second chamber 130 comprising has a compressible component that may be in the form of a bellow that can be compressed and decompressed second, wherein the first chamber 110 is either matingly-fitted with the second chamber 130 or is integral with the second chamber 130. Chang teaches the second chamber 130 may be constructed from any material, including but not limited to a thermoplastic (i.e., jacket; see para [0070] et seq.) Accordingly, it would have been obvious to one of ordinary skill in the art at the time the claimed invention was effectively filed to have included in the compressible wall element of Veraitch a jacket material, like that taught by Chang for the expected benefit of providing insultation to the inside of the compressible chamber to avoid temperature fluctuations which could impact the cell culture inside the chamber.
Citations to art
In the above citations to documents in the art, an effort has been made to specifically cite representative passages, however rejections are in reference to the entirety of each document relied upon. Other passages, not specifically cited, may apply as well.
Response to Arguments
Applicant's arguments filed February 27, 2026 have been fully considered but they are not persuasive. In response to the previous 35 USC 102/103 rejection of the claims over Veraitch, applicant argues that Veraitch does not disclose the compressible wall element is joined to the rigid base by a joint chosen from a group consisting of: adhesive joining, weld joining, and molding.
The examiner respectfully disagrees. The addition of the closed Markush group in independent claims 1, 20 and 23 does not limit the “product by process steps” in product claims. That is, the process of making a joint using “welding, adhesion, over-mold, and molding” steps do not impart any change to structure of the end product. For the reasons discussed above, the examiner asserts that Veraitch teaches the same or similar cell culture container as claimed.
Furthermore, applicant’s arguments do not dispute the examiner’s product-by process interpretation of the claims. As acknowledged by applicant in the outstanding Remarks beginning at page 7, line 3, the claims were rejected under 35 USC 102 and/or 103, however applicant’s arguments fail to address at least the 103 portion of the rejection. The argument that Veraitch fails to meet all claimed process/limitations of making the end product does not overcome a proper 102/103 rejection because the reference need only to substantially meet all the structure of the end product.
As set forth in MPEP 2113 II, once the examiner provides a rationale tending to show that the claimed product appears to be the same or similar to that of the prior art, although produced by a different process, the burden shifts to applicant to come forward with evidence establishing an nonobvious difference between the claimed product and the prior art product. The issue is whether the claimed process steps of making the cell culture container exhibits/provides any unexpected properties compared to the Veraitch cell culture container. Applicant must provide evidence (not arguments) comparing the claimed cell culture container and the cell culture container of Veraitch to establish unexpected properties since the materials appeared to be identical or only slightly different. Thus, for the reasons delineated above, the claim remain rejected over the grounds and prior art set forth in the previous Official action.
Conclusion
No claims are allowed.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure include:
Lipkens et al., (US 2015/0252317) teach a disposable bioreactor system includes a bag having a first end and a second end. An acoustophoresis device is disposed at the first end of the bag, and is separable from the bag. An actuating mechanism is operably connected to the second end of the bag. The actuating mechanism is configured to move the second end of the bag towards the acoustophoresis device, so that fluids within the volume of the bag flow past the acoustophoresis device and carry desired biomolecules out of the bag for collection, while cells and other debris remain within the bag for disposal;
Fan et al., (US 2019/0062681) teach an apparatus for positioning and securing an excised biological tissue specimen for imaging and analysis. In some embodiments, an apparatus includes a sample bag defining an inner volume configured to receive a biological tissue sample, and a sealing member coupled to the sample bag. An imaging window is disposed and configured to be placed in contact with at least a portion of the biological tissue sample, and a positioning member is coupled to the imaging window and is configured to be disposed against the sealing member to substantially seal the inner volume. The positioning member includes a vacuum port disposed and configured to be aligned with a vacuum source to withdraw air from the inner volume of the sample bag; and
Bores et al., (US 2018/0362910) teach a laboratory system has a plurality of bottom opening sample transport pods for carrying one or more cassettes with cell culture vessels therein may have an aseptic interior environment and may cooperate with cell culture growing/processing stations having load ports allowing transfer of the cassettes with cell culture vessels into the stations while maintaining the aseptic integrity of the interior of the pods and the cassette and cell culture vessels. Internal environmental monitoring and control, purging, and tracking as well as automated robotic operation may be provided.
All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). 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 P. Kathryn Wright whose telephone number is (571)272-2374. The examiner can normally be reached on 9:30am-7:30 pm EST.
Examiner interviews are available via telephone 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.
E-mail communication Authorization
Per updated USPTO Internet usage policies, Applicant and/or applicant’s representative is encouraged to authorize the USPTO examiner to discuss any subject matter concerning the above application via Internet e-mail communications. See MPEP 502.03. To approve such communications, Applicant must provide written authorization for e-mail communication by submitting the following statement via EFS Web (using PTO/SB/439) or Central Fax (571-273-8300):
Recognizing that Internet communications are not secure, I hereby authorize the USPTO to communicate with the undersigned and practitioners in accordance with 37 CFR 1.33 and 37 CFR 1.34 concerning any subject matter of this application by video conferencing, instant messaging, or electronic mail. I understand that a copy of these communications will be made of record in the application file.
Written authorizations submitted to the Examiner via e-mail are NOT proper. Written authorizations must be submitted via EFS-Web (using PTO/SB/439) or Central Fax (571-273-8300). A paper copy of e-mail correspondence will be placed in the patent application when appropriate. E-mails from the USPTO are for the sole use of the intended recipient, and may contain information subject to the confidentiality requirement set forth in 35 USC § 122. See also MPEP 502.03.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Capozzi can be reached on (571) 270-3638. 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.
/P. Kathryn Wright/Primary Examiner, Art Unit 1798
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