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 .
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) filed on 2/13/2026 is in compliance with 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Interpretation
In claim 1, the term “vial” will be interpreted as any closed or closable vessel especially for liquids (MPEP § 2111.01 I).
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 1-4 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wagner et al. (US 2023/0065504 A1) (hereinafter referred to as Wagner, see PTO-892).
Regarding claim 1, Wagner discloses a system (abstract) for developing a viable culture of retinal pigment epithelial (RPE) cells on a mesh supported membrane, comprising:
at least one bioreactor vial ([0193], “cell culture container 106 may be a closed/sealed sterile environment for the cell culture 104 and fluid media used in cell culture processes”);
an automated handling system that receives at least one least one bioreactor vial ([0199], “mechanical or robotic systems that may move or manipulate the cell culture container”);
a fluid delivery system for adding and removing support fluids within said at least one bioreactor vial ([0199], “liquid handling systems that inject or extract various liquids to/from the cell culture 104 or the cell culture container 106”); and
a controller for directing and controlling operation of said system ([0198]-[0200] generally discloses a controller; [0200], “computing subsystem…to perform the specified cell culture process”).
The limitations “that receives at least one bioreactor vial”, “for adding and removing support fluids within said at least one bioreactor vial”, and “for directing and controlling operation of said system” are each directed towards the intended manner of operating the claimed automated handling system, fluid delivery system, and controller, respectively, and do not differentiate the claimed elements of note from the prior art elements because all structural limitations are taught in the prior art (MPEP § 2114 II). Nonetheless, Wagner discloses the functions as claimed as set forth above.
The limitation “for developing a viable culture of retinal pigment epithelial (RPE) cells on a mesh supported membrane” is merely a recitation of a purpose or intended use of the invention and has been given an appropriate patentable weight (MPEP § 2111.02 II). Examiner notes that “a viable culture of retinal pigment epithelial (RPE) cells” and “a mesh supported membrane” are not positively recited, consequently. Nonetheless, Wagner meets the limitation of note because Wagner’s system is disclosed to be capable of culturing retinal pigment epithelial cells on a supported membrane ([0792]).
Regarding claim 2, Wagner discloses the system of claim 1, said at least one bioreactor vial further comprising: a plurality of bioreactor vials ([0027], “the cell culture system further comprises a plurality of cell culture containers”).
Regarding claim 3, Wagner discloses system of claim 1, further comprising: a thermal control system to monitor a temperature of said at least one bioreactor vial and to maintain said at least one bioreactor vial at a predetermined temperature ([0199], “environmental control systems that control the temperature or other environmental parameters of the cell culture 104 or the cell culture container 106”).
Regarding claim 4, Wagner discloses the system of claim 1, further comprising: an imaging system ([0195] discloses an imaging subsystem) to observe and monitor development of said RPE cell culture within said at least one bioreactor vial ([0190]).
Claim Rejections - 35 USC § 103
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.
Claims 5-8 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Wagner in view of Nozaki et al. (US 2015/0072401 A1) (hereinafter referred to as Nozaki, presented on IDS dated 2/13/2026).
Regarding claim 5, Wagner discloses the system of claim 1.
Wagner does not explicitly disclose the structural details of the bioreactor vial as claimed.
However, Nozaki in the analogous art of automated cell culturing teaches a cell culture vessel, i.e., a bioreactor vial, comprising a bottom shell (Fig. 2, vessel body 200 – see annotated figure below) having side walls and a tapered bottom wall (Fig. 2, first vessel 203 is tapered), said bottom wall forming a bioreactor well (Fig. 2, submerged portion of first vessel 203); and
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a top shell (Fig. 2, lid portion 202) configured to be received in sealed, mating relation with said bottom shell (Fig. 2, lid portion 202 in sealed, mated relation with vessel body 200).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify bioreactor vial of Wagner to further comprise the claimed elements because Nozaki teaches that the claimed bioreactor vial is well known in the art, and one of ordinary skill in the art would be motivated to utilize a bioreactor vial known to be capable of culturing cells.
The limitation “for receiving a mesh supported membrane scaffold therein” is directed toward the intended manner of operating the claimed bioreactor well and does not differentiate the claimed bioreactor well from the prior art bioreactor well because all structural limitations are taught in the prior art (MPEP § 2114 II). The prior art bioreactor well would be fully capable of receiving a mesh supported membrane scaffold therein because the prior art bioreactor well is taught to be provided with a membrane (Nozaki: [0068]).
The limitation “configured to be received in sealed, mating relation with said bottom shell” is directed toward the intended manner of operating the claimed top shell and does not differentiate the claimed top shell from the prior art top shell because all structural limitations are taught in the prior art (MPEP § 2114 II). Nonetheless, the prior art top shell meets the claimed function as set forth above.
Regarding claim 6, the prior art combination teaches the system of claim 5, further comprising: at least one port in said top shell to allow access to an interior of said at least one bioreactor vial (Nozaki: Fig. 2, discharge port 209 and supply port 211).
Regarding claim 7, the prior art combination teaches the system of claim 5, further comprising:
at least one access port in said top shell to allow exchange of support fluids to and from an interior of said at least one bioreactor vial (Nozaki: Fig. 2, port 211); and
at least one vent port in said top shell to allow exchange of gas to and from an interior of said at least one bioreactor vial (Nozaki: Fig. 2, port 209).
Regarding claim 8, the prior art combination teaches the system of claim 5, further comprising: a vial drain (Nozaki: Fig. 2, port 208).
The prior art combination does not explicitly disclose or teach the claimed position of the vial drain relative to the tapered bottom wall. Nonetheless, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the prior art combination vial drain such that the vial drain is at a low point in the tapered bottom well as such a modification would amount to mere rearrangement of parts. It has been held that rearrangement of parts is unpatentable because the shifting of parts would not modify the operation of the device (MPEP § 2144.04 VI). In this case, the prior art vial drain would predictably allow the exchange of media regardless of position.
Regarding claim 11, the claim as written is directed toward the intended manner of operating the claimed bioreactor well and does not differentiate the claimed bioreactor well from the prior art bioreactor well because all structural limitations are taught in the prior art (MPEP § 2114 II). The prior art combination bioreactor well would be fully capable of achieving every claimed intended use because the prior art structure is substantially identical to the claimed structure, absent clear evidence to the contrary and absent a showing of unexpected results (MPEP § 2112.01 I). Additionally, Examiner notes that the “mesh supported membrane scaffold” is drawn to the intended use of the system (claim 5).
Claims 9 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Wagner and Nozaki as applied to claim 5 above, and further in view of Holenstein et al. (US 2023/0114908 A1) (hereinafter referred to as Holenstein, see PTO-892).
Regarding claim 9, the prior art combination teaches the system of claim 5.
The prior art combination does not explicitly disclose or teach fins extending upwardly from said tapered bottom wall adjacent said bioreactor well.
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However, Holenstein in the analogous art of tools for generating artificial tissue teaches it is known in the art to use steps, i.e., fins, extending upwardly from a bottom wall (Fig. 3A, steps 104a – see figure below) for the purpose of supporting components ([0172]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the prior art combination system to further comprise fins extending upwardly from said tapered bottom wall for the purpose of supporting components in the system, and the ordinarily skilled artisan would be motivated to provide support for components within the bioreactor vial.
The limitation wherein the fins are adjacent said bioreactor well, it has been held that rearrangement of parts is unpatentable because the shifting of parts would not modify the operation of the device (MPEP § 2144.04 VI). In this case, the fins would predictably provide support from the tapered bottom wall, regardless of placement on the tapered bottom wall.
Regarding claim 10, the claim as written is directed toward the intended manner of operating the claimed fins and does not differentiate the claimed fins from the prior art fins because all structural limitations are taught in the prior art (MPEP § 2114 II). Additionally, Examiner notes that the “mesh supported membrane scaffold” is drawn to the intended use of the system and is not positively recited (claim 5).
Claims 12-15 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Wagner in view of Nozaki and Hsu et al. (US 2023/0203415 A1) (hereinafter referred to as Hsu, see PTO-892).
Regarding claim 12, Wagner discloses the system of claim 1.
Wagner does not explicitly disclose structural details of the bioreactor vial as claimed.
However, Nozaki teaches the at least one bioreactor vial further comprising: a bottom shell having side walls and a tapered bottom wall, said bottom wall forming a bioreactor well for receiving a mesh supported membrane scaffold therein; and
a top shell attached to said bottom shell, said top shell configured to be received in sealed, mating relation with said bottom shell, as set forth above.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify bioreactor vial of Wagner to further comprise the elements of note because Nozaki teaches that such a bioreactor vial is well known in the art, and one of ordinary skill in the art would be motivated to utilize a bioreactor vial known to be capable of culturing cells.
The prior art combination does not explicitly disclose the top shell attached to said bottom shell via a hinge.
However, Hsu in the analogous art of tissue engineering teaches it was known in the art to attach a top block, i.e., top shell, with a base block, i.e., bottom shell, via a hinge (Fig. 7).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the prior art combination system to attach the top shell and bottom shell using a hinge, as Hsu discloses it was known in the art to use a hinge in a comparable manner, and the ordinarily skilled artisan would be motivated to allow the bioreactor vial to open without separating the top shell from the bottom shell, thereby reducing user error.
The limitation “for receiving a mesh supported membrane scaffold therein” is directed toward the intended manner of operating the claimed bioreactor well and does not differentiate the claimed bioreactor well from the prior art bioreactor well because all structural limitations are taught in the prior art (MPEP § 2114 II). The prior art bioreactor well would be fully capable of receiving a mesh supported membrane scaffold therein because the prior art bioreactor well is taught to be provided with a membrane (Nozaki: [0068]).
The limitation “configured to be received in sealed, mating relation with said bottom shell” is directed toward the intended manner of operating the claimed top shell and does not differentiate the claimed top shell from the prior art top shell because all structural limitations are taught in the prior art (MPEP § 2114 II). Nonetheless, the prior art top shell meets the claimed function as set forth above.
Regarding claim 13, the prior art combination teaches the system of claim 12, the top shell having an open position and a closed position wherein said top shell is received in sealed, mating relation with said bottom shell, as set forth above. Examiner is interpreting claim 13 as directed toward the intended use of the top shell. I.e., the top shell can be opened and closed, wherein in a closed position, said top shell is received in sealed, mating relation with said bottom shell.
Regarding claim 14, the limitation “allows addition of support fluids to an interior of said at least one bioreactor vial, and removal of support fluids from an interior of said at least one bioreactor vial” is contingent on the opening of the top shell and has been given appropriate patentable weight (MPEP § 2111.04 II). No further prior art rejections are required as all structure necessary to meet the claim is taught and/or anticipated by the prior art of record.
Regarding claim 15, the prior art combination teaches the system of claim 12, further comprising: a vial drain (Nozaki: Fig. 2, port 208). positioned at a low point in said tapered bottom wall.
The prior art combination does not explicitly disclose or teach the claimed position of the vial drain relative to the tapered bottom wall. Nonetheless, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the prior art combination vial drain such that the vial drain is at a low point in the tapered bottom well as such a modification would amount to mere rearrangement of parts. It has been held that rearrangement of parts is unpatentable because the shifting of parts would not modify the operation of the device (MPEP § 2144.04 VI). In this case, the prior art vial drain would predictably allow the exchange of media regardless of position.
Regarding claim 18, the claim as written is directed toward the intended manner of operating the claimed bioreactor well and does not differentiate the claimed bioreactor well from the prior art bioreactor well because all structural limitations are taught in the prior art (MPEP § 2114 II). The prior art combination bioreactor well would be fully capable of achieving every claimed intended use because the prior art structure is substantially identical to the claimed structure, absent clear evidence to the contrary and absent a showing of unexpected results (MPEP § 2112.01 I). Additionally, Examiner notes that the “mesh supported membrane scaffold” is drawn to the intended use of the system (claim 12).
Claims 16 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Wagner, Nozaki, and Hsu as applied to claim 12 above, and further in view of Holenstein.
Regarding claim 16, the prior art combination teaches the system of claim 12.
The prior art combination does not explicitly disclose or teach fins extending upwardly from said tapered bottom wall adjacent said bioreactor well.
However, Holenstein in the analogous art of tools for generating artificial tissue teaches it is known in the art to use steps, i.e., fins, extending upwardly from a bottom wall for the purpose of supporting components, as set forth above.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the prior art combination system to further comprise fins extending upwardly from said tapered bottom wall for the purpose of supporting components in the system, and the ordinarily skilled artisan would be motivated to provide support for components within the bioreactor vial.
The limitation wherein the fins are adjacent said bioreactor well, it has been held that rearrangement of parts is unpatentable because the shifting of parts would not modify the operation of the device (MPEP § 2144.04 VI). In this case, the fins would predictably provide support from the tapered bottom wall, regardless of placement on the tapered bottom wall.
Regarding claim 17, the claim as written is directed toward the intended manner of operating the claimed fins and does not differentiate the claimed fins from the prior art fins because all structural limitations are taught in the prior art (MPEP § 2114 II). Additionally, Examiner notes that the “mesh supported membrane scaffold” is drawn to the intended use of the system (claim 12).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Pebay et al. (US 2018/0282682 A1), drawn to an automated system for maintenance and differentiation of pluripotent stem cells.
Lu, B., Zhu, D., Hinton, D. et al. Mesh-supported submicron parylene-C membranes for culturing retinal pigment epithelial cells. Biomed Microdevices 14, 659–667 (2012), drawn to a mesh-supported membrane for culturing RPE cells.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ADRIAN J CARREON whose telephone number is (571)272-6818. The examiner can normally be reached Monday - Friday 8:30 AM - 5 PM.
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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/A.J.C./ Examiner, Art Unit 1799
/William H. Beisner/ Primary Examiner, Art Unit 1799
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