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 .
Status of the Claims
The amendment filed 6/18/2026 has been entered. Claims 1-3 and 15-18 remain pending in the application; claims 31-43 have been newly added; and claims 4-14 and 19-30 have been cancelled. Applicant’s amendments to the claims have overcome each objection and 112(b) rejection previously set forth in the Non-Final Office Action mailed 3/18/2026.
Information Disclosure Statement
The information disclosure statements (IDSs) submitted on 3/13/2026 and 6/18/2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Response to Arguments
Applicant’s arguments filed 6/18/2026 have been considered but they are moot in view of a new grounds of rejection necessitated by the amendments to the claims.
Applicant added limitations to independent claim 1 for each bioreactor node comprising “an enclosed, flexible, oxygen-permeable membrane configured to contain a biotic or abiotic material for a bioreaction”. These new limitations do not distinguish the claimed invention over the prior art. The examiner acknowledges that neither Byrd (US 2012/0091058 A1) (already of record) nor Downs (US 2002/0164653 A1) (already of record) explicitly teach bioreactor chambers that are enclosed, flexible, and have an oxygen-permeable membrane; however, Everett et al. (US 2007/0113474 A1) (already of record) does disclose bioreactor chambers that are enclosed, flexible, and have an oxygen-permeable membrane and which are mounted on a support rail, which will be discussed in further detail in the 35 USC § 102 section below.
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, 15-16, and 18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Everett et al. (US 2007/0113474 A1) (already of record).
Regarding claim 1, Everett et al. discloses a bioreactor system (abstract) comprising: a chamber support assembly (bioreactor assembly 10, rack 12) configured to mount a support rail (support rail 24), the support rail supporting a set of bioreactor chamber nodes (para. 0042 “containers 11 supported by a rack 12”), each bioreactor chamber node comprising an enclosed, flexible, oxygen-permeable membrane (para. 0090 “flexible bag… gas-permeable polymer membrane”) configured to contain a biotic or abiotic material for a bioreaction (abstract “seal separate wall structure portions of the container together, and end caps to the wall portions, to define an aseptic environment”); and a fluid manifold comprising a fill line fluid connection configured to permit filling of the set of bioreactor chamber nodes (para. 0074; fill and drain conduits 52), and a drain line fluid connection configured to permit draining of the set of bioreactor chamber nodes (para. 0074; fill and drain conduits 52).
Regarding claim 2, Everett et al. discloses a bioreactor system wherein the chamber support assembly comprises a bioreactor chamber set lock with a notch configured to locate the set of bioreactor chamber nodes in position after the set of bioreactor chamber nodes is inserted into the chamber support assembly (paras. 0014-0015 “clamp”).
Regarding claim 15, Everett et al. discloses a bioreactor system wherein each bioreactor chamber node is enclosed by: a rigid top cap mounted to a top portion of the enclosed, flexible, oxygen-permeable membrane, the rigid top cap configured to mount to the support rail; or a rigid bottom cap mounted to a bottom portion of the enclosed, flexible, oxygen- permeable membrane, the rigid bottom cap comprising at least one fluid access port (end cap 41; para. 0073).
Regarding claim 16, Everett et al. discloses a bioreactor system wherein the fill line fluid connection and a plurality of fluid access ports of each of the bioreactor chamber nodes of the bioreactor system are connected to permit filling of the set of bioreactor chamber nodes of the bioreactor system in a single filling (para. 0074 “fill conduits 52 may connect to a central header manifold from which the conduits branch”).
Regarding claim 18, Everett et al. discloses a bioreactor system further comprising a system fluid manifold that distributes a single fluidic fill path to a plurality of sets of the bioreactor chamber nodes, or that collects a single fluidic drain path from a plurality of sets of the bioreactor chamber nodes (para. 0074 “fill conduits 52 may connect to a central header manifold from which the conduits branch”).
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.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Everett et al. (US 2007/0113474 A1) (already of record) in view of Griffin et al. (US 2024/0200012 A1) (already of record).
Regarding claim 3, Everett et al. discloses a bioreactor system, but does not disclose wherein the chamber interface assembly further comprises: a valve actuator configured to rotate a plurality of valves to pinch closed base tubing, the base tubing providing fluid connection between at least two bioreactor chamber nodes of the set of bioreactor chamber nodes. However, Griffin et al. teaches that pinch valve actuators which pinch flow tubes are known in the art (para. 0017) which pinch a line to prevent fluid flow therethrough (para. 0124). It would have been obvious to a person of ordinary skill in the art to use the Griffin et al. configuration of pinch valve actuators in modified Everett et al.’s device with a reasonable expectation that it would pinch flow lines to prevent fluid flow therethrough. This method for improving Everett et al.’s device was within the ability of one of ordinary skill in the art based on the teachings of Griffin et al. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Everett et al. and Griffin et al. to obtain the invention as specified in claim 3.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Everett et al. (US 2007/0113474 A1) (already of record) in view of Ahsan (US 2018/0057782 A1) (already of record).
Regarding claim 17, Everett et al. discloses a bioreactor system, but does not disclose a controlled environment containment surrounding the bioreactor system, the controlled environment containment comprising a gas surrounding the bioreactor system. However, Ahsan teaches a photobioreactor system housed in a room (para. 0030 “a room (and/or other location) that houses system”) and a control system that controls the composition of gases within the room (para. 0030) which control the environment surrounding the photobioreactor for the growth of biomass (para. 0030; para. 0004). It would have been obvious to a person of ordinary skill in the art to use the Ahsan configuration of a photobioreactor system housed in a room and a controlled composition of gases within the room in Everett et al.’s device with a reasonable expectation that it would control the environment surrounding the photobioreactor. This method for improving Everett et al.’s device was within the ability of one of ordinary skill in the art based on the teachings of Ahsan. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Everett et al. and Ahsan to obtain the invention as specified in claim 17.
Claims 31-33 and 39-42 are rejected under 35 U.S.C. 103 as being unpatentable over Everett et al. (US 2007/0113474 A1) (already of record) in view of Downs (US 2002/0164653 A1) (already of record).
Regarding claim 31, Everett et al. discloses a bioreactor system, but does not disclose a chamber interface assembly that comprises an optical guide configured to aim an optical fiber at an optical access window of an individual bioreactor chamber node of the set of bioreactor chamber nodes. However, Downs teaches transport robotics and sample processing components comprising fiber optics (para. 0196) which allow sample processing to occur while the sample containers are physically in the rotor and increases throughput of the system (para. 0196). It would have been obvious to a person of ordinary skill in the art to use the Downs configuration of transport robotics and sample processing components comprising fiber optics in Everett et al.’s device with a reasonable expectation that it would allow sample processing to occur while the sample containers are physically in the rotor and increase throughput of the system. This method for improving Everett et al.’s device was within the ability of one of ordinary skill in the art based on the teachings of Downs. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Everett et al. and Downs to obtain the invention as specified in claim 31.
Regarding claim 32, Everett et al. discloses a bioreactor system, but does not disclose wherein the chamber interface assembly comprises an optical fiber for each bioreactor chamber node of the set of bioreactor chamber nodes. However, Downs teaches fiber optics (para. 0196) which allow sample processing to occur while the sample containers are physically in the rotor and increases throughput of the system (para. 0196). It would have been obvious to a person of ordinary skill in the art to use the Downs configuration of fiber optics in Everett et al.’s device with a reasonable expectation that it would allow sample processing to occur while the sample containers are physically in the rotor and increase throughput of the system. This method for improving Everett et al.’s device was within the ability of one of ordinary skill in the art based on the teachings of Downs. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Everett et al. and Downs to obtain the invention as specified in claim 32.
Regarding claim 33, Everett et al. discloses a bioreactor system, but does not disclose wherein the chamber interface assembly further comprises more than one optical fiber for each bioreactor chamber node of the set of bioreactor chamber nodes. However, Downs teaches fiber optics (para. 0196) which allow sample processing to occur while the sample containers are physically in the rotor and increases throughput of the system (para. 0196). It would have been obvious to a person of ordinary skill in the art to use the Downs configuration of fiber optics in Everett et al.’s device with a reasonable expectation that it would allow sample processing to occur while the sample containers are physically in the rotor and increase throughput of the system. This method for improving Everett et al.’s device was within the ability of one of ordinary skill in the art based on the teachings of Downs. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Everett et al. and Downs to obtain the invention as specified in claim 33.
Regarding claim 39, Everett et al. discloses a bioreactor system, but does not disclose an optical multiplexer module configured for optical sensing of the bioreactor chamber nodes of the set of bioreactor chamber nodes. However, Downs teaches detection elements comprising fiber optics and the ability to multiplex sample processing components (para. 0196) which increase throughput of the system (para. 0196). It would have been obvious to a person of ordinary skill in the art to use the Downs configuration of detection elements comprising fiber optics and multiplexing sample processing components in Everett et al.’s device with a reasonable expectation that it would increase throughput of the system. This method for improving Everett et al.’s device was within the ability of one of ordinary skill in the art based on the teachings of Downs. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Everett et al. and Downs to obtain the invention as specified in claim 39.
Regarding claim 40, Everett et al. discloses a bioreactor system, but does not disclose wherein the optical multiplexer module is configured to restrict sensing to one bioreactor chamber node of the set of bioreactor chamber nodes at a given time and is configured to change the one bioreactor chamber node to be sensed. However, Downs teaches transport robotics and the ability to multiplex sample processing components to insert sample processing components into one sample container (para. 0196) which allow sample processing to occur while the sample containers are physically in the rotor and increases throughput of the system (para. 0196). It would have been obvious to a person of ordinary skill in the art to use the Downs configuration of transport robotics and the ability to multiplex sample processing components to insert sample processing components into one sample container in Everett et al.’s device with a reasonable expectation that it would allow sample processing to occur while the sample containers are physically in the rotor and increase throughput of the system. This method for improving Everett et al.’s device was within the ability of one of ordinary skill in the art based on the teachings of Downs. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Everett et al. and Downs to obtain the invention as specified in claim 40.
Regarding claim 41, Everett et al. discloses a bioreactor system, but does not disclose an optical multiplexer module comprising a linear stage to position an optical sensor relative to at least one optical fiber. However, Downs teaches the ability to multiplex sample processing components and transport robotics which position fiber optics within sample containers (para. 0196) which allow sample processing to occur while the sample containers are physically in the rotor and increases throughput of the system (para. 0196). It would have been obvious to a person of ordinary skill in the art to use the Downs configuration of the ability to multiplex sample processing components and transport robotics which position fiber optics within sample containers in Everett et al.’s device with a reasonable expectation that it would allow sample processing to occur while the sample containers are physically in the rotor and increase throughput of the system. This method for improving Everett et al.’s device was within the ability of one of ordinary skill in the art based on the teachings of Downs. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Everett et al. and Downs to obtain the invention as specified in claim 41.
Regarding claim 42, Everett et al. discloses a bioreactor system, but does not disclose at least one optical fiber configured to perform optical sensing of at least one bioreactor chamber node of the set of bioreactor chamber nodes. However, Downs teaches detection elements comprising fiber optics and the ability to multiplex sample processing components (para. 0196) which increase throughput of the system (para. 0196). It would have been obvious to a person of ordinary skill in the art to use the Downs configuration of detection elements comprising fiber optics and multiplexing sample processing components in Everett et al.’s device with a reasonable expectation that it would increase throughput of the system. This method for improving Everett et al.’s device was within the ability of one of ordinary skill in the art based on the teachings of Downs. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Everett et al. and Downs to obtain the invention as specified in claim 42.
Claim 34 is rejected under 35 U.S.C. 103 as being unpatentable over Everett et al. (US 2007/0113474 A1) (already of record) in view of Downs (US 2002/0164653 A1) (already of record) as applied to claim 31 above, and further in view of Kobida, JR. et al. (US 2025/0122463 A1) (already of record).
Regarding claim 34, Everett et al. discloses a bioreactor system, but does not disclose wherein a chamber interface assembly comprises a linear actuator configured to position the optical guide relative to the optical access window of the bioreactor chamber nodes. However, Kobida, JR. et al. teaches that a linear actuator which adjusts positions of probes is known in the art to precisely locate the probe with respect to a sight glass (para. 0029). Though modified Everett et al. does not explicitly teach a linear actuator, it would have been obvious to a person of ordinary skill in the art to use a linear actuator because the substitution of one known element for another would have predictably resulted in a bioreactor system that precisely positions a probe with respect to a sight glass, with reasonable expectation. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to substitute the teachings of modified Everett et al. with the teachings of Kobida, JR. et al. to obtain the invention as specified in claim 34.
Claims 35-38 are rejected under 35 U.S.C. 103 as being unpatentable over Everett et al. (US 2007/0113474 A1) (already of record) in view of Downs (US 2002/0164653 A1) (already of record) as applied to claim 31 above, and further in view of Holmes et al. (US 2018/0112174 A1) (already of record).
Regarding claim 35, Everett et al. discloses a bioreactor system, but does not disclose wherein a chamber interface assembly further comprises a strain gauge configured to sense load when weight is added to one or more of the bioreactor chamber nodes of the set of bioreactor chamber nodes. However, Holmes et al. teaches a strain gauge (para. 0027) which allows the device to add liquids to a bioreactor based on weight (para. 0025). It would have been obvious to a person of ordinary skill in the art to use the Holmes et al. configuration of a strain gauge in modified Everett et al.’s device with a reasonable expectation that it would allow liquid to be added to a bioreactor based on weight. This method for improving modified Everett et al.’s device was within the ability of one of ordinary skill in the art based on the teachings of Holmes et al. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of modified Everett et al. and Holmes et al. to obtain the invention as specified in claim 35.
Regarding claim 36, Everett et al. discloses a bioreactor system wherein the set of bioreactor chamber nodes is configured to be mounted on a support rail (para. 0042 “containers 11 supported by a rack 12”; support rail 24), but does not disclose wherein the strain gauge is configured to sense load when weight is added to one or more of the bioreactor chamber nodes via additional load on the base of the one or more bioreactor chamber nodes. However, Holmes et al. teaches a strain gauge (para. 0027) which allows the device to add liquids to a bioreactor based on weight (para. 0025). It would have been obvious to a person of ordinary skill in the art to use the Holmes et al. configuration of a strain gauge in modified Everett et al.’s device with a reasonable expectation that it would allow liquid to be added to a bioreactor based on weight. This method for improving modified Everett et al.’s device was within the ability of one of ordinary skill in the art based on the teachings of Holmes et al. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of modified Everett et al. and Holmes et al. to obtain the invention as specified in claim 36.
Regarding claim 37, Everett et al. discloses a bioreactor system, but does not disclose wherein the chamber interface assembly comprises a plurality of strain gauges configured to sense load when weight is added to one or more of the bioreactor chamber nodes of the set of bioreactor chamber nodes. However, Holmes et al. teaches a strain gauge (para. 0027) which allows the device to add liquids to a bioreactor based on weight (para. 0025). It would have been obvious to a person of ordinary skill in the art to use the Holmes et al. configuration of a strain gauge in modified Everett et al.’s device with a reasonable expectation that it would allow liquid to be added to a bioreactor based on weight. This method for improving modified Everett et al.’s device was within the ability of one of ordinary skill in the art based on the teachings of Holmes et al. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of modified Everett et al. and Holmes et al. to obtain the invention as specified in claim 37.
Regarding claim 38, Everett et al. discloses a bioreactor system wherein the set of bioreactor chamber nodes is mounted on the support rail (para. 0042 “containers 11 supported by a rack 12”; support rail 24). Regarding the limitation “in a mechanically-compressed state”, it has been held that a claim containing a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus if the prior art apparatus teaches all the structural limitations of the claim (MPEP § 2114 II). Therefore, the apparatus disclosed by modified Everett et al. would be fully capable of achieving every claimed intended use because Everett et al. discloses flexible bioreactor bags (para. 0090) and would be structurally capable of being mechanically compressed absent clear evidence otherwise.
Claim 43 is rejected under 35 U.S.C. 103 as being unpatentable over Everett et al. (US 2007/0113474 A1) (already of record) in view of Downs (US 2002/0164653 A1) (already of record) as applied to claim 31 above, and further in view of Griffin et al. (US 2024/0200012 A1) (already of record) Holmes et al. (US 2018/0112174 A1) (already of record).
Regarding claim 43, Everett et al. discloses a bioreactor system, but does not disclose a chamber interface assembly comprising: a guide rail configured to fit with an alignment rail of a bioreactor chamber node of the set of bioreactor chamber nodes; a valve actuator configured to rotate a plurality of valves to pinch closed base tubing, the base tubing providing fluid connection between at least two bioreactor chamber nodes of the set of bioreactor chamber nodes; and a strain gauge configured to determine a weight of the bioreactor chamber node of the plurality of bioreactor chamber nodes.
Regarding the limitation “a guide rail configured to fit with an alignment rail”, Downs teaches transport robotics which position fiber optics within sample containers (para. 0196) which allow sample processing to occur while the sample containers are physically in the rotor and increases throughput of the system (para. 0196). It would have been obvious to a person of ordinary skill in the art to use the Downs configuration of the ability to multiplex sample processing components and transport robotics which position fiber optics within sample containers in Everett et al.’s device with a reasonable expectation that it would allow sample processing to occur while the sample containers are physically in the rotor and increase throughput of the system. This method for improving Everett et al.’s device was within the ability of one of ordinary skill in the art based on the teachings of Downs. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of Everett et al. and Downs to obtain the invention as specified in claim 43.
Regarding the limitation “a valve actuator configured to rotate a plurality of valves to pinch closed base tubing”, Griffin et al. teaches that pinch valve actuators which pinch flow tubes are known in the art (para. 0017) which pinch a line to prevent fluid flow therethrough (para. 0124). It would have been obvious to a person of ordinary skill in the art to use the Griffin et al. configuration of pinch valve actuators in modified Everett et al.’s device with a reasonable expectation that it would pinch flow lines to prevent fluid flow therethrough. This method for improving modified Everett et al.’s device was within the ability of one of ordinary skill in the art based on the teachings of Griffin et al. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of modified Everett et al. and Griffin et al. to obtain the invention as specified in claim 43.
Regarding the limitation “a strain gauge configured to determine a weight of the bioreactor chamber node of the set of bioreactor chamber nodes”, Holmes et al. teaches a strain gauge (para. 0027) which allows the device to add liquids to a bioreactor based on weight (para. 0025). It would have been obvious to a person of ordinary skill in the art to use the Holmes et al. configuration of a strain gauge in modified Everett et al.’s device with a reasonable expectation that it would allow liquid to be added to a bioreactor based on weight. This method for improving modified Everett et al.’s device was within the ability of one of ordinary skill in the art based on the teachings of Holmes et al. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine the teachings of modified Everett et al. and Holmes et al. to obtain the invention as specified in claim 43.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ASHLEY LOPEZLIRA whose telephone number is (703)756-5517. The examiner can normally be reached Mon - Fri: 8:30-5:00.
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/ASHLEY LOPEZLIRA/Examiner, Art Unit 1799
/MICHAEL A MARCHESCHI/Supervisory Patent Examiner, Art Unit 1799
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