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 .
Preliminary Remarks
The amendment filed on 12/17/2025 has been entered. Claim 1 has been amended, no claims have been added. Also, please note non-elected claims, 12-20, were not included on the claim set submitted on 12/17/2025, and applicant has not indicated on the claim set submitted that said claims are withdrawn or canceled. For the purpose of examination, the claims are presumed to be canceled.
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 and 4-11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2004/0077075A1-Jensen et al. (hereafter Jensen).
Regarding claim 1, Jensen discloses a system comprising a first bioreactor (a variety of microscale bioreactors, para. [0005], lines 1-9), wherein the first bioreactor comprises: a first housing (bioreactor comprises a vessel or culturing cells, para. [0061], line 2); plurality of first bioreactor tiles (bioreactor assemblies/microfermentor arrays, para. [0012], lines 1-2; para. [0009], lines 3-6) positioned within the first housing, wherein each of the first bioreactor tiles is configured to house cells capable of producing one or more chemical products (bioreactor assemblies/microfermentor arrays, para. [0012], lines 1-2; para. [0009], lines 3-6); that is, the bioreactor assemblies/microfermentor arrays are capable of house cells capable of producing one or more chemical products.
Jensen discloses a first fluid management system (fluid control elements, para. [0079], lines 11-13), configured to: provide liquid nutrient media to the first bioreactor tiles to support growth of the cells (that is, the fluid control elements of Jensen are capable of providing liquid nutrient media to the first bioreactor tiles to support growth of the cells); and Jensen discloses harvest the one or more chemical products from the first bioreactor tiles (para. [0053], lines 10-11);
Jensen discloses a first illumination system configured to supply the first bioreactor tiles with illumination light used to support growth of the cells (light to the system, para. [0087], lines 20-23; para. [0115], light sources; that is, the light/light sources of the system of Jensen are capable of supplying the first bioreactor tiles with illumination light used to support growth of the cells).
Jensen discloses a first environmental control system (para. [0009], lines 1-3; that is, the control means is capable of providing the first bioreactor tiles with one or more sets of environmental conditions that support growth of the cells) positioned within the first housing and configured to provide the first bioreactor tiles with one or more sets of environmental conditions that support growth of the cells;
Jensen discloses one or more first sensors (para. [0112], lines 3-5; that is, the sensors of the system of Jensen are capable of sensing one or more conditions associated with the first fluid management system, the first illumination system, the first environmental control system, the first bioreactor tiles, or the cells) positioned within the first housing and configured to sense one or more conditions associated with the first fluid management system, the first illumination system, the first environmental control system, the first bioreactor tiles, or the cells;
Jensen discloses a first controller (data acquisition systems and/or bioprocess control, para. [0087], lines 16-17; and para. [0085], lines 20-23); that is, the data acquisition systems and/or bioprocess control is capable of receive data regarding the one or more conditions from the one or more first sensors) configured to: receive data regarding the one or more conditions from the one or more first sensors (software and computers, e.g., for data acquisition and/or bioprocess control, para. [0087], lines 15-17); and Jensen discloses determining an instruction to address the one or more conditions (a microfermenter integrated optical density, dissolved oxygen, and pH sensors together with, para. [0039]).
Jensen discloses provide, based on the received data, one or more operating parameters to the first fluid management system, the first illumination system, or the first environmental control system to address the one or more conditions (para. [0085], lines 20-23; a microfermenter integrated optical density, dissolved oxygen, and pH sensors together with, para. [0039]). Further, Jensen discloses the microfermentor and associated optics interfaces with instrumentation and computer software to measure and/or control bioprocess parameters (para. [0148], lines 9-11).
Regarding claim 4, Jensen discloses further comprising a second bioreactor (a variety of microscale bioreactors, para. [0005], lines 1-9), wherein the second bioreactor comprises: a second housing (bioreactor comprises a vessel or culturing cells, para. [0061], line 2); a plurality of second bioreactor tiles (bioreactor assemblies/microfermentor arrays, para. [0012], lines 1-2; para. [0009], lines 3-6) positioned within the second housing, wherein each of the second bioreactor tiles is configured to house cells capable of producing one or more chemical products (that is, the bioreactor assemblies/microfermentor arrays are capable of house cells capable of producing one or more chemical products);
Jensen discloses a second fluid management system (fluid control elements, para. [0079], lines 11-13), configured to: provide liquid nutrient media to the second bioreactor tiles to support growth of the cells (that is, the fluid control elements of Jensen are capable of providing liquid nutrient media to the first bioreactor tiles to support growth of the cells); and Jensen discloses harvest the one or more chemical products from the first bioreactor tiles (para. [0053], lines 10-11); and Jensen discloses harvest the one or more chemical products from the second bioreactor tiles (para. [0053], lines 10-11);
Jensen discloses a second illumination system configured to supply the second bioreactor tiles with illumination light used to support growth of the cells (light to the system, para. [0087], lines 20-23; para. [0115], light sources; that is, the light/light sources of the system of Jensen are capable of supplying the first bioreactor tiles with illumination light used to support growth of the cells).
Jensen discloses a second environmental control system (each bioreactor comprises an environmental control system, para. [0009], lines 1-3; that is, the control means is capable of providing the second bioreactor tiles with one or more sets of environmental conditions that support growth of the cells) positioned within the first housing and configured to provide the second bioreactor tiles with one or more sets of environmental conditions that support growth of the cells in the second bioreactor;
Jensen discloses one or more second sensors (para. [0112], lines 3-5; that is, the sensors of the system of Jensen are capable of sensing one or more conditions associated with the second fluid management system, the second illumination system, the second environmental control system, the second bioreactor tiles, or the cells) positioned within the first housing and configured to sense one or more conditions associated with the second fluid management system, the second illumination system, the second environmental control system, the second bioreactor tiles, or the cells;
Jensen discloses a second controller (data acquisition systems and/or bioprocess control, para. [0087], lines 16-17; and para. [0085], lines 20-23); that is, the data acquisition systems and/or bioprocess control is capable of receive data regarding the one or more conditions from the one or more first sensors) configured to: receive data regarding the one or more conditions from the one or more second sensors;
Jensen discloses provide, based on the received data, one or more operating parameters to the first fluid management system, the first illumination system, or the first environmental control system (para. [0085], lines 20-23).
Regarding claim 5, Jensen discloses further comprising a bioreactor facility, wherein the first bioreactor and the second bioreactor (a variety of microscale bioreactors, para. [0005], lines 1-9) are located within the bioreactor facility (para. 0044, lines 13-17; para. [0110], lines 1-7).
Regarding claim 6, Jensen discloses a facility-management server (software and computers, para. [0087], lines 15-19), wherein the facility-management server (software and computers, para. [0087], lines 15-19) is configured to: communicate with the first controller (data acquisition systems and/or bioprocess control, para. [0087], lines 16-17; and para. [0085], lines 20-23) to: receive data regarding the one or more conditions from the one or more first sensors (sensors, para. [0112], lines 3-5); and receive the one or more operating parameters provided to the first fluid management system, the first illumination system, or the first environmental control system (para. [0087], lines 16-19; and para. [0046], lines 13-16);
Jensen discloses communicate with the second controller (each bioreactor has a controller, data acquisition systems and/or bioprocess control, para. [0087], lines 16-17; and para. [0085], lines 20-23, each bioreactor comprises the latter feature) to: receive data regarding the one or more conditions from the one or more second sensors (para. [0087], lines 16-19; and para. [0046], lines 13-16);
Jensen discloses receive the one or more operating parameters provided to the second fluid management system, the second illumination system, or the second environmental control system (para. [0085], lines 20-23);
Jensen discloses determine, based on: (i) the one or more conditions from the one or more first sensors (sensors, para. [0112], lines 3-5); (ii) the one or more operating parameters provided to the second fluid management system, the second illumination system, or the second environmental control system (para. [0087], lines 16-19; and para. [0046], lines 13-16); or (iii) the one or more conditions from the one or more second sensors, one or more revised operating parameters for the first fluid management system, the first illumination system, or the first environmental control system;
Jensen discloses determine, based on: (i) the one or more conditions from the one or more second sensors (sensors, para. [0112], lines 3-5); (ii) the one or more operating parameters provided to the first fluid management system, the first illumination system, or the first environmental control system (para. [0087], lines 16-19; and para. [0046], lines 13-16); or (iii) the one or more conditions from the one or more first sensors, one or more revised operating parameters (para. [0085], lines 20-23) for the second fluid management system, the second illumination system, or the second environmental control system;
Jensen discloses and provide, to the first controller (data acquisition systems and/or bioprocess control, para. [0087], lines 16-17; and para. [0085], lines 20-23), the one or more revised operating parameters for the first fluid management system, the first illumination system, or the first environmental control system (para. [0087], lines 16-19; and para. [0046], lines 13-16);
Jensen discloses and provide, to the second controller (each bioreactor has a controller, data acquisition systems and/or bioprocess control, para. [0087], lines 16-17; and para. [0085], lines 20-23, each bioreactor comprises the latter feature), the one or more revised operating parameters for the second fluid management system, the second illumination system, or the second environmental control system.
Regarding claim 7, Jensen discloses wherein the first controller (each bioreactor has a controller, data acquisition systems and/or bioprocess control, para. [0087], lines 16-17; and para. [0085], lines 20-23, that is, the controller of Jensen is capable of raising a first flag when the data regarding the one or more conditions from the one or more first sensors corresponds to a first trigger condition), is configured to raise a first flag when the data regarding the one or more conditions from the one or more first sensors corresponds to a first trigger condition, wherein the second controller (each bioreactor has a controller, data acquisition systems and/or bioprocess control, para. [0087], lines 16-17, that is, the controller is capable of raising a second flag when the data regarding the one or more conditions from the one or more second sensors corresponds to a second trigger condition) is configured to raise a second flag when the data regarding the one or more conditions from the one or more second sensors corresponds to a second trigger condition, wherein: receiving the data regarding the one or more conditions from the one or more first sensors comprises identifying that the first flag is raised; or receiving the data regarding the one or more conditions from the one or more second sensors comprises identifying that the second flag is raised (sensors, para. [0112], lines 3-5).
Regarding claim 8, Jensen discloses wherein the first trigger condition or the second trigger condition represents: a clog, a threshold change in temperature over a predetermined period of time, a threshold change in humidity over a predetermined period of time, a threshold change in pressure over a predetermined period of time, a threshold change in pH within a solution over a predetermined period of time, a threshold change in illumination intensity over a predetermined period of time, a threshold change in illumination wavelength over a predetermined period of time, a growth milestone relating to the cells in the first bioreactor, a growth milestone relating to the cells in the second bioreactor, or a chemical production milestone (para. [0046], lines 13-18; and para. [0193], lines 1-8).
Regarding claim 9, Jensen discloses comprising a facility-wide environmental control system positioned within the facility (environmental control system, para. [0046], lines 6-8; that is the environmental control system of Jensen is capable of to providing the first bioreactor and the second bioreactor with one or more sets of external environmental conditions, wherein the facility-management server is configured to provide one or more operating parameters to the facility-wide environmental control system, wherein the first environmental control system is configured to augment the one or more sets of external environmental conditions to provide the first bioreactor tiles with the one or more sets of environmental conditions that support growth of the cells) and configured to provide the first bioreactor and the second bioreactor with one or more sets of external environmental conditions (further, the control system of Jensen is capable of provide the first bioreactor and the second bioreactor with one or more sets of external environmental conditions), wherein the facility-management server (software and computers, para. [0087], lines 15-19, that is, the computers and software of Jensen is capable of providing one or more operating parameters to the facility-wide environmental control system) is configured to provide one or more operating parameters to the facility-wide environmental control system, wherein the first environmental control system (environmental control system, para. [0046], lines 6-8; that is, the environmental control system is capable of augment the one or more sets of external environmental conditions to provide the first bioreactor tiles with the one or more sets of environmental conditions that support growth of the cells) is configured to augment the one or more sets of external environmental conditions to provide the first bioreactor tiles with the one or more sets of environmental conditions that support growth of the cells, and wherein the second environmental control system (environmental control system, para. [0046], lines 6-8; each bioreactor of Jensen has an environmental control system, is capable of augmenting the one or more sets of external environmental conditions to provide the second bioreactor tiles with the one or more sets of environmental conditions that support growth of the cells) is configured to augment the one or more sets of external environmental conditions to provide the second bioreactor tiles with the one or more sets of environmental conditions that support growth of the cells.
Regarding claim 10, Jensen discloses further comprising a facility-wide fluid management system (para. [0105], lines 5-7; that is, the fluid system of Jensen is capable of provide the first bioreactor and the second bioreactor with one or more fluids used for operation or retrieve the one or more chemical products from the products from the first bioreactor and the second bioreactor and also capable of providing the first bioreactor and the second bioreactor with one or more fluids used for operation or retrieve the one or more chemical products from the products from the first bioreactor and the second bioreactor) positioned within the facility and configured to provide the first bioreactor and the second bioreactor with one or more fluids used for operation or retrieve the one or more chemical products from the products from the first bioreactor and the second bioreactor (para. [0105], lines 1-7).
Regarding claim 11, Jensen discloses wherein the facility comprises a floor surface and a subfloor surface (para. [0087],lines 1-4), and wherein the facility-wide fluid management system comprises pipes, pumps, chambers, reservoirs, tanks, or valves located between the floor surface and the subfloor surface (para. [0087], lines 4-6; para. [0063], line 17).
Therefore, the reference of Jensen meet the limitations of claims 1 and 4-11.
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 2-3 are rejected under 35 U.S.C. 103 as being unpatentable over a different embodiment of US 2004/0077075A1-Jensen et al. (hereafter Jensen).
Regarding claim 2, Jensen teaches wherein each of the first bioreactor tiles (bioreactor assemblies/microfermentor arrays, para. [0012], lines 1-2; para. [0009], lines 3-6) comprises: a substrate (para. [0076], line 10) having a first channel, a second channel, and a third channel (channels, para. [0076], lines 10-12) defined therein, wherein the first channel is separated from the second channel by a first partial wall structure, wherein the second channel is separated from the third channel by a second partial wall structure (para. [0063], lines 2-12), wherein the first channel is configured to receive the liquid nutrient media from the first fluid management system, wherein the second channel is configured to house the cells capable of producing the one or more chemical products, and wherein the third channel is configured to house the one or more chemical products produced by the cells (that is, the channels of Jensen are capable of housing the cells capable of producing the one or more chemical products, and wherein the third channel is configured to house the one or more chemical products produced by the cells). However, Jensen does not explicitly discloses a waveguide.
For claim 2, a different embodiment of Jensen teaches a waveguide (waveguide sensors, para. [0137], lines 1-2), which reads on the instant claim limitation of a waveguide.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the device of Jensen to include an optical waveguide as taught by a different embodiment of Jensen. Further, Jensen teaches waveguides are used to guide light in or out of the system (para. [0062], lines 14-15); that is, the optical waveguides of the different embodiment of Jensen are capable of receiving the illumination light from the first illumination system at a first end of the optical waveguide; propagate the illumination light toward a second end of the optical waveguide; allow at least a portion of the illumination light to escape the optical waveguide from a first surface of the optical waveguide as the illumination light propagates toward the second end of the optical waveguide; and provide the portion of the illumination light that escapes the optical waveguide from the first surface to the second channel or the third channel (channels, para. [0063], lines 1-2; para. [0076], lines 11-12) to support growth of the cells or production, by the cells, of the one or more chemical products.
Regarding claim 3, Jensen discloses wherein the third channel (channels, para. [0076], lines 10-12; and para. [0063], lines1-2; that is, the channels, third channel, is capable of housing an air mixture, and wherein the air mixture is capable of enabling gas exchange for the cells) is further configured to house an air mixture, and wherein the air mixture is configured to enable gas exchange for the cells.
Response to Arguments
Applicant's arguments filed 12/17/2025 have been fully considered but they are not persuasive. On the top of page 7, applicant discussed the rejected claims, 1-11, and the relied upon art of Jensen. Further, applicant discussed support for the amendment of claim 1 and reference the support for the latter in the specification of the instant application. On the bottom of page 7, applicant recites a portion of the limitations of independent claim 1, in particular, pertaining to a first controller configured to receive data regarding the one or more conditions from the one or more sensors, and provide, based on the received data, one or more parameters to the first fluid management system, the first illumination system, or the first environmental control system. Furthermore, applicant asserts the relied upon citation of Jensen, para. [0085, lines 20-23) does not recite the limitation of the claims as stated. In response, for clarification purposes, para. [0087], lines 11-17) discloses software and computers of the microfermenters for data acquisition and/ or bioprocess control. Further, para. [0148], lines 1-6; and lines 9-11), where again, Jensen reiterates the ability bioprocess parameters to be dictated by computer software, where it is well known in the art, that computers and software are configured to permit instruction or execute various steps.
On the top and middle of page 8 of applicant’s remarks, applicant recites some of the features of the claimed invention and provides citations for support. On the bottom of page 8 of applicant’s remarks, applicant asserts “a close reading of that paragraph (Jensen, [0095]) does not reveal any interactions or responses by a controller as a result of a reading by a sensor…”. In response, the latter appears to be a typo by applicant, since para. [0095] was not relied upon in the rejection mailed on 06/18/2025. Paragraph [0086], lines 2-4, disclose the microfermentor(s) and/or sensor(s) interfere with data acquisition systems. Moreover, the entire document of Jensen discloses analytical sensors integrated into the microfermentor; which allows for monitoring (which may include detection and/or measurement of a variable of interest (para. [0112], lines 3-5). Further, Jensen discloses the invention further provides a chamber to contain the microfermentors and microfermentor arrays and to provide environmental control (abstract).
On the top of page 9, applicant asserts “because at no point does the Jensen reference describe or claim providing parameters to at least one bioreactor in response to data gathered by sensors in order to change or modify the bioreactor conditions, it would not have been obvious to a person having ordinary skills in the art to modify the Jensen reference to cure its inherent deficiency.”. The latter argument is not found persuasive for the reasons discussed above in this section. Also, para. [0110], lines 10-16, Jensen discloses “in order to optimize bioprocesses and to perform optimized bioprocesses it is desirable to be able to monitor a variety of parameters including, but not limited to, biomass and environmental variables (e.g., pH, oxygen concentration, metabolite concentration) during the course of a fermentation, for example to allow selection of fermentation. Further, Jensen discloses the microscale bioreactor incorporates multiple sensors (e.g., at least 2, 3, 4, 5, or even more), thus allowing monitoring of multiple bioprocess parameters (para. [0147], lines 3-6). Therefore, claims 1-11 stand rejected for the reasons discussed above in this section and the rejection above.
Conclusion
THIS ACTION IS MADE FINAL. 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.
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/L.A.A./Examiner, Art Unit 1799
/MICHAEL L HOBBS/Primary Examiner, Art Unit 1799