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 .
Claim Objections
Claim 1 is objected to because of the following informalities:
In step “c)”, after both “4·” and “5·” delete “1014” and amend to “1014”.
In step “d)”, delete “an” before “edible filamentous fungus”.
Appropriate correction is required.
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 1-5 are 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.
Regarding claim 1, in lines 1-2 the limitation “a protein content of at least 10%” renders the claim indefinite since the basis of the percentage is unclear e.g., weight, volume, etc. The specification (page 11 lines 17-19) does not provide clarification.
In step d), the limitation “automatically amending said set of conditions” renders the claim indefinite since it is unclear what feature(s) are encompassed by the term “automatically”. The claim does not recite or otherwise indicate that the process includes any feature or device recognized by the art for performing the “automatically amending” limitation e.g., a controller. It is unclear if the limitation in question is performed by such a device or some other unrecited feature. Examiner notes the specification discloses control system 6 for controlling the conditions of fermentation (page 25 lines 25-29). The rejection may be overcome by amending the claim to include language that reflects the above disclosure.
Claims 2-5 are rejected by virtue of their dependence on a rejected base claim.
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 1-2 are rejected under 35 U.S.C. 103 as being unpatentable over Zhang et al. (US 2019/0256391 A1) in view of Macur et al. (US 2020/0268031 A1) and Shinohara et al. (US 2022/0356432 A1).
Regarding claim 1, Zhang et al. teaches a method for manufacturing a nutrient-rich biomass (abstract) comprising at least one fermented substrate and at least one strain of an edible filamentous fungus, said method comprising the steps of:
a) providing at least one substrate to be fermented, said substrate maintained at a moisture content of 30-40% i.e., having total solid loading of from 60-70% (paragraph 41), wherein said at least one substrate is cracked corn but can also include other grains such as rice, barley or wheat, or agricultural residues like wheat straw or corn stover (paragraph 41);
b) inoculating said at least one substrate with at least one strain of an edible filamentous fungus thus obtaining at least one inoculated substrate (paragraph 41);
c) setting a set of conditions, wherein said set of conditions comprises maintaining a substrate moisture content of 30-40% and incubation (maintaining) a temperature of 30oC with or without aeration (flow rate of gas) for fungal growth (paragraphs 40-41);
d) fermenting said at least one inoculated substrate at said set of conditions while continuously monitoring at least one parameter such as the moisture content, temperature, and aeration as stated above, thus obtaining a protein-rich biomass comprising at least one fermented substrate and at least one strain of an edible filamentous fungus; wherein said at least one strain of an edible filamentous fungus is selected from the group consisting of Rhizopus spp., Aspergillus spp., Neurospora spp., Monascus spp., and Rhizomucor spp (paragraphs 20-21).
Zhang et al. does not teach the biomass being “a protein-rich biomass having a protein content of at least 10%.”
Macur et al. teaches a method of production of edible filamentous fungal biomat formulations (abstract), the fungus species selected to be e.g., Rhizopus oligosporus (paragraph 10), comprising growing the fungus via fermentation with a substrate including grains (paragraph 189). The fungus comprises at least about 30 wt% protein (paragraph 182), and the finished biomat (fermentation product) comprises greater than about 40 wt% protein (paragraph 104). The reference further teaches that filamentous fungi grown or cultured as disclosed have a surprisingly high protein content (paragraph 180), where the result may be due in part to the media used to grow the fungus.
It would have been obvious to one of ordinary in the art before the effective filing date of the claimed invention to modify the process of Zhang et al. to control the process parameters such that the obtained biomass has a protein content of at least 10 wt% since the reference obtains a “nutrient-rich” liquid of the fungi, which would necessarily comprise fungal protein, and also teaches the fermentation can be performed for a duration of time to achieve a desired yield and/or density of the fungus (paragraphs 274-276), since the prior art recognizes fermentation of the claimed fungus strains to obtain a biomass having increased protein content, since process conditions such as growth media can be controlled to obtain a desired increase in protein content of the obtained biomass, since the evidence of record does not indicate criticality or unexpected results associated with the feature, and since the claimed values would have been used during routine experimentation and optimization based on the particular genus/species of fungus, nutritional substrate, and fermentation conditions.
Zhang et al. does not teach automatically amending said set of conditions as a function of said at least one parameter during fermentation.
Marcur et al. further teaches biomat growth characteristics are controlled by controlling various parameters (set of conditions) of the bioreactor e.g., temperature, humidity, pressure, wavelength of amount of light, etc. (paragraph 290).
Shinohara et al. teaches a culturing device (abstract), comprising environment adjustment part 13 which includes a heating device and CO2 supply device. Sensors 23 detect the internal environment of the culture device e.g., temperature and CO2 concentration, and outputs the information to controller 5 (paragraph 25). The controller determines if the environment in the culture device is within permitted values, and if not, adjusts the conditions using environment adjustment part 13 (paragraph 45). The controller performs the function automatically (paragraph 35).
It would have been obvious to one of ordinary in the art before the effective filing date of the claimed invention to modify the process of Zhang et al. to automatically amend the set of conditions as a function of the at least one parameter during fermentation since the reference already suggests adjusting conditions to favor fungal growth (paragraph 44; claim 4), since the prior art recognizes automatic control of operating conditions to ensure an optimal environment for a culture, to prevent the risk of human error causing issues with the fermentation, and since the court held that broadly providing an automatic or mechanical means to replace a manual activity which accomplished the same result is not sufficient to distinguish over the prior art, see MPEP 2144.04 III.
Regarding claim 2, Zhang et al. does not teach robot-assisted loading and/or unloading as claimed.
Shinohara et al. further teaches loading and unloading of the culturing container is performed automatically by a robot arm (paragraph 47).
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 process of Zhang et al. to load/unload using robot assistance since the prior art recognizes such a feature, and to facilitate process efficiency, where automating a manual process is obvious as stated for claim 1.
Claims 3-5 are rejected under 35 U.S.C. 103 as being unpatentable over Zhang et al. in view of Macur et al. and Shinohara et al. as applied to claim 1 above, and in view of Coleman et al. (US 3,829,363).
Regarding claim 3, Zhang et al. does not teach adding at least one binder to said at least one substrate simultaneously with step a.
Coleman et al. teaches a method for manufacturing protein biomass from Aspergillus niger (abstract), where a source of nutrients is provided by starch-containing substrates and waste residues from processing agricultural crops, the waste including potato starch (column 1 lines 59-65; column 2 lines 12-13). The reference recognizes the problem of disposal of waste from said potato processing and aims to provide a solution by incorporating the waste as a substrate for fungus fermentation (column 1 lines 24-34 and 70 to column 2 line 3). It is noted that potato starch is recognized as a binder in Applicant’s specification (page 10 lines 1-3).
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 process of Zhang et al. to add potato starch to the at least one substrate simultaneously with step a) since the prior art recognizes potato starch as a nutrient source for fungus fermentation, to minimize waste as taught by Coleman et al., and to reduce manufacturing cost by utilizing a “cheap” nutrient source.
Regarding claim 4, Zhang et al. does not teach heat treatment of the protein-rich biomass immediately after step d).
Coleman et al. further teaches, after the end of the fermentation period, the temperature of the product is elevated for a time sufficient to sterilize the product (column 3 lines 38-42).
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 process of Zhang et al. to immediately heat treat the product after fermentation in order to similarly sterilize the biomass and kill the fungi, to stop the fermentation such that the protein can be extracted, to prevent proliferation of contaminants, and to ensure the biomass product is safe for consumption.
Regarding claim 5, Zhang et al. does not teach drying the biomass.
Coleman et al. further teaches the fermentation product is sterilized, the fungal protein recovered by filtration, then dried for analysis (column 4 lines 51-60).
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 process of Zhang et al. to dry the product to similarly allow for analysis to determine protein content, to increase the concentration of the desired filamentous fungi, and to facilitate preservation for storage and/or transport as is known for dried food products.
Response to Arguments
Applicant's arguments filed 7/1/2026 have been fully considered but the amendments to claim 1 necessitated new grounds of rejection.
Claim 1 is no longer rejected under 35 USC 102(a)(1) to Zhang et al. The claim is rejected under 35 USC 103 as unpatentable over Zhang in view of Macur et al. and Shinohara et al. Marcur et al. teaches a fermented filamentous fungus product contains greater than 10 wt% protein and adjusting fermentation conditions such as temperature, humidity, light, etc. to control growth characteristics of the fungi. Shinohara et al. teaches the environmental conditions of a culturing device is automatically controlled based on sensor data i.e., closed-loop feedback control as is known in the art.
Applicant argues on page 9 that the claimed method enables large-scale solid-state fermentation at high production capacity with uniform mass transfer and complete automation without human intervention, and produces no effluent requiring further treatment, rendering it environmentally benign and consistent with circular-economy principles. The effects arise from the specific combination of recited process conditions with the automatic closed-loop adjustment.
This is not persuasive since the prior art recognizes monitoring and adjusting environmental conditions during the fermentation to optimize growth conditions of the filamentous fungi (Marcur) and teaches a system for providing automatic closed-loop feedback control (Shinohara). Further, one of ordinary skill would have been able to scale the process of Zhang to obtain a desired production capacity, particularly since the prior art already acknowledges scaling such systems/methods is “relatively straightforward” as taught by Marcur (paragraph 278), see also MPEP 2144.04 IV.A.
Regarding the features of uniform mass transfer, automation without human intervention, and elimination of the need for further effluent treatment, none of the argued features are claimed. Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Regardless, Zhang acknowledges effluent such as anaerobic digestate often requires costly disposal and teaches using such wastewaters to produce microalgae can provide economic and environmental benefits (paragraphs 27 and 31). The process treats wastewater using filamentous fungi (paragraph 5), which would eliminate the need for further effluent treatment.
Regarding the argued effects arising from the specific combination of recited process conditions with the automatic closed-loop adjustment, the prior art renders obvious the claimed features as stated in the prior art rejection above. The prior art also suggests to one of ordinary skill that treating wastewater with filamentous fungi provides environmental benefits as stated above. There is no evidence of record that indicates the argued effects are unexpected.
Applicant argues on page 10 that Zhang does not identify scale-up challenges, does not teach, suggest, or motivate one of ordinary skill to bridge the gap between its basic process and the claimed automated, responsive system, and therefore modification would not have been obvious.
This is not persuasive since Zhang does not particularly limit the scale of its process, since the prior art recognizes scaling of filamentous fungi culturing processes as “relatively straightforward,” and since automated systems are obvious as stated above.
Applicant argues on page 10 that Zhang does not teach the claimed protein content and said content would not have been expected based on its teachings.
This is not persuasive since the prior art teaches culturing filamentous fungi using wastewater to obtain a desired high-protein biomass having a protein content above 10 wt% and adjusting conditions during the culturing to optimize growth of said fungi (Marcur). While Zhang does not explicitly recite the claimed protein content, the process uses the same filamentous fungi as Applicant’s and Macur’s process. Therefore, one of ordinary skill would have reasonably expected the process of Zhang could be modified (e.g., by similarly adjusting growth conditions) to obtain a biomass having increased protein content.
Applicant argues on page 11 that Shinohara does not teach automatic closed-loop feedback control and a protein content of at least 10% as claimed, where Shinohara’s mechanical handling solution and feedback control system addresses fundamentally different technical problems, and combination would require impermissible hindsight.
This is not persuasive since the reference is not relied on to teach the argued features. Marcur teaches monitoring and adjusting conditions within the fermenter to optimize growth of the fungi, where the process is performed to obtain a desired increased protein content of the final biomass. Shinohara teaches culturing systems include necessary sensors and control devices to perform automatic feedback control, where modification of Zhang to include the argued features would have been obvious as stated in the prior art rejection. There is no evidence that shows said features are critical or unexpected.
Applicant argues on page 11 that Coleman’s sterilization step is a simple, open-loop heating process which is different from that of the claimed process, and does not teach the claimed protein content of the biomass.
This is not persuasive for the same reasons stated for Shinohara above. Coleman is not relied on to teach the argued features. Said features are taught and rendered obvious by the combination of Zhang, Marcur, and Shinohara as applied to claim 1.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Pattillo (US 2020/0093167 A1) teaches fermentation processes using waste nutrient streams from crop and food processing (paragraph 12) to obtain shelf-stable protein food ingredients that comprise fungi cultivated in “a refined, controlled, environment” using optimized fermentation systems (paragraph 15), including filamentous fungi (paragraphs 16-17).
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 BRYAN KIM whose telephone number is (571)270-0338. The examiner can normally be reached 9:30-6.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Erik Kashnikow can be reached at (571)-270-3475. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/B.K/Examiner, Art Unit 1792
/ERIK KASHNIKOW/Supervisory Patent Examiner, Art Unit 1792
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