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 .
The amendment filed Jully 7, 2026 has been entered. Claims 1-14 and 16-19 are pending.
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.
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, 4-6, 8-11 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Dennis et al. (US 2015/0176042).
Regarding claims 1, 2, 4, 9 and 10, Dennis et al. disclose a method of producing a pasteurized biomass, the method comprising the steps of: (a) obtaining a biomass by cultivating (i.e., fermenting) microorganisms in a growth medium (i.e., fermentation broth) ([0024]-[0045]); and (b) pasteurizing the biomass to kill the cells and inactivate undesirable substances present in the biomass ([0046]). Dennis et al. disclose the biomass is pasteurized at a temperature in the range of 55° to 121°C for a time of 4 minutes to 120 minutes ([0046]). Dennis et al. disclose the pH of the fermentation medium (i.e., fermentation broth) is between 3 and 10 (i.e., pH of the biomass-[0040], [0055]).
While Dennis et al. do not disclose the precisely claimed pasteurization temperature and pH of the biomass, in the case where the claimed ranges overlap or lie inside ranges disclose by the prior art a prima facie case of obviousness exists (MPEP §2144.05 I).
While Dennis et al. disclose a pasteurization time of 4 minutes, a prima facie case of obviousness exists where the claimed ranges do not overlap with the prior are but are merely close. Titanium Metals Corp. of America v. Banner, 778 F 2d 775, 227 USPQ 773, 779 (Fed. Cir. 1985). Here, a claimed time of 2 minutes is so close to the 4 minutes taught by Dennis, prima facie one skilled in the art would have expected the resulting pasteurization to have the same effect.
In the alternative, one of ordinary skill in the art prior to the effective filing date of the present application would have been motivated to adjust, in routine processing, the temperature and time of the pasteurization process to obtain the desired microbial and enzyme inactivation (i.e., vegetative cells of pathogenic and spoilage microorganisms and enzymes that cause deterioration of food quality) without affecting product quality.
Regarding claims 3 and 5, Dennis et al. disclose all of the claim limitations set forth above. Dennis et al. disclose the biomass is washed with water and concentrate up to 30% solids (i.e., dry matter content of at most 6% and at least 7% dry matter-[0049]).
Regarding claim 6, Dennis et al. disclose all of the claim limitations as set forth above. Dennis et al. disclose the biomass is obtained from the cultivation of fungi (i.e., fungal strain – [0012], [0027], claim 25).
Regarding claim 8, Dennis et al. disclose all of the claim limitations as set forth above. Dennis et al. teach the pasteurization can be performed using a suitable heating means as known to those of skill in the art, such as by direct steam injection (i.e., steam infusion element).
Regarding claim 11, Dennis et al. disclose all of the claim limitations as set forth above. Given Dennis et al. disclose pasteurizing a biomass in a process substantially similar to that presently claimed, inherently the germ content of the pasteurized biomass would exhibit a log10 reduction of at least 7.
Regarding claim 16, Dennis et al. disclose all of the claim limitations as set forth above. Given Dennis et al. disclose a biomass comprising lipid and produced by a method substantially similar to the method presently claimed, inherently the biomass could comprise lipid and protein in amounts presently claimed.
Claims 1-14 and 16-19 are rejected under 35 U.S.C. 103 as being unpatentable over Wozniak (WO 2018/140790 ) in view of Dennis et al. (US 2015/0176042).
Regarding claims 1, 2, 4, 6 and 13, Wozniak discloses a method of producing a fermentation product (i.e., biomass) comprising the steps of: (a) obtaining a biomass from the cultivation of one or more microorganisms, including fungus, in a growth medium (i.e., fermentation broth – [0013], [0017], [0058]); and (b) extracting the biomass ([0058]).
Wozniak discloses the fermentation production (i.e., biomass) has a pH in the range of 3 to 4 ([0072], [0092]). While Wozniak does not disclose the precisely claimed pH for the biomass, in the case where the claimed ranges overlap or lie inside ranges disclose by the prior art a prima facie case of obviousness exists (MPEP §2144.05 I).
While Wozniak discloses the biomass can be mixed with animal feeds (Abstract), the reference is silent with respect to pasteurization of the biomass.
Dennis et al. teach a method of producing a pasteurized biomass, the method comprising the steps of: (a) obtaining a biomass by cultivating (i.e., fermenting) microorganisms, including fungi, in a growth medium (i.e., fermentation broth- [0012], [0024]-[0045]); and (b) pasteurizing the biomass to kill the cells and inactivate undesirable substances present in the biomass ([0046]). Dennis et al. teach the biomass is pasteurized at a temperature in the range of 55° to 121°C for a time of 4 minutes to 120 minutes ([0046]).
Wozniak and Dennis et al. are combinable because they are concerned with the same field of endeavor, namely, production of biomass from the cultivation of fungi. It would have been obvious to one of ordinary skill in the art prior to the effective filing date of the present application to have pasteurized, as taught by Dennis, the biomass of Wozniak to kill the cells and inactivate undesirable substances present in the biomass and obtain a pasteurized biomass.
While Dennis et al. teach a pasteurization time of 4 minutes, a prima facie case of obviousness exists where the claimed ranges do not overlap with the prior are but are merely close. Titanium Metals Corp. of America v. Banner, 778 F 2d 775, 227 USPQ 773, 779 (Fed. Cir. 1985). Here, a claimed time of 2 minutes is so close to the 4 minutes taught by Dennis, prima facie one skilled in the art would have expected the resulting pasteurization to have the same effect.
In the alternative, one of ordinary skill in the art prior to the effective filing date of the present application would have been motivated to adjust, in routine processing, the temperature and time of the pasteurization process to obtain the desired microbial and enzyme inactivation (i.e., vegetative cells of pathogenic and spoilage microorganisms and enzymes that cause deterioration of food quality) without affecting product quality.
Regarding claim 3, modified Wozniak disclose all of the claim limitations as set forth above. Wozniak disclose the fermentation product (i.e., biomass) can be an extracted fermentation product and can be processed, e.g., filtered, isolated, separated ([0058]-[0059]). Here, a process of filtering is considered a type of sieving.
Regarding claim 5, modified Wozniak disclose all of the claim limitations as set forth above. Wozniak disclose the fermentation product (i.e., biomass) can be substantially dry and/or solid form and can have a moisture content between about 0.25% and about 20% ([0009], [0058]). In this instance, the biomass would comprise at least 7% dry matter (for example, when the moisture content is 20%, the solid content would be 80%).
Regarding claims 7 and 17-19, modified Wozniak disclose all of the claim limitations as set forth above. Wozniak disclose the biomass can be a fungal biomass ([0063]). Wozniak disclose the fungi can include, without limitation, strains of the genus Rhizomucor ([0063]).
While Wozniak does not disclose the specific strain, Rhizomucor pusillus, given Wozniak disclose the fungi and include, without limitation, strains of the genus Rhizomucor, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the present application to have used any strain of Rhizomucor, including Rhizomucor pusillus CBS 143028 or a strain that is a single colony isolate or a derivative thereof with a reasonable expectation of success.
Regarding claim 8, modified Wozniak disclose all of the claim limitations as set forth above. Dennis et al. teach the pasteurization can be performed using a suitable heating means as known to those of skill in the art, such as by direct steam injection (i.e., steam infusion element).
Regarding claims 9 and 10, modified Wozniak disclose all of the claim limitations as set forth above. Dennis et al. teach pasteurizing the biomass at a temperature in the range of 55° to 121°C for a time of 4 minutes to 120 minutes ([0046]). While the reference does not teach the precisely claimed time of “at most 5 minutes” or temperature of “at least 74 °C”, in the case where the claimed ranges overlap or lie inside ranges disclose by the prior art a prima facie case of obviousness exists (MPEP §2144.05 I).
Regarding claim 11, modified Wozniak disclose all of the claim limitations as set forth above. Given Dennis et al. disclose pasteurizing a biomass in a process substantially similar to that presently claimed, inherently the germ content of the pasteurized biomass would exhibit a log10 reduction of at least 7.
Regarding claim 12, modified Wozniak disclose all of the claim limitations as set forth above. Wozniak disclose the biomass is obtained from the culturing (i.e., submerged fermentation) of a fungus. Wozniak disclose the fungi can include, without limitation, strains of the genus Rhizomucor ([0063]).
While Wozniak does not disclose the specific strain, Rhizomucor pusillus, given Wozniak disclose the fungi and include, without limitation, strains of the genus Rhizomucor, it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the present application to have used any strain of Rhizomucor, including Rhizomucor pusillus with a reasonable expectation of success.
Moreover, given Dennis et al. teach the pasteurization can be performed using a suitable heating means as known to those of skill in the art ([0046]), it would have been obvious to one of ordinary skill in the art prior to the effective filing date of the present invention to have used any known method including an in-line heating unit where the residence time of about 1 to 2 minutes is at a temperature of 86°C with a reasonable expectation of success.
Regarding claim 14, modified Wozniak discloses all of the claim limitations as set forth above. Wozniak discloses an animal feed comprising the biomass ([0007], [0019], [0025]-[0026]).
Regarding claim 16, modified Wozniak discloses all of the claim limitations as set forth above. Given, as modified, Wozniak disclose a method of pasteurizing a biomass substantially the same as presently claimed, inherently the biomass would comprise lipid and protein in the claimed amounts.
Response to Arguments
Note, the rejection of claims 1-6, 8, 10, 11, 13 and 16 under 35 U.S.C. 103 as being unpatentable over Bijl et al. (EP 2 264 142 A2) in view of Dennis et al. (US 2015/0176042) is withdrawn in light of Applicant’s amendment and remarks filed July 17, 2026.
Applicant's arguments filed July 7, 2026 have been fully considered but they are not persuasive.
Here, the arguments are direct to the combination of Bijl et al. and Dennis et al. The arguments are mute because the rejection has been withdrawn.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Huggins et al. (US 20190373935) teach fungal mycelium and edible product therefrom (i.e., biomass). Huggins et al. teach cooking the biomass at elevated temperatures of less than 100C for 1 to 60 minutes ([0076]). Huggins et al. does not teach the claimed pH. Huggins et al. teach holding at a pH of 5.8 ([0039]-[0042]).
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 ELIZABETH A GWARTNEY whose telephone number is (571)270-3874. The examiner can normally be reached M-F: 9 a.m. - 5 p.m. EST.
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ELIZABETH A. GWARTNEY
Primary Examiner
Art Unit 1759
/ELIZABETH GWARTNEY/ Primary Examiner, Art Unit 1759
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