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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on March 18, 2026 has been entered.
Claims 1-14 and 16-19 are pending examination.
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 1-6, 8, 10, 11, 13 and 16 are rejected 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).
Regarding claims 1, 2, 4, 10 and 13, Bijl et al. disclose a method of pasteurizing a biomass comprising the steps of: (a) providing a biomass obtained by fermenting a microorganism of choice in a fermentation broth ([0041]-[0044], [0118]); (b) pasteurizing the biomass at a temperature ranging from 60° to 100°C for 30 to 90 minutes; and (c) separating the biomass from the fermentation broth to obtain a pasteurized biomass ([0045][0046], [0048], [0062] ).
Bijl et al. disclose adjusting the pH of the pasteurized fermentation broth to prevent the out-growth of many microbial species at a pH range of from 3 to 4 ([0052]-[0059]). Bijl et al. disclose the pH of the broth can be adjusted before or after pasteurization ([0060]).
While Bijl et al. disclose a pasteurization temperature overlapping the claimed range, Bijl et al. does not disclose a pasteurization time of at most 3.5 minutes.
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 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]).
Bijl et al. and Dennis et al. are combinable because they are concerned with the same field of endeavor, namely methods of producing a pasteurized biomass. Given Dennis et al. teach effectively pasteurizing a biomass to kill the cells and inactivated undesirable substances present in the biomass by pasteurizing at a temperature in the range of 55° to 121°C for a time of 4 minutes to 120 minutes, 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 employed the pasteurization process of Dennis et al. with the biomass of Bijl et al. because doing so would decrease the time required for pasteurization.
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 3.5 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.
Regarding claim 3, Bijl et al. disclose all of the claim limitations as set forth above. Bijl et al. disclose the biomass is separated from the fermentation broth using a solid-liquid separation technique ([0062]-[0064]).
While Bijl et al. disclose that solid-liquid separation generally, absent evidence to the contrary, it would have been obvious to one of ordinary skill in the art to have used any known solid-liquid separation technique capable of separating the fermentation broth from the biomass, including a sieve, with a reasonable expectation of success.
Regarding claim 5, modified Bijl et al. disclose all of the claim limitations as set forth above. Bijl et al. disclose the biomass has a dry matter content ranging from 25 to 80% ([0015], [0063]). While Bijl et al. do not disclose the precisely claimed range for dry matter content, 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 6, modified Bijl et al. disclose all of the claim limitations as set forth above. Bijl et al. disclose the biomass can be derived from a fungus (i.e., fungal strain – [0027]).
Regarding claim 8, modified Bijl et al. disclose all of the claim limitations as set forth above. Bijl et al. disclose the pasteurization of the biomass can be performed by direct heating with steam (i.e., steam infusion element) or by indirect heating using a medium via heat exchangers ([0046]).
Regarding claim 11, modified Bijl et al. disclose all of the claim limitations as set forth above. Given Bijl et al. disclose a method of pasteurizing a biomass substantially the same as presently claimed, inherently the germ count of the pasteurized biomass would have log10 reduction of at least 7.
Regarding claim 16, modified Bijl et al. disclose all of the claim limitations as set forth above. Given Bijl et al. disclose a method of pasteurizing a biomass substantially the same as presently claimed, inherently the biomass would comprise lipid and protein in the claimed ranges.
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 3.5 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.
Regarding claims 3 and 5, Dennis et al. disclose all of the claim limitations as 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, 2, 4, 6- 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 3.5 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.
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
Applicant's arguments filed March 18, 2026 have been fully considered but they are not persuasive.
Applicant submits “Bijl, Dennis or Wozniak are silent on pasteurizing a biomass for at most 3.5 minutes at a temperature of at least 80°C.
In this case, Dennis et al teach a process of 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]).
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 3.5 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.
Applicant submits “the claimed pasteurization parameters achieve unexpected results.” Applicant notes Examples 2 and 3 of the specification and state “the specific combination of short pasteurization time at high temperature produces both effective microbe kill and superior organoleptic qualities.
First, note Applicant disclose a process wherein a biomass is pasteurized for at most 45 minutes at a temperature of at least 70°C (p. 3/L1-6 of Specification). The data of Examples 2 and 3 is not unexpected. The effective of time, temperature and type of pasteurization (e.g., batch or inline) are known. The skilled artisan would know how to adjust, in routine processing, time, temperature and type of pasteurization to obtain a product with effective log10 reduction (i.e., microbe kill) while maintaining a desired sensory profile.
Conclusion
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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