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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 05 June 2026 has been entered.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-9, 12, and, 16 are rejected under 35 U.S.C. 103 as being unpatentable over Geistlinger et al. (herein referred to as Geistlinger, US 20160073671 A1) in view of Gibbons et al. (herein referred to as Gibbons, US 20130142905 A1), Ajami et al. (herein referred to as Ajami, US 20170105438 A1), Kamijo et al. (herein referred to as WO 2010101175 A1), and Legg (US 5728574 A)
With regard to Claim 1, Geistlinger teaches food products that have meat-like structure, texture, and properties, and that comprise substantial amounts of microbial biomass (abstract). Geistlinger teaches mixing a first protein powder ([0093] The microbial biomass may be added to the dough in any form, including but not limited to dry powder) with a liquid and other ingredients to form a powder mixture ([0009], [0025] Geistlinger reads such that microbial biomass and water and optional other ingredients are combined to form a dough).
Geistlinger teaches extruding the powder mixture with thermoplastic extrusion ([0090], [0091]). Geistlinger teaches any physiochemical parameter or extruder configuration parameter may influence the appearance, texture, and properties of the protein fibrous product ([0091]). Geistlinger teaches the physiochemical and configuration parameters are not mutually exclusive. Optimal physiological and configuration parameters for the thermoplastic extrusion of the meat structured protein products provided herein can be determined experimentally by titrating a particular parameter against the structure, sensory, and physical chemical characteristics (e.g., microscopic protein structure, sensory panel scores, MC, TPA profile) of the end products, and identifying the setting of the parameter at which the meat structured protein products provided herein are obtained ([0091]). Thus, it would have been obvious to one with ordinary skill in the art to adjust the moisture content (“MC”) to achieve the desired result such as reducing the level of endotoxins. Therefore, Geistlinger reads on utilizing high moisture extrusion.
Geistlinger teaches cutting the extruded mixture ([0090]). Lastly Geistlinger teaches the extrusion consists of a cooling die ([0091]). Therefore, it would have been obvious to one with ordinary skill in the art that the extrudate is cooled by traveling through a cooling die.
Geistlinger is silent to the other ingredients being sodium chloride.
Ajami teaches food products that have structures, textures, and other properties comparable to those of animal meat, and that may therefore serve as substitutes for animal meat (abstract). Ajami teaches adding sodium chloride (NaCl) as taste agent which modulates the taste of the meat-like food product ([0090]).
It would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention to modify the other ingredient taught by Geistlinger to be sodium chloride (NaCl) as taught by Ajami to modulate the taste of the meat-like food product.
Geistlinger teaches the first protein powder is a microbial biomass, and in preferred embodiments a bacterial biomass ([0019], [0093]) but is silent to the downstream processes to produce the first protein powder.
Kamijo teaches freeze-dried powdered bacterial cells and a method for producing the same (page 1). Kamijo teaches the powder can be used as food additives (page 15-16) Kamijo teaches cultivating whole bacterial cells to obtain a biomass and separating a liquid phase and a solid phase of the biomass and concentrating the biomass by removing the liquid phase (page 17 Experimental example 1). Kamijo further teaches dry the biomass to obtain a powder (page 17 Experimental example 1). The method taught by Kamijo improves the survival rate of beneficial bacterial especially during high temperature storage (page 8)
It would have been obvious to one with ordinary skill in the art to obtain the first protein powder taught by Geistlinger by the downstream processing taught by Kamijo to improve the survival rate of beneficial bacterial especially during high temperature storage of the powder.
However, Kamijo is silent to incubating the biomass with a heat treatment.
Legg teaches a method of improving the viability of a dried bacterial cell mass (col 1 lines 26-27). Legg teaches heat shocking the culture for 5-15 minutes after cultivation (Col 2 lines 25-27) and prior to drying. Legg teaches the heat shock improves cellular viability after drying (Co1 lines 38-41). Legg teaches exposure to a temperature of around 37° C for a period of from five to 15 minutes is generally suitable (Col 1 lines 40-41). But stating “generally suitable” Legg’s is stating this is a preferred embodiment of the disclosure. Per MPEP 2123 (I) a reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art, including nonpreferred embodiments. Therefore, because Legg’s is specific to the organism Pseudomonas ftuorescens for the heat shock treatments, one with ordinary skill in the art would be motivated to modify the temperature at which the heat shock is performed at in accordance with the microorganism in which is being heat shocked. See MPEP 2144.05(II)(A) Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Therefore it would have been obvious to one with ordinary skill in the art to modify Kamijo in view of Legg’s to heat shock the cultivate biomass to improve cellular viability after drying.
With regard to Claim 2, Geistlinger is silent to freezing the extrudate mix.
Ajami teaches the similar or superior meat-like attribute stabilities persist over storing the meat-like food products (i.e., extrudate) at suitable storage conditions. In some such embodiments, the suitable storage conditions include storage at temperatures of less than about 15° C. In some embodiments, the similar or superior meat-like attribute stabilities persist over one or more cycles of freezing and thawing ([0226]).
It would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention to modify Geistlinger in view of Ajami to optimize the conditions for the extrudate mixture to ensure similar or superior meat-like attribute stabilities persist. This optimization would include the temperature, and Ajami makes it clear that suitable storage is less than about 15° C and includes freezing. See MPEP 2144.05(II)(A) Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)
With regard to Claim 3, Geistlinger teaches adding at least one second protein powder ([0074], Table 1 utilizes yeast powder) and at least one soluble fiber ([0126]- [0127] Geistlinger reads such that the doughs, meat structured protein products, and extended meat products provided herein may comprise various other microbial compounds and other non-microbial ingredients including pectin). Because Geistlinger teaches optional other ingredients are combined to form a dough it would be obvious to one with ordinary skill in the art that this is the step in which the additional protein and fiber that is taught would be added ([0009]).
With regard to Claim 4, Geistlinger teaches the dough (i.e., powdered mixture) comprises between about 20% and about 30% weight microbial biomass ([0008], [0068]), at least about 30% by weight of water ([0008]), 5% and about 68% by weight of at least one second protein powder ([0099]), and 0.01% and about 5% by weight pectins ([0127]). See MPEP 2144.05(I) In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990)
Geistlinger is silent to quantity of sodium chloride.
Ajami teaches adding sodium chloride (NaCl) as taste agent which modulates the taste of the meat-like food product ([0090]).
It would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention to modify the other ingredient taught by Geistlinger to be sodium chloride (NaCl) as taught by Ajami in an amount sufficient enough to achieved to modulate the taste of the meat-like food product to the desired taste. See MPEP 2144.05(II)(A) Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
With regard to Claim 5, Geistlinger teaches the second protein powder is pea protein isolate ([0100]). Geistlinger teaches the pea protein can be in any other form, meaning one with ordinary skill in the art would reasonably deduce to utilize the pea isolate in a powdered form ([0100]).
With regard to Claim 6, Geistlinger teaches the dough (i.e., powder mixture) is mixed in a closed barrel during extrusion ([0090]). Geistlinger teaches the extruder can be a twin screw extruder ([0147]).
With regard to Claim 8, Geistlinger teaches the liquid is water ([0009]).
With regard to Claim 7, Geistlinger teaches any physiochemical parameter or extruder configuration parameter may influence the appearance, texture, and properties of the protein fibrous product ([0091]). Geistlinger teaches optimal physiological and configuration parameters for the thermoplastic extrusion of the meat structured protein products provided herein can be determined experimentally by titrating a particular parameter against the structure, sensory, and physical chemical characteristics (e.g., microscopic protein structure, sensory panel scores, MC, TPA profile) of the end products, and identifying the setting of the parameter at which the meat structured protein products provided herein are obtained ([0091]). In addition Geistlinger teaches The extruder may be selected from any commercially available extruder ([0092]).
Thus, through routine optimization one with ordinary skill in the art would configure the extrusion parameters to achieve the desired structure, sensory, and physical chemical characteristics of the end product. See MPEP 2144.05(II)(A) "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
With regard to Claim 9, as showing in the rejection of claim 8 Geistlinger teaches the claimed water. Since claim 9 does not further limit the “water” and only further limits the “protein slurry” which was optionally recited in Claim 8 and has not been positively recited in claim 9, the limitations of claim 9 are seen to have been met.
Claims 10 and 12-16 are rejected under 35 U.S.C. 103 as being unpatentable over Geistlinger et al. (herein referred to as Geistlinger, US 20160073671 A1) in view of Gibbons et al. (herein referred to as Gibbons, US 20130142905 A1), Ajami et al. (herein referred to as Ajami, US 20170105438 A1), Kamjo et al. (herein referred to as WO 2010101175 A1), Rutt et al. (herein referred to as Rutt, US 20170020159 A1), Legg (US 5728574 A) and Dyson et al. (herein referred to as Dyson, US 20190390158 A1).
With regard to Claim 10, Geistlinger teaches the meat structured protein products may be derived from a single or from multiple natural and/or modified microbial sources ([0098]). But is silent to the bacterial strain being bacterial strain VTT-E-193585 or a derivative thereof.
The examiner would like to note that VTT-E-193585 strain is from the genus Xanthobacter.
Dyson teaches a high-protein and/or high vitamin ingredient derived from the microorganism cells which can be utilized in the production of a vegetarian or vegan food product ([0432]-[0433]). Dyson teaches the microorganism cell is a bacterial cell and can be from the genus Xanthobacter ([0077], [0246]). Dyson teaches Xanthrobacter is an oxyhydrogen species and oxyhydrogen strains may also be obtained by routine processes, such as isolation from soil samples or geothermal fluid samples using enrichment methods ([0467]).
It would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention to modify Geistlinger in view of Dyson to utilize a microorganism from the genus Xanthobacter or specifically Dyson teaches specific strains may be obtained by routine processes because Dyson clearly shows bacterial strains from the genus Xanthrobacter are suitable for use as a protein source in vegetarian or vegan food product See MPEP 2144.07 Art Recognized Suitability for an Intended Purpose.
The Xanthobacter species utilization taught by Dyson reads on the instant claims because in the instant specification, the applicant states “Optionally, the said isolated bacterial strain or a derivative thereof utilize hydrogen gas as energy source and carbon dioxide as carbon source” and Dyson specifically teaches the Xanthobacter species are knallgas strains which can use hydrogen and carbon dioxide as their energy source. Thus, one with ordinary skill in the art would reasonably deduce that the utilization of bacteria from the genus Xanthobacter species taught by Dyson reads on the instant claims utilization of strain VTT-E-193585 and derivatives thereof because of the overlapping use of a hydrogen energy source. See MPEP 2144.08(II)(A)(4)(c) See, e.g., Dillon, 919 F.2d at 693, 696, 16 USPQ2d at 1901, 1904. See also In re Deuel, 51 F.3d 1552, 1558, 34 USPQ2d 1210, 1214 (Fed. Cir. 1995) ("Structural relationships may provide the requisite motivation or suggestion to modify known compounds to obtain new compounds. For example, a prior art compound may suggest its homologs because homologs often have similar properties and therefore chemists of ordinary skill would ordinarily contemplate making them to try to obtain compounds with improved properties."). And The closer the physical and/or chemical similarities between the claimed species or subgenus and any exemplary species or subgenus disclosed in the prior art, the greater the expectation that the claimed subject matter will function in an equivalent manner to the genus. See, e.g., Dillon, 919 F.2d at 696, 16 USPQ2d at 1904 (and cases cited therein). Cf. Baird, 16 F.3d at 382-83, 29 USPQ2d at 1552 (disclosure of dissimilar species can provide teaching away)
With regard to Claim 12, Kamijo teaches the drying the biomass (page 17 Experimental example 1) but is silent to homogenizing the biomass prior to drying.
Rutt teaches a protein material and food ingredient from biomass (abstract). Rutt teaches cultivating bacterial cells to obtain a biomass ([0020]). Rutt teaches separating a liquid phase and a solid phase of biomass and concentrating the biomass by removing the liquid phase ([0021], [0048], Rutt reads such that the biomass is centrifuged which one with ordinary skill in the art would recognize would separate the biomass into a solid and liquid phase). Rutt teaches drying the biomass to obtain a protein powder ([0047], [0049]). Rutt teaches in some embodiments the methods involve one or more steps of mechanical homogenization or mixing ([0029]). Rutt teaches he methods can involve performing the steps in any order, and one or more of the steps can be eliminated. One or more of the steps can be repeated to optimize the yield or quality of protein material from the biomass ([0028]).
It would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention to modify the combination of Geistlinger and kamijo in view of Rutt to homogenize the bacterial cells of the biomass before the drying step to optimize the yield or quality of protein material from the biomass.
With regard to Claim 13, the combination of Geistlinger and Rutt is silent to the pressure in which the homogenization is carried out.
Dyson teaches utilizing high pressure homogenization on cells grown to preserving proteins to be harvested, and not imparting any off flavors ([0564]). Dyson teaches utilizing pressures from 5,000 to 15,000 psig ([0564] about 344 bar – 1,034 bar). See MPEP 2144.05(I) In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934.
It would have been obvious to one with ordinary skill before the effective filing date of the claimed invention to modify Geistlinger in view of Dyson to utilizing pressures from 5,000 to 15,000 psig during homogenization to preserve the proteins to be harvested and no impart any off flavors.
With regard to Claim 14, Geistlinger teaches the microbial biomass can be further treated to maintain purity and/or freshness using filtration ([0112]). However, Geistlinger is silent to the filtration being nanofiltration or ultrafiltration.
Dyson teaches using nanofiltration for the recovery of biosynthetic chemical products and/or spent nutrients from the aqueous broth solution ([0355]).It would have been obvious to one with ordinary skill in the art before he effective filing date of the claimed invention to modify Geistlinger in view of Dyson to use nanofiltration on the homogenized bacterial cells to recover biosynthetic chemical products and/or spent nutrients from the aqueous broth solution.
With regard to Claim 15, Kamijo is silent to adjusting the biomass pH.
Dyson teaches utilizing high pressure homogenization on cells grown to preserving proteins to be harvested, and not imparting any off flavors ([0564]). Dyson teaches part of the homogenization process includes adjusting the pH to above 5.5 ([0564]). See MPEP 2144.05(I) In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934.
It would have been obvious to one with ordinary skill before the effective filing date of the claimed invention to modify Geistlinger in view of Dyson to adjust the pH to above 5.5 during homogenization to preserve the proteins to be harvested and no impart any off flavors.
With regard to Claim 16, Kamijo is silent to wherein the bacterial cells are cultivated by gas fermentation and the feed comprises at least one of selected from CO2, CH4, H2, 02, NH3 and at least one mineral.
Rutt teaches cultivation can be done in open ponds or in a photobioreactor or fermentation vessels of any appropriate size. The microbes or algae can be either phototrophic or heterotrophic. In some embodiments only light and carbon dioxide are provided but nutrients can be included in any culture medium, for example nitrogen, phosphorus, potassium, and other nutrients. In other embodiments sugars and other nutrients are included in the culture medium. ([0020]). Rutt teaches the biomass utilized in the present invention can be derived from any organism or class of organisms ([0020]).
It would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention to modify Kamijo in view of Rutt to include the appropriate cultivation feed, such as CO2, to grow the desired organism or class of organisms to be used as the biomass. One with ordinary skill in the art would recognize the feed to grow organisms is unique to that specific organism and therefore to optimize parameters such as yield the nutrients, such as minerals, in the feed should be optimized to align with the desired organism and outcome.
Response to Arguments
Applicant's arguments filed 05 June 2026 have been fully considered but they are not persuasive.
Applicant’s arguments with respect to claim(s) 1 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. In this case, Kamijo is now relied upon to teach the claimed downstream processing and Legg is now relied upon to teach the heat treatment of the biomass.
Further, applicant argues that the recited incubation step provides the unexpected result of reducing the endotoxin response of the final product. As stated above, Dyson is no longer relied upon to teach the claim incubations step. However, the applicant points to paragraph [0046] of the specification as evidence for unexpected result. Paragraph [0046] merely states, “Specifically, incubating facilitates disrupt the cell wall to release endotoxins, that could be harmful to the humans if they translocate from the gut into the bloodstream.” With no further data or evidence to support the unexpected result. The examiner would like to point to MPEP 716.02(b) The evidence relied upon should establish "that the differences in results are in fact unexpected and unobvious and of both statistical and practical significance." Ex parte Gelles, 22 USPQ2d 1318, 1319 (Bd. Pat. App. & Inter. 1992) (Mere conclusions in appellants’ brief that the claimed polymer had an unexpectedly increased impact strength "are not entitled to the weight of conclusions accompanying the evidence, either in the specification or in a declaration."). In this case the specification merely states that “incubating facilitates disrupt the cell wall to release endotoxins” and the applicant further states that as a result the incubation reduces the endotoxin response of the final product. This disclosure without further data is not sufficient to show the incubation step results in unexpected results. Therefore applicant’s argument is not found to be persuasive.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KARLA I DIVIESTI whose telephone number is (571)270-0787. The examiner can normally be reached Monday-Friday 7am-3pm (MST).
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/K.I.D./Examiner, Art Unit 1792
/ERIK KASHNIKOW/Supervisory Patent Examiner, Art Unit 1792
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