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 .
This office action is in response to applicant’s submission dated January 29, 2026. Any objections and/or rejections made in previous actions and not repeated below are hereby withdrawn.
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.
Claim 14 is 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.
The term “firm tofu-like” in claim 14 is a relative term which renders the claim indefinite. The term “firm tofu-like” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. For the purposes of examination, “firm tofu-like” will be interpreted as a meat analog that can be pan-fried, stir-fried, deep-fried, put in a stew, or used to make filling or spreads.
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.
Claims 1-5, and 7-14 are rejected under 35 U.S.C. 103 as being unpatentable over Geistlinger et al. (US 20160073671 A1) in view of Dyson et al. (WO 2018144965 A1).
With respect to Claim 1, Geistlinger et al. teaches a method of producing a structured protein product comprising microbial biomass in order to produce a meat analog. [0008] Geistlinger et al. teaches that the method can comprise mixing the liquid and dry components to form a dough, heating and shearing the dough, forming protein structures through methods such as enzymatic activity, including the use of transglutaminase, and setting the extruded mass. [0089] The meat analog can be processed using a variety of methods, including chopping or shredding and subsequent forming, as well as filling sausage casings. [0085] Additionally, Geistlinger et al. teaches the meat analog product can comprise other non-microbial ingredients [0126], including cross-linking agents such as transglutaminase, magnesium and calcium salts. [0127]
Geistlinger et al. also teaches growing the microbial biomass, harvesting the biomass, dissociating the microbes, lysing the microbes, and further treating the microbes. [0105] The process taught by Geistlinger et al. comprises growing the microbes under controlled conditions, including aerated fermentation, [0107] can be harvested through sedimentation and resuspension in order to make a slurry. [0108]
Geistlinger et al. teaches the limitations of mixing a microbial biomass protein slurry with transglutaminase, adding a calcium or magnesium salt, and setting the protein in a closed mold. Geistlinger et al. is silent to the incubation conditions recited in claim 1.
Dyson et al. teaches compositions and methods for the production of nutrients from low-cost and sustainable feedstocks, [48] specifically coupled with microorganisms designed to capture and process waste gases into organic compound. [49] Additionally, Dyson et al. teaches a method of cultivating select microorganisms for this purpose, [50] including bacterial cells such as Xanthobacter. [77] Dyson et al. also teaches the production of a biomass from the microorganisms that can be used as a feed for other organisms, [83] and methods of processing the biomass through harvesting, lysing, homogenizing and more. [88]
In a specific embodiment, Dyson et al. teaches culturing Xanthobacter, [525] wherein the culture is incubated at 30°C. [529] Dyson et al. also teaches homogenizing the culture with the parameters of between 5,000 to 15,000 psi, resulting in a microbial biomass protein slurry. [565] The slurry taught by Dyson et al. is then incubated from 40-60°C, then the protein is separated by centrifugation with the addition of CaCl2 in order to improve the rate of sedimentation. [566]
Geistlinger et al. and Dyson et al. exist within the same field of endeavor in that they teach protein compositions derived from microbial sources. Where Geistlinger et al. teaches a meat analog product comprising a microbial biomass and transglutaminase, Dyson et al. teaches the cultivation and homogenization of a microbial biomass for further processing. Also, Geistlinger et al. teaches the use of a calcium salt, and Dyson et al. teaches a specific salt in the form of CaCl2.
Geistlinger et al. in view of Dyson et al. teaches all of the steps of mixing a microbial biomass with transglutaminase, adding CaCl2 and incubating the mixture in temperatures that range from 30-60°C, but does not disclose these steps in the exact order recited in claim 1. According to MPEP 2144.04 IV. C, “selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results”. Therefore, it would have been obvious to one of ordinary skill in the art, to have reordered the incubation steps and component addition steps in such a way as to have rendered the order recited in claim 1 obvious.
Additionally, the incubation temperatures taught in Dyson et al. overlap with the temperature recited in claim 1. According to MPEP 2144.05 I, “In the case where the claimed ranges ‘overlap or lie inside the ranges disclosed by the prior art’ a prima facie case of obviousness exists”. Therefore, the temperatures taught in Dyson et al. render obvious the temperature limitations recited in claim 1.
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the instant invention, to have used the teaching of Dyson et al. to produce a microbial biomass protein slurry and the teaching of Geistlinger et al. to develop a method of producing a meat analog comprising the steps of mixing a microbial biomass protein slurry with transglutaminase, incubating a first time at 28-40°C, adding an aqueous CaCl2- solution, incubating a second time at 28-40°C, incubating a third time at 40-60°C, heating the mixture to between 60-85°C, and setting the mixture in a closed mold, thereby rendering claim 1 obvious.
With respect to Claim 2, Geistlinger et al. in view of Dyson et al. teaches the method for producing a meat analog composition recited in claim 1, as detailed above. Additionally, Geistlinger et al. teaches the use of maltodextrin in the microbial biomass. [0113] Therefore, Geistlinger et al. in view of Dyson et al. renders obvious claim 2.
With respect to Claim 3, Geistlinger et al. in view of Dyson et al. teaches the method for producing a meat analog composition recited in claim 1, as detailed above. Additionally, Geistlinger et al. teaches that the organoleptic qualities of the composition can be improved through conditions such as temperature and pressure. [0073] Of those temperatures listed, Geistlinger et al. teaches that it would be advantageous to use temperatures lower than ambient, such as between 4-10°C. [0073]
The temperature range taught by Geistlinger et al. overlaps with the range recited in claim 3. According to MPEP 2144.05 I, “In the case where the claimed ranges ‘overlap or lie inside the ranges disclosed by the prior art’ a prima facie case of obviousness exists”. Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the instant invention, to have used the teaching of Geistlinger et al. in view of Dyson et al. to press the protein mixture at a temperature between 5-7°C, thereby rendering claim 3 obvious.
With respect to Claim 4, Geistlinger et al. in view of Dyson et al. teaches the method for producing a meat analog composition recited in claim 1, as detailed above. Geistlinger et al. teaches the microbial biomass may be pH controlled, for example, resulting in a slurry with a pH between 3 and 7. [0108] According to MPEP 2144.05 I, “In the case where the claimed ranges ‘overlap or lie inside the ranges disclosed by the prior art’ a prima facie case of obviousness exists”. Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the instant invention, to have adjusted the pH of the protein mixture taught by Geistlinger et al. in view of Dyson et al. to between 5 and 8, thereby rendering claim 4 obvious.
With respect to Claim 5, Geistlinger et al. in view of Dyson et al. teaches the method for producing a meat analog composition recited in claim 1, as detailed above. Geistlinger et al. teaches that the non-microbial components of the invention can comprise 0.01-5% by weight of the total composition [0126] and that the non-microbial components comprise transglutaminase and calcium salts, [0127] such as the CaCl2 taught in Dyson et al. [566]
The amount of transglutaminase and CaCl2 taught by Geistlinger et al. in view of Dyson et al. overlaps with the amount recited in claim 5. According to MPEP 2144.05 I, “In the case where the claimed ranges ‘overlap or lie inside the ranges disclosed by the prior art’ a prima facie case of obviousness exists”. Geistlinger et al. and Dyson et al. are silent to the molarity of the CaCl2, but the composition inherently has a molarity.
According to MPEP 2144.05 II, “[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”. Geistlinger et al. in view of Dyson et al. does not teach the concentration of CaCl2 recited in claim 5, but does teach the general conditions of adding CaCl2 solution. One of ordinary skill in the art would have been motivated to determine the optimum concentration of CaCl2 in order to produce the most desirable meat analog.
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the instant invention, to have modified the teaching of Geistlinger et al. in view of Dyson et al. in order to develop a method of producing a meat analog wherein the composition of the protein mixture before the second incubation cycle comprises 3-5% transglutaminase and 1.5-2.5% CaCl2 at a molarity between 2.5-3.5, thereby rendering claim 5 obvious.
With respect to Claim 7 and 8, Geistlinger et al. in view of Dyson et al. teaches the method for producing a meat analog composition recited in claim 1, as detailed above. Geistlinger et al. teaches the meat analog product can comprise between 2-70% microbial biomass, [0068] and between 50-90% moisture content. [0079] According to MPEP 2144.05 I, “In the case where claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”.
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the instant invention, to have used the teaching of Geistlinger et al. in view of Dyson et al. to develop a method of producing a meat analog product comprising the step of using a microbial biomass protein slurry comprising between 75-95% water and 5-25% or 20-25% bacterial biomass, thereby rendering claim 7 and 8 obvious.
With respect to Claim 9, Geistlinger et al. in view of Dyson et al. teaches the method for producing a meat analog composition recited in claim 1, as detailed above. Geistlinger et al. is silent to the use of a bacterial biomass comprising an isolated bacterial strain deposited as VTT-E-193585 or a derivative thereof. VTT-E-193585 is a strain of Xanthobacter bacteria. Dyson et al. teaches that a bacterial strain that can be used for the production of the microbial biomass taught can be Xanthobacter. [77]
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the instant invention, to have used the bacterial strain recited, or a derivative thereof, to [produce a microbial biomass protein slurry, as taught by Dyson et al., in the method taught by Geistlinger et al. to produce a meat analog product, thereby rendering claim 9 obvious.
With respect to Claim 10, Geistlinger et al. in view of Dyson et al. teaches the method for producing a meat analog composition recited in claim 1, as detailed above. Geistlinger et al. is silent to a downstream process comprising cultivating bacterial cells and homogenizing them into a slurry.
Dyson et al. teaches compositions and methods for the production of nutrients from low-cost and sustainable feedstocks, [48] specifically coupled with microorganisms designed to capture and process waste gases into organic compound. [49] Additionally, Dyson et al. teaches a method of cultivating select microorganisms for this purpose, [50] including bacterial cells such as Xanthobacter. [77] Dyson et al. also teaches the production of a biomass from the microorganisms that can be used as a feed for other organisms, [83] and methods of processing the biomass through harvesting, lysing, homogenizing and more. [88]
In a specific embodiment, Dyson et al. teaches culturing Xanthobacter using H2, CO2, and O2 gases. [525] Dyson et al. teaches that the culture is incubated at 30°C, and samples are removed from the culture twice a day. [529] The removed samples are centrifuged in order to separate the liquid and the solid phase, after which the solid pellet is saved and stored. [529] Dyson et al. also teaches homogenizing the grown cells with the parameters of between 5,000 to 15,000 psi, resulting in a microbial biomass protein slurry. [565]
Geistlinger et al. and Dyson et al. exist within the same field of endeavor in that they teach protein compositions derived from microbial sources. Where Geistlinger et al. teaches a meat analog product comprising a microbial biomass and transglutaminase, Dyson et al. teaches the cultivation and homogenization of a microbial biomass for further processing. Additionally, one would have been motivated to combine Dyson et al. with Geistlinger et al. in order to utilize already existing waste products from low-cost feeds.
The teaching of Dyson et al. reads on the limitations of cultivating bacterial cells by gas fermentation, incubating the biomass, separation of the liquid and solid phases and retention of the solid phase, and homogenizing the cells in order to obtain the microbial biomass protein slurry, as recited in claim 10. Dyson et al. teaches incubating at 30°C and sampling twice per day, but does not teach incubating between 55-75°C for 15 to 40 minutes.
According to MPEP 2144.05 II, “[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”. Dyson et al. does not teach the exact conditions, but does teach incubating at an elevated temperature and removing samples from incubation after a predetermined amount of time. It would have been obvious to one of ordinary skill in the art to have modified the teaching of Dyson et al. in the interest of determining the optimum temperature and amount of time required in order to improve the method taught.
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the instant invention, to have used the teaching of Geistlinger et al. in view of Dyson et al. to produce a meat analog product comprising a microbial biomass protein slurry, wherein the slurry is produced from a downstream process comprising gas fermentation, incubation at 55-75°C for between 15-40 minutes, isolating the solid phase, and homogenizing the solid phase, thereby rendering claim 10 obvious.
With respect to Claims 11 and 12, Geistlinger et al. in view of Dyson et al. teaches the method for producing a meat analog composition recited in claim 10, as detailed above. Dyson et al. also teaches homogenizing the grown cells with the parameters of between 5,000 to 15,000 psi, [565] about 345-1034 bar, a range that overlaps with the ranges recited in claims 11 and 12. According to MPEP 2144.05 I, “In the case where claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”.
Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the instant invention, to have used the teaching of Geistlinger et al. in view of Dyson et al. to produce a method of developing a meat analog comprising a method of developing a microbial protein slurry, wherein the slurry is homogenized at a pressure ranging from 800-2000 bar or 700-1000 bar, thereby rendering claims 11 and 12 obvious.
With respect to Claim 13, Geistlinger et al. in view of Dyson et al. teaches the method for producing a meat analog composition recited in claim 10, as detailed above. In a specific embodiment, Dyson et al. teaches culturing Xanthobacter using H2, CO2, and O2 gases. [525] Additionally, Dyson et al. teaches that the culture medium can comprise various nutrients, such as minerals. [295] Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the application, to have used the teaching of Geistlinger et al. in view of Dyson et al. to produce a method for developing a meat analog, wherein the method comprises using a feed for cultivation by gas fermentation comprising H2, CO2, and O2, and at least one mineral, thereby rendering claim 13 obvious.
With respect to Claim 14, claim 14 recites a product obtained by the process according to claim 1, which amounts to a product by process claim. According to MPEP 2113 I, “Even though product-by process claims are limited by and defined by the process, determination of patentability is based on the product itself”. The process according to claim 1 is rendered obvious by Geistlinger et al. in view of Dyson et al., as detailed in the rejection above. Additionally, Geistlinger et al. teaches that the composition may be cooked through frying, sauteing, deep frying and more. According to the interpretation of “tofu-like” as set forth in the 112b rejection above, a composition that can be fried reads on the limitation of “tofu-like”. Therefore, Geistlinger et al. in view of Dyson et al. renders obvious claim 14.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Geistlinger et al. (US 20160073671 A1) in view of Dyson et al. (WO 2018144965 A1) as applied to claim 1 above, in further view of Joy of Blending (How fast does a Vitamix really spin? (Independent measurements of Vitamix RPM), joyofblending.com).
With respect to Claim 6, Geistlinger et al. in view of Dyson et al. teaches the method for producing a meat analog composition recited in claim 1, as detailed above. The method of Geistlinger et al. comprises a step wherein the microbes may be ground in a blender in order to produce a microbial slurry. [0109]
Joy of Blending teaches the average rotational speed of a commonly available blender. [Pg. 2, Par. 1] Results of Joy of Blending’s experiment teaches that the speed of the blenders range from 900-28,500 rpm. [Pg. 3, Table 1]
Geistlinger et al., Dyson et al. and Joy of Blending exist within the same field of endeavor in that they teach food production techniques. Where Geistlinger et al. and Dyson et al. teach methods for producing a meat analog based on a microbial biomass, Joy of Blending teaches the technical aspects of the use of blenders in food production.
The range of speeds for blenders recited in Joy of Blending overlap with the range recited in claim 6. According to MPEP 2144.05 I, “In the case where claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. Therefore, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the instant invention, to have used the teachings of Geistlinger et al. in view of Dyson et al. to develop a method of producing a meat analog composition comprising a microbial biomass comprising a blending step, wherein the blending occurs at a speed between 10,000 and 20,000 rpm according to the teaching of Joy of Blending, thereby rendering claim 6 obvious.
Response to Arguments
Applicant's arguments filed January 29, 2026 have been fully considered but they are not persuasive.
Applicant asserts on Page 7, Lines 5-6, that “the term ‘firm tofu-like’ structure is defined at least within paragraph [0035] of publication of present application,” and includes the section: The “firm tofu-like structure’, as used herein refers to a tofu structure that does not crumble on picking it up and it is easy to chop. The firm tofu-like structure can be pan-fried, stir-fried, deep-fried, put in a stew, used as filling or to make spreads. The firm tofu-like structure resembles feta on its structure. Applicant concludes on lines 12-4, “claim 14 uses exact language, "firm tofu-like structure", as defined in the specifications and with a described method of ascertainment and standard accessible to one of ordinary skill in the art, the clarity objection should be overcome”.
Applicant is directed to MPEP 2173.02 II, “If the language of the claim is such that a person of ordinary skill in the art could not interpret the metes and bounds of the claim so as to understand how to avoid infringement, a rejection of the claim under 35 U.S.C. 112(b)[…], is appropriate.” Additionally, MPEP 2145 VI states, “Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims”.
One of ordinary skill in the art would not have been able to interpret the meaning of the term “tofu-like” such that they would be able to avoid infringement without first reading limitation from the specification into the claims. Additionally, examiner respectfully disagrees that with applicant’s assertion the claim 14 uses exact language. By applicant’s own definition in the instant specification, the composition does not crumble on picking up and is easy to chop and resembles feta on its structure. Examiner asserts that feta is known to crumble when being picked up and, though chops easily, does not easily maintain its shape through the chopping process. Additionally, the list of uses does not further clarify the definition of tofu-like in that the breadth of things that can be stir-fried, pan-fried, deep-fried, put in a stew, or used as a filling or to make spreads consists of a breadth that is lacking limitation. For example. Stews major component is a liquid, pan or stir-fried dishes usually consist of a starch, such as rice or noodles, and proteins and vegetables, and the range of items known to be deep fried comprise both ice cream and hard-boiled eggs.
For the reasons enumerated above, applicant’s assertion is found to be unpersuasive, the rejection of claim 14 under 112(b) is maintained
Applicant asserts on Page 8, Lines 6-9, “the outstanding Action does not appear to make any citation to a teaching within Dyson which would teach step-wise incubation, let alone the specific step-wise incubation of the claimed invention which occurs after addition MgCl₂/CaCl₂”, and concludes on lines 9-10 that, “teaching only a single incubation at between 40-60°C which would not teach the claimed step-wise incubation”.
Applicant is directed to MPEP 2144.04 IV. C, which states, “selection of any order of performing process steps is prima facie obvious in the absence of new or unexpected results” and “Selection of any order of mixing ingredients is prima facie obvious”. The combination of Geistlinger et al. and Dyson teaches all the steps and all the ingredients recited in claim 1, and it would therefore have been obvious to one of ordinary skill in the art to have used the teachings to modify the method taught by the combination in any order, including the sequence of adding ingredients and the sequence of incubation.
For this reason, applicant’s arguments are found to be unpersuasive.
Applicant asserts on Page 8, Lines 18-20, “even if there were some disclosure of step-wise incubation within the cited art, the ordered steps of the claimed method would still be patentable for at least the reason that the ordered steps of the claimed invention provided a novel and unexpected result” Applicant is directed to MPRP 2145 I, “Arguments presented by applicant cannot take the place of evidence in the record”. Applicant has presented no evidence on the record that the order of steps recited in claim 1 produces a novel and unexpected result as compared to the method presented in the prior art of record.
Applicant asserts on Page 8, Line 24, that “the sequence of steps achieves a partial cross-linking without gelation”. Applicant is directed to MPEP 2145 VI, “Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims”. The limitation asserted is not a limitation recited in claim 1, and therefore, it is found to be unpersuasive.
For this reason and those enumerated above, the obviousness rejection of claim 1 is maintained.
Applicant asserts on Page 9, Lines 6-7, that, “Geistlinger combined with Dyson do not teach methods to produce a similar food protein product”. Applicant is directed to applicant’s own definition of “firm tofu-like structure”, as described in the initial response to the 112(b) rejection of claim 14, and reminded that Geistlinger et al. teaches that the composition may be cooked through frying, sauteing, and deep frying. These uses fall within the limitations applicant has applied to define “tofu-like”. For this reason, applicant’s assertion is found to be unpersuasive.
For the reasons enumerated above, applicant’s assertions have been found to be unpersuasive, and the rejections of claims 1-14 are maintained.
Conclusion
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 JOSEPH CULLEN MERCHLINSKY whose telephone number is (571)272-2260. The examiner can normally be reached Monday - Friday 9:00am - 5:00pm.
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/J.C.M./Examiner, Art Unit 1791
/Nikki H. Dees/Supervisory Patent Examiner, Art Unit 1791