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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 19 May 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 1-2, 4-5, 8-10, and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Den Dulk (US 20150289542 A1) in view of Howsam (US 6635301 B1) Hsieh et al. (herein referred to as Hsieh, US 20120093994 A1), Hsieh et al. (herein referred to as Hsieh2, WO 2012051428 A1), and Uphus (US 7017732 B2)
With regard to Claim 1, Den Dulk teaches a method for preparing a plant-based whole meat analogue ([0001]). Den Dulk teaches formulating a mixture include at least one plant proteinaceous material ([0028], [0033]). Den Dulk teaches extruding the homogenous dough using a co-rotating twin screw extruder having intermeshing screws ([0009]) with a velocity of at least 1000 RPM (~16 Hz) and pressure of 10 to 70 bar (1 to 7 MPa) ([0009], [0030]). Den Dulk teaches extruding the formulate mixture at a water content of less than 60 wt.% ([0009], [0021]). 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). Den Dulk teaches the temperature in the extruder increasing from 20℃ to 170℃ ([0043]) and further cooling the formulated hot melt in a cooling die at a temperature between 50° C. to 120°C ([0016])
However, Den Dulk is silent to the mixture including at least one flavoring and coloring ingredient and at least one thickening and stabilizing ingredient.
Howsam teaches a method for preparing a plant-based whole cut meat analogue (abstract). The meat analogue products are meant to mimic the texture, color and flavor of animal products such as chicken and other meat products (Col 3 lines 6-21 , Col 9 lines 35-38). Howsam teaches using naturally occurring and available plant protein sources and other plant ingredients (Claim 1 and Table 2). Howsam teaches formulating a mixture comprising at least one plant proteinaceous material (Col 3, lines 41-44), at least one flavoring and coloring ingredient (Col 4, line 41), and at least one thickening and stabilizing ingredient (Col 2, lines 44-45, Howsam reads such the compound is a binding and cross linking compound).
It would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention to modify Den Dulk in view of Howsam to include at least one flavoring and coloring ingredient and at least one thickening and stabilizing ingredient to mimic the texture, color and flavor of animal products such as chicken and other meat products
However, Den Dulk is silent to the extruder comprising a plurality of evenly space temperature segments and the temperature-ramp profile.
Hsieh teaches analog meat compositions produced from vegetable protein and processes for producing the analog meat compositions (abstract). Hsieh teaches using extrusion to make the analog meat composition. Hsieh teaches the extrusion processing is a multi-step and multifunctional operation, which leads to mixing, hydration, shear, homogenization, compression, deaeration, pasteurization or sterilization, stream alignment, shaping, expansion and/or fiber formation. Ultimately, the vegetable protein, typically introduced to the extruder in the form of a dry blend, is processed to form a fibrous material ([0006]). Hsieh teaches the extrusion apparatus generally comprises a plurality of heating zones. In one embodiment, the protein mixture is heated in the respective heating zones to temperatures of about 25℃., about 40℃, about 95℃, about 150℃ and about 170℃. One skilled in the art may adjust the temperatures in one or more zones to achieve the desired properties ([00067]). 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); Similarly 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).
It would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention to modify Den Dulk to utilize the extrusion conditions taught by Hsieh to form a fibrous material.
Further, Hsieh teaches the extruder can rotate within the barrel in the same or opposite directions ([0066]). Heish teaches rotation of the screws in opposite directions is referred to as double flow or counter-rotating ([0066]). However, the combination of Den Dulk and Hsieh is silent to the twin-screw extruder is operated in a counter-rotating mode during the ramp up process between 160-175°C.
Uphus teaches a multiple-extruder configuration in which two co-rotating twin-screw extruders and a counterrotating twin screw extruder are connected to each other with respect to the flow of material (abstract). Uphus teaches the counter-rotating twin-screw extruder, which follows the two co-rotating twin-screw extruders, then serves to build up the pressure (Col 2 lines 5-7).
Therefore, it would have been obvious to one with ordinary skill in the art to modify the combination of Den Dulk and Hsieh to operate the twin-screw extruder in a counter rotating mode during the ramp up process between 160-170°C (i.e., the last step in the ramp up) to build up the pressure.
Further the combination of Den Dulk and Hsieh teaches the ramping up of temperature in the extruder, but the combination is silent to the ramping down.
Hsieh2 teaches analog meat compositions produced from vegetable protein and processes for producing the analog meat compositions (abstract). Hsieh2 teaches a similar “ramping-up” method has described above in Hsieh, but continues to teach after the “ramping up” phase to “ramp down” the temperature. Hsieh2 specifically teaches an additional zone (adjacent the extruder exit port) which is set to a temperature of about 140 °C to about 80 °C. Hsieh2 The extruder may be set in other temperature zone arrangements, as desired ([0063]). Hsieh2 teaches the extrudates (or structured plant protein products) produced in accordance with the process described herein comprise protein fibers that are substantially aligned ([0067]).
Therefore, 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 Den Dulk and Hsieh to include the “ramping down” method taught by Hsieh2 to achieve protein fibers that are substantially aligned. Hsieh clearly teaches one with ordinary skill in the art may adjust the ramping down temperature zones as needed to achieve the desired result. 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).
Continuing, with regard to cooling, Den Dulk teaches texturing, or tempering, of the extrudate in a cooling die. Den Dulk teaches the temperature in the present container and/or cooling die is between 50° C. to 120° C ([0016]). But Den Dulk is silent to the plurality of cooling segments.
Howsam teaches the cooling process includes cooling the hot melt in a multi-channel and temperature controlled cooling die (Col 5 lines 50-55, col 6 lines 12-13).
Therefore, Howsam imparts reasoning for obviousness because the teaching shows that the claimed plurality of cooling segments was known for such a thing to have been successfully achieved and published at the time of filing, which means it was within the general skill of one with ordinary skill in the art to select a plurality of cooling segments because it would be obvious to one of skill in the art to do such a thing on the basis of its suitability for a similar intended use. See MPEP 2144.07 that discussed that when the prior art recognizes something is suitable for a similar intended use/purpose, such a thing is obvious.
Continuing, Den Dulk teaches texturing, or tempering, of the extrudate in a cooling die. ([0016]) but is silent to further processing after the cooling die.
After cooling Howsam teaches shaping and forming the cooled extrudate (claim 1). Howsam teaches the die is temperature controlled and by cooling reduces the viscosity of the protein lava to obtain a cohesive, texturized, extrudate slab or ribbon (abstract). Howsam teaches the slab or ribbon extrudate, after exiting the extruder, is generally subjected to further process steps in order to obtain the desired end product. Thus Howsam reads such that the process modifies the texture of the elongated layered protein fibers, that form after cooling, by mechanical shaping. So it is known to have specially designed forming dies at or within the cooling die and cutting devices to impart a specific shape on the extrudate to mimic actual animal or vegetable products (Col 2 lines 42-48). Howsam teaches the mixture is formed into an extrudate with an elongated and solidified protein fibrous structure (Claim 1) of a predetermined toughness and predetermined chewiness to simulate whole cut meant (Col 9, lines 8-14 Howsam reads such that the shredded end product is to have a dense, fibrous, structure that resembles not only in appearance but also in texture, bite and feel of flaked or shredded meat such as, tuna fish or chicken breast meat). Howsam teaches the properties of the viscous mass at the end of the thermo-mechanical conversion process, which the precursors undergo within the extruder barrel, are dependent on the process variables (e.g. temperature in the different sections of the extruder barrel, screw speed/barrel section pressure, moisture content, precursor formulation, etc.) (Col 1 lines 58-64). It would have been obvious to one with ordinary skill in the art to modify the process variables taught by Howsam to achieve the desired properties of the viscous mass, such as an elongated and solidified protein fibrous structure (claim 1), so the protein fibers are elongated and layered along a laminar flow to achieve the desired end product that resembles not only in appearance but also in texture, bite and feel of flaked or shredded meat. Lastly, Howsam teaches mechanical shaping (i.e., shredding) the extrudate to obtains a plurality of extrudate shreds that resemble in consistency and texture flaked or shredded meat (claim 1).
It would have been obvious to one with ordinary skill in the art to modify Den Dulk in view of Howsam to modify the texture and flavor of the elongated protein fibers by mechanical shaping in order to obtain the desired end product
However, Howsam is silent to shaping and forming the cooled extrudate with a shaping die selected from: a flat shaping die wherein the extrudate forms a continuous strip and a 360 circular shaping die generating an extruded product through a circular plane; producing a cooled extrudate having a thickness of 5-15 mm.
Hsieh teaches a die wherein the extrudate flows through the die aperture(s) wherein the extrudate has a thickness of 5-15mm ([0074]). Hsieh teaches the width and height dimensions of the cooling die are selected and set prior to extrusion of the mixture to provide the fibrous material extrudate with the desired dimensions. The width of the die aperture(s) may be set so that the extrudate resembles from a cubic chunk of meat to a steak filet, where widening the width of the die aperture(s) decreases the cubic chunk-like nature of the extrudate and increases the filet-like nature of the extrudate ([0074]). Hsieh teaches The extrudate may be cut after exiting the cooling die ([0075]). One with ordinary skill in the art would recognize that if the extrudate may be cut after the die, than the extrudate leaving the die must be in a continuous form. In addition Hsieh teaches the shaping die is flat. The examiner would like to highlight figure 2A which clearly shows a flat slab produced by the method taught by Hsieh.
Therefore, 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 Den Dulk and Howsam in view of Hsieh to incorporate the shaping and forming of the cooled extrudate as described above in Hsieh to provide the fibrous material extrudate with the desired dimensions.
With regard to Claim 2, Den Dulk teaches the extrudate has a water content of less than 60 wt.% ([0009], [0021]) and a protein content of 25 to 35 wt. % ([0033]). 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)
With regard to Claim 4, Den Dulk teaches at least one plant proteinaceous material is pea ([0028]).
However, Den Dulk is silent to the use of flavoring and coloring ingredients
Howsam teaches the use of flavoring and coloring ingredients but is silent to the specific ingredient used. Additionally, Howsam teaches the use of thickening and stabilizing ingredients but is silent to the specific ingredient.
Hsieh teaches an analogue meat composition from vegetable protein that simulates the fibrous structure of animal meat and has a desirable meat-like moisture, texture, mouthfeel, flavor and color (abstract). Hsieh teaches the meat analog compositions may include a variety of flavorings, spices, antioxidants, fibers, or other ingredients to nutritionally enhance the final food application ([0088]). Hsieh teaches the flavoring agent can include an animal meat flavor, an animal meat oil, spice extracts, spice oils, natural smoke solutions, natural smoke extracts, yeast extract, and shiitake extract. Additional flavoring agents may include onion flavor, garlic flavor, or herb flavors ([0090]).
Hsieh teaches the meat analogue may further comprise a thickening agent such as alginic acid and its salts, agar, carrageenan and its salts, processed Eucheuma seaweed, gums (carob bean, guar, tragacanth, and xanthan), pectins, sodium carboxymethylcellulose, and modified starches.
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 Den Dulk and Howsam in view of Hsieh to include to the flavor/coloring ingredients and thickening/stabilizing ingredients taught by Hsieh to naturally enhance the final food application ([0088]).
With regard to Claim 5, Den Dulk is silent to the mixture further comprises a protein source selected from: yeast, fish, chicken, and beef
Howsam teaches suitable ingredients that can used to prepare such a product contain high amounts of plant protein, with possible addition of or substitution of a small portion of the plant protein with animal protein such as fish or animal meat, or meat by-products, or other protein sources (Col 9 lines 25-30).
Therefore, Howsam imparts reasoning for obviousness because the teaching shows the claimed inclusion of fish or animal meat was known for such a thing to have been successfully achieved and published at the time of filling, which means it was within the general skill of one with ordinary skill in the art to include fish or animal meat, because it would have been obvious to one of skill in the art to do such a thing on the basis of its suitability for a similar intended use. See MPEP 2144.07 that discussed that when the prior art recognizes something is suitable for a similar intended use/purpose, such a thing is obvious.
With regard to Claim 8, Den Dulk teaches texturing, or tempering, of the extrudate in a cooling die. ([0016]) but is silent to further processing after the cooling die.
Howsam teaches the cooling process comprises pushing the hot melt extrudate into a cooling chamber comprising multiple segments to cool to a temperature between 50℃ and 90℃ (Col 3 lines 49-53, Col 6 lines 10-13 Howsam reads such that the cooling die is preferably a multi-channel cooling die). Howsam teaches the cooling die is temperature controlled and by cooling reduces the viscosity of the protein lava to obtain a cohesive, texturized, extrudate slab or ribbon (abstract). Howsam teaches the slab or ribbon extrudate, after exiting the extruder, is generally subjected to further process steps in order to obtain the desired end product. So it is known to have specially designed forming dies at or within the cooling die and cutting devices to impart a specific shape on the extrudate to mimic actual animal or vegetable products (Col 2 lines 42-48).
It would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention that Howsam teachings cooling the extrudate and through routine optimization one with ordinary skill in the art could optimize the temperature for the desired results. See MPEP 2144.05(II) which states 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).
It would have been obvious to one with ordinary skill in the art to modify Den Dulk in view of Howsam to modify the texture and flavor of the elongated protein fibers by mechanical shaping in order to obtain the desired end product
With regard to the shape of the die, Hsieh teaches the width and height dimensions of the cooling die are selected and set prior to extrusion of the mixture to provide the fibrous material extrudate with the desired dimensions. The width of the die aperture(s) may be set so that the extrudate resembles from a cubic chunk of meat to a steak filet, where widening the width of the die aperture(s) decreases the cubic chunk-like nature of the extrudate and increases the filet-like nature of the extrudate ([0074]). Hsieh teaches the extrudate may be cut after exiting the cooling die ([0075]). One with ordinary skill in the art would recognize that if the extrudate may be cut after the die, than the extrudate leaving the die must be in a continuous form. In addition Hsieh teaches the shaping die is flat. The examiner would like to highlight figure 2A which clearly shows a flat slab produced by the method taught by Hsieh.
Therefore, 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 Den Dulk and Howsam in view of Hsieh to incorporate the shaping and forming of the cooled extrudate as described above in Hsieh to provide the fibrous material extrudate with the desired dimensions.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Den Dulk (US 20150289542 A1), ion view of Howsam (US 6635301 B1), Hsieh (US 20120093994 A1), Hsieh2 (WO 2012051428 A1), Uphus (US 7017732 B2), and Giezen et al. (herein referred to as Giezen, WO 2012158023 A1)
With regard to Claim 3, Den Dulk is silent to the post-treating process.
Giezen teaches an extrusion process is disclosed for turning vegetable protein compositions such as soy protein into a fibrous, meat-like structure (abstract). Giezen teaches flavor can be infused into the product via an aqueous liquid to provide a flavor to the composition (Page 15, lines 3-9). Giezen teaches the absorption of aqueous liquids facilitates adding desired taste components, as well as allows to vary the product in terms of juiciness and bite (page 7 lines 10-13). Giezen teaches combination of features (such as temperature) is responsible for the creation of a relatively open structure in the composition. This open structure has an improved capability of being infused with an aqueous liquid (page 6, lines 5-9). Giezen reads such that the flavor infusion happens after the product has left the extruder (page 6, lines 23-26). Giezen teaches the flavor is preferrable a broth (claim 9). One with ordinary skill in the art would recognize a “broth” as a natural flavor.
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 Den Dulk in view of Giezen to infuse the extrudate taught by Den Dulk with flavor to achieve the desired taste as well as allow to vary the product in terms of juiciness and bite.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Den Dulk (US 20150289542 A1) in view of Howsam (US 6635301 B1), Hsieh (US 20120093994 A1), Hsieh2 (WO 2012051428 A1), Uphus (US 7017732 B2) and Moscicki et al. (herein referred to as Moscicki, “Extrusion-Cooking and related Techniques”).
With regard to Claim 7, Den Dulk teaches extruding the homogenous dough using a co-rotating twin screw extruder having intermeshing screws ([0009]).
However Den Dulk is silent to the twin-screw extruder being in a counter-rotating mode.
Uphus teaches a multiple-extruder configuration in which two co-rotating twin-screw extruders and a counterrotating twin screw extruder are connected to each other with respect to the flow of material (abstract). Uphus teaches the counter-rotating twin-screw extruder, which follows the two co-rotating twin-screw extruders, then serves to build up the pressure (Col 2 lines 5-7).
Therefore, it would have been obvious to one with ordinary skill in the art to modify the combination of Den Dulk and Hsieh to operate the twin-screw extruder in a counter rotating mode during the ramp up process between 160-170°C (i.e., the last step in the ramp up) to build up the pressure.
With regard to the mixture transfer rate, Moscicki teaches counter-rotating in twin screw extruder has been around since the 1930s and are commonly used in the processing or fiber and cellulose rich materials and have been used for pet food products (page 8, page 18, page 19). Moscicki teaches Counter-rotating twin-screw food extruders are special-purpose machinery Their screws rotate much more slowly (up to 150 rpm) but can mix the material effectively and their work resembles a positive-displacement pump generating high pressure in the barrel closed C-shaped chamber on the screws, which is needed for high viscosity material (page 18).
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 Den Dulk and Hsieh to incorporate a counter-rotating twin screw extruder in the highest temperature segment because the slower speed can mix more effectively.
Claims 9-13 are rejected under 35 U.S.C. 103 as being unpatentable over Howsam (US 6635301 B1) in view of Hsieh (US 20120093994 A1), Hsieh2 (WO 2012051428 A1), Den Dulk (US 20150289542 A1), Uphus (US 7017732 B2), and Gonzalez-Cavieres et al. (herein referred to as Gonzalez-Cavieres, “Advances in vacuum microwave drying (VMD) systems for food products”)
With regard to Claim 9, Den Dulk teaches a method for preparing a plant-based whole meat analogue ([0001]). Den Dulk teaches formulating a mixture include at least one plant proteinaceous material ([0028], [0033]). Den Dulk teaches extruding the homogenous dough using a co-rotating twin screw extruder having intermeshing screws ([0009]) with a velocity of at least 1000 RPM (~16 Hz) and pressure of 10 to 70 bar (1 to 7 MPa) ([0009], [0030]). Den Dulk teaches extruding the formulate mixture at a water content of less than 60 wt.% ([0009], [0021]). 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). Den Dulk teaches the temperature in the extruder increasing from 20℃ to 170℃ ([0043]) and further cooling the formulated hot melt in a cooling die at a temperature between 50° C. to 120°C ([0016])
However, Den Dulk is silent to the mixture including at least one flavoring and coloring ingredient and at least one thickening and stabilizing ingredient.
Howsam teaches a method for preparing a plant-based whole cut meat analogue (abstract). The meat analogue products are meant to mimic the texture, color and flavor of animal products such as chicken and other meat products (Col 3 lines 6-21 , Col 9 lines 35-38). Howsam teaches using naturally occurring and available plant protein sources and other plant ingredients (Claim 1 and Table 2). Howsam teaches formulating a mixture comprising at least one plant proteinaceous material (Col 3, lines 41-44), at least one flavoring and coloring ingredient (Col 4, line 41), and at least one thickening and stabilizing ingredient (Col 2, lines 44-45, Howsam reads such the compound is a binding and cross linking compound).
It would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention to modify Den Dulk in view of Howsam to include at least one flavoring and coloring ingredient and at least one thickening and stabilizing ingredient to mimic the texture, color and flavor of animal products such as chicken and other meat products
However, Den Dulk is silent to the extruder comprising a plurality of evenly space temperature segments and the temperature-ramp profile.
Hsieh teaches analog meat compositions produced from vegetable protein and processes for producing the analog meat compositions (abstract). Hsieh teaches using extrusion to make the analog meat composition. Hsieh teaches the extrusion processing is a multi-step and multifunctional operation, which leads to mixing, hydration, shear, homogenization, compression, deaeration, pasteurization or sterilization, stream alignment, shaping, expansion and/or fiber formation. Ultimately, the vegetable protein, typically introduced to the extruder in the form of a dry blend, is processed to form a fibrous material ([0006]). Hsieh teaches the extrusion apparatus generally comprises a plurality of heating zones. In one embodiment, the protein mixture is heated in the respective heating zones to temperatures of about 25℃., about 40℃, about 95℃, about 150℃ and about 170℃. One skilled in the art may adjust the temperatures in one or more zones to achieve the desired properties ([00067]). 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); Similarly 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).
It would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention to modify Den Dulk to utilize the extrusion conditions taught by Hsieh to form a fibrous material.
Further the combination of Den Dulk and Hsieh teaches the ramping up of temperature in the extruder, but the combination is silent to the ramping down.
Hsieh2 teaches analog meat compositions produced from vegetable protein and processes for producing the analog meat compositions (abstract). Hsieh2 teaches a similar “ramping-up” method has described above in Hsieh, but continues to teach after the “ramping up” phase to “ramp down” the temperature. Hsieh2 specifically teaches an additional zone (adjacent the extruder exit port) which is set to a temperature of about 140 °C to about 80 °C. Hsieh2 The extruder may be set in other temperature zone arrangements, as desired ([0063]). Hsieh2 teaches the extrudates (or structured plant protein products) produced in accordance with the process described herein comprise protein fibers that are substantially aligned ([0067]).
Therefore, 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 Den Dulk and Hsieh to include the “ramping down” method taught by Hsieh2 to achieve protein fibers that are substantially aligned. Hsieh clearly teaches one with ordinary skill in the art may adjust the ramping down temperature zones as needed to achieve the desired result. 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).
Continuing, with regard to cooling, Den Dulk teaches texturing, or tempering, of the extrudate in a cooling die. Den Dulk teaches the temperature in the present container and/or cooling die is between 50° C. to 120° C ([0016]). But Den Dulk is silent to the plurality of cooling segments.
Howsam teaches the cooling process includes cooling the hot melt in a multi-channel and temperature controlled cooling die (Col 5 lines 50-55, col 6 lines 12-13).
Therefore, Howsam imparts reasoning for obviousness because the teaching shows that the claimed plurality of cooling segments was known for such a thing to have been successfully achieved and published at the time of filing, which means it was within the general skill of one with ordinary skill in the art to select a plurality of cooling segments because it would be obvious to one of skill in the art to do such a thing on the basis of its suitability for a similar intended use. See MPEP 2144.07 that discussed that when the prior art recognizes something is suitable for a similar intended use/purpose, such a thing is obvious.
Further, Den Dulk is silent to the dehydrating and drying process. Per the applicants specification, the extrudate product can be dehydrated by microwave vacuum dying process (applicants specification page 21 lines 9-11)
Gonzalez-Cavieres teaches vacuum microwave drying (VMD) is a fats and efficient process for reducing moisture content and the process prevents oxidation and maintains food quality attributes such as color, texture, and flavor. A VMD system reduces drying time between 70 and 90% compared with hot air drying and freeze-drying systems (1. Introduction). Gonzalez-Cavieres teaches VDM systems have become increasingly popular in being applied to meat (1. Introduction). Gonzalez-Cavieres teaches VMD is controlled by different system parameters, such as power, frequency (Hz), vacuum (kPa), temperature (◦C), moisture loss (mol/m3), food composition, and dielectric properties (1. Introduction). All these parameters are interrelated but must be configured for food being used.
It would have been obvious to one with ordinary skill in the art before the effective filing date of he claimed invention to modify Den Dulk to utilize vacuum microwave drying to reduce moisture as taught by Gonzalez-Cavieres because it is fast and efficient while simultaneously preventing oxidation and maintaining the food’s quality attributes such as color, texture, and flavor (1. Introduction). It would have been obvious to one with ordinary skill in the art that the vacuum drying would inherently dehydrate the extrudate product. See MPEP 2112.01 Gonzalez-Cavieres teaches for each food parameters such as power, frequency (Hz), vacuum (kPa), temperature (◦C), moisture loss (mol/m3), food composition, and dielectric properties need to be adjusted for each food being used. Therefore, it would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention to adjust the parameters to optimized the desired properties of the final product such as color, texture, and flavor. See 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." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)
With regard to Claim 10, Den Dulk teaches texturing, or tempering, of the extrudate in a cooling die. ([0016]) but is silent to further processing after the cooling die.
Howsam teaches the method further comprises cutting, shredding, and shaping into various whole cut meat analogue form such as beef chunks or slices to impart a specific shape on the extrudate to mimic actual animal or vegetable products (Col 2 lines 42-49, Claim 17).
It would have been obvious to one with ordinary skill in the art to modify Den Dulk in view of Howsam to include further cutting to impart a specific shape on the extrudate to mimic actual animal or vegetable products.
With regard to Claim 11, Den Dulk is silent to the reducing the moisture content.
Gonzalez-Cavieres teaches vacuum microwave drying (VMD) is a fats and efficient
process for reducing moisture content and the process prevents oxidation and maintains food quality attributes such as color, texture, and flavor. A VMD system reduces drying time between 70 and 90% compared with hot air drying and freeze-drying systems (1. Introduction). Gonzalez-Cavieres teaches VDM systems have become increasingly popular in being applied to meat (1. Introduction). Gonzalez-Cavieres teaches VMD is controlled by different system parameters, such as power, frequency (Hz), vacuum (kPa), temperature (◦C), moisture loss (mol/m3), food composition, and dielectric properties (1. Introduction). All these parameters are interrelated but must be configured for food being used.
It would have been obvious to one with ordinary skill in the art before the effective filing date of he claimed invention to modify Den Dulk to utilize vacuum microwave drying to reduce moisture as taught by Gonzalez-Cavieres because it is fast and efficient while simultaneously preventing oxidation and maintaining the food’s quality attributes such as color, texture, and flavor (1. Introduction). Gonzalez-Cavieres teaches for each food parameters such as power, frequency (Hz), vacuum (kPa), temperature (◦C), moisture loss (mol/m3), food composition, and dielectric properties need to be adjusted for each food being used. Therefore, it would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention to adjust the parameters to optimized the desired properties of the final product such as color, texture, and flavor. See 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." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955)
With regard to Claim 12, Den Dulk is silent to the method further comprising mechanical tearing and cutting the extrudate product into pieces desirable sizes and natural meat look with a fibrous structure.
Howsam teaches the method further comprising mechanical tearing and cutting the extrudate product into pieces desirable sizes and natural meat look with a fibrous structure (Col 2 lines 42-49, Claim 17). The applicants specification teaches the irregular shape is a result of the extrudate product being “torn”. Thus, Howsam’s method of shredding would be equivalent to the mechanical tearing described by the applicant to achieve the irregular shapes as claimed (Col 8 lines 32-55). Howsam teaches the shredding makes the product closely resemble in texture and structure a meat product (Col 3 lines 28-30)
It would have been obvious to one with ordinary skill in the art to modify Den Dulk in view of Howsam to include mechanical tearing to make the product closely resemble the texture and structure a meat product.
With regard to Claim 13, Den Dulk is silent to the microwave vacuum heating and drying process.
Gonzalez-Cavieres teaches vacuum microwave drying (VMD) is a fats and efficient process for reducing moisture content and the process prevents oxidation and maintains food quality attributes such as color, texture, and flavor. Gonzalez-Cavieres teaches the drying process is useful to preserve food quality and stability and prevent spoilage and contamination during storage (1.Introduction). A VMD system reduces drying time between 70 and 90% compared with hot air drying and freeze-drying systems (1. Introduction). Gonzalez-Cavieres teaches VDM systems have become increasingly popular in being applied to meat (1. Introduction). Gonzalez-Cavieres teaches VMD is controlled by different system parameters, such as power, frequency (Hz), vacuum (kPa), temperature (◦C), moisture loss (mol/m3), food composition, and dielectric properties (1. Introduction). All these parameters are interrelated but must be configured for food being used.
It would have been obvious to one with ordinary skill in the art before the effective filing date of he claimed invention to modify Den Dulk to utilize vacuum microwave drying to reduce moisture as taught by Gonzalez-Cavieres because it is fast and efficient while simultaneously preventing oxidation and maintaining the food’s quality attributes such as color, texture, and flavor (1, Introduction). Gonzalez-Cavieres teaches for each food parameters such as power, frequency (Hz), vacuum (kPa), temperature (◦C), moisture loss (mol/m3), food composition, and dielectric properties need to be adjusted for each food being used. Therefore, it would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention to adjust the parameters to optimized the desired properties of the final product such as storage capability (i.e. shelf life), color, texture, and flavor. See 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." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Claims 14-16 are rejected under 35 U.S.C. 103 as being unpatentable over Den Dulk (US 20150289542 A1) in view of Howsam (US 6635301 B1), Hsieh (US 20120093994 A1), Hsieh2 (WO 2012051428 A1), Uphus (US 7017732 B2), Gonzalez-Cavieres et al. (herein referred to as Gonzalez-Cavieres, “Advances in vacuum microwave drying (VMD) systems for food products”), Stewart et al. (herein referred to as Stewart, US 20170135380 A1) and Giezen (WO 2012158023 A1)
With regard to Claim 14, Den Dulk is silent to the steps of generating a reaction flavor of the animal protein.
Steward teaches a pre-seasoned, ready to cook or packaged frozen food product comprising a base food component such as meat or poultry, coated with a Jamaican jerk spice seasoning comprising herbs, spices and salt (abstract). Steward teaches marinating the product for a predetermined amount of time into ingredients containing high sulfur amino acids such as onion garlic and a secondary ingredient such as soy sauce ([0011]). Stewart teaches The seasoning composition may comprise either a dry mix of spices or a wet marinade ([0005]) and Coating the base food such as meat in wet marinade may result in juicier meat after cooking ([0010]).
It would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention to marinate the extrudate product of the desired shape and size taught by the combination of Den Dulk in view of the marinate taught by Stewart because the wet marinate contains the claimed first and second ingredients and may result in juicier meat after cooking. Additionally, the amount of the ingredients can be adjusted through routine optimization to obtained the desired flavor. See MPEP 2144.05(II) 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).
However, the combination of Den Dulk and Steward are silent to the reaction conditions.
Giezen teaches an extrusion process is disclosed for turning vegetable protein compositions such as soy protein into a fibrous, meat-like structure (abstract). Giezen teaches flavor can be infused into the product via an aqueous liquid to a temperature of 100℃ (Page 15, lines 3-9). Giezen teaches combination of features (such as temperature) is responsible for the creation of a relatively open structure in the composition. This open structure has an improved capability of being infused with an aqueous liquid (page 6, lines 5-9). Giezen reads such that the flavor infusion happens after the product has left the extruder and it at 100℃ and atmospheric pressure (page 6, lines 23-26)
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 Den Dulk and Steward in view of Giezen to incorporate the flavor ingredients at a temperature of 100℃ and atmospheric pressure because the composition will have a more open structure which improves the capability of the product to be infused with aqueous medium carrying the flavor.
With regard to Claim 15, Den Dulk is silent to the process of marinating the product to achieve the flavor.
Steward teaches marinating the product for a predetermined amount of time into ingredients containing high sulfur amino acids such as onion garlic and a secondary ingredient such as soy sauce ([0011]). Stewart teaches the seasoning composition may comprise either a dry mix of spices or a wet marinade ([0005]) and Coating the base food such as meat in wet marinade may result in juicier meat after cooking ([0010]).
Giezen teaches an extrusion process is disclosed for turning vegetable protein compositions such as soy protein into a fibrous, meat-like structure (abstract). Giezen teaches flavor can be infused into the product via an aqueous liquid to a temperature of 100℃ (Page 15, lines 3-9). Giezen teaches combination of features (such as temperature and pressure) is responsible for the creation of a relatively open structure in the composition. This open structure has an improved capability of being infused with an aqueous liquid (page 6, lines 5-9). Giezen reads such that the flavor infusion happens after the product has left the extruder and it at 100℃ and atmospheric pressure (page 6, lines 23-26)
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 Den Dulk in view of Steward and Giezen to infuse the flavor ingredients at a desired amount to achieve the desired flavor profile and at a temperature of 100℃ at atmospheric pressure because the composition will have a more open structure which improves the capability of the product to be infused with aqueous medium carrying the flavor. See MPEP 2144.05(II) 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 16, Den Dulk is silent to analyzing volatiles, semi-volatiles, and other chemical compositional attributes.
Howsam teaches the presence of nutritional additives, flavoring and conservation agents, initial moisture contents and the like, affect the inner structure and texture of the extrudate and therefore its susceptibility to mimic specific types of meat. In other words, not all formulations will be useful where the end product to be mimicked is chicken meat or tuna flakes, and mixtures and formulations can only be exchanged to a certain extent for the same end product to be mimicked (Col 3 lines 6-16).
It would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention that by determining the useful formulations for the desired meat product, one with ordinary skill in the art would have to analyze the chemical compositions that correlated to the flavor performance of the respective animal protein. Thus Howsam imparts reasoning for obviousness for one with skill in the art to analyze the chemical compositions that correlated to the flavor performance of the respective animal protein because it was known to have been successfully achieved and published at the time of filing. It would have been obvious to one of skill in the art to do such a thing on the basis of its suitability for a similar intended use. See MPEP 2144.07 that discussed that when the prior art recognizes something is suitable for a similar intended use/purpose, such a thing is obvious.
However, Howsam is silent to the temperature and pressure conditions.
Giezen teaches an extrusion process is disclosed for turning vegetable protein compositions such as soy protein into a fibrous, meat-like structure (abstract). Giezen teaches flavor can be infused into the product via an aqueous liquid to a temperature of 100℃ (Page 15, lines 3-9). Giezen teaches combination of features (such as temperature and pressure) is responsible for the creation of a relatively open structure in the composition. This open structure has an improved capability of being infused with an aqueous liquid (page 6, lines 5-9). Giezen reads such that the flavor infusion happens after the product has left the extruder and it at 100℃ and atmospheric pressure (page 6, lines 23-26)
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 Den Dulk and Howsam in view of Giezen to infuse the flavor ingredients at a desired amount to achieve the desired flavor profile and at a temperature and pressure wherein the composition will have a more open structure which improves the capability of the product to be infused with aqueous medium carrying the flavor. See MPEP 2144.05(II) 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).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Den Dulk (US 20150289542 A1) in view of Howsam (US 6635301 B1), Hsieh (US 20120093994 A1), Hsieh2 (WO 2012051428 A1), Uphus (US 7017732 B2), Gonzalez-Cavieres et al. (herein referred to as Gonzalez-Cavieres, “Advances in vacuum microwave drying (VMD) systems for food products”), Stewart (US 20170135380 A1), Giezen (WO 2012158023 A1), and Blortz et al. (herein referred to as Blortz, US 5985337 A)
With regard to Claim 17, the combination of Den Dulk, Howsam, Gonzalez-Cavieres Stewart, and Giezen are silent to adding a proteolytic enzyme.
Blortz teaches a process for preparing a protein hydrolysate from protein containing animal products, in which the animal products are hydrolysed using endopeptidases and exopeptidases (abstract). Blortz teaches an embodiment in which endopeptidase and exopeptidase hydrolyze rind which results in a high content of free amino acids such as glycine which tastes sweet. Blortz noted there was no bitterness from this reaction (Col 3 line 62 – Col 4 line 2).
It would be obvious to one with ordinary skill in the art to modify Den Dulk in view of Blortz to utilize endopeptidases and exopeptidases which produce free amino acids such as glycine that give the product a sweet taste. Because the combination of Den Dulk, Howsam, Stewart, Giezen, and Blortz teach the claimed hydrolysis it would have been obvious the desired properties stated in the claim would be inherently present. See MPEP 2112.02 (II) which states when the claim recites using an old composition or structure and the "use" is directed to a result or property of that composition or structure, then the claim is anticipated. In re May, 574 F.2d 1082, 1090, 197 USPQ 601, 607 (CCPA 1978)
Claims 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over Den Dulk (US 20150289542 A1) in view of Howsam (US 6635301 B1), Hsieh (US 20120093994 A1), Hsieh2 (WO 2012051428 A1), Uphus (US 7017732 B2), Gonzalez-Cavieres et al. (herein referred to as Gonzalez-Cavieres, “Advances in vacuum microwave drying (VMD) systems for food products”), Dixon et al. (herein referred to as Dixon, WO 2011014256 A2) and Kyriakopoulou et al. (herein referred to as Kyriakopoulou, “Functionality of Ingredients and Additives in Plant-Based Meat Analogues”)
With regard to Claim 18, Den Dulk is silent to expanding the protein fiber structure and mechanically tearing.
Howsam teaches the protein fiber structure is expanded (Col 2 line 12) and teaches tearing the meat into a plurality of pieces of predetermined size (Col 9, lines 1-8).
However, Howsam is silent to mixing the pieces with an emulsion.
Dixon teaches a wet pet food comprising meat emulsion chunks and binders (abstract). Dixon teaches mixing meat emulsion pieces of a predetermined size with one or more binders ([0014]). Wherein said binders can be starches, maltodextrins, water soluble plant proteins or hydrocolloid gums ([0034]). Dixon teaches the amount of moisture and the types and amount of binders can be varied within the given ranges to alter the texture, viscosity, and palatability of the composition ([0040]). Dixon teaches embodiments where the meat emulsion and binder are heated and thus causing the viscosity of the binder to increase ([0034]).
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 Den Dulk and Howsam in view of Dixon to mix the plurality of pieces of a predetermined size with a binder containing starches, maltodextrins, water soluble plant proteins or hydrocolloid gums and heating the mixture to increase the viscosity of the binder in order to create a product with the desired texture, viscosity, and palatability that has the desired physical characteristics of a dry food compositions such as the final product being stable at ambient conditions without preservatives ([0031]).
However, the combination of Den Dulk, Howsam, and Dixon are silent to the emulsion (“binder” as taught by Dixon) containing a vegetable fat and oil.
Kyriakopoulou discusses key ingredients for the production of meat analogue products, with special focus on protein sources, and underline the importance of ingredient functionality (abstract). Kyriakopoulou teaches fat is an essential component as it improves juiciness, tenderness, and overall palatability of the emulsion-type products (Page 3, Fats). Kyriakopoulou teaches fats with higher melting points are used when manufacturing cooked coarse cutting sausages or emulsion-type products with fat inclusions and oil in its native oleosome structure can also form fat containing gels when heated, which can be suitable for this type of products (Page 3, Fats). In some embodiments Kyriakopoulou teaches using liquid oils such as sunflower and canola oil and solid fats such as coconut or palm oils to achieve the right balance to give the product a pleasant mouthfeel, similar to corresponding meat products (2.2. Burgers, Patties, and Nuggets)
Therefore, 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 Den Dulk, Howsam and Dixon to use plant fats and oil, such as sunflower oil, canola oil, coconut oil, or palm oil in the emulsion (“binder”) as taught by Kyriakopoulou to improves juiciness, tenderness, and overall palatability of the emulsion-type products.
With regard to Claim 19, Den Dulk is silent to the adding flavoring ingredients.
Howsam teaches adding flavoring ingredients (table 4) to further mimic specific types of meat (Col 3 lines 6-13).
It would have been obvious to one with ordinary skill in the art to modify Den Dulk in view of Howsam to add flavoring ingredients to further mimic specific types of meat.
With regard to Claim 20, Den Dulk is silent to employing transglutaminase.
Kyriakopoulou teaches enzymes like transglutaminase that induce crosslinks between the protein molecules can be used, improving the binding properties and the sliceability of finely-textured plant-protein products (3.2 Binding and texturizing agents).
It would have been obvious to one with ordinary skill in the art to modify the combination of Den Dulk in view of Kyriakopoulou to incorporate transglutaminase to enable crosslinking among separate extrudate protein pieces because transglutaminase induces cross linking and improves the binding properties and the sliceability of finely-textured plant-protein products.
Because the combination of Den Dulk, Howsam, Dixon, and Kyriakopoulou teach the claimed method and product composition, the product would inherently simulate a thick whole cut meat analogue with greater thickness and desired fat content and structure. See MPEP 2112.01(II) "Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Id.
Response to Arguments
Applicant's arguments filed 19 May 2026 have been fully considered but they are not persuasive.
With regard to the pressure of the extruder barrel being between 7-10 MPa and the limitation of the extruder rotating at 16-22 Hz is now taught by the primary reference Den Dulk. Applicants arguments in view of Hsieh and Hsieh2 teaching different rotating speeds are not found to be persuasive because those references are not relied upon to teaches the rotating speed of the extruder.
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 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