DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
The Amendment filed March 5, 2026 has been entered. Claims 1-14 and 16 are pending. Claims 1, 7-9, and 12-14 have been amended. Claim 15 has been cancelled. Claim 16 is new.
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 1-4, 8-12 and 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over Coomes et al. (US 2019/0269150 A1; Sep. 5, 2019) in view of Trottet et al. (US 2018/0064137 A1; March 8, 2018).
Regarding claim 1, Coomes discloses a method for obtaining a substitute for cooked animal flesh ([0003]) comprising mixing water and plant proteins, heating and homogenizing the mixture in an extruder to form a melt, feeding the heated and homogenized mixture through an extruder die, and obtaining a substitute for cooked animal flesh (Fig. 1, [0002]-[0003], [0025]-[0031]).
While Coomes teaches mixing water and plant proteins, Cooms fails to teach the mixture further comprising a food oil and fails to teach the claimed amounts of each ingredient.
Trottet discloses a process for preparing a meat-analogue food product, wherein plant proteins, water and oil are mixed together and further extruded ([0007]-[0011]). Trottet teaches that the additional presence of oil gives the product a more meat-like nutrition, appearance, texture and taste ([0003]-[0006]). Trottet further teaches that the meat-analogue food product has water content of 40-70% by weight, a food oil content of 2-15 % by weight, and a plant protein content of 15-35% by weight ([0032]-[0036]) thus overlapping the claimed ranges of 8-20% plant proteins, 2-10% food oil, and 70-90% water. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. (MPEP 2144.05 I)
As Trottet teaches a meat-analogue comprising plant proteins, food oil and water, wherein the meat-analogue has a more meat-like nutrition, appearance, texture and taste ([0003]-[0006]), it would have been obvious to one of ordinary skill in the art to further include food oil in the product of Coomes. Doing so would give the product of Coomes a more meat-like nutrition, appearance, texture and taste as taught by Trottet.
It further would have been obvious to one of ordinary skill in the art to have the plant protein, water and food oil in similar amounts as taught by Trottet as Trottet teaches that such amounts are suitable for producing a meat-analogue having nutrition, appearance, texture and taste similar to real meat.
As stated above, Coomes teaches heating and homogenizing, but teaches that they are performed in-barrel in the extruder and fails to specifically teach that the homogenizing is performed before the heating ([0029]-[0031]).
However, as Coomes teaches that both are performed at the same time in-barrel, it would have been obvious to perform one before the other as it would not result in a significantly different mixture, which would still be heated and homogenized after mixing and before extrusion. This is merely a change in order of processing steps, which is obvious absent new or unexpected results (See MPEP 2144.04 IV C). In the instant case, since both heating and homogenizing are performed between the mixing and extrusion steps of Coomes, changing the order of heating and/or homogenizing is not expected to produce a new or unexpected result as changing the order still produces a heated and homogenized product before extrusion.
Coomes teaches that the heating and homogenizing is performed at temperatures ranging from 60 to 150 C ([0039]-[0040]), thus overlapping the claimed homogenization temperature of 50-90 C and the claimed heating temperature of 70-95 C. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. (MPEP 2144.05 I)
With respect to a homogenization pressure of 100-600 bar and a speed of 100-400 m/s, Coomes fails to specifically teach such parameters.
However, as stated above, Trottet teaches an extruded meat-analogue product and further teaches that the pressure developed in the extruder and speed of movement through the extruder barrel can be controlled by screw thread elements, the speed of rotation of the screw and the rate of introduction of material into the extruder barrel ([0022]).
As Coomes teaches homogenizing in-barrel, it would have been obvious to one of ordinary skill in the art to vary certain processing parameters, such as speed of rotation of the screw in the extruder, to result in a desired homogenization pressure and speed. This is merely routine experimentation that is well within the ordinary skill in the art. As stated in MPEP 2144.05: "Where 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). In the instant case, as Coomes teaches the step of homogenization, determining the exact pressure and speed is an obvious variant over the prior art absent a showing otherwise.
With respect to heating the product for 10 to 30 minutes while stirring at 50-200 rpm, Coomes fails to specifically teach such parameters.
However, as stated above with respect to the homogenization conditions, it would have been obvious to one of ordinary skill in the art to vary certain processing parameters as taught by Trottet, such as speed of rotation of the screw in the extruder, to result in a desired heating time and speed. This is merely routine experimentation that is well within the ordinary skill in the art. As stated in MPEP 2144.05: "Where 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). In the instant case, as Coomes teaches the step of heating in a barrel that rotates, which corresponds to stirring, determining the exact time for heating and speed of stirring is an obvious variant over the prior art absent a showing otherwise.
Coomes further teaches that the extruder operates at a screw speed of about 371 to 421 rpm ([0029]), thus falling within the claimed range of 200 to 500 rpm, and at a temperature of 120 to 160 C ([0031]), thus falling within the claimed temperature of 50 to 200 C.
With respect to feeding the heated and homogenized product in step c into an extruder at a rate of up to 25 kilograms per minute, Coomes discloses that the product is fed through the extruder at a rate of about 15.6 kg/hr ([0040]), which is 0.26 kg/min, thus falling within the claimed range of up to 25 kg/min.
As stated above, the mixture is heated and homogenized in-barrel in an extruder and therefore the product after step c is not necessarily fed into the extruder at the claimed rate. However, Coomes teaches multiple barrels and therefore it would have been obvious to feed the heated product to the last barrel at the claimed rate as Coomes teaches that the product is fed through the extruder die at a rate of about 15.6 kg/hr ([0040]), which is 0.26 kg/min, thus falling within the claimed range of up to 25 kg/min.
Regarding claim 2, Coomes teaches a mixing step, but fails to specifically disclose that it is carried out for 1-5 minutes at a speed of 200-800 rpm at a temperature of 10-30 C.
However, it would have been obvious to one of ordinary skill in the art to vary the parameters for mixing in order to ensure all the ingredients are thoroughly mixed together.
As stated above with respect to claim 1, it would have been obvious to one of ordinary skill in the art to vary certain processing parameters as taught by Trottet, such as speed of rotation and temperature, to result in a desired mixing time. This is merely routine experimentation that is well within the ordinary skill in the art. As stated in MPEP 2144.05: "Where 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). In the instant case, as Coomes teaches the step of mixing, determining the exact time, speed, and temperature is an obvious variant over the prior art absent a showing otherwise.
Regarding claim 3, with respect to a homogenization pressure of 150-300 bar, as stated above with respect to claim 1, Trottet teaches an extruded meat-analogue product and further teaches that the pressure developed in the extruder and speed of movement through the extruder barrel can be controlled by screw thread elements, the speed of rotation of the screw and the rate of introduction of material into the extruder barrel ([0022]).
As Coomes teaches homogenizing in-barrel, it would have been obvious to one of ordinary skill in the art to vary certain processing parameters, such as speed of rotation of the screw in the extruder, to result in a desired homogenization pressure and speed. This is merely routine experimentation that is well within the ordinary skill in the art. As stated in MPEP 2144.05: "Where 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). In the instant case, as Coomes teaches the step of homogenization, determining the exact pressure and speed is an obvious variant over the prior art absent a showing otherwise.
Regarding claim 4, Coomes teaches that the heating is performed at temperatures ranging from 60 to 150 C ([0039]-[0040]), thus overlapping the claimed temperature of 80-95 C. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. (MPEP 2144.05 I)
Regarding claim 8, Coomes teaches that the outlet nozzle of the extruder through which the product is ejected can be rectangular (Fig. 4A. [0033]) with a height by width ratio ranging from 0.04 to 0.16 ([0034]). The claim requires a width of 5-50 mm and a height of 1-30 mm.
It would have been obvious to one of ordinary skill in the art to vary the size of the outlet nozzle depending on the desired size of the extrudate.
As stated in MPEP 2144.04 IV A: Changes in size/proportion are merely obvious variants over the prior art. In Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984), the Federal Circuit held that, where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device.
In the instant case, Coomes teaches a rectangular nozzle opening, which is the same as claimed, and therefore varying the dimensions of the rectangular opening would not result in the device performing differently than the prior art device, as the product still exits through the outlet nozzle in a similar manner. It is well within the ordinary skill in the art to determine the optimum dimensions depending on the desired size of the extruded product.
Regarding claim 9, Coomes teaches that the plant proteins consist of proteins from pea and wheat ([0026]). Coomes further teaches an example wherein the plant proteins consist of 89% proteins from wheat, pea and soy ([0039]), thus falling within the claimed range of 50-98%.
Regarding claim 10, the examiner notes that microalgae is an optional component in claim 9 and therefore not required. Claim 10 does not require that the plant proteins consist of proteins from microalgae.
Coomes meets the claimed plant proteins through the teaching of wheat, soy, and pea and therefore meets the limitations of claim 10.
Regarding claim 11, Trottet teaches that the food oil can be sunflower oil, rapeseed oil, palm oil, coconut oil, peanut oil, or olive oil ([0036]).
Regarding claim 12, as stated above with respect to claim 1, Coomes in view of Trottet render obvious a plant-based substitute for cooked animal flesh obtained by the method of claim 1, wherein the product comprises: a water content of 40-70% by weight, a food oil content of 2-15 % by weight, and a plant protein content of 15-35% by weight ([0032]-[0036]) thus overlapping the claimed ranges of 8-20% plant proteins, 2-10% food oil, and 70-90% water. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. (MPEP 2144.05 I)
Regarding claim 14, as stated above, Coomes in view of Trottet render obvious a composition comprising 15-35% by weight plant protein that can be soy protein ([0033]), 2-15% by weight food oil that can be sunflower oil ([0036]) and 70% by weight water. The prior art teaches overlapping ranges of soy protein and sunflower oil as the claim requires 20% soy protein and 8% sunflower oil. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. (MPEP 2144.05 I)
With respect to the amount of water, the claims require an amount of 72% while the prior art teaches 70%. It is apparent, however, that the instantly claimed amount of 72% and that taught by Trottet are so close to each other that the fact pattern is similar to the one in In re Woodruff , 919 F.2d 1575, USPQ2d 1934 (Fed. Cir. 1990) or Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed.Cir. 1985) where despite a “slight” difference in the ranges the court held that such a difference did not “render the claims patentable” or, alternatively, that “a prima facie case of obviousness exists where the claimed ranges and prior art ranges do not overlap but are close enough so that one skilled in the art would have expected them to have the same properties”.
In light of the case law cited above and given that there is only a “slight” difference between the amount of 70% disclosed by Trottet and the amount disclosed in the present claims, it therefore would have been obvious to one of ordinary skill in the art that the amount of 72% disclosed in the present claims is but an obvious variant of the amounts disclosed in Trottet, and thereby one of ordinary skill in the art would have arrived at the claimed invention.
Further, as stated in MPEP 2144.05: 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. "Where 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 of ordinary skill in the art to vary the amount of water depending on the desired properties of the food product.
Regarding claim 15, Coomes and Trottet teach using the plant-based substitute for cooked animal flesh as food described above.
It would have been obvious to further use the product of Coomes and Trottet is food preparations involving meat and animal flesh and Coomes and Trottet are directed towards providing plant-based meat substitutes.
Claims 5-7 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Coomes et al. (US 2019/0269150 A1; Sep. 5, 2019) and Trottet et al. (US 2018/0064137 A1; March 8, 2018) as applied to claim 1 above, and further in view of Walther et al. (US 2015/0044334 A1; Feb. 12, 2015).
Regarding claim 5, Coomes and Trottet render obvious the process as described above, wherein the method comprises heating and homogenizing. The prior art, however, fails to further teach a step of mixing the homogenized product with transglutaminase.
Walther discloses a method for producing an extruded protein product comprising plant protein, wherein an enzyme that can be transglutaminase can be added to the product stream after a heating step ([0025], [0042], [0068]-[0069], [0075]). Walther teaches that the addition of an enzyme can provide the product with desired appearance or function ([0025]).
It would have been obvious to add transglutaminase to the method of Coomes depend on the desired appearance or function provided by the enzyme as taught by Walther ([0025]).
Additionally, as Walther teaches that the transglutaminase is added after a mixing and heating step, it would have been obvious to one of ordinary skill in the art to add the transglutaminase after the homogenizing step in Coomes.
Further, as stated in MPEP 2144.04 IV C:The order of processing steps is obvious absent a new or unexpected result over the prior art.
Regarding claim 6, with respect to the amount of the transglutaminase added, it would have been obvious to one of ordinary skill in the art to vary the amount depending on the desired appearance or function provided by the enzyme as taught by Walther ([0025]).
As stated in MPEP 2144.05: 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. "Where 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)
Regarding claims 7 and 16, with respect to mixing the transglutaminase for 60 to 240 minutes at a speed of 50 to 200 rpm at a temperature of 30 to 60 C or 30 to 40 C, it would have been obvious to vary the mixing parameters to result in a desired product. This is merely routine experimentation that is well within the ordinary skill in the art.
As stated in MPEP 2144.05: "Where 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). In the instant case, as the prior art teaches the step of adding transglutaminase, determining the exact time, temperature and speed for mixing in the transglutaminase is an obvious variant over the prior art absent a showing otherwise.
Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Coomes et al. (US 2019/0269150 A1; Sep. 5, 2019) and Trottet et al. (US 2018/0064137 A1; March 8, 2018) as applied to claim 12 above, and further in view of Geistlinger et al. (US 2016/0073671 A1; March 17, 2016).
Regarding claim 13, as stated above, Coomes in view of Trottet render obvious a plant-based substitute for cooked animal flesh obtained by the method of claim 1, wherein the product comprises: a water content of 40-70% by weight, a food oil content of 2-15 % by weight, and a plant protein content of 15-35% by weight ([0032]-[0036]).
Trottet further teaches that the plant protein can include algae protein ([0031]), but fails to specifically teach chlorella protein.
Geistlinger discloses a food product having meat-like structure, texture and properties, wherein the food product comprises microbial biomass that can be algae, wherein the algae can be chlorella ([0002], [0115]-[0117]). Geistlinger teaches that algae comprise nutritionally valuable constituents including proteins, enzyme, minerals, vitamins, trace elements, and antioxidants ([0117]).
As Trottet teaches that the plant protein can be algae protein and Geistlinger teaches that chlorella is a suitable algae source for providing meat-like structure, texture and properties, it would have been obvious to one of ordinary skill in the art to have the plant protein of Coomes in view of Trottet be chlorella protein as it would predictably provide meat-like structure, texture and properties to the product of Coomes.
It would have been obvious to include the chlorella protein in a similar amount as taught by Trottet as Trottet teaches that such amount of 15-35% by weight plant protein is suitable for providing a meat like analogue product.
Therefore, the combination of the prior art as described above render obvious a composition comprising 15-35% by weight plant protein that can be chlorella protein, 2-15% by weight food oil that can be rapeseed oil ([0036]) and 70% by weight water. The prior art teaches overlapping ranges of chlorella protein and rapeseed oil as the claim requires 18% chlorella protein and 5% rapeseed oil. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. (MPEP 2144.05 I)
With respect to the amount of water, the claims require an amount of 77% while the prior art teaches 70%. However, it would have been obvious to one of ordinary skill in the art to vary the amount of water depending on the desired properties of the food product. As stated in MPEP 2144.05: 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. "Where 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)
Response to Arguments
Applicant’s claim amendments have overcome the 112 and 101 rejections from the previous Office Action and therefore they have been withdrawn.
Applicant's arguments with respect to the 103 rejections have been fully considered but they are not persuasive.
Applicant argues that the prior art teaches a consolidated in-barrel processing method, wherein all significant transformations of the material are performed within the confines of the extruder itself. Applicant states that the presently claimed method introduced distinct, new and critical processing steps upstream of the extruder to create a specific intermediate structured gel before the material is subjected to extrusion.
This is not found persuasive as the material of the prior art is still subjected to heating and homogenizing before extrusion through an extruder die. Even though the heating and homogenizing steps are performed in-barrel and not a separate equipment, such steps still occur prior to the extrusion process. Therefore, it is not clear how performing such heating and homogenizing in a different apparatus would result in a different product than what is suggested by the prior art.
Further, the claims do not even specify that the heating and homogenizing are excluded from being performed in-barrel. The only apparatus recited in the claims is in step d where the mixture is fed to an extruder. As stated above, Coomes discloses that the product is fed through the extruder at a rate of about 15.6 kg/hr ([0040]), which is 0.26 kg/min, thus falling within the claimed range of up to 25 kg/min. The mixture is heated and homogenized in-barrel in an extruder and then fed through an extrusion die to undergo an “extrusion process”. Coomes teaches multiple barrels and therefore it would have been obvious to feed the heated product to the last barrel at the claimed rate, thus rendering obvious step d of feeding the product into an extruder.
Applicant further argues that the claimed process provides unexpectedly superior fibrous texture which is shown in the comparative sensory analysis detailed in Example 2. Example 2 shows that Sample A received scores for fibrous appearance and mouthfeel that were significantly greater than the average scores of Sample B, wherein Sample B is a product representative of the prior art. Applicant then states that this evidence demonstrates that the claimed method is new and unexpected over the prior art as applied in the rejection above.
This is not found persuasive as the specification does not recite how Sample B was made so that it could be compared to the method as described in Coomes and Trottet. The specification only recites that Sample B was found on the market.
A showing of unexpected results over the prior art would be a comparison of the product method from the method as claimed and that suggested by the prior art. As no showing has been demonstrated, this argument is not found persuasive.
For the reasons stated above, a 103 rejection is maintained.
Conclusion
No claims are allowed.
THIS ACTION IS MADE FINAL. 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 STEPHANIE A KOHLER whose telephone number is (571)270-1075. The examiner can normally be reached Monday-Friday 8am-5pm.
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/STEPHANIE A KOHLER/Primary Examiner, Art Unit 1791
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