/ETAILED 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 .
Status of the Application
Receipt of the Request for Continued Examination (RCE under 37 CFR 1.114) and the Response and Amendment filed 3 October 2025 is acknowledged.
Applicant has overcome the objection to claim 11 by cancellation of the claim. The objection has been withdrawn.
The status of the claims upon entry of the present amendment stands as follows:
Pending claims: 1-8 and 13-16
Withdrawn claims: 14-15
Previously canceled claims: None
Newly canceled claims: 9-12
Amended claims: 1
New claims: None
Claims currently under consideration: 1-8, 13, and 16
Currently rejected claims: 1-8, 13, and 16
Allowed claims: None
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 3 October 2025 has been entered.
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.
Claims 1-8, 13, and 16 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claims 1, 4, 6, 8 recite percentages without indicating how the percentage is to be determined, for example, percent by weight, percent by volume, etc. This renders the limitations indefinite. For purposes of examination, the percentages are considered to be percent by weight, as is used elsewhere in the claims.
Claims 2-8, 13, and 16 are also rejected due to their dependency from claim 1.
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 1-8, 13, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Varadan et al. (US 2017/0188612 A1, US PGPub of WO 2015/153666 A1 cited on the IDS filed on 2 December 2022) in view of Ishikawa et al. (WO 2020/004058 A1, cited on the IDS filed on 18 December 2024) as evidenced by Nutritionix (Calories in 100g Vital Wheat Gluten. (2025). Nutritionix. Retrieved 10 January 2025 from https://web.archive.org/web/20250110123712/https://www.nutritionix.com/food/vital https://oilpalmblog.wordpress.com/2014/01/25/1-composition-of-palm-oil/ -wheat-gluten/100-g), Oil Palm Knowledge Base-1 (Composition of Palm Oil. (2014, January 25). Oil Palm Knowledge Base. Retrieved 19 December 2025 from https://web.archive.org/web/20140131111506/https://oilpalmblog.wordpress.com/2014/01/25/1-composition-of-palm-oil/), Oil Palm Knowledge Base-2 (Quality and Identity Characteristics of Palm Oil Part 3 – Identity Characteristics: Physical. (2014, August 31). Oil Palm Knowledge Base. Retrieved 19 December 2025 from https://oilpalmblog.wordpress.com/2014/08/31/quality-and-identity-characteristics-of-palm-oil-part-3-identity-characteristics-physical/), Deffense (Deffense, E., (1985). Fractionation of palm oil. J Am Oil Chem Soc, 62(2), 376-385. https://doi.org/10.1007/BF02541408, cited on the IDS filed on 26 May 2023), and Dhaygude et al. (Dhaygude, V., Soós, A., Zeke, I., & Somogyi, L. (2018). Comparison between static and dynamic analyses of the solid fat content of coconut oil. Hung J Ind Chem, 46(2), 33-36. https://doi.org/10.1515/hjic-2018-0015).
Regarding claim 1, Varadan teaches “a meat replica composition that includes about 5% to about 88%...by weight of a meat dough; about 0% to about 40%…by weight of a carbohydrate-based gel; about 5% to about 35%…by weight of a fat; about 0.00001% to about 10%…by weight of a flavoring agent; about 0% to about 15% (e.g., about 2% to about 15% or about 2% to about 10%) by weight of a binding agent; and about 0.01% to about 4%…by weight of a heme-containing protein and/or an iron salt.” ([0005]; see also claim 114). While the scope of the invention of Varadan is not limited to the examples provided ([0101]), Example 11 is highlighted below as relevant to teaching elements of the claimed invention.
Varadan teaches a replica burger in Example 11 ([0122]). Table 3 of Varadan ([0122]) has been expanded below to include the protein, fat, and water components of each listed ingredient. As evidenced by Nutritionix, 100g of vital wheat gluten contains 75 g of protein (p. 1, “Nutrition Facts”). Therefore, vital wheat gluten is comprised of 75% protein. Using this information, the percentage of protein, fat, and water were calculated from the information disclosed in Examples 5-7, 10, and 11 as shown in the table below:
Example 11 Burger
Ingredient
%
% Protein
% Fat
% Water
Meat dough (Example 10)
54.1
15.01
4.87
30.16
Vital wheat gluten (75% protein)
25
18.75
Soft connective tissue replica (Example 7)
25
8.75
15
Soy protein
20
20
Wheat gluten (75% protein)
20
15
Water
60
60
Dough broth (Example 5)
50
0.25
9
40.75
LegH
0.5
0.5
Coconut Oil
18
18
Water
81.5
81.5
Coconut oil with flavor system (Example 6)
13.5
13.5
RuBisCO
5.3
5.3
LegH
1.2
1.2
1% agar preparation
20
19.8
16x precursor mix 2
5.9
5.9
Total
100
21.51
18.37
55.86
Bold text indicates main ingredients in the burger composition, plain text indicates subcomponents of the burger ingredients, and italic text indicates ingredients of the subcomponents. Percentages of protein, fat, and water were determined for each subcomponent, and then for the overall burger.
With regard to determining the water amount, the soft tissue replica of Example 7 comprises 60% water as determined by the feed rate of dry protein mixture and water in the extrusion process ([0111]). The dough broth of Example 5 is prepared using 1x precursor mix 1, which appears to be an aqueous solution, 0.5% leghemoglobin, and 18% coconut oil ([0108]). Water was conservatively calculated as the non-leghemoglobin, non-coconut oil component. Similarly, 16x precursor mix 2 was conservatively considered to be 100% water, even though in actuality, 16x precursor 2 comprises many grams of dissolved solids to provide 16x the mM amounts in Table 2. The true amount of water is therefore lower than the 55.86% calculated in the table above.
The proteins used in the burger are wheat gluten, soy, RuBisCo, and LegH, all of which are vegetable proteins. At least RuBisCO and gluten also serve as binders ([0021]). Total protein in the burger was calculated to be 21.51%, and total fat in the burger was calculated to be 18.37%.
Therefore, regarding the limitations of claim 1, Varadan teaches a meat analogue product, comprising:
from 10-60% by weight vegetable protein – The burger of Example 11 comprises 21.51% vegetable protein.
at least 0.1% by weight of binding agent – Varadan teaches a meat replica composition that includes about 2% to about 15% by weight of a binding agent ([0005]). “The binding agent can be an isolated plant protein (e.g., a RuBisCO, an albumin, a gluten, a conglycinin, or mixtures thereof)” ([0021]). The burger of Example 11 comprises 5.3% RuBisCO.
from 10-60% by weight of water – The burger of Example 11 comprises, at most, 55.86% water.
from 5-40% by weight of non-hydrogenated vegetable fat – Varadan discloses, “Broadly, the document provides methods for making ground meat replicas that include preparing a meat replica dough (referred to herein as “meat dough”) that includes an optional edible fibrous component, combining the meat dough with a fat (typically a non-animal-based fat…” ([0039]). The meat replica includes about 5% to about 35% by weight of fat ([0005]). Varadan further discloses, “The oils can be hydrogenated (e.g., a hydrogenated vegetable oil) or non-hydrogenated.” ([0073]). The burger of Example 11 comprises 18.37% fat (coconut oil), which is not disclosed as being hydrogenated.
Regarding the limitation, wherein the vegetable fat has: a saturated fatty acid (SAFA) content of at least 40%, a fatty acid content having a C12 content of less than 10% by weight, a fatty acid content having at least 40% C16:0, and a solid fat content (SFC) at 20 °C of at least 40%, wherein the vegetable fat comprises interesterified palm stearin, Varadan teaches, “In some embodiments, a broth such as a flavored broth can be used in the meat dough. For example, a meat dough can be formed using roughly equal proportions of isolated plant protein and a broth.” ([0069]). “…a broth can be made by combining an iron complex…and/or an iron salt…with one or more flavor precursors…and a fat (e.g., a non-animal-based fat), and heating the mixture to obtain a flavored broth containing one or more flavor compounds…Oil fractions such as stearin (e.g., palm stearin) or olein also can be used.” ([0073]). Such a broth was used in preparation of the meat dough used in the burger of Example 11 ([0122]; Table 3). The broth of Example 5 (used in Example 11) comprises an iron complex (LegH (see [0022])), flavor precursors (1x precursor mix 1), and a fat (coconut oil) ([0108]). Although Examples 5 and 11 use coconut oil as the fat, Varadan also discloses that palm stearin is a suitable fat for use in making the broth ([0073]). Varadan does not discuss that the palm stearin is interesterified palm stearin or explicitly discuss the specific physicochemical features of the vegetable fat.
However, Ishikawa teaches edible oils and fats for processed foods containing meat and/or vegetable proteins, including hamburgers ([0001]). One of these edible oils and fats is an interesterified palm stearin (“Interesterified oil 1”), which is a mixture of 75% palm stearin (iodine value 35), 10% palm oil, and 15% soybean oil, which was then subjected to interesterification ([0045]).
As evidenced by Deffense, palm oil includes 50% saturated and 50% unsaturated fatty acids, and can readily be separated into a high melting fraction (stearin) and a low melting fraction (olein) (see Abstract). Therefore, the high melting stearin fraction, being enriched in saturated fatty acids, necessarily comprises a higher percentage of fatty acids than the oil itself (i.e., >50% saturated fatty acids). Deffense additionally provides that palm stearin with an iodine value (IV) of ~35 has an SFC at 20°C of 68.6%, and a C16:0 content of 60.1% (p. 380, Table 4 “Code 234-1”). As evidenced by the instant specification in the table presented on pages 5-6, interesterified palm stearin comprising 90% palm oil stearin IV 35 has a C12 content of 0.3% and a SAFA content of 69.3%. As evidenced by Oil Palm Knowledge Base-1, palm oil does not contain any appreciable amount of C12 fatty acids (i.e., under 1%), and has a C16:0 content of 45% (p. 6, Table). Oil Palm Knowledge Base-1 also provides that soybean oil has a saturated fatty acid content of 15%, does not contain any appreciable amount of C12 fatty acids (i.e., under 1%), and has a C16:0 content of 11% (p. 6, Table). As evidenced by Oil Palm Knowledge Base-2, palm oil has an SFC at 20°C of about 25% (p. 2, final ¶ and p. 3, Figure, “PO”).
These disclosures and facts are summarized in the table below and were used to calculate, by proportion, the percentages of SAFA, C12:0, C16:0, and the SFC at 20°C present in the interesterified palm stearin disclosed by Ishikawa.
Oil Composition
%
SAFA (%)
C12:0 (%)
C16:0 (%)
SFC 20 (%)
Palm Stearin IV 35
75
69
0.3
60
68.6
Palm Oil
10
50
45
25
Soybean Oil
15
15
11
Ishikawa Interesterified Palm Stearin
100
59
0.225
51.15
53.95
As shown in the table directly above, and specifically regarding the vegetable fat of claim 1, the interesterified palm stearin composition of Ishikawa comprises a SAFA content of at least 40% (i.e., 59%), a fatty acid content having a C12 content of less than 10% by weight (i.e., about 0.2%), a fatty acid content having at least 40% C16:0 (i.e., 51.15%), and an SFC at 20°C of at least 40% (i.e., 53.95%). Soybean oil is liquid at 20°C and therefore does not contribute to the solid fat content.
MPEP § 2144.07 states, “The selection of a known material based on its suitability for its intended use support[s] a prima facie obviousness determination”. Therefore, where Varadan teaches that palm stearin is suitable for making the meat dough, and where Ishikawa teaches that the interesterified palm stearin is suitable for use in processed foods containing meat and/or vegetable proteins, including hamburgers, it would have been obvious to use the interesterified palm stearin of Ishikawa as the palm stearin in Varadan in preparing the meat dough.
Regarding the remaining fat in the burger, Example 11 of Varadan uses coconut oil at 13.5%. As evidenced by Oil Palm Knowledge Base-1, coconut oil comprises 47% C12 fatty acids, a SAFA content of 83%, and a C16:0 content of 9% (p. 6, Table). For completeness of the comparison, Dhaygude evidences that non-hydrogenated coconut oil (NHCO) has an SFC at 20°C of 34.54% (p. 34, col. 2, § 3.2, ¶ 2; see also p. 34, Figure 1, “NHCO”). Where the interesterified palm stearin of Ishikawa represents 4.87% of the burger, and coconut oil represents 13.5% of the burger, the burger comprises 18.37% fat. The coconut oil is 73.5% of the fat. At this rate, the amount of C12 fatty acids is higher than the claimed amount.
However, Varadan also teaches that the fat mixed with the meat dough can be cocoa butter ([0018]), representing an obvious functional equivalent for the purposes of preparing the meat replica/burger. As evidenced by Oil Palm Knowledge Base-1, cocoa butter does not contain any appreciable amount of C12 fatty acids (i.e., under 1%), has a SAFA content of 63%, and a C16:0 content of 25% (p. 6, Table). As evidenced by Oil Palm Knowledge Base-2, cocoa butter has an SFC at 20°C of about 75% (p. 2, final ¶ and p. 3, Figure, “CB”).
These disclosures and facts are summarized in the table below and were used to calculate, by proportion, the percentages of SAFA, C12:0, C16:0, and the SFC at 20°C present in the vegetable oil in amounts as disclosed in Example 11 of Varadan comprising the interesterified palm stearin disclosed by Ishikawa and either coconut oil or cocoa butter as disclosed by Varadan.
Varadan/Ishikawa Oil Composition
Ex. 11 %
SAFA (%)
C12:0 (%)
C16:0 (%)
SFC 20 (%)
Ishikawa Interesterified Palm Stearin
4.87
59
0.225
51.15
53.95
Coconut Oil
13.5
83
47
9
34.54
Cocoa Butter
13.5
63
25
75
Ishikawa + Coconut Oil
18.37
76.64
34.60
20.17
39.69
Ishikawa + Cocoa Butter
18.37
61.94
0.06
31.93
69.42
As shown in the table directly above, the use of coconut oil in the vegetable fat of Varadan as modified by Ishikawa results in a C12 content above 10%. However, the use of cocoa butter in the vegetable fat of Varadan as modified by Ishikawa results in a C12 content below 1%, which is inside the claimed range of under 10%. It is noted that the use of cocoa butter and meat dough at the proportions disclosed in Example 11 of Varadan result in a C16:0 content of about 32%, which is below the claimed “at least 40%. However, Varadan teaches that the meat replica includes about 5% to about 88% by weight of a meat dough and about 5% to about 35% by weight of a fat ([0005]).
MPEP § 2144.05(II)(A) states, “The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.”
Therefore, it would have been obvious for one of ordinary skill in the art to optimize the amount of meat dough and added fat (cocoa butter) by routine experimentation to achieve the desired organoleptic properties for the meat replica. For example, the burger of Example 11 comprises 54.1% meat dough and 13.5% added fat. Increasing the amount of meat dough and/or the amount of stearin in the broth of the meat dough increases the amount of C16:0 fatty acids from the intersterified palm stearin, which has a higher density of C16:0 fatty acids than cocoa butter, and reducing the amount of added fat reduces the amount of C16:0 fatty acids from the cocoa butter, which has a lower density of C16:0 fatty acids. In doing so, one of ordinary skill in the art would have arrived at a formulation comprising vegetable fat having at least 40% C16:0 fatty acids as claimed.
Claim 1 is therefore rendered obvious.
Regarding claim 2, Varadan also teaches that the amount of protein is from 15-50% by weight – As described regarding claim 1 above, the meat replica in Example 11 of Varadan comprises 21.51% protein. This value falls within the claimed range. Claim 2 is therefore rendered obvious.
Regarding claim 3, Varadan also teaches that the amount of non-hydrogenated vegetable fat is from 5-35% by weight – Varadan teaches that the meat replica includes about 5% to about 35% by weight of fat ([0005]). Varadan further discloses, “The oils can be hydrogenated (e.g., a hydrogenated vegetable oil) or non-hydrogenated.” ([0073]). Claim 3 is therefore rendered obvious.
Regarding claim 4, Varadan as modified by Ishikawa teaches the meat analogue product according to claim 1, wherein the vegetable fat has a monounsaturated fatty acid content of 20-40% – As described regarding claim 1, Varadan teaches that palm stearin is an obvious suitable vegetable fat. As evidenced by the instant specification in the table presented on pages 5-6, interesterified palm stearin comprising 90% palm oil stearin IV 35 has a monounsaturated fatty acid (MUFA) content of 24.9%. As evidenced by Oil Palm Knowledge Base-1, palm oil has a MUFA content of 40%, and soybean oil has a MUFA content of 24% (p. 6, Table). The MUFA content of the interesterified palm stearin of Ishikawa can be approximated as (24.9 x 0.75) + (40 x 0.1) + (24 x 0.15) = 33.08% MUFA. As evidenced by Oil Palm Knowledge Base-1, cocoa butter comprises 32% MUFA (p. 6, Table). Any proportional combination of the two fats would result in an amount of MUFA that falls within the claimed range of 20-40%. Therefore, where it would have been obvious to use the interesterified palm stearin of Ishikawa and cocoa butter as the fat in Varadan as described regarding claim 1, claim 4 is also rendered obvious.
Regarding claim 5, Varadan as modified by Ishikawa teaches the meat analogue product according to claim 1, wherein the vegetable fat has a polyunsaturated fatty acid content of less than 10% by weight – As described regarding claim 1, Varadan teaches that palm stearin is an obvious suitable vegetable fat. As evidenced by the instant specification in the table presented on pages 5-6, interesterified palm stearin comprising 90% palm oil stearin IV 35 has a polyunsaturated fatty acid (PUFA) content of 5.8%. As evidenced by Oil Palm Knowledge Base-1, palm oil has a PUFA content of 10%, and soybean oil has a PUFA content of 61% (p. 6, Table). The PUFA content of the interesterified palm stearin of Ishikawa can be approximated as (5.8 x 0.75) + (10 x 0.1) + (61 x 0.15) = 14.5% PUFA. As evidenced by Oil Palm Knowledge Base-1, cocoa butter comprises 3% PUFA (p. 6, Table). The proportional combination of interesterified palm stearin and cocoa butter described regarding Example 11 of Varadan with regard to claim 1 above results in (14.5 x 0.265) + (3 x 0.735) = 6.05% PUFA. Routine experimentation to arrive at a C16:0 content of at least 40% as described regarding claim 1 above would affect the PUFA content as well.
Additionally, Varadan teaches that the oils used in the composition can be palm oil ([0018], [0073]). Varadan further states, “For example, the non-animal fat can be coconut oil, or a combination of coconut oil and stearin. In some embodiments, the fat can contain non-animal (e.g., plant) products, or it can be a combination of animal and non-animal based precursors (e.g., lard), or exclusively animal-based fat.” ([0073]). Therefore, Varadan teaches combinations of fats. As evidenced by Oil Palm Knowledge Base-1, palm oil comprises 45% C16:0 and 10% PUFAs (p. 6, Table). Substituting some of the interesterified palm stearin with palm oil would contribute more C16:0 fatty acids and fewer PUFAs to the overall vegetable oil of the meat replica.
MPEP § 2144.07 states, “The selection of a known material based on its suitability for its intended use support[s] a prima facie obviousness determination”. Therefore, where Varadan as modified by Ishikawa renders obvious the use of interesterified palm stearin in the burger of Varadan as described regarding claim 1, and where Varadan further teaches that palm oil is another suitable fat for making the meat dough and that combinations of fats are also suitable, it would have been obvious to add palm oil to the composition of Varadan as modified by Ishikawa. In doing so, one of ordinary skill in the art would arrive at a vegetable fat having a PUFA content less than 10% by weight by no more than routine experimentation among the amounts of the interesterified palm stearin, palm oil, and cocoa butter. Claim 5 is therefore rendered obvious.
Regarding claim 6, Varadan as modified by Ishikawa teaches the meat analogue product according to claim 1, wherein the vegetable fat has a solid fat content at 20 °C of at least 50% – The interesterified palm stearin of Ishikawa has an SFC at 20°C of 53.95%, and cocoa butter has SFC at 20°C of 75% (see table above). Any proportional combination of the two fats would result in an SFC at 20°C that falls within the claimed range of at least 50%. Therefore, where it would have been obvious to use the interesterified palm stearin of Ishikawa and cocoa butter as the fat in Varadan as described regarding claim 1, claim 6 is also rendered obvious.
Regarding claim 7, Varadan as modified by Ishikawa teaches the meat analogue product according to claim 1, wherein the vegetable fat has a fatty acid content having a C12 content of less than 8% by weight – The interesterified palm stearin of Ishikawa has a C12 content of about 0.2%, and cocoa butter does not contain any appreciable amount of C12 fatty acids (i.e., under 1%) (see table above). Any proportional combination of the two fats would result in a C12 content that falls within the claimed range of less than 8% by weight. Therefore, where it would have been obvious to use the interesterified palm stearin of Ishikawa and cocoa butter as the fat in Varadan as described regarding claim 1, claim 7 is also rendered obvious.
Regarding claims 8, Varadan as modified by Ishikawa teaches the meat analogue according to claim 1, wherein the vegetable fat has a fatty acid content wherein the sum of C16:0 and C18:0 is at least 40% – where it would have been obvious to use the interesterified palm stearin of Ishikawa and cocoa butter as the fat in Varadan as described regarding claim 1, the composition would comprise at least 40% C16:0. Hence, the sum of C16:0 and C18:0 is at least 40%. Therefore, where it would have been obvious to use the interesterified palm stearin of Ishikawa and cocoa butter as the fat in Varadan as described regarding claim 1, claim 8 is also rendered obvious.
Regarding claim 13, Varadan and Ishikawa teach the meat analogue according to claim 1, wherein the vegetable fat comprises shea stearin – Varadan teaches, “In some embodiments, a broth such as a flavored broth can be used in the meat dough. For example, a meat dough can be formed using roughly equal proportions of isolated plant protein and a broth.” ([0069]). “…a broth can be made by combining an iron complex…and/or an iron salt…with one or more flavor precursors…and a fat (e.g., a non-animal-based fat), and heating the mixture to obtain a flavored broth containing one or more flavor compounds…A non-animal fat can include…palm oil…shea butter…Oil fractions such as stearin (e.g., palm stearin) or olein also can be used.” ([0073]). Hence, Varadan teaches that shea stearin is a suitable ingredient.
Such a broth was used in preparation of the meat dough used in the burger of Example 11 ([0122]; Table 3). The broth of Example 5 (used in Example 11) comprises an iron complex (LegH (see [0022])), flavor precursors (1x precursor mix 1), and a fat (coconut oil) ([0108]). Although Examples 5 and 11 use coconut oil as the fat, Varadan also discloses that palm stearin and shea stearin are suitable fats for use in making the broth ([0073]). Varadan further states, “For example, the non-animal fat can be coconut oil, or a combination of coconut oil and stearin. In some embodiments, the fat can contain non-animal (e.g., plant) products, or it can be a combination of animal and non-animal based precursors (e.g., lard), or exclusively animal-based fat.” ([0073]). Therefore, Varadan teaches combinations of fats.
MPEP § 2144.07 states, “The selection of a known material based on its suitability for its intended use support[s] a prima facie obviousness determination”. Therefore, where Varadan as modified by Ishikawa renders obvious the use of interesterified palm stearin in the burger of Varadan as described regarding claim 1, and where Varadan further teaches that shea stearin is another suitable fat for making the meat dough and that combinations of fats are also suitable, it would have been obvious to add shea stearin to the composition of Varadan as modified by Ishikawa. Claim 13 is therefore rendered obvious.
Regarding claim 16, Varadan as modified by Ishikawa teaches the meat analogue product according to claim 1, wherein the meat analogue product has a ratio by weight of the protein to the non-hydrogenated vegetable fat of from 3:1 to 1:2 – Varadan teaches a replica burger in Example 11 ([0122]). Table 3 of Varadan ([0122]) has been expanded below to include the protein and fat components of each listed ingredient. As evidenced by Nutritionix, 100g of vital wheat gluten contains 75 g of protein (p. 1, “Nutrition Facts”). Therefore, vital wheat gluten is comprised of 75% protein. Using this information, the percentage of protein and fat were calculated from the information disclosed in Examples 5-7, 10, and 11 as shown in the table below:
Example 11 Burger
Ingredient
%
% Protein
% Fat
Protein:Fat
Meat dough (Example 10)
54.1
15.01
4.87
Vital wheat gluten (75% protein)
25
18.75
Soft connective tissue replica (Example 7)
25
8.75
Soy protein
20
20
Wheat gluten (75% protein)
20
15
Water
60
Dough broth (Example 5)
50
0.25
9
LegH
0.5
0.5
Coconut Oil
18
18
Water
81.5
Coconut oil with flavor system (Example 6)
13.5
13.5
RuBisCO
5.3
5.3
LegH
1.2
1.2
1% agar preparation
20
16x precursor mix 2
5.9
Total
100
21.51
18.37
1.17
Bold text indicates main ingredients in the burger composition, plain text indicates subcomponents of the burger ingredients, and italic text indicates ingredients of the subcomponents. Percentages of protein and fat were determined for each subcomponent, and then for the overall burger.
Total protein in the burger was calculated to be 21.51%, and total fat in the burger was calculated to be 18.37%. The ratio of protein to fat was calculated to be 1.17:1. This value lies inside the claimed range of 3:1 to 1:2.
It is noted that the use of cocoa butter and meat dough at the proportions disclosed in Example 11 of Varadan result in a C16:0 content of about 32%, which is below the claimed “at least 40%. However, Varadan teaches that the meat replica includes about 5% to about 88% by weight of a meat dough and about 5% to about 35% by weight of a fat ([0005]).
MPEP § 2144.05(II)(A) states, “The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set of percentage ranges is the optimum combination of percentages.”
Therefore, it would have been obvious for one of ordinary skill in the art to optimize the amount of meat dough and added fat (cocoa butter) by routine experimentation to achieve the desired organoleptic properties for the meat replica. For example, the burger of Example 11 comprises 54.1% meat dough and 13.5% added fat. Increasing the amount of meat dough and/or the amount of stearin in the broth of the meat dough increases the amount of C16:0 fatty acids from the intersterified palm stearin, which has a higher density of C16:0 fatty acids than cocoa butter, and reducing the amount of added fat reduces the amount of C16:0 fatty acids from the cocoa butter, which has a lower density of C16:0 fatty acids. In doing so, one of ordinary skill in the art would have arrived at a formulation comprising vegetable fat having at least 40% C16:0 fatty acids as claimed. Similarly, the ratio of protein to fat would increase or decrease from the 1.17:1 value in the table above, within or overlapping the claimed range of 3:1 to 1:2. In a case of overlapping ranges, the claimed range is prima facie obvious, MPEP § 2144.05(I).
Therefore, where it would have been obvious to use the interesterified palm stearin of Ishikawa and cocoa butter as the fat in Varadan as described regarding claim 1, and for the reasons described above, claim 16 is also rendered obvious.
Response to Arguments
Claim Objections:
Applicant has overcome the objection to claim 11 by cancelation. Accordingly, the objection has been withdrawn.
Claim Rejections – 35 U.S.C. § 103: Applicant’s arguments filed on 3 October 2025 have been fully considered, but they are not persuasive.
Applicant first argued that the reference to Example 16, Table 5 of Varadan in combination with paragraph [0073] of Varadan is improper because the citations refer to different embodiments of the invention (p. 4, ¶ 2 – p. 6, ¶ 2). Thus, the skilled person would not have been motivated to replace the coconut oil with palm stearin as they would not have turned to paragraph [0073], which describes a different embodiment (p. 5, ¶ 4).
Applicant’s argument has been fully considered, but it is moot. Without acquiescing to the validity of Applicant’s argument, the rejection of the amended claims does not cite Example 16, Table 5, and instead refers to the burger of Example 11, Table 3 in Varadan, as well as other teachings in Varadan and in combination with Ishikawa. Applicant is reminded that the claims were rejected under 35 U.S.C. § 103 as being obvious in view of the prior art. Rejections under 35 U.S.C. § 102 as being anticipated by the prior art require that “each and every element as set forth in the claim is found, either expressly or inherently described, in a single prior art reference.” (see MPEP § 2131). However, no such requirement exists regarding obviousness rejections. Relevant teachings from anywhere in the same reference, including different embodiments, or a combination of references can be used to support an obviousness rejection.
Applicant next argued that Varadan does not teach all elements of the amended claim 1, which specifies that the vegetable fat comprises interesterified palm stearin (p. 6, ¶ 3).
In response to Applicant’s amendment, the rejection of claim 1 now also relies on Ishikawa, which teaches the use of interesterified palm stearin in meat and/or plant protein compositions including burgers.
Appliant further argued that the inventors surprisingly found that interesterified palm stearin provides more desirable organoleptic properties than palm stearin, and the presence of a property not possessed by the prior art is evidence of non-obviousness. (p. 6, ¶ 4). Applicant argued that the skilled person starting from Varadan would not have been motivated to provide a meat analogue product comprising interesterified palm stearin, let alone in combination with other specific features of amended claim 1, still less with any expectation that doing so would lead to an improvement in the organoleptic properties of the meat analogue product (pp. 6-7, bridging ¶).
Appliant’s argument has been considered, but it is not persuasive. Amended claim 1 relies on Varadan and Ishikawa, which teaches the use of interesterified palm stearin in meat and/or plant protein compositions including burgers, and that burgers comprising the intersterified palm stearin as part of the oil and fat composition also have enhanced organoleptic properties, including enhanced granular texture of the proteins and a juicy texture ([0018]). Therefore, the property is possessed by the prior art.
Applicant’s assertion of unexpected technical results is acknowledged. Applicant’s argument has been considered, but it is not found to be persuasive. MPEP § 2145 states, “If a prima facie case of obviousness is established, the burden shifts to the applicant to come forward with arguments and/or evidence to rebut the prima facie case. See, e.g., In re Dillon, 919 F.2d 688, 692, 16 USPQ2d 1897, 1901 (Fed. Cir. 1990) (en banc)”, and “[r]ebuttal evidence may include evidence of ‘secondary considerations,’ such as ‘commercial success, long felt but unsolved needs, [and] failure of others.’ Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 4459, 467. See also, e.g., In re Piasecki, 745 F.2d 1468, 1473, 223 USPQ 785, 788 (Fed. Cir. 1984) (commercial success). Rebuttal evidence may also include evidence that the claimed invention yields unexpectedly improved properties or properties not present in the prior art. Rebuttal evidence may consist of a showing that the claimed compound possesses unexpected properties. Dillon, 919 F.2d at 692-93, 16 USPQ2d at 1901. A showing of unexpected results must be based on evidence, not argument or speculation. In re Mayne, 104 F.3d 1339, 1343-44, 41 USPQ2d 1451, 1455-56 (Fed. Cir. 1997)”. However, as provided by MPEP § 2145(II), “[m]ere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention. In re Wiseman, 596 F.2d 1019, 201 USPQ 658 (CCPA 1979)”, and “‘[t]he fact that appellant has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious.’ Ex parte Obiaya, 227 USPQ 58, 60 (Bd. Pat. App. & Inter. 1985)”. Furthermore, “[e]vidence of unexpected results must be weighed against evidence supporting prima facie obviousness in making a final determination of the obviousness of the claimed invention. In re May, 574 F.2d 1082, 197 USPQ 601 (CCPA 1978).” See MPEP § 716.02(c)(I). “‘Expected beneficial results are evidence of obviousness of a claimed invention, just as unexpected results are evidence of unobviousness thereof.; In re Gershon, 372 F.2d 535, 538, 152 USPQ 602, 604 (CCPA 1967)”. See MPEP § 716.02(c)(II).
“Whether the unexpected results are the result of unexpectedly improved results or a property not taught by the prior art, the ‘objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support.’ In other words, the showing of unexpected results must be reviewed to see if the results occur over the entire claimed range. In re Clemens, 622 F.2d 1029, 1036, 206 USPQ 289, 296 (CCPA 1980)”. See MPEP § 716.02(d).
In the present case, Applicant does not provide any evidence comparing the claimed interesterified palm stearin with non-interesterified palm stearin to demonstrate that interesterified palm stearin has more desirable organoleptic properties. Applicant’s data compare burgers prepared with interesterified palm stearin, shea stearin, or a combination of sunflower oil and coconut oil. Additionally, Applicant’s evidence of any preference for burgers comprising interesterified palm stearin is not commensurate in scope with the claimed invention. The examples are not commensurate in scope with the claimed invention because it cannot be ascertained whether the alleged unexpected result would occur over the entire claimed ranges and combinations of the claimed ingredients, or features of the ingredients, from the examples provided, and none of the claims are directed toward the specific embodiment provided by any of the examples.
Applicant’s arguments are not persuasive, and in response to Applicant’s amendments, claims 1-8, 13, and 16 are rejected under 35 U.S.C. § 103 as presented hereinabove.
Conclusion
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/JAMES P. SHELLHAMMER/Examiner, Art Unit 1793
/EMILY M LE/Supervisory Patent Examiner, Art Unit 1793