DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
This office action is in response to the application filed on May 24, 2023. The earliest effective filing date of the application is November 24, 2020.
Priority
The present application is a 371 National Stage Application of PCT/US2021/059680 which has a filing date of November 17, 2021.
Status of Application
The amendment filed December 10, 2025 with the Remarks has been entered. The status of the claims upon entry of the present amendment stands as follows:
Pending claims: 1 – 12 and 16 – 21
Previously cancelled claims: 13 – 15
Withdrawn claims: None
Amended claims: 1 – 3, 6 – 8, and 17
New claims: 18 – 21
Claims currently under consideration: 1 – 12 and 16 – 21
The status of the objections and rejections regarding the disclosure upon entry of the present amendment stands as follows:
Objections: The previous objections to claims 6, 8, and 17 are withdrawn in light of Applicant’s amendments. New objections to claims 18, 19, and 21 are presented below.
Withdrawn Rejections: A previous rejection under 35 U.S.C. § 112(b) of claim 1 has been withdrawn in light of applicant’s amendments. The previous rejections under 35 U.S.C. § 112(b) of claims 2 and 7 have been withdrawn in light of applicant’s amendments.
35 U.S.C. § 112 Rejections: New rejections under 35 U.S.C. § 112(b) of claims 2, 7, and 18 – 21 are presented below.
35 U.S.C. § 103 Rejections: The previous rejections under 35 U.S.C. § 103 of claims 1, 2, 4, 5, and 7 – 12 over Ozvural are maintained below. The previous rejections under 35 U.S.C. § 103 of claims 1, 3 – 7, 10, 11, 16, and 18 – 21 over Verkuijl are maintained below. New rejections under 35 U.S.C. § 103 of claims 18 – 21 over Verkuijl are presented below.
Double Patenting: The double patenting rejection of claim 1 over copending Application No. 18/254,304 is maintained.
Claim Objections
Claims 1, 3, 18, 19, and 21 are objected to because of the following informalities:
Claims 1, 18, 19, and 21 recite “a ratio of C18 content to C16 content in a range of from 1.0 to 10.0” which appears to be claiming a ratio of C18 to C16 in a range of from 1.0:1.0 to 10.0:1.0.
Claims 3 and 19 recite “the randomly interesterified triglyceride has an SUS/SSU ratio in a range of from 0.5 to 1.0” which appears to be claiming the randomly interesterified triglyceride has an SUS/SSU ratio in a range of from 0.5:1.0 to 1.0:1.0.
Claim 21 recites “a ratio of C18 content to C16 content in a range of from 1.3 to 10.0” which appears to be claiming a ratio of C18 to C16 in a range of from 1.3:1.0 to 10.0:1.0.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1 – 12 and 16 – 21 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 1, 18, 19, and 20 fail to disclose the basis (i.e., weight, volume, molar, etc) of the range of palmitic acid (C16) to stearic acid (C18) ratios in the final product. The basis of the range of palmitic acid (C16) to stearic acid (C18) ratios in the final product is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. For the purpose of examination, the range of palmitic acid (C16) to stearic acid (C18) ratios in the final product is interpreted to be by weight.
Claim 3 fails to disclose the basis (i.e., weight, volume, molar, etc) of the range of SUS/SSU ratios in the final product. The basis of the range of SUS/SSU ratios in the final product is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. For the purpose of examination, the range of SUS/SSU ratios in the final product is interpreted to be by mole.
Claim 19 fails to disclose the basis (i.e., weight, volume, molar, etc) of the range of SUS/SSU ratios in the final product. The basis of the range of SUS/SSU ratios in the final product is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. For the purpose of examination, the range of SUS/SSU ratios in the final product is interpreted to be by mole.
Claims 20 recites “not based on meat or fish” which renders the claim indefinite. It is unclear what the metes and bounds are encompassed by “based on”. For example, a meat substitute product comprising a small amount of meat relative to plant protein ingredients may not be considered “based on” meat. For the purpose of examination, the meat substitute product of claim 20 is interpreted to not comprise meat or fish.
Claims 2, 4 – 12, 16, 17, and 21 are rejected as dependent on a rejected base claim.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 2, 5, 7 – 11, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Ozvural et al. (Utilization of interesterified oil blends in the production of frankfurters. Meat Science, Elsevier Science. Vol 78. Iss 3. Pp. 211-216 (2007) – IDS Filed on May 24, 2023) in view of Talbot (Saturated fats in foods and strategies for their replacement: an introduction In: Reducing Saturated Fats in Foods. Woodhead Publishing Limited. Pp. 3 – 28. (2011)).
Regarding claim 1, Ozvural teaches a frankfurter (i.e., a meat substitute product) comprising beef meat (i.e., a protein ingredient) and beef fat (Treatment 1) comprising a negligible amount of C12:0 (i.e., lauric acid – i.e., less than 5.0 wt%), 24.43 wt% C16:0 (i.e., palmitic acid), and 23.53 wt% C18:0 (i.e., stearic acid – p. 212, 2.3 Preparation of frankfurters; p. 215, Table 4). In total, C16:0 (i.e., palmitic acid) and C18:0 (i.e., stearic acid) make up 49.96 wt% of the fat blend. The weight ratio of C18:0 (i.e., stearic acid) to C16:0 (i.e., palmitic acid) and is 0.95:1.00.
Ozvural does not teach the weight ratio of C18:0 (i.e., stearic acid) to C16:0 (i.e., palmitic acid) in a range of from 1.0:1.0 to 10.0:1.0.
Talbot teaches saturated fat (such as stearic acid and palmitic acid) increase blood cholesterol (p. 4, paragraph 2). Talbot teaches stearic acid does not raise either HDL-cholesterol or LDL-cholesterol in the body, while palmitic acid raises both (p. 15, paragraph 2). Talbot teaches that in regards to cardiovascular health, the ratio of total cholesterol:HDL-cholesterol is a better indicator of health compared to the levels of any individual type of cholesterol (p. 15, paragraph 3). Therefore, stearic acid has a neutral effect on cardiovascular health, while palmitic acid has a negative effect. Talbot also teaches that saturated fats (such as stearic acid and palmitic acid) have similar melting points due to their long, straight structure (p. 8, paragraph 2).
One of ordinary skill in the art would have adjusted the weight ratio of stearic acid to palmitic acid during routine optimization by replacing some of the palmitic acid with stearic acid to find the frankfurter with the best effect on the total cholesterol:HDL- cholesterol ratio while maintaining the total saturated fat content in the fat to ensure crystallization properties comparable to natural beef fat. MPEP §2144.05(II) states 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). The claimed weight ratio of stearic acid (C18) to palmitic acid (C16), 1.0:1.0 to 10.0:1.0, would thus be obvious.
Regarding claim 2, Ozvural teaches the beef fat comprises 42.54 wt% C18:1 (i.e., oleic acid) and 3.19 wt% C18:2 (i.e., linoleic acid – p. 215, Table 4). The total of C18:1 (i.e., oleic acid) and C18:2 (i.e., linoleic acid) makes up 45.73 wt% of the fat blend.
Regarding claim 5, Ozvural teaches the frankfurter (i.e., meat substitute product) comprises 22% beef meat (15% fat}, 34% beef meat (28-30% fat), and 10 wt% beef fat (p. 212, 2.3 Preparation of frankfurters). According to these amounts, the frankfurter (i.e., meat substitute product) of Ozvural comprises 23.16 ± 0.34 wt% beef fat (i.e., triglycerides).
Regarding claims 7 and 17, Ozvural teaches a frankfurter (i.e., meat substitute product) comprising beef meat (i.e., a protein ingredient) and beef fat.
The recitation “the protein ingredient is sourced from plants, fungi, algae, insects, culture meat, or a mixture of two of more thereof” is interpreted broadly to encompass any proteins naturally present in plants, fungi, algae, insects, culture meat, or a mixture of two of more thereof, regardless of their original source. Determination of patentability of products is based on the product itself. In this case, the proteins in beef meat are the same as the proteins naturally present in beef culture meat. Therefore, the inventions of claims 7 and 17 are rendered obvious by Ozvural.
Regarding claim 8, Ozvural teaches the frankfurter (i.e., meat substitute product) comprises a casing (p. 212, 2.3 Preparation of frankfurters).
Regarding claim 9, Ozvural teaches the frankfurter (i.e., meat substitute product) is produced creating a meat/fat mixture, chopping the meat/fat mixture for 20-30 s in a cutter at low speed and mixing with the curing ingredients, seasonings and about half of the ice, then chopping the mixture for 2-3 min at high speed and the remaining ice is added (p. 212, 2.3 Preparation of frankfurters). Ozvural teaches after chopping, the batter (i.e., emulsion) is stuffed by a vacuum staffer in 28mm diameter casings (p. 212, 2.3 Preparation of frankfurters). The process as described by Ozvural produces an emulsified product.
Regarding claim 10, Ozvural teaches a frankfurter (i.e., a sausage) comprising beef meat (i.e., a protein ingredient) and a fat blend. Ozvural teaches the frankfurter is heat-processed and smoked (p. 212, 2.3 Preparation of frankfurters).
As to the claim limitation "the meat substitute product is a cold cut", this limitation is deemed to be an intended use in so far as the structure of the product is concerned. As stated by the instant specification, cold cuts are heat treated (i.e., cooked) or cured meats, often sausages, served cold ([0014]). MPEP § 2111.02.II states if the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. Therefore a claimed intended use must result in structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. Given that the frankfurter of Ozvural is identical to that of the presently claimed in terms of structure and composition, because it is a cooked sausage, it meets the intended use of the sausage served cold (i.e., as a cold cut). Therefore, the frankfurter (i.e., meat substitute product) of Ozvural is a cold cut.
Regarding claim 11, Ozvural teaches a frankfurter (i.e., a sausage) comprising beef meat (i.e., a protein ingredient) and a fat blend.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Ozvural et al. (Utilization of interesterified oil blends in the production of frankfurters. Meat Science, Elsevier Science. Vol 78. Iss 3. Pp. 211-216 (2007) – IDS Filed on May 24, 2023) in view of Talbot (Saturated fats in foods and strategies for their replacement: an introduction In: Reducing Saturated Fats in Foods. Woodhead Publishing Limited. Pp. 3 – 28. (2011)) as evidenced by Smart Dog University (Make-At-Home Cheap (And Easy) Dog Training Treats. Smart Dog University. (2009). Retrieved from: https://smartdoguniversity.com/makeathome-cheap-and-easy-dog-training-treats/).
While Ozvural does not teach the frankfurter (i.e., meat substitute product) is a pet food, the limitation "the meat substitute product is a pet food" recited in claim 12 is deemed to be an intended use in so far as the structure of the product is concerned. The instant specification states the term "pet food" means any food composition intended to be consumed by a pet ([0015]). As evidenced by Smart Dog University, pet owners regularly purchase frankfurters for their dogs as treats (p. 7, comment 2). MPEP § 2111.02.II states if the body of a claim fully and intrinsically sets forth all of the limitations of the claimed invention, and the preamble merely states, for example, the purpose or intended use of the invention, rather than any distinct definition of any of the claimed invention’s limitations, then the preamble is not considered a limitation and is of no significance to claim construction. Therefore a claimed intended use must result in structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. Given that the frankfurter of Ozvural is identical to that of the presently claimed in terms of structure and composition, because it is a frankfurter, it meets the intended use of the frankfurters regularly fed to dogs (i.e., as pet food). Therefore, the frankfurter (i.e., meat substitute product) of Ozvural is a pet food.
Claims 1, 4 – 7, 10, 11, 16, 18, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Verkuijl et al. (WO 2021098966 A1 – IDS Filed on May 24, 2023) in view of Talbot (Saturated fats in foods and strategies for their replacement: an introduction In: Reducing Saturated Fats in Foods. Woodhead Publishing Limited. Pp. 3 – 28. (2011)).
Regarding claim 1, Verkuijl teaches a meat analogue product (i.e., meat substitute product), comprising:
from 10 – 60% by weight vegetable protein;
at least 0.1% by weight of binding agent;
from 10 – 60% by weight of water; and
from 5 – 40% by weight of non-hydrogenated vegetable fat;
wherein the vegetable fat has a saturated fatty acid (SAFA) content of at least 40%, and a solid fat content (SFC) at 20 °C of at least 20% (Claim 1).
Verkuijl teaches the non-hydrogenated vegetable fat has a fatty acid content having a C12 content of less than 10% by weight (Claim 7). Verkuijl teaches the non-hydrogenated vegetable fat has a fatty acid content wherein the sum of C16:0 and C18:0 is at least 40%, preferably from 50 to 70% (Claim 8). Verkuijl teaches the non-hydrogenated vegetable fat has a fatty acid content having at least 40% C16:0; and/or the non-hydrogenated vegetable fat comprises at least 40% C18:0 (Claim 9).
The range of lauric acid weight percent in the non-hydrogenated vegetable fat, less than 10 wt%, as disclosed by Verkuijl, overlaps with the claimed range of less than 5.0 wt%. MPEP § 2114.05 teaches that it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have selected the overlapping portion of the ranges disclosed by the reference because selection of overlapping portion of ranges has been held to be a prima facie case of obviousness.
The range of palmitic (C16) and stearic acid (C18) weight percent in the non-hydrogenated vegetable fat, 50 to 70 wt%, as disclosed by Verkuijl, overlaps with the claimed range of 35 to 65%. MPEP § 2114.05 teaches that it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have selected the overlapping portion of the ranges disclosed by the reference because selection of overlapping portion of ranges has been held to be a prima facie case of obviousness.
Verkuijl does not teach the weight ratio of C18:0 (i.e., stearic acid) to C16:0 (i.e., palmitic acid) in a range of from 1.0:1.0 to 10.0:1.0.
Talbot teaches saturated fat (such as stearic acid and palmitic acid) increase blood cholesterol (p. 4, paragraph 2). Talbot teaches stearic acid does not raise either HDL-cholesterol or LDL-cholesterol in the body, while palmitic acid raises both (p. 15, paragraph 2). Talbot teaches that in regards to cardiovascular health, the ratio of total cholesterol:HDL-cholesterol is a better indicator of health compared to the levels of any individual type of cholesterol (p. 15, paragraph 3). Therefore, stearic acid has a neutral effect on cardiovascular health, while palmitic acid has a negative effect. Talbot also teaches that saturated fats (such as stearic acid and palmitic acid) have similar melting points due to their long, straight structure, while unsaturated fats (such as oleic and linoleic acid) have lower melting points as a result of their curved structure (p. 8, paragraph 2).
One of ordinary skill in the art would have adjusted the weight ratio of stearic acid to palmitic acid during routine optimization by replacing some of the palmitic acid with stearic acid to find the meat analogue with the best effect on the total cholesterol:HDL- cholesterol ratio while maintaining the total saturated fat content in the fat to ensure desired crystallization properties. MPEP §2144.05(II) states 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). The claimed weight ratio of stearic acid (C18) to palmitic acid (C16), 1.0:1.0 to 10.0:1.0, would thus be obvious.
Regarding claim 4, Verkuijl teaches the meat analogue (i.e., meat substitute product) comprises from 5 – 40% by weight of non-hydrogenated vegetable fat (Claim 1).
The range of non-hydrogenated vegetable fat (i.e., randomly interesterified triglyceride) weight percent in the meat analogue (i.e., meat substitute product), 5 – 40 wt%, as disclosed by Verkuijl, overlaps with the claimed range of 1.0 to 10.0 wt%. MPEP § 2114.05 teaches that it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have selected the overlapping portion of the ranges disclosed by the reference because selection of overlapping portion of ranges has been held to be a prima facie case of obviousness.
Regarding claim 5, Verkuijl teaches the meat analogue (i.e., meat substitute product) comprises from 5 – 40% by weight of non-hydrogenated vegetable fat (Claim 1).
Regarding claim 6, Verkuijl teaches the meat analogue (i.e., meat substitute product) has a solid fat content (SFC) at 20 °C of at least 20% (Claim 1). Therefore, the fat is 80% liquid at 20 °C. Verkuijl teaches the meat analogue (i.e., meat substitute product) comprises from 5 – 40% by weight of non-hydrogenated vegetable fat (i.e., randomly interesterified triglyceride – Claim 1). Therefore, the meat analogue (i.e., meat substitute product) comprises 4 – 32% by weight liquid fat at 20 °C.
The range of liquid oil weight percent in the total weight of the meat analogue (i.e., meat substitute product), 4 – 32 wt%, as disclosed by Verkuijl, overlaps with the claimed range of 4to 30 wt%. MPEP § 2114.05 teaches that it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have selected the overlapping portion of the ranges disclosed by the reference because selection of overlapping portion of ranges has been held to be a prima facie case of obviousness.
Regarding claims 7, Verkuijl teaches a meat analogue (i.e., meat substitute product) comprising a non-hydrogenated vegetable fat, mungbeans (i.e., a plant protein source), and super pea protein isolate (i.e., a plant protein source – p. 7, Examples 2, Table; p. 7, paragraph 4).
The recitation “the protein ingredient is sourced from plants, fungi, algae, insects, culture meat, or a mixture of two of more thereof” is interpreted broadly to encompass any proteins naturally present in plants, fungi, algae, insects, culture meat, or a mixture of two of more thereof, regardless of their original source. Determination of patentability of products is based on the product itself. In this case, the proteins in mungbeans and super pea protein isolate are the same as those naturally present in mungbeans and peas. Therefore the invention of claim 7 is rendered obvious by Verkuijl.
Regarding claim 10, Verkuijl teaches the meat analogue (i.e., meat substitute product) may be brought into a desired form such as a sausage (p. 5, paragraph 2). Verkuijl teaches the meat analogue may subsequently be cooked, for instance by baking or grilling (p. 5, paragraph 2).
As to the claim limitation "the meat substitute product is a cold cut", this limitation is deemed to be an intended use in so far as the structure of the product is concerned. As stated by the instant specification, cold cuts are heat treated (i.e., cooked) or cured meats, often sausages, served cold ([0014]). In article claims, a claimed intended use must result in structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. MPEP 2111.02. Given that the meat analogue (i.e., meat substitute product) of Verkuijl is identical to that of the presently claimed in terms of structure and composition, it meets the intended use of the claimed article.
Regarding claim 11, Verkuijl teaches the meat analogue (i.e., meat substitute product) may be brought into a desired form such as a sausage (p. 5, paragraph 2).
Regarding claim 16, Verkuijl teaches a meat analogue (i.e., meat substitute product) comprising a non-hydrogenated vegetable fat, mungbeans, and super pea protein isolate (i.e., a plant protein source – p. 7, Example 2, Table; p. 7, paragraph 4).
Regarding claim 18, Verkuijl teaches a meat analogue product (i.e., meat substitute product), comprising:
a. from 10 – 60% by weight vegetable protein;
b. at least 0.1% by weight of binding agent;
c. from 10 – 60% by weight of water; and
d. from 5 – 40% by weight of non-hydrogenated vegetable fat;
wherein the vegetable fat has a saturated fatty acid (SAFA) content of at least 40%, and a solid fat content (SFC) at 20 °C of at least 20% (Claim 1).
Verkuijl teaches the non-hydrogenated vegetable fat has a fatty acid content having a C12 content of less than 10% by weight (Claim 7). Verkuijl teaches the non-hydrogenated vegetable fat has a fatty acid content wherein the sum of C16:0 and C18:0 is at least 40%, preferably from 50 to 70% (Claim 8). Verkuijl teaches the non-hydrogenated vegetable fat has a fatty acid content having at least 40% C16:0; and/or the non-hydrogenated vegetable fat comprises at least 40% C18:0 (Claim 9).
The range of lauric acid weight percent in the non-hydrogenated vegetable fat, less than 10 wt%, as disclosed by Verkuijl, overlaps with the claimed range of less than 5.0 wt%. MPEP § 2114.05 teaches that it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have selected the overlapping portion of the ranges disclosed by the reference because selection of overlapping portion of ranges has been held to be a prima facie case of obviousness.
The range of palmitic (C16) and stearic acid (C18) weight percent in the non-hydrogenated vegetable fat, 50 to 70 wt%, as disclosed by Verkuijl, overlaps with the claimed range of 35 to 65%. MPEP § 2114.05 teaches that it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have selected the overlapping portion of the ranges disclosed by the reference because selection of overlapping portion of ranges has been held to be a prima facie case of obviousness.
Verkuijl does not teach the weight ratio of C18:0 (i.e., stearic acid) to C16:0 (i.e., palmitic acid) in a range of from 1.0:1.0 to 10.0:1.0.
Talbot teaches saturated fat (such as stearic acid and palmitic acid) increase blood cholesterol (p. 4, paragraph 2). Talbot teaches stearic acid does not raise either HDL-cholesterol or LDL-cholesterol in the body, while palmitic acid raises both (p. 15, paragraph 2). Talbot teaches that in regards to cardiovascular health, the ratio of total cholesterol:HDL-cholesterol is a better indicator of health compared to the levels of any individual type of cholesterol (p. 15, paragraph 3). Therefore, stearic acid has a neutral effect on cardiovascular health, while palmitic acid has a negative effect. Talbot also teaches that saturated fats (such as stearic acid and palmitic acid) have similar melting points due to their long, straight structure, while unsaturated fats (such as oleic and linoleic acid) have lower melting points as a result of their curved structure (p. 8, paragraph 2).
One of ordinary skill in the art would have adjusted the weight ratio of stearic acid to palmitic acid during routine optimization by replacing some of the palmitic acid with stearic acid to find the meat analogue with the best effect on the total cholesterol:HDL- cholesterol ratio while maintaining the total saturated fat content in the fat to ensure desired crystallization properties. MPEP §2144.05(II) states 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). The claimed weight ratio of stearic acid (C18) to palmitic acid (C16), 1.0:1.0 to 10.0:1.0, would thus be obvious.
With respect to the liquid oil content of the meat analogue (i.e., meat substitute product), Verkuijl teaches the meat analogue (i.e., meat substitute product) has a solid fat content (SFC) at 20 °C of at least 20% (Claim 1). Therefore, the fat is 80% liquid at 20 °C. Verkuijl teaches the meat analogue (i.e., meat substitute product) comprises from 5 – 40% by weight of non-hydrogenated vegetable fat (i.e., randomly interesterified triglyceride – Claim 1). Therefore, the meat analogue (i.e., meat substitute product) comprises 4 – 32% by weight liquid fat at 20 °C.
The range of liquid oil weight percent in the total weight of the meat analogue (i.e., meat substitute product), 4 – 32 wt%, as disclosed by Verkuijl, overlaps with the claimed range of 4to 30 wt%. MPEP § 2114.05 teaches that it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have selected the overlapping portion of the ranges disclosed by the reference because selection of overlapping portion of ranges has been held to be a prima facie case of obviousness.
Regarding claim 21, Verkuijl does not teach the weight ratio of C18:0 (i.e., stearic acid) to C16:0 (i.e., palmitic acid) in a range of from 1.0:1.0 to 10.0:1.0.
Talbot teaches saturated fat (such as stearic acid and palmitic acid) increase blood cholesterol (p. 4, paragraph 2). Talbot teaches stearic acid does not raise either HDL-cholesterol or LDL-cholesterol in the body, while palmitic acid raises both (p. 15, paragraph 2). Talbot teaches that in regards to cardiovascular health, the ratio of total cholesterol:HDL-cholesterol is a better indicator of health compared to the levels of any individual type of cholesterol (p. 15, paragraph 3). Therefore, stearic acid has a neutral effect on cardiovascular health, while palmitic acid has a negative effect. Talbot also teaches that saturated fats (such as stearic acid and palmitic acid) have similar melting points due to their long, straight structure, while unsaturated fats (such as oleic and linoleic acid) have lower melting points as a result of their curved structure (p. 8, paragraph 2).
One of ordinary skill in the art would have adjusted the weight ratio of stearic acid to palmitic acid during routine optimization by replacing some of the palmitic acid with stearic acid to find the meat analogue with the best effect on the total cholesterol:HDL- cholesterol ratio while maintaining the total saturated fat content in the fat to ensure desired crystallization properties. MPEP §2144.05(II) states 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). The claimed weight ratio of stearic acid (C18) to palmitic acid (C16), 1.0:1.0 to 10.0:1.0, would thus be obvious.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Verkuijl et al. (WO 2021098966 A1 – IDS Filed on May 24, 2023) in view of in view of Talbot (Saturated fats in foods and strategies for their replacement: an introduction In: Reducing Saturated Fats in Foods. Woodhead Publishing Limited. Pp. 3 – 28. (2011)) as applied to claim 1 above, and further in view of Adlof et al. (Synthesis and Analysis of Symmetrical and Nonsymmetrical Disaturated/Monounsaturated Triacylglycerols. J. Agric. Food Chem. Vol 51. Pp. 2096 – 2099. (2003)).
As stated by the instant specification, the abbreviation S is used to denote a saturated fatty acid residue having 12 to 24 carbon atoms and the abbreviation U denotes an unsaturated fatty acid residue having 12 to 24 carbon atoms ([0022]). Thus, a triglyceride having saturated fatty acids at the 1- and 3- positions and an unsaturated fatty acid at the 2- position of the glycerol backbone is denoted SUS ([0022]). Likewise, a triglyceride having 2 saturated fatty acids at the 1- or 3- position and at the 2- position of the glycerol backbone and an unsaturated fatty acid at the remaining 1- or 3- position is denoted SSU ([0022]). Therefore, the notation SUS and SSU are interpreted in light of the above definition.
Verkuijl does not teach the non-hydrogenated vegetable fat has a SUS/SSU mole ratio in a range of from 0.5:1.0 to 1.0:1.0.
Adlof synthesizes and compares SUS and SSU triglycerides. Adlof teaches SUS and SSU triglycerides have different melting points (Table 1).
While Verkuijl does not teach the non-hydrogenated vegetable fat has an SUS/SSU mole ratio in a range of from 0.5:1.0 to 1.0:1.0, one of ordinary skill in the art would have adjusted the SUS/SSU mole ratio during routine optimization to find the non-hydrogenated vegetable fat that results in the meat analogue (i.e., meat substitute product) with the desired melting point. MPEP §2144.05(II) states 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). The claimed SUS/SSU mole ratio, 0.5:1.0 to 1.0:1.0, would thus be obvious.
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Verkuijl et al. (WO 2021098966 A1 – IDS Filed on May 24, 2023) in view of in view of Talbot (Saturated fats in foods and strategies for their replacement: an introduction In: Reducing Saturated Fats in Foods. Woodhead Publishing Limited. Pp. 3 – 28. (2011)) and Adlof et al. (Synthesis and Analysis of Symmetrical and Nonsymmetrical Disaturated/Monounsaturated Triacylglycerols. J. Agric. Food Chem. Vol 51. Pp. 2096 – 2099. (2003)).
Verkuijl teaches a meat analogue product (i.e., meat substitute product), comprising:
a. from 10 – 60% by weight vegetable protein;
b. at least 0.1% by weight of binding agent;
c. from 10 – 60% by weight of water; and
d. from 5 – 40% by weight of non-hydrogenated vegetable fat;
wherein the vegetable fat has a saturated fatty acid (SAFA) content of at least 40%, and a solid fat content (SFC) at 20 °C of at least 20% (Claim 1).
Verkuijl teaches the non-hydrogenated vegetable fat has a fatty acid content having a C12 content of less than 10% by weight (Claim 7). Verkuijl teaches the non-hydrogenated vegetable fat has a fatty acid content wherein the sum of C16:0 and C18:0 is at least 40%, preferably from 50 to 70% (Claim 8). Verkuijl teaches the non-hydrogenated vegetable fat has a fatty acid content having at least 40% C16:0; and/or the non-hydrogenated vegetable fat comprises at least 40% C18:0 (Claim 9).
The range of lauric acid weight percent in the non-hydrogenated vegetable fat, less than 10 wt%, as disclosed by Verkuijl, overlaps with the claimed range of less than 5.0 wt%. MPEP § 2114.05 teaches that it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have selected the overlapping portion of the ranges disclosed by the reference because selection of overlapping portion of ranges has been held to be a prima facie case of obviousness.
The range of palmitic (C16) and stearic acid (C18) weight percent in the non-hydrogenated vegetable fat, 50 to 70 wt%, as disclosed by Verkuijl, overlaps with the claimed range of 35 to 65%. MPEP § 2114.05 teaches that it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have selected the overlapping portion of the ranges disclosed by the reference because selection of overlapping portion of ranges has been held to be a prima facie case of obviousness.
Verkuijl does not teach the weight ratio of C18:0 (i.e., stearic acid) to C16:0 (i.e., palmitic acid) in a range of from 1.0:1.0 to 10.0:1.0.
Talbot teaches saturated fat (such as stearic acid and palmitic acid) increase blood cholesterol (p. 4, paragraph 2). Talbot teaches stearic acid does not raise either HDL-cholesterol or LDL-cholesterol in the body, while palmitic acid raises both (p. 15, paragraph 2). Talbot teaches that in regards to cardiovascular health, the ratio of total cholesterol:HDL-cholesterol is a better indicator of health compared to the levels of any individual type of cholesterol (p. 15, paragraph 3). Therefore, stearic acid has a neutral effect on cardiovascular health, while palmitic acid has a negative effect. Talbot also teaches that saturated fats (such as stearic acid and palmitic acid) have similar melting points due to their long, straight structure, while unsaturated fats (such as oleic and linoleic acid) have lower melting points as a result of their curved structure (p. 8, paragraph 2).
One of ordinary skill in the art would have adjusted the weight ratio of stearic acid to palmitic acid during routine optimization by replacing some of the palmitic acid with stearic acid to find the meat analogue with the best effect on the total cholesterol:HDL- cholesterol ratio while maintaining the total saturated fat content in the fat to ensure desired crystallization properties. MPEP §2144.05(II) states 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). The claimed weight ratio of stearic acid (C18) to palmitic acid (C16), 1.0:1.0 to 10.0:1.0, would thus be obvious.
Verkuijl does not teach the non-hydrogenated vegetable fat has a SUS/SSU mole ratio in a range of from 0.5:1.0 to 1.0:1.0.
Adlof synthesizes and compares SUS and SSU triglycerides. Adlof teaches SUS and SSU triglycerides have different melting points (Table 1).
While Verkuijl does not teach the non-hydrogenated vegetable fat has an SUS/SSU mole ratio in a range of from 0.5:1.0 to 1.0:1.0, one of ordinary skill in the art would have adjusted the SUS/SSU mole ratio during routine optimization to find the non-hydrogenated vegetable fat that results in the meat analogue (i.e., meat substitute product) with the desired melting point. MPEP §2144.05(II) states 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). The claimed SUS/SSU mole ratio, 0.5:1.0 to 1.0:1.0, would thus be obvious.
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Verkuijl et al. (WO 2021098966 A1 – IDS Filed on May 24, 2023) in view of Talbot (Saturated fats in foods and strategies for their replacement: an introduction In: Reducing Saturated Fats in Foods. Woodhead Publishing Limited. Pp. 3 – 28. (2011)), and applied to claim 1 above, and further in view of Lu (CN 112741332 – WIPO Machine Translation).
Verkuijl teaches binding agents provide a bound structure and enable the other components to form a cohesive mass, in particular the binding agent help to include fat, water and proteins into the product (p. 3, paragraph 2). Verkuijl teaches the meat analogue product may be brought in a desired form, such as a burger, a ball, a sausage or a skewer (p. 5, paragraph 2).
Verkuijl does not explicitly state the meat analogue (i.e., meat substitute product) is emulsified.
Lu teaches a vegetable protein steamed bean curd roll product comprising emulsified soy protein, vegetable oil, and ice water (p. 1, steps 1 – 6). Lu teaches by forming an emulsified “chicken” plant protein product with plant protein, vegetable fat, and water, the emulsion pulp can increase the fat sensation of the “chicken” meat, so that the taste of the meat is more concentrated, and at the same time, the resulting “chicken” meat is more elastic, the chewiness of the “chicken” meat is improved (p. 1, paragraph 8).
Verkuijl and Lu are combinable because they are concerned with the same field of endeavor, namely, meat analogues. It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to have formed the meat analogue product (i.e., meat substitute product) of Verkuijl into an emulsified “chicken” meat, as taught by Lu, because the emulsion pulp can increase the fat sensation of the “chicken” meat, so that the taste of the meat is more concentrated, and at the same time, the resulting “chicken” meat is more elastic, the chewiness of the “chicken” meat is improved.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 1 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 2, of copending Application No. 18/254,304 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because application claim 1 is obvious over copending application claims 1 and 2.
Claim 1 of copending Application No. 18/254,304 teaches a meat substitute product comprising a randomly interesterified triglyceride, and at least one texturized protein ingredient, wherein the randomly interesterified triglyceride has a content of palmitic acid (C16) and stearic acid (C18) in a range of from 35 to 65 wt%, and a ratio of C18 over C16 in a range of from 1.0 to 15.0. Claim 2 of copending Application No. 18/254,304 teaches the meat substitute product according to claim 1, wherein the randomly interesterified triglyceride has a content of lauric acid (C12) of less than 5.0 wt%.
The range of ratio of C18 over C16, 1.0 to 15.0, as disclosed by copending Application No. 18/254,304, overlaps with the claimed range of 1.0 to 10.0. MPEP § 2114.05 teaches that it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have selected the overlapping portion of the ranges disclosed by the reference because selection of overlapping portion of ranges has been held to be a prima facie case of obviousness.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant's arguments filed December 10, 2025 have been fully considered but they are not persuasive.
Applicant argues the broadest reasonable interpretation of “randomly interesterified triglyceride” should be as defined in the specification, “a triglyceride composition in which fatty acids are randomly distributed over the glycerol backbone as a result of interesterification” (p. 5, paragraph 4).
Applicant’s argument has been carefully considered however the argument is not persuasive. Contrary to Applicant’s assertion, no such definition is provided in the specification. That is, while paragraphs [0019] – [0026] provide context to the meaning of “randomly interesterified triglyceride”, there is no explicit definition of the term. Given the interesterification may not be fully random ([0020]); any triglyceride composition comprising a lauric acid (C12) content of less than 5.0 wt%, a content of palmitic acid (C16) and stearic acid (C18) content in a range of from 35 wt% to 65 wt%, and a ratio of C18 content to C16 content in a range of from 1.0 to 10.0 (as recited in [0026]; and Claim 1) is considered to be encompassed by “randomly interesterified triglyceride”.
Applicant argues the specification expressly defines “liquid oil” as triglycerides with a melting point of less than 20 °C, including blends whose melting point is below 20 °C (p. 5, paragraph 5; p. 6, paragraph 1).
Applicant’s argument has been carefully considered and is persuasive. Therefore, the interpretation of “liquid oil” has been adjusted to be triglycerides with a melting point of less than 20 °C, including blends whose melting point is below 20 °C.
Applicant argues the broadest reasonable interpretation of “protein ingredient” should include components which contain both protein and non-protein matter (p. 6, paragraph 2).
Applicant’s argument has been carefully considered and is persuasive. Therefore, the interpretation of “protein ingredient” has been expanded to include components which contain both protein and non-protein matter.
Applicant argues the broadest reasonable interpretation of “animal protein ingredient” should include components which contain both animal protein and non-protein matter (p. 6, paragraph 2).
Applicant’s argument has been carefully considered and is persuasive. Therefore, the interpretation of “animal protein ingredient” has been expanded to include components which contain both protein and non-protein matter.
Applicant argues there is no need to alter the numerical range or convert it to colon notation with respect to the objection of claim 3 (p. 7, paragraph 1).
Applicant’s argument has been carefully considered however the argument is not persuasive. While the meaning of the claim may be ascertained by the abbreviated notation, colon notation removes ambiguity from ratio range interpretation.
Applicant argues altering the “comprising” of previously presented claim 17 to “consists of” would improperly exclude embodiments where the at least one protein ingredient includes both animal and non-animal protein ingredients (p. 7, paragraph 4).
Applicant’s argument has been carefully considered and is persuasive. Therefore, the objection to claim 17 is withdrawn.
Applicant argues the Office’s rationale is conclusory with respect to the Talbot reference (p. 8 – 10).
Applicant’s argument has been carefully considered however the argument is not persuasive. The Office agrees the statement that “the higher the ratio, the better for one’s health” is conclusory. The statement “the higher the ratio, the better for one’s health” was an incorrect choice of words. The Office apologizes for the incorrect choice of words when summarizing the teachings of Talbot. However, it should be recognized that the Talbot reference is still considered to provide a basis for an obviousness rejection (see Fig 1.10 below showing the effect of stearic and palmitic acid on total:HDL cholesterol ratio). The grounds of rejection has not shifted.
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Applicant argues the frankfurter of Ozvural is not a meat substitute product because it comprises meat (p. 11, paragraph 3).
Applicant’s argument has been carefully considered however the argument is not persuasive. The instant specification defines meat substitute products as food or feed compositions that mimic animal processed whole-muscle meat products as well as processed restructured meat products such as burgers, patties, sausages and the like ([0010]). The definition does not exclude sausages comprising animal meat and animal fat.
Applicant argues the record does not recognize the claims C18:0/C16:0 ratio as a result effective variable (p. 13, paragraph 4; p. 14, paragraph 1).
Applicant’s argument has been carefully considered however the argument is not persuasive. Talbot shows the C18:0/C16:0 ratio is a result effective variable, as shown in paragraph 23 above.
Conclusion
No claims are allowed.
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.
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/L.J.M./Examiner, Art Unit 1793
/EMILY M LE/Supervisory Patent Examiner, Art Unit 1793