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 . Claims 10, 12-20, 23, 25 and 31-33 are examined herein.
Background: On the Election
In the reply filed on 9/05/2023, Applicant’s election of Group II, claims 10-23, 25 and 31-32 was is acknowledged.
Applicant’s election of Species, in a phone call with Mr. David Postolski on 9/26/2023, was based on the election of Example 4, including:
A.3 milk that is plant based and mimics animal milk, including:
casein, including: beta casein, kappa casein; and
whey, including: beta- lactoglobulin;
B.2 wherein added recombinant proteins were made in yeast;
D.3 wherein an animal free milk product is produced; and
F.1 type of milk made mimics cow milk in that it comprises the type of proteins in A3, that were made to mimic similar types of proteins found in bovine milk.
Elected Species C2 and E2 are not claimed in the Group elected, therefore said species are withdrawn
In the response, of 1/16/2024, Applicant affirmed said species election, and the restriction was deemed proper and made final.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 1 and all claims dependent on it, are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement.
The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 10 requires: A plant-based substitute milk composition comprising:
65 to 85 wt.% of a plant-based milk extract selected from the group consisting of: oat milk, soy milk, almond milk, and mixtures thereof, based on the total amount of the plant-based substitute milk composition;
up to 7 wt.% of one or more recombinant casein proteins other than a beta casein protein produced by a yeast expression system, based on the total amount of the plant-based substitute milk composition, wherein the one or more recombinant casein proteins include a casein encoded by a nucleotide sequence at least 90% identical to SEQ ID NO: 13;
up to 7 wt% of one or more recombinant whey proteins produced by a yeast expression system, based on the total amount of the plant-based substitute milk composition;
1 to 5 wt% of one or more recombinant royal jelly (RJ) proteins produced by a yeast expression system, based on the total amount of the plant-based substitute milk composition, wherein the one or more recombinant RJ proteins include Major Royal Jelly Protein 1 (MRJP1) encoded by a nucleotide sequence at least 90% identical to SEQ ID NO: 1;
0.001 to 0.03 wt% of one or more vitamins selected from the group consisting of vitamin D2 and vitamin B12, based on the total amount of the plant-based substitute milk composition;
0.05 to 0.5 wt% of one or more plant-derived salts selected from the group consisting of calcium citrate and potassium chloride, based on the total amount of the plant-based substitute milk composition;
0.5 to 2 wt% of one or more plant-derived fats and/or oils selected from the group consisting of: sunflower oil and coconut oil, based on the total amount of the plant-based substitute milk composition;
0.01 to 0.3 of one or more plant-derived flavoring agents selected from the group consisting of vanillin and almond extract, based on the total amount of the plant-based substitute milk composition;
1 to 3 wt.% of one or more plant-derived sugar and/or sweeteners selected from the group consisting of sucrose and fructose, based on the total amount of the plant-based substitute milk composition;
at least 2 g per 100 mL of a total protein content of; and
an antioxidant activity of at least 10% greater than the plant-based milk extract alone, as measured by a DPPH radical scavenging assay;
wherein the plant-based substitute milk composition is free of animal-derived ingredients.
However, when looking toward the pending Specification, the only discussion on amounts of ingredients in plant-based milk compositions, comprising an amount of plant-based milk or extract, is in Example 4, wherein the compositions therein, comprise:
plant-based milk or extract in an amount of about zero to 98 wt%, wherein the amount of water therein is about zero to 95 wt%;
MRJPs range from about zero to 50 wt%;
casein proteins range from about zero to 50 wt%; and
whey proteins range from about zero to 50 wt%
wherein these amounts are based on the total volume of a hybrid milk.
1. Pending Example 4 does not disclose that said compositions further comprise:
0.001 to 0.03 wt% of one or more vitamins selected from the group consisting of vitamin D2 and vitamin B12, based on the total amount of the plant-based substitute milk composition;
0.05 to 0.5 wt% of one or more plant-derived salts selected from the group consisting of calcium citrate and potassium chloride, based on the total amount of the plant-based substitute milk composition;
0.5 to 2 wt% of one or more plant-derived fats and/or oils selected from the group consisting of: sunflower oil and coconut oil, based on the total amount of the plant-based substitute milk composition;
0.01 to 0.3 of one or more plant-derived flavoring agents selected from the group consisting of vanillin and almond extract, based on the total amount of the plant-based substitute milk composition;
1 to 3 wt.% of one or more plant-derived sugar and/or sweeteners selected from the group consisting of sucrose and fructose, based on the total amount of the plant-based substitute milk composition;
at least 2 g per 100 mL of a total protein content; and
an antioxidant activity of at least 10% greater than the plant-based milk extract alone, as measured by a DPPH radical scavenging assay;
wherein the plant-based substitute milk composition is free of animal-derived ingredients.
Therefore, one of skill in the art of making plant-based milk would not understand that the inventor, at the time the application was filed, had possession of the claimed composition.
2. Further, in Example 4, it is noted that the plant-based milk or extracts range from zero to 98 wt%, which is toward all plant-based extracts, including: plant-derived salts; plant-derived fats and/or oils; plant-derived flavorings; and plant-derived sugar and/or sweeteners.
Therefore, one of skill in the art of making plant-based milk would not understand that the inventor, at the time the application was filed, had possession of the claimed composition, comprising: plant-based milk or extracts range from zero to 98 wt%; and
0.05 to 0.5 wt% of one or more plant-derived salts selected from the group consisting of calcium citrate and potassium chloride, based on the total amount of the plant-based substitute milk composition;
0.5 to 2 wt% of one or more plant-derived fats and/or oils selected from the group consisting of: sunflower oil and coconut oil, based on the total amount of the plant-based substitute milk composition;
0.01 to 0.3 of one or more plant-derived flavoring agents selected from the group consisting of vanillin and almond extract, based on the total amount of the plant-based substitute milk composition; and
1 to 3 wt.% of one or more plant-derived sugar and/or sweeteners selected from the group consisting of sucrose and fructose, based on the total amount of the plant-based substitute milk composition.
3. Also, Example 4 makes clear, that the amounts of ingredients discussed are
based on the total volume of a hybrid milk.
Therefore, one of skill in the art would not understand that the inventor, at the time the application was filed, had possession of the claimed plant-based milk substitute composition, because the only disclosure showing an amount of plant-based milk or extracts range from zero to 98 wt% is toward a hybrid milk.
4. Then there is the matter of the unit used for the ingredients listed: Example 4 is clear, that the amounts of ingredients are based on the wt% per total volume of a hybrid milk.
Therefore, one of skill in the art would not understand that the inventor, at the time the application was filed, had possession of the claimed plant-based milk substitute composition, comprising ingredient amounts based on wt% of a total composition.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 10 and all claims dependent on it, 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.
Claim 10 is toward: A plant-based substitute milk composition (see preamble), wherein “a total composition” is also claimed and thereafter “the total composition” is claimed multiple times. It is unclear as to what “a total composition”/“the total composition” is referring to: the plant-based substitute milk composition or something else. Under 35 U.S.C. § 112(b), Appellant’s claims must particularly point out and distinctly claim the subject matter the applicant regards as the invention. The statutory language of particularity and distinctness indicates that claims must be cast in clear and not vague or ambiguous, terms. If, instead, “a claim is amenable to two or more plausible claim constructions, the USPTO is justified in requiring the applicant to more precisely define the metes and bounds of the claimed invention by holding the claim unpatentable under 35 U.S.C. § 112, second paragraph, as indefinite.” Ex parte Miyazaki, 89 USPQ2d 1207, 1211 (BPAI 2008) (precedential).
Claim 10 recites plant-based milk extract selected from the group consisting of oat milk, soy milk, almond milk, and mixtures thereof, which comprises 65 to 85 wt% of a total composition and also claims a variety of other plant-based ingredients, which is unclear if they are part of the plant-based milk extract, or in addition to those types of ingredients commonly known to be part of plant-based milk extract selected from the group consisting of oat milk, soy milk, almond milk, and mixtures thereof.
Claim 10 requires several limitations towards amounts of individual types of proteins, including: MRJPs range from about zero to 50 wt%; casein proteins range from about zero to 50 wt%; and whey proteins range from about zero to 50 wt%, which presents a combined upper range of total protein of 150 wt%; then requires a range of total protein at least 2 g per 100 mL of a total protein content of, which presents a lower limit of about 2 wt% of total protein, which imparts a broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation in the same claim. This is considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c).
Claim Interpretation
With regard to the prior art, the phrase: “a total composition” and “the total composition”, encompasses: the plant-based substitute milk composition and/or based on the total amount of the plant-based substitute milk composition.
With regard to the prior art, claim 10, encompasses:
A plant-based substitute milk composition comprising:
65 to 85 wt.% of a plant-based milk extract selected from the group consisting of: oat milk, soy milk, almond milk, and mixtures thereof, based on the total amount of the plant-based substitute milk composition;
up to 7 wt.% of one or more recombinant casein proteins other than a beta casein protein produced by a yeast expression system, based on the total amount of the plant-based substitute milk composition, wherein the one or more recombinant casein proteins include a casein encoded by a nucleotide sequence at least 90% identical to SEQ ID NO: 13;
up to 7 wt% of one or more recombinant whey proteins produced by a yeast expression system, based on the total amount of the plant-based substitute milk composition;
1 to 5 wt% of one or more recombinant royal jelly (RJ) proteins produced by a yeast expression system, based on the total amount of the plant-based substitute milk composition, wherein the one or more recombinant RJ proteins include Major Royal Jelly Protein 1 (MRJP1) encoded by a nucleotide sequence at least 90% identical to SEQ ID NO: 1;
0.001 to 0.03 wt% of one or more vitamins selected from the group consisting of vitamin D2 and vitamin B12, based on the total amount of the plant-based substitute milk composition;
a total protein content; and
an antioxidant activity of at least 10% greater than the plant-based milk extract alone, as measured by a DPPH radical scavenging assay;
wherein the plant-based substitute milk composition is free of animal-derived ingredients.
Claim Rejections - 35 USC § 103
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 ordiPark teaches
nary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 10, 12-20, 22-23, 25 and 31-33 are rejected under 35 U.S.C. 103 as being unpatentable over MNT in view of the combination of Schott, Pandya (2017/0273328), Zemel, Collazo, Johnson, Liu and Lin, as evidenced by GenBank: NM 181029.2, GenBank: AF388203.1, and Mikołajczak.
MNT: Medical News Today: Almond, hemp, oat, soy and cow’s milk: which is best?; written by Jessica Caporuscio; published online at least by May 08, 2020 at: https://web.archive.org/web/20200508020851/https://www.medicalnewstoday.com/articles/325425
Schott: published as: EP 0230513 A2, on: Aug 05, 1987.
Zemel: published as: EP 0195167 A2, on Sep. 24, 1986.
Collazo: Health Promoting Properties of Bee Royal Jelly: Food of the Queens; copyright 2021.
Johnson: published as: EP 2874642 B1, on June 02, 2019.
Liu: published as: CN 1130042 A, on Sep. 04, 1996.
Lin: Quantification of Major Royal Jelly Protein 1 in Fresh Royal Jelly by Ultraperformance Liquid Chromatography-Tandem Mass Spectrometry; J Agric Food Chem. 2018 Feb 7;66(5):1270-1278.
GenBank: NM 181029.2; printed from: https://www.ncbi.nlm.nih.gov/nuccore/NM_181029.2/ on 8/19/2025.
GenBank: AF388203.1.; printed from: https://www.ncbi.nlm.nih.gov/nuccore/AF388203.1 on 8/19/2025.
Mikołajczak: Phenolic compounds in plant oils: A review of composition, analytical methods, and effect on oxidative stability; Trends in Food Science & Technology 113 (2021) 110–138.
Independent claim 10
A plant-based substitute milk composition, free of animal derived ingredients
MNT teaches about plant-based milk beverages, including: almond, soy and oats, as claimed (see the short article), therefore the composition is a plant-based milk beverage, as claimed. MNT teaches these products are alternatives to cow’s milk, therefore provides the beverages are substitute milk compositions, as claimed.
On beverages that are free of animal-derived ingredients: MNT does not provide the use of animal-derived ingredients in said beverages, therefore provides beverages that are free of animal-derived ingredients, as claimed.
Plant based milk extract
MNT does not discuss the amount of the plant-based milk extracts in the beverages, as claimed.
Schott also teaches methods of making plant-based beverages wherein no animal derived ingredients are discussed, and further provides that the carrier of said beverage comprises 50 to 90 wt% of soy extracts (ref. clm. 1)
Therefore, Schott encompasses the use of 65 to 85 wt.% of a plant-based milk extract based on the total amount of the plant-based substitute milk composition, as claimed.
It would have been obvious to one of skill in the art, at the time of filing to modify plant-bases beverages comprising plant-based extracts, as MNT, to include ----------------------------the use of 65 to 85 wt.% of a plant-based milk extract, as claimed, because Schott shows that it was known to use encompassing amounts of plant-based extracts in plant-based beverages, which imparts that it was known for such a thing to have been successfully achieved and published at the time of filing, which means it was within the general skill of a worker in the art to select this, because it would be obvious to one of skill in the art to do such a thing on the basis of its suitability for a similar intended use. See MPEP 2144.07 that discussed that when the prior art recognizes something is suitable for a similar intended use/purpose, such a thing is obvious.
Vitamins
MNT discusses that the plant based milks comprise vitamins (see the Table in the Nutritional values section), however, does not discuss the amounts of vitamins in the plant-based milks, as claimed.
Pandya also teaches about non-dairy plant based milk beverage products (0005-0006) used as dairy milk substitutes (0006), comprising: multiple plant-based extracts (0036, 0064, 0067 and 0234); and further provides said compositions comprise about 0.15 to 1.5 wt% of ash (0159), wherein the ash comprises one or more, including up to 20 different micronutrients, including vitamin B12 (0036, 0154), which encompasses 0.001 to 0.03 wt% of vitamin B12, based on the total amount of the plant-based substitute milk composition, as claimed.
It would have been obvious to one of skill in the art, at the time of filing to modify plant-bases beverages comprising vitamins, as MNT, to include ----------------------------the use of 0.001 to 0.03 wt% of vitamin B12, based on the total amount of the plant-based substitute milk composition; as claimed, because Pandya shows that it was known to use a mixture of vitamins which encompasses the claimed fraction of B12 in plant-based beverages, which imparts that it was known for such a thing to have been successfully achieved and published at the time of filing, which means it was within the general skill of a worker in the art to select this, because it would be obvious to one of skill in the art to do such a thing on the basis of its suitability for a similar intended use. See MPEP 2144.07 that discussed that when the prior art recognizes something is suitable for a similar intended use/purpose, such a thing is obvious.
Calcium citrate or potassium chloride
The modified teaching, in Pandya, provides the use of one or more salts, including: CaCl (0334); and calcium, citrate, potassium and chloride (0154); which imparts the use of: calcium citrate and potassium chloride, as claimed.
The modified teaching does not discuss the amount, 0.05 to 0.5 wt% of calcium citrate and/or potassium chloride, based on the total amount of the plant-based substitute milk composition, as claimed.
Zemel also teaches about plant-based beverages fortified with calcium (ti.) and further provides the use of about 0.2 to 0.75 grams (about 0.2 to 0.75 ml) of calcium citrate per 100 ml of the beverage (5th para. on pg. 3), which encompasses 0.05 to 0.5 wt% of calcium citrate, based on the total amount of the plant-based milk composition, as claimed.
It would have been obvious to one of skill in the art, at the time of filing to modify plant-bases beverages comprising calcium, as the modified teaching above, to include ----------------------------the use of 0.05 to 0.5 wt% of calcium citrate, based on the total amount of the plant-based milk composition, as claimed, because Zemel shows that it was known to use encompassing amounts of calcium citrate in plant based beverages, which imparts that it was known for such a thing to have been successfully achieved and published at the time of filing, which means it was within the general skill of a worker in the art to select this, because it would be obvious to one of skill in the art to do such a thing on the basis of its suitability for a similar intended use. See MPEP 2144.07 that discussed that when the prior art recognizes something is suitable for a similar intended use/purpose, such a thing is obvious.
The modified teaching does not discuss that the calcium citrate is plant based, however, in this case the teaching of the use of the use of calcium citrate encompasses such a thing, because in this specific case the various permutations of types of it in the generic are so small (plant based or not plant based) that the teaching is as comprehensive and fully as if it had written the name of each permutation.
Therefore, absent a showing of criticality, with evidence, it would have been obvious to one of skill in the art, at the time of filing/the invention to modify the method of using calcium citrate, as the modified teaching above, to include it is plant based, as claimed, because in this specific case the various permutations of types in the generic are so small (plant based or not) that the teaching is as comprehensive and fully as if it had written the name of each permutation.
Plant-derived fats and/or oils
MNT provides that 240 milliliters (i.e. about 240 grams) of plant milk beverages have from about 2.5 to 11 grams of total fat (i.e. about 1 to 4.5 wt% of total fat) (see the Table in the Nutritional values section), which encompasses 0.5 to 2 wt% of one or more plant-derived fats/oils, based on the total amount of the plant-based substitute milk composition, as claimed.
Further, the modified teaching, in Pandya, provides that the fats/oils in plant-based beverages include: sunflower oil and coconut oil (0013), as claimed.
Plant-derived flavoring agents
The modified teaching, in Pandya, provides from about 0.01 to 6 wt% of flavoring agents (0008), including vanilla and almond flavors (0153), which encompasses the claimed amount of 0.01 to 0.3 of one or more flavoring agents, including vanillin and almond extracts, as claimed.
Pandya also provides the use of about 0 to 4.5 wt% lipids (0012), including: almond oil (0149), a known plant derived flavoring extract, which encompasses the use of a plant-derived flavoring agent selected from almond extract, as claimed.
It would have been obvious to one of skill in the art, at the time of filing to modify plant-based beverages comprising almond oil, as the modified teaching above, to included that the almond oil is a known plant based flavoring, as claimed, because one in the art of using almond oil would have the common knowledge that it is known to be used as a flavoring agent.
Plant-derived sweeteners
The modified teaching, in Pandya, provides the use of about 0.1 to 6 wt% of one or more sweeteners (0010), including sucrose and fructose (0036), which encompasses 1 to 3 wt% based on the total amount of the plant-based substitute milk composition, as claimed.
Recombinant casein protein
On casein proteins (0035): Pandya teaches the recombinant proteins include 2.5 to less than 10 wt/v% of casein proteins (0035), including: beta or casein kappa caseins (0008), which encompasses: up to 7 wt.% of one or more recombinant casein proteins other than a beta casein protein produced by a yeast expression system, based on the total amount of the plant-based substitute milk composition.
On the one or more recombinant casein proteins include a casein encoded by a nucleotide sequence at least 90% identical to SEQ ID NO: 13: When looking for light in the pending Specification, it is noted that SEQ ID NO: 13, is a casein alpha-S1 (CSN1S1), that includes: e Bos taurus (cow, cattle, bovine): GenBank: NM 181029.2 (gene sequence: 645 bp).
When entering the accession number "NM_181029.2" in the search bar of the NCBI Nucleotide database, the search results provide a record for this sequence, including the gen name: Bos taurus casein alpha s1 (CSN1S1), mRNA, and its synonyms, include: CSN1S1, alpha-S1-casein, and casein alpha-S1.
The modified teaching, in Pandya, provides the use of alpha-s1 casein protein including recombinant types (0035), wherein only some are formed from yeasts, which therefore provides an option of using types other than those produced by a yeast expression, therefore makes obvious the use of the specifically claimed one or more recombinant casein proteins include a casein encoded by a nucleotide sequence at least 90% identical to SEQ ID NO: 13.
Further, the modified teaching, in Pandya, provides that said isolated protein, are at least greater than 99% pure (0051).
It would have been obvious to one of skill in the art, at the time of filing to modify the method of using alpha-s1 casein protein including recombinant types, wherein some are formed from yeasts, as an ingredient in plant-based beverages, as the modified teaching above, to include:
alpha-s1 casein recombinant protein is also known as a casein alpha-S1 (CSN1S1), that includes: SEQ ID NO: 13, e Bos taurus (cow, cattle, bovine): GenBank: NM _181029.2 (gene sequence: 645 bp), as claimed; and
wherein the alpha-s1 casein recombinant protein is a type other than those produced by a yeast expression, include a casein encoded by a nucleotide sequence at least 90% identical to SEQ ID NO: 13, as also claimed,
because the NCBI Nucleotide database provides evidence that the gen name: Bos taurus casein alpha s1 (CSN1S1), mRNA, has synonyms, including: CSN1S1, alpha-S1-casein, and casein alpha-S1; and
in Pandya, provides the use of alpha-s1 casein protein including recombinant types (0035), wherein only some protein types are formed from yeasts, which shows
that it was known for casein protein known as SEQ ID NO: 13, e Bos taurus (cow, cattle, bovine): GenBank: NM _181029.2 (gene sequence: 645 bp), wherein said isolated proteins are at least greater than 99% pure, including: recombinant protein types other than those produced by a yeast expression, therefore provides that it was known to have successfully achieved and published the use of the claimed type of proteins at the time of filing used when making plant-based milks, which means it was within the general skill of a worker in the art to select such a thing, because it would be obvious to one of skill in the art to do such a thing on the basis of its suitability for a similar intended use. See MPEP 2144.07 that discussed that when the prior art recognizes something is suitable for a similar intended use/purpose, such a thing is obvious.
Recombinant whey protein
The modified teaching, in Pandya, provides the recombinant proteins include at least 0.1 wt/v% of whey proteins, including: beta-lactoglobulin, including types synthesized in eukaryotic microbes with yeast (0035), which encompasses up to 7 wt% of one or more recombinant whey proteins produced by a yeast expression system, based on the total amount of the plant-based substitute milk composition, as claimed.
Recombinant royal jelly (RJ) protein
The modified teaching, in Pandya, provides the use of plant-based sweeteners, including types from bees (i.e. honey, comprising MRJP1) (0234), however, does not discuss the use of one or more recombinant royal jelly proteins, including: MRJP1.
Collazo also teaches about supplemented functional foods (ab.) including types from bees and further provides that MRJP 1 provides health benefits, including: nematicidal activity, antitumor effect, hypocholesterolemic effect, and anti-hypertensive activity (Table 1).
Rationale: The prior art, in Collazo, provides there are many health benefits from using MRJP 1 in supplemented foods, therefore provides an advantage, a convincing line of reasoning to suggested motivation, for using RJ proteins. See MPEP 2144.II that states: The strongest rationale for combining references is a recognition, expressly or impliedly in the prior art or drawn from a convincing line of reasoning based on established scientific principles or legal precedent, that some advantage or expected beneficial result would have been produced by their combination.
Further, the prior art, in Collazo imparts a secondary reasoning for obviousness because it shows that it was known for MRJP 1 to have used when making supplemented foods, which means this was successfully achieved and published at the time of filing, therefore it was within the general skill of a worker in the art to select the claimed MRJP 1, which means it would be obvious to one of skill in the art to do such a thing on the basis of its suitability for a similar intended use. See MPEP 2144.07 that discussed that when the prior art recognizes something is suitable for a similar intended use/purpose, such a thing is obvious.
Therefore, it would have been obvious to one of skill in the art, at the time of filing/the invention to modify the method of making nutritional compositions, comprising: water, carbohydrates, lipids, vitamins, mineral, flavoring agents, and coloring agents, as the modified teaching above, to include the use of MRJP 1, because Collazo teaches there are many health benefits from their consumption, therefore provides an advantage, a convincing line of reasoning to suggested motivation (see MPEP 2144.II); and further provides that it was known for such a thing to have been successfully achieved and published at the time of filing, which means it was within the general skill of a worker in the art to select the claimed component for use in beverages, on the basis of its suitability for a similar intended use (see MPEP 2144.07).
On the royal jelly proteins being derived from yeast: As for the what the recombinant royal jelly proteins are derived from, a yeast expression system, this is a product by process limitation, wherein the determination of patentability is based solely on the claimed product itself. The patentability of a product does not depend on its method of production. In this case, since the product in the product-by-process claim, recombinant royal jelly proteins, are the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process. See In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985).
Therefore, it would have been obvious to one of skill in the art, at the time of filing to modify the method of using MRJP 1 in supplemented foods, as the modified teaching above, to include types derived from, a yeast expression system, as claimed, absent a showing of criticality, with evidence, of the MRJP 1 derived from, a yeast expression system possessing markedly different characteristics from their naturally occurring counterparts, ------------because the teaching above provides the same component, therefore shows that it was known for such a thing to have been successfully achieved and published at the time of filing, which means it was within the general skill of a worker in the art to select it for use in supplemented foods, because it would be obvious to one of skill in the art to do such a thing on the basis of its suitability for a similar intended use. See MPEP 2144.07 that discussed that when the prior art recognizes something is suitable for a similar intended use/purpose, such a thing is obvious.
On the MJRP1 being a recombinant type: The modified teaching does not discuss that the MJRP1 is derived (i.e. recombinant).
Johnson provides that it was known to use recombinant (0072) MJRPs (0072), including MRJP1 (0025), including SEQ ID 1: Major Royal Jelly Protein 1 (0035) in foods (0073).
It would have been obvious to one of skill in the art, at the time of filing to modify foods comprising MJRP1, as the modified teaching above, to include that the MJRP! Is a recombinant type, as------------ required of the claim, because Johnson shows that it was known for to use recombinant MRJP1 for use in foods, which shows that such a thing was successfully achieved and published at the time of filing, which means it was within the general skill of a worker in the art to do such a thing because it would be obvious to one of skill in the art to do such a thing on the basis of its suitability for a similar intended use. See MPEP 2144.07 that discussed that when the prior art recognizes something is suitable for a similar intended use/purpose, such a thing is obvious.
On the MRJP1 being the type encoded by a nucleotide sequence at least 90% identical to SEQ ID NO: 1; When looking for light in the pending Specification, it is noted that SEQ ID NO: 1, is a MRJP1: GenBank: AF388203.1 (gene sequence: 1299 bp). When entering the accession number " AF388203.1" in the search bar of the NCBI Nucleotide database, the search results provide a record for this sequence, including the gen name: Apis mellifera major royal jelly protein MRJP1 (mrjp1) gene, wherein its synonyms, include: MRJP1 and major royal jelly protein MRJP1.
The modified teaching, in Collazo, provides the use of the major royal jelly protein MRJP1; and in Johnson, provides that the MRJP1 used in foods has a sequence identification, of SEQ ID 1: Major Royal Jelly Protein 1, which imparts the claim of the MRJP1 being encoded by a nucleotide sequence at least 90% identical to SEQ ID NO: 1, as claimed.
On the amount of MRJP1: The modified teaching does not discuss the amount of the MRJP1 in the food/beverage.
Liu also teaches about foods/beverage comprising MRJP1, and further provides the use of 15 to 25 wt% of fresh royal jelly (3rd line from the bottom of pg. 2).
Lin shows that fresh royal jelly has 41.96 to 55.01 mg/g (about 4.2 to 5.5 wt%) of MRJP1 (ab.).
Therefore the 15 to 25 wt% of fresh royal jelly in Liu, provides about 0.6 to 1.4 wt% of MRJP1, in view of Lin, which encompasses the use of 1 to 5 wt % of MRJP1, based on the total amount of the food/beverage composition, as claimed.
It would have been obvious to one of skill in the art, at the time of filing to modify the method of using MRJP1 in food/beverage compositions, as the modified teaching above, to include the amount therein, including 1 to 5 wt%---------------------, as claimed, because the combination of Liu and Lin shows that it was known for such a thing to have been successfully achieved and published at the time of filing, which means it was within the general skill of a worker in the art to select the claimed amount of MRJP1 for use in food/beverages, as claimed, because it would be obvious to one of skill in the art to do such a thing on the basis of its suitability for a similar intended use. See MPEP 2144.07 that discussed that when the prior art recognizes something is suitable for a similar intended use/purpose, such a thing is obvious.
Protein content
MNT shows (in the Nutritional values table) that 240 ml (i.e. about 240 g) of plant-based milk beverages have from about 1 to 9 wt% of protein, which encompasses at least 2 g per 100 mL (i.e. at least about 2 wt%) of a total protein content, as claimed.
Further, the modified teaching, in Pandya, provides an example of 3.3 % of one or more isolated milk proteins (0042), including: recombinant casein protein in an amount of at least or equal to 2.5% (w/v) and less 10% (w/v) and recombinant whey protein is an amount of at least 0.1 % (w/v) and less than or equal to 1 % (0035), which encompasses at least about 2 wt%) of a total protein content, as claimed.
Function of the composition
Since the modified teaching provides a similar composition comprising similar amounts of similar ingredients, which reflects the breadth of the claimed composition, it would be reasonable to expect that it will have an antioxidant activity of at least 10% greater than the plant-based milk extract alone, when measured by a DPPH radical scavenging assay, absent a showing of criticality, because the teaching of a similar composition imparts a suggestion in or expectation that the composition taught will have the same or a similar utility.
Therefore, it would have been obvious to one of skill in the art, at the time of filing/the invention to modify the method of making food compositions, as the modifed teaching above, to include that said composition will function to have an antioxidant activity of at least 10% greater than the plant-based milk extract alone, when measured by a DPPH radical scavenging assay, as claimed, because the composition established through the teachings above provides a sufficiently close relationship between the ingredients to create an expectation that such a similar compositions would have similar capabilities, properties or functionality because the claims are not physically or structurally distinguishable over the prior art compositions. See MPEP 2144. III, which states that when case law imparts legal precedence, wherein the facts in this prior legal decision are sufficiently similar to those in an application, wherein the court applied the law of obviousness to similar facts. This includes a wide spectrum of illustrations and accompanying reasoning (i.e. obviousness) that exist in case law. In re Eli Lilly & Co., 902 F.2d 943, 14 USPQ2d 1741 (Fed. Cir. 1990). Herein, although not cited in the MPEP, more recent caselaw on the topic, “In re Dillon, 919 F.2d 688 (1990)” ( (https://cite.case.law/f2d/919/688/)) provides that when a claimed compositions has been made obvious from combined teachings, it is clear that the discovery that the claimed composition possesses a property not disclosed for the prior art subject matter, and this itself does not defeat a prima facie case.
In summary, all of the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded predictable results to one of ordinary skill in the art at the time of the invention. The prior art included each element claimed although not necessarily in a single reference, and one of ordinary skill in the art could have combined the elements as claimed by the known use of the claimed known ingredients in edible compositions, and in combination, each element merely would have performed the same function as it did separately, and one of ordinary skill in the art would have recognized that the results of the combination were predictable. Further, a predictable use of prior art elements according to their established functions to achieve a predictable result is prima facie obvious. See KSR Int'l Inc. v. Teleflex Inc., 127 S Ct. 1727, 1741, 82 USPQ2d 1385, 1396 (2007).
Further, attention is invited to In re Levin, 84 USPQ 232, although not discussed in the MPEP, this case and the cases cited therein, which are considered in point in fact situation of this specific instant case.
At page 234, the Court stated as follows: This court has taken the position that new recipes or formulas for food which involve the addition or elimination of common ingredients, or for treating them in ways which differ from the former practice, do not amount to invention, merely because it is not disclosed that, in the constantly developing art of preparing food, no one else ever did the particular thing upon which the applicant asserts his right to a patent. In all such cases, there is nothing patentable unless the applicant by a proper showing further establishes a coaction or cooperative relationship between the selected ingredients which produces a new, unexpected and useful function. In re Benjamin D. White, 17 C.C.P.A. (Patents) 956, 39 F.2d 974, 5 USPQ 267; In re Mason et al., 33 C.C.P.A. (Patents) 1144, 156 F.2d 189, 70 USPQ 221.
Dependent claims
As for claim 12, the modified teaching, in Pandya teaches the compositions comprise plant oils, including sunflower, coconut, corn, grapeseed, olive, rapeseed, safflower, sesame, palm, flaxseed, soy, walnuts and others (0149), all well known to comprise, at least: ferulic acid, quercetin, kaempherol, naringin, hesperidin, and apigenin. Mikołajczak provides evidence of this (see Tables 2-3).
Therefore, it would have been obvious to one of skill in the art, at the time of filing to modify the method of using plant oils, including: sunflower, coconut, corn, grapeseed, olive, rapeseed, safflower, sesame, palm, flaxseed, soy, walnuts and others, as the modified teaching above, to include -------------------------------the flavonoids therein, including: ferulic acid, quercetin, kaempherol, naringin, hesperidin, and apigenin, as claimed, because they are inherently provided therein, as evidenced by Mikołajczak.
As for claim 13, MNT further provides vitamins, including are one or more members selected from the group consisting of: vitamin D (see the Nutritional value Table), which encompasses vitamin D, as claimed.
Also, the modified teaching, in Pandya, provides teaches the one or more vitamins, include: vitamin A, vitamin B, vitamin C, vitamin D, vitamin E, and vitamin K (0009).
As for claim 14, the modified teaching, in Pandya, provides one or more salts, include: salt, commonly known as sodium chloride (0240); calcium (0009); CaCl (0334); citrate (0015); phosphorus; potassium; zinc; iron; copper; chloride, manganese, and selenium (0036).
As for claim 15, the modified teaching, in Pandya, provides one or more sugars or sweeteners comprise one or more sugar compounds, wherein the one or more sugar compounds are one or more members selected from the group consisting of: glucose (i.e. dextrose) (0036), as claimed.
As for claim 16, with regard to the species election of pending Example 4, the modified teaching, in Pandya, provides that the compositions comprise: at least beta and kappa type recombinant casein proteins; and at least beta-lactoglobulin, alpha-lactalbumin (0035) recombinant whey proteins.
As for claim 17, the modified teaching, in Pandya, provides there are benefits to using cloned (i.e. recombinant) proteins, because: their use minimizes food borne pathogens; their production creates a lower environmental impact; and they provide similar nutritional profiles (see background).
The modified teaching, in Collazo, provides supplemented functional foods (ab.) including types from bees and further provides MRJP types, including MRJP 1-9, for the functional benefits (Table 1), which encompasses MRJP 2-4, as claimed.
As for claim 18, the modified teaching, in Pandya, provides one or more fats or oils, including: sunflower oil, a vegetable oil (0013), and peanut oil another variety of vegetable oil (0036), as claimed.
As for claim 19, the modified teaching, in Pandya, provides that the compositions made have the following free amino acids, including: alanine (Ala), arginine (Arg),aspartic acid (Asp), cysteine (Cys), glutamic acid (Glu), glycine (Gly)threonine (Thr), histidine (His), isoleucine (Ile), leucine (Leu), lysine (Lys), methionine (Met), phenylalanine (Phe), proline (Pro), serine (Ser), tyrosine (Tyr), and valine (Val) (see the sequence listing on pg. 40), which encompasses the one or more free amino acids (FAAs), from the group claimed.
As for claim 20, the modified teaching of the use of beta casein protein (0008 of Pandya) (the generic) encompasses A2 beta casein protein (the species), because in this specific case the various permutations of types of beta casein protein (A1 or A2) in the generic are so small (two species) that the teaching is as comprehensive and fully as if it had written the name of each permutation. See, MPEP 2144.08.II.4 that discusses that when a genus is so small that, when considered in light of the totality of the circumstances it would anticipate the claimed species or subgenus because one skilled in the art would envisage each member of the genus, especially when the total circumstances involved include a limited number of variations for the genus, including in this case, when there are only two alternatives. Further, see MPEP 2144. 08 that discusses the obviousness of species when art teaches genus, wherein secondary considerations include those based on (the size of the genus, the expressed teachings, structural similarity, similar properties, predictability in the art, other teachings), which shows that based on the fact-finding as a whole (the size of the genus, the expressed teachings, structural similarity, similar properties, predictability in the art, other teachings), as discussed above, indicates why said species would have been an obvious selection based on the teaching of the genes.
Also, it is not seen that patentability can be predicated on the specific type of beta casein protein one would have chosen to use, especially as the specifically claimed type, A2, would have been an obvious matter of design.
Therefore, it would have been obvious to one of skill in the art, at the time of filing/the invention to modify the method of making foods/beverages comprising beta casein proteins, as the modified teaching above, to include the A2 type, as claimed, because the modified teaching in Pandya provides the use of beta casein protein, the generic) of A types of beta casein encompasses A2 beta casein protein (the species), because in this specific case the various permutations of types of beta casein protein (A1 or A2) in the generic are so small (two species) that the teaching is as comprehensive and fully as if it had written the name of each permutation; also, it is not seen that patentability can be predicated on the specific A type of beta casein one would have chosen to use, especially as the specifically claimed type, A2, would have been an obvious matter of design.
Further Pandya provides the use of both alpha S1 and S2 caseins (0029), wherein the patentability of a product does not depend on its method of production. In this case, since the product in the product-by-process claim, recombinant A type caseins, are the same as or obvious from a product of the prior art, therefore the claim is unpatentable even though the prior product was made by a different process or from a distinct source. See In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985).
As for claim 23, the modified teaching, in Pandya, provides recombinant casein proteins, including: kappa (0008) beta (0035), alpha-s1 (0346) and alpha-s2 (0350), as claimed. Pandya also provides recombinant whey proteins, including: beta-lactoglobulin (0337), alpha-lactalbumin (SEQ ID NOs 91-92), serum albumin (SEQ ID NOs 120-126), immunoglobins, lactoferrin and transferrin (0018, 0023), as claimed.
As for claim 25, the modified teaching, in Pandya, provides that the compositions are in optional forms, including powdered (0022, and the examples), which mean it is dried.
Herein, compositions are claimed, wherein the pending disclosure provides not criticality regarding the composition being modified in a manipulative sense based on the particulars of the type of apparatus type for powdering (i.e. drying) the compositions made.
Rationale: In this case the matter of the type of drying apparatus used to powder the compositions made: spray drying, freeze drying, shelf drying, using a bed dryer, drum/roller drying, supercritical drying or dielectric drying, do not distinguish over the teaching of powdered compositions made by Pandya, because the effect of the specifically claimed apparatus is absent a showing of criticality based on the wide variety of types of apparatus capable of powdering foods, wherein a similar result was achieved by Pandya.
Therefore, absent a showing of criticality, it would have been obvious to one of skill in the art, at the time of filing to modify the method of powdering nutritional edible compositions, as Pandya, to include the use of spray drying, freeze drying, shelf drying, using a bed dryer, drum/roller drying, supercritical drying or dielectric drying, to powder the composition made, because these types of drying foods do not distinguish over the teaching of powdered compositions made by Pandya.
Further, attention is invited to In re Tarczy-Hornoch 158 USPQ 141, 150 (CCPA 1968); In re Edwards 128 USPQ 387 (CCPA 1961); Stalego v. Heymes 120 USPQ 473, 478 (CCPA 1959);