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 March 29, 2023. The earliest effective filing date of the application is September 29, 2020.
Priority
The present application is a 371 National Stage Application of PCT/CN2021/077196 which has a filing date of February 22, 2021.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on February 26, 2026 has been entered.
Status of Application
The amendment filed February 26, 2026 with the Request for Continued Examination has been entered. The status of the claims upon entry of the present amendment stands as follows:
Pending claims: 1, 2, 7 – 11, and 13 – 17
Withdrawn claims: 7 – 11, 13, and 14
Previously cancelled claims: 3, 4, and 12
Newly cancelled claims: 5 and 6
Amended claims: 1, 2, 7, 9, and 14
Claims currently under consideration: 1, 2, and 15 – 17
By not repeating the previously presented objection/rejection(s), it is sufficiently clear that said objection/rejection(s) are withdrawn.
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, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Mikkelsen et al. (US 20160262424 A1) in view of Sauer (Functionality and Stability of Micellar Casein Concentrates During Heat Treatment and Storage. Cornell University. (2012)).
Regarding claim 1, Mikkelsen teaches a denatured whey protein composition according to the present invention contains:
a total amount of protein of at least 60% (w/w) on a dry weight basis, and
insoluble whey protein particles having a particle size in the range of 1-10 micron,
where the amount of said insoluble whey protein particles is in the range of 50-100% (w/w) relative to the total amount of protein ([0057] – [0060]).
Mikkelsen teaches the denatured whey protein composition obtainable according to the method of the invention is advantageously used as a component of a food ingredient powder ([0525]). Mikkelsen teaches the food ingredient powder additionally comprises casein either in the form of a caseinate composition or a concentrate of micellar casein ([0549]). Mikkelsen teaches the food ingredient powder contains a total amount of casein in the range of 0 – 20% (w/w – [0549]). Mikkelsen further teaches a food product containing the denatured whey protein composition may further comprise alginates ([0291]).
While Mikkelsen is silent with respect to whether the micellar casein is bovine micellar casein, Sauer teaches about 80% of the proteins in bovine milk are represented by caseins, which are associated into casein micelles (Chapter 1, p. 2, paragraph 3). Sauer teaches caseins are made up of four sub‐groups of αs1‐, αs2‐, β‐ and κ‐casein, present in milk in the ratio of roughly 4:1:4:1.3 (Chapter 1, p. 2, paragraph 3).
Mikkelsen and Sauer are combinable because they are concerned with the same field of endeavor, namely, micellar casein. It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to select bovine micellar casein as the micellar casein concentrate in the composition of Mikkelsen, as taught by Sauer, because Sauer shows that it was known for bovine micellar casein to exist at the time of filing, which means it was within the general skill of a worker in the art to select bovine micellar casein as the micellar casein concentrate when making the denatured whey protein composition of Mikkelsen, 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.
By selecting a bovine micellar casein as the micellar casein concentrate in the denatured whey protein composition of Mikkelsen, the food ingredient powder contains a total amount of β-casein in the range of 0 – 7.8% (w/w). A composition that comprises 50 – 100 wt% of whey, and 0 – 7.8 wt% of β-casein, relative to the total amount of protein comprises whey and β-casein in a mass ratio of at most 13.4:86.6, relative to the β-casein. In this case, the limitation “a mass ratio of β-casein to whey protein is not lower than 4.5:95.5” is interpreted to mean the mass ratio of β-casein to whey protein is not lower than 4.5:95.5 relative to the β-casein.
The range of mass ratios of β-casein to whey protein, at most 13.4:86.6, relative to the β-casein, as disclosed by Mikkelsen and Sauer, overlaps with the claimed range of not lower than 4.5:95.5 relative to the β-casein. 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.
With respect to the precisely claimed method by which the composition of claim 1 is produced, this recitation is directed toward a method of production of the product of claim 1. MPEP § 2113.I teaches even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. Therefore, the structure implied by the process steps of claims 1 have been considered when assessing the patentability of the product.
The structure implied by claim 1 is interpreted to be a whey protein composition comprising whey protein and β-casein, wherein a mass ratio of β-casein to whey protein is not lower than 4.5:95.5, wherein the whey protein composition if a micronized whey protein composition, wherein the micronization is carried out by high-speed physical shearing at a pH value of 6.5 – 9.0.
Mikkelsen teaches a method of producing a denatured whey protein composition, the method comprising the steps of
a) providing a solution comprising whey protein, said solution having a pH in the range of 5 – 8, said solution comprising: water, a total amount of whey protein of at least 1% (w/w), a total amount of protein of at least 60% (w/w) on a dry weight basis, a total amount of fat of at most 3% (w/w) on a dry weight basis ([0036] – [0041]);
b) heating said solution to a temperature in the range of 70 – 160 °C and keeping the temperature of the solution within this range for sufficient time to form insoluble whey protein microparticles having a particle size in the range of 1-10 micron ([0044]);
c) optionally, cooling the heat-treated solution ([0045]);
d) optionally, converting the heat treated solution to a powder ([0046]);
wherein at least step b) involves subjecting the solution to mechanical (i.e., physical) shear ([0047]). Mikkelsen teaches the insoluble whey protein particles are typically produced by heating a solution of whey protein at an appropriate pH while subjecting the solution to a high degree of internal shear by subjecting the solution to high linear flow rates which promote turbulence ([0109]).
The range of shearing temperature in step (b), 70 – 160 °C, as disclosed by Mikkelsen, overlaps with the claimed range of 80 – 100 °C. 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 shearing pH, 5 – 8, as disclosed by Mikkelsen, overlaps with the claimed range of 6.5 – 9. 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.
While Mikkelsen does not teach the physical shearing is carried out under a shearing speed of 6000 – 20000 rpm, In re Best, 562 F.2d 1252, 1255 (CCPA 1977) states: where, as here, the claimed and prior art products are identical or substantially identical, or are produced by identical or substantially identical processes, the PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his claimed product. Whether the rejection is based on "inherency" under 35 U.S.C. § 102, on “prima facie obviousness” under 35 U.S.C. § 103, jointly or alternatively, the burden of proof is the same, and its fairness is evidenced by the PTO' s inability to manufacture products or to obtain and compare prior art products. See MPEP § 2112.01. Because Mikkelsen teaches the shearing is performed at high speeds, the process of making the denatured whey protein composition of Mikkelsen is substantially identical to the process of making of claim 1.
Finally, with respect to the preamble of the claim, “A whey protein composition for reducing a digestion rate of a whey protein and a release rate of leucine”, MPEP § 2111.02.II teaches, “[i]f 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.” In the instant case, the noted preamble merely states the purpose or intended use of the claimed composition. Therefore, the preamble does not limit the claim.
Regarding claim 2, the range of mass ratios of β-casein to whey protein, at most 13.4:86.6, relative to the β-casein, as disclosed by Mikkelsen, overlaps with the claimed range of 4.5:95.5 – 50:50 relative to the β-casein. 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 15, Mikkelsen teaches the present denatured whey protein composition may be used as a food ingredient and preferably as an ingredient for high protein food products ([0247]). Mikkelsen teaches in the context of the present invention, the term “food” relates to ingestible products in general and therefore encompasses both liquid foods such as beverages, semi-liquid foods (e.g. gels or highly viscous foods products such as spreadable cheese) and non-liquid foods such as bread or hard cheese ([0249]).
Regarding the recitation “excipients and/or nutrients” there is no definition in the instant disclosure defining “excipients and/or nutrients”. Therefore, “excipients and/or nutrients” is interpreted to mean anything edible. Therefore the food products of Mikkelsen comprise excipients and/or nutrients.
Regarding the limitation “nutritional supplement”, there is no definition in the instant disclosure defining “nutritional supplement”. Therefore, “nutritional supplement” is interpreted to mean anything edible. Therefore the food products of Mikkelsen are considered to be nutritional supplements.
Regarding the limitation “muscle synthesis promoter”, there is no definition in the instant disclosure defining “muscle synthesis promoter”. Therefore, “muscle synthesis promoter” is interpreted to mean anything edible that aids in muscle synthesis, including proteins such as β-lactoglobulin and α-lactalbumin (i.e., whey proteins) and β-casein. Therefore the food products of Mikkelsen are considered to be muscle synthesis promoters.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Mikkelsen et al. (US 20160262424 A1) in view of Sauer (Functionality and Stability of Micellar Casein Concentrates During Heat Treatment and Storage. Cornell University. (2012)), as applied to claim 15 above, and further in view of Palmer et al. (US 20050002989 A1).
Mikkelsen does not teach the food product is a nutritional bar wherein the excipients and/or nutrients are glucose syrup, glycerin, maltodextrin, coconut oil, and lecithin.
Palmer teaches two granola-style nutrition bars comprising glucose syrup, polydextrose syrup, inulin syrup, sugar, […], coconut oil, lecithin, glycerol (i.e., glycerin), […], fruit fibre, soy protein nuggets, and a dairy coating (Example 1; [0101]). Palmer teaches maltodextrin can be included in the bulking ingredients of the granola-style nutrition bars the in combination or alone ([0072]). Palmer teaches in addition to the soy and/or rice protein, other types of protein may also be included in the nutritional bars (either within the protein nugget or within the bar external to the nugget) such as whey protein isolate and whey protein concentrate and caseins ([0041]).
Mikkelsen and Palmer are combinable because they are concerned with the same field of endeavor, namely, protein supplementation. 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 selected the granola-style protein bar of Palmer as the food product of Mikkelsen, wherein the sodium caseinate is replaced by the denatured whey protein composition of Mikkelsen because the granola-style protein bar of Palmer is a known food product that may be supplemented with additional proteins such as whey protein and caseins proteins and the denatured whey protein composition of Mikkelsen is a known powdered milk protein also useful for milk protein supplementation. MPEP § 2144.06.I teaches it is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art. Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have combined the denatured whey protein composition of Mikkelsen with the granola-style protein bar of Palmer to arrive at a nutritional bar comprising the denatured whey protein composition of Mikkelsen, glucose syrup, glycerin, maltodextrin, coconut oil, and lecithin, which is also useful for protein supplementation.
Further, with respect to the precisely claimed excipients/nutrients, attention is invited to In re Levin, 84 USPQ 232 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 cooking 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.
All 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 known cooking methods, 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).
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Mikkelsen et al. (US 20160262424 A1) in view of Sauer (Functionality and Stability of Micellar Casein Concentrates During Heat Treatment and Storage. Cornell University. (2012)), as applied to claim 15 above, and further in view of Click (Click Coffee & Protein Powder, Mocha, 16g Protein, 1lb, 15.8oz. Walmart.com. (2017) Retrieved from: https://www.walmart.com/ip/Click-Coffee-Protein-Powder-Mocha-16g-Protein-1lb-15-8oz/47325118) and RocGastro (Fructose Intolerance. Gastroenterology Associates of Rochester. (2016)).
Mikkelsen does not teach the food product is a powdered dairy product wherein the excipients and/or nutrients are lactose, fructose, cream, vitamins, minerals, and lecithin.
Click teaches a coffee protein powder comprising sodium caseinate (i.e., protein), spray dried coffee, fructose, cocoa powder, nonfat dried milk (i.e., contains lactose), sunflower oil creamer (sunflower oil, maltodextrin, sodium caseinate, dipotassium phosphate, mono and diglycerides, soy lecithin, silicon dioxide, tocopherols), natural flavors, sunflower lecithin, sea salt, carrageenan, and sucralose (p. 1, Ingredients). Click also teaches the coffee protein powder comprises vitamins and minerals (p.1 , Nutrition Facts).
Mikkelsen and Click are combinable because they are concerned with the same field of endeavor, namely, protein supplements. 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 selected the coffee protein powder composition of Click as the food product of Mikkelsen, wherein the sodium caseinate is replaced by the denatured whey protein composition of Mikkelsen because the coffee protein powder of Click is a known food product comprising a powdered milk protein that is useful for protein supplementation, and the denatured whey protein composition of Mikkelsen is a known powdered milk protein also useful for milk protein supplementation. MPEP § 2144.06.I teaches it is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art. Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have combined the denatured whey protein composition of Mikkelsen with the coffee protein powder of Click to form a third composition useful for protein supplementation.
While the modified composition of Mikkelsen does not teach the composition comprises glucose, RocGastro teaches glucose, like fructose, is another form of sugar that is natural to the body; however it is more easily absorbed than fructose and can actually help the absorption of fructose. Foods that have equal or more glucose than fructose are considered more “intestinal friendly” (p. 1, paragraph 1).
It would have been obvious to a person having ordinary skill in the art before the effective filing date of the claimed invention to include glucose with the fructose in the coffee protein powder of Click, as taught by RocGastro because glucose is more easily absorbed than fructose and glucose assists in the absorption of fructose.
While the modified composition of Mikkelsen does not teach the food composition comprises cream, MPEP § 2144.06.II states an express suggestion to substitute one equivalent component or process for another is not necessary to render such substitution obvious. In re Fout, 675 F.2d 297, 213 USPQ 532 (CCPA 1982). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have used cream in place of the sunflower oil creamer in the coffee protein powder of Click because sunflower oil creamer is a known cream alternative.
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 combined the teachings of Mikkelsen and Click, as described above, to arrive at a coffee protein powder comprising the denatured whey protein composition of Mikkelsen, spray dried coffee, fructose and glucose, cocoa powder, nonfat dried milk (i.e., contains lactose), cream, natural flavors, sunflower lecithin, sea salt, carrageenan, sucralose, and the vitamins and minerals listed above. Therefore the invention of claim 17 is rendered obvious by Mikkelsen in view of Click.
Further, with respect to the precisely claimed excipients/nutrients, attention is invited to In re Levin, 84 USPQ 232 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 cooking 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.
All 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 known cooking methods, 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).
Response to Arguments
Applicant's arguments filed February 26, 2026 have been fully considered but they are not persuasive.
Applicant argues in view of the Lin teaching, those skilled in the art would have had no motivation to add polysaccharides other than suflated polysaccharides to the whey protein composition disclosed in Mikkelsen (p. 5, paragraph 1).
Applicant’s argument has been carefully considered but it is moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant argues Lin teaches away from adding alginate (p. 5, paragraph 2).
Applicant’s argument has been carefully considered but it is moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant argues Sauer, Palmer, and Click provide no teaching or suggestion that would address the deficiencies in the combined teachings of Lin and Mikkelsen (p. 5, paragraph 4).
Applicant’s argument has been carefully considered but it is moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
No claims are allowed.
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/JEFFREY P MORNHINWEG/Primary Examiner, Art Unit 1793
/L.J.M./Examiner, Art Unit 1793
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