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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 01/07/2026 has been entered.
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 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.
Claim(s) 1-2, 4-6, 10-11, 18-19, and 23-24 are rejected under 35 U.S.C. 103 as being unpatentable over Breuille et al. US 2019/0111083 in view of Reygaert (Green Tea Catechins: their use in treating and preventing infectious diseases) in view of Smulders US 2019/0069589 in view of Braun US 2018/0368461.
Regarding claim 1, Breuille discloses a liquid nutritional composition (composition can be powdered nutritional product to be reconstituted in water) ([0072], [0022]).
Breuille discloses that the composition comprises protein, and that the protein comprises micellar casein in an amount of at least 70% (protein source can be solely micellar casein protein or can be a combination of whey protein and micellar casein protein) ([0052]-[0054]).
Breuille discloses that the composition comprises green tea catechins ([0059]), which in view of Reygaert includes at least one or more of epicatechin, epigallocatechin, epicatechin 3-gallate, and epigallocatechin 3-gallate (Pg. 2 right col., lines 5-10).
Breuille discloses that the nutritional composition has a weight ratio between (a) the sum of the amounts of one or more of epicatechin, epigallocatechin, epicatechin 3-gallate, and epigallocatechin 3-gallate and (b) total protein that is a ratio in the range of 1:1 to 1:40 ([0062]), overlapping the claimed ratio range of (a) to (b) of 1:1000 to 1:5 (0.001:1 = 1:1000 and 0.2:1= 1:5) ([0062], [0059]). Therefore, making the claimed ratio obvious, since Breuille teaches a range of ratios which overlap the claimed range of ratios (MPEP 2144.05.I).
Claim 1 differs from Breuille in the recitation that the liquid nutritional composition comprises a content of total protein of 10-25% w/w.
It is noted that Breuille discloses that the powder composition contains 0.2-100% protein ([0020], [0052]).
Smulders discloses a liquid nutritional composition comprising 11% w/w total protein (Example 3, Table 8, Composition 14: 106.9g MCI + 13g whey / 1088g = 11% protein). It is noted that Smulders discloses that of the total protein of the liquid nutritional composition, 85wt% of the total protein is micellar protein (Example 3, Table 8, Composition 14: 106.9grams MCI + 13g whey / 1088g = 11%) ([0043], [0084], [0188]). Thus, Smulders teaches a desirable protein content for a liquid nutritional composition comprises 11 % w/w total protein. It would have been obvious to one of ordinary skill in the art to modify the liquid nutritional composition to comprise total protein in an amount of 11% w/w as taught by Smulders (i.e. adjust the amount of the powdered nutritional composition of Breuille that is mixed with a liquid to form the liquid nutritional composition with 11% w/w protein), which content lies inside the claimed range, in order to provide a liquid nutritional composition with a desirable amount of protein. It has been held that combining prior art elements according to known methods to yield predictable results supports a conclusion of obviousness (MPEP 2143.I.A).
Additionally, Braun discloses a common amount of protein for a nutritional liquid composition includes 5-20% protein, the protein can be/include casein ([0001], [0026], [0031]). Therefore, it would have been obvious to one of ordinary skill in the art to modify the liquid nutritional composition to comprise a total protein in an amount of 5-20% w/w as additionally taught by Braun (i.e. adjust the amount of the powdered nutritional composition of Breuille that is mixed with a liquid to form the liquid nutritional composition with 5-20% w/w protein), which content overlaps the claimed range, in order to provide a liquid nutritional composition with a desirable amount of protein. It has been held that combining prior art elements according to known methods to yield predictable results supports a conclusion of obviousness (MPEP 2143.I.A).
Claim 1 differs from Breuille in the recitation that the liquid nutritional composition is specifically homogenous, however Smulders additionally teaches a common step of processing a liquid nutritional composition includes homogenization in order to disrupt any aggregates that may have formed ([0142]-[0144]). Therefore, it would have been obvious to ordinary skill in the art to modify the liquid nutritional composition of Breuille to be homogenous in order to eliminate any aggregates or lumps ([0144], [0186]).
Claim 1 differs from Breuille in the recitation that the liquid nutritional composition has a pH in the range of 6-8.
Smulders discloses a preferable pH for a liquid nutritional composition which includes micellar casein protein includes a pH in the range of 6-8, more preferably in the range of 6.2 to 7.5 and most preferably in the range of 6.4 to 7.2 ([0095], [0096]). Therefore, it would have been obvious to one of ordinary skill in the art to modify the liquid nutritional composition of Breuille to have a pH in the range of 6-8 as taught by Smulders in order to provide the liquid nutritional composition with a preferable pH. It has been held that combining prior art elements according to known methods to yield predictable results supports a conclusion of obviousness (MPEP 2143.I.A).
Regarding claim 1, claim 1 differs from Modified Breuille in the recitation that the nutritional liquid is heat treated. Smulders teaches heat treating a nutritional liquid composition in order to sterilize the nutritional liquid for increased shelf life ([0143]). It would have been obvious to one of ordinary skill in the art to modify Modified Breuille such that the nutritional liquid is heat treated as suggested by Smulders in order to increase the shelf life of the nutritional liquid.
Regarding the remaining limitations of claim 1 that the liquid composition does not exhibit cold gelation, has a viscosity after storage at 5 °C for 63 days in the range of 5-100 cP at a temperature of 5 °C and a shear rate of 145 s-1, since Modified Breuille teaches the product as claimed and where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes claimed properties or functions are presumed to be inherent, the property of the product as claimed (that the liquid composition has a viscosity after storage at 5 °C for 63 days in the range of 5-100 cP at a temperature of 5 °C and a shear rate of 145 s-1) is presumed to be inherent to the product made obvious by modified Breuille (MPEP 2112.01).
Regarding claim 2, claim 2 is rejected for the same reasons given above as for claim 1.
Regarding claim 4, claim 4 is rejected for the same reasons given above as for claim 1.
Regarding claim 5, Modified Breuille discloses that the protein source can be a combination of whey protein and micellar casein. Claim 5 differs from Breuille in the recitation that the micellar casein is in an amount of 70-84% w/w.
Smulders, as already relied upon above, teaches providing that a liquid nutritional composition comprising protein and discloses that the protein comprises 60-90wt% micellar casein and 10-40wt% whey protein based on the total protein ([0118]) in order to provide the liquid nutritional composition with a high protein content while still having a low viscosity ([0097]). It would have been obvious to one of ordinary skill in the art to modify Breuille such that the micellar casein is in an amount of 70-84% w/w as suggested by Smulders in order to provide the liquid nutritional composition with a high protein content while still having a low viscosity.
Regarding claim 6, Modified Breuille discloses that the protein source can be micellar casein alone, and thus teaches that the micellar casein is in an amount of 100% w/w relative to total protein (‘083, [0052]-[0054]).
Regarding claim 10, claim 10 is rejected for the same reasons given above as for claim 1.
Regarding claim 11, claim 11 differs from Modified Breuille in the recitation that the nutritional liquid is sterile. Smulders teaches heat treating a nutritional liquid composition in order to sterilize the nutritional liquid for increased shelf life ([0143]). It would have been obvious to one of ordinary skill in the art to modify Modified Breuille such that the nutritional liquid is a sterile as suggested by Smulders in order to increase the shelf life of the nutritional liquid.
Regarding claim 18, claim 18 differs from Modified Breuille in the recitation that the nutritional liquid is a sterilized heat treated liquid. Smulders teaches heat treating a nutritional liquid composition in order to sterilize the nutritional liquid for increased shelf life ([0143]). It would have been obvious to one of ordinary skill in the art to modify Modified Breuille such that the nutritional liquid is a sterilized heat treated liquid as suggested by Smulders in order to increase the shelf life of the nutritional liquid.
Regarding claim 19, claim 19 differs from Modified Breuille in the recitation that the nutritional liquid is specifically a packaged nutritional liquid. Smulders teaches packaging liquid nutritional compositions was common in the art ([0172], [0032]). It would have been obvious to one of ordinary skill in the art to modify Modified Breuille such that the nutritional liquid is specifically a packaged heat treated homogenous nutritional liquid as taught by Smulders in order to protect the nutritional liquid composition for distribution to consumers. It has been held that combining prior art elements according to known methods to yield predictable results supports a conclusion of obviousness (MPEP 2143.I.A).
Regarding claims 23 and 24, claims 23 and 24 are rejected for the same reasons given above as for claim 1.
Claims 8-9 are rejected under 35 U.S.C. 103 as being unpatentable over Breuille et al. US 2019/0111083 in view of Reygaert (Green Tea Catechins: their use in treating and preventing infectious diseases) in view of Smulders US 2019/0069589 in view of Braun US 2018/0368461 in view of Velikov US 2009/0035440.
Regarding claim 8, claim 8 differs from Modified Breuille in the recitation that the nutritional composition has an energy content of 1-3 kcal/g. Velikov discloses food may be low calorie when having an energy content of less than 1 kcal per g of the food and high calorie food has energy content of more than 1 kcal per g of food ([0065]). It would have been obvious to one of ordinary skill in the art to adjust the energy content of Modified Breuille such that the nutritional composition has an energy content of 1-3 kcal/g in order to provide a high calorie nutritional composition.
Regarding claim 9, claim 9 differs from Modified Breuille in the recitation that the nutritional composition has an energy content of at most 1 kcal/g. Velikov discloses food may be low calorie when having an energy content of less than 1 kcal per g of the food and high calorie food has energy content of more than 1 kcal per g of food ([0065]). It would have been obvious to one of ordinary skill in the art to adjust the energy content of Modified Breuille such that the nutritional composition has an energy content at most 1 kcal/g in order to provide a low-calorie nutritional composition.
Response to Arguments
Applicant's arguments filed 01/07/2026 have been fully considered but they are not persuasive.
On pg. 8 of the remarks Applicant argues that the Examiner has provided no evidence that one of ordinary skill in the art would recognize the properties of the presently claimed composition relied upon by the Examiner in the rejection. Applicant argues that the claims have additionally been amended to recite a “cold gelation” resistant heat treated homogenous nutritional liquid composition.
This argument has not been found persuasive, MPEP 2112.01 recites that “when the structure recited in the reference is substantially identical to that of the claims, claimed properties or functions are presumed to be inherent”. Therefore since Modified Breuille teaches the product as claimed and where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes claimed properties or functions are presumed to be inherent, the property of the product as claimed (that the liquid composition does not exhibit cold gelation, has a viscosity after storage at 5 °C for 63 days in the range of 5-100 cP at a temperature of 5 °C and a shear rate of 145 s-1) is presumed to be inherent to the product made obvious by modified Breuille (MPEP 2112.01).
In response to Applicant’s argument that Breuille fails to teach a cold gelation composition and that Breuille addresses a different problem and therefore cannot serve as the basis for rejecting the presently claimed invention, it is noted that the prior art makes obvious the claimed composition and "The fact that appellant has recognized another advantage which would flow naturally from following the suggestion of the prior art cannot be the basis for patentability when the differences would otherwise be obvious.", “Mere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention.” (MPEP 2145.I). Additionally, MPEP 716 requires the claims to be commensurate in scope with the evidence of unexpected results and while Applicant has provided data for a few specific points within the claimed range of micellar protein and claimed range of ratio of polyphenol and protein, MPEP 716 recites “Whether the unexpected results are the result of unexpectedly improved results or a property not taught by the prior art, the "objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support." In other words, the showing of unexpected results must be reviewed to see if the results occur over the entire claimed range.” MPEP 716.02(d). Therefore, the data is not sufficient to overcome the obviousness rejection at this time, as the evidence is not commensurate in scope with the claims.
On Pg 8-9 of the remarks Applicant argues that even if Smulders was used as a primary reference that Smulders teaches explicitly a composition comprising at least 10% hydrolyzed whey protein. Applicant argues that Smulders teaches away from the compositions of the claimed invention because Smulders teaches the use of at least 10% hydrolyzed whey protein to avoid cold gelling, rather than catechins.
This argument has not been found persuasive. First it is noted that Smulders is not the primary reference being modified and a rejection has not been made using Smulders as the primary reference. Second, the claims do not require the total protein to be only micellar casein, see claims 1, 5, and 6. The claims also do not prevent hydrolyzed whey protein from being present in the total protein. Smulders does teach the use of micellar casein in the protein composition of a nutritional liquid composition, as claimed (Example 3, Table 8, Composition 14) and therefore is relevant to the claims and the primary reference. Additionally, Smulders is not being relied upon for teaching the use or catechins, as this is already taught by the primary reference. As detailed in the office action Smulders was relied upon because Smulders discloses a liquid nutritional composition comprising 11% w/w total protein (Example 3, Table 8, Composition 14: 106.9g MCI + 13g whey / 1088g = 11% protein). It is noted that Smulders discloses that of the total protein of the liquid nutritional composition, 85wt% of the total protein is micellar protein (Example 3, Table 8, Composition 14: 106.9grams MCI + 13g whey / 1088g = 11%) ([0043], [0084], [0188]). Thus, Smulders teaches a desirable protein content for a liquid nutritional composition comprises 11 % w/w total protein. It would have been obvious to one of ordinary skill in the art to modify the liquid nutritional composition to comprise total protein in an amount of 11% w/w as taught by Smulders (i.e. adjust the amount of the powdered nutritional composition of Breuille that is mixed with a liquid to form the liquid nutritional composition with 11% w/w protein), which content lies inside the claimed range, in order to provide a liquid nutritional composition with a desirable amount of protein. It has been held that combining prior art elements according to known methods to yield predictable results supports a conclusion of obviousness (MPEP 2143.I.A).
In response to Applicants argument on Pg. 9 of the remarks that when casein is present in Braun it shall be in combination with whey protein in a ratio of 30/70 to 70/30, this is not persuasive because it is clear from paragraph [0026] that casein can be the protein source on its own and it is only a preferred embodiment to provide casein in combination with whey.
In response to Applicant’s on Pg. 10 of the remarks regarding Velikov, Velikov was only relied upon for the general teaching that food may be low calorie when having an energy content of less than 1 kcal per g of the food and high calorie food has energy content of more than 1 kcal per g of food ([0065]). As such it would have been obvious to one of ordinary skill in the art to adjust the energy content of Modified Breuille such that the nutritional composition has an energy content of 1-3 kcal/g in order to provide a high calorie nutritional composition.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Hayakawa et al. US 2016/0143340 discloses a beverage comprising catechins and protein, where the ratio of catechins to protein is 0.02-0.10 ([0029]). Hayakawa discloses that the protein is present in an amount of at least 2.5 mass%. Hayakawa discloses that the inventors of the present invention found that a packaged beverage which has a certain level of viscosity but which has a smooth texture and a good sensation in throat, forms a small amount of precipitate, and provides a small change in color tone due to heat sterilization can be obtained by, even in a beverage containing a high concentration of protein and having a certain level of viscosity, blending a specific polyphenol at a predetermined quantitative ratio and controlling the pH to fall within a specific range so that the median diameter of colloidal particles in the beverage can be retained when the beverage is subjected to heat sterilization ([0019],[0049], [0059], [0060],[0131],[0301]).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ASHLEY AXTELL whose telephone number is (571)270-0316. The examiner can normally be reached M-F 9:00- 5:30.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, ERIK KASHNIKOW can be reached at 571-270-3475. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/A.A/
Ashley AxtellExaminer, Art Unit 1792
/VIREN A THAKUR/Primary Examiner, Art Unit 1792
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