Patent Application 16075294 - High caloric high protein nutritional formula

Title: High caloric, high protein nutritional formula comprising collagen

Application Information

Invention Title: High caloric, high protein nutritional formula comprising collagen
Application Number: 16075294
Submission Date: 2025-05-20T00:00:00.000Z
Effective Filing Date: 2018-08-03T00:00:00.000Z
Filing Date: 2018-08-03T00:00:00.000Z
National Class: 426
National Sub-Class: 580000
Examiner Employee Number: 95276
Art Unit: 1791
Tech Center: 1700

Rejection Summary

102 Rejections: 0
103 Rejections: 1

Cited Patents

The following patents were cited in the rejection:

US 0266137🔗

Office Action Text

DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .

Status of the Application
Receipt of the Request for Continued Examination (RCE under 37 CFR 1.114), the Response, and Amendment filed 04/12/2025 is acknowledged.
The status of the claims upon entry of the present amendment stands as follows:
Pending claims: 1, 3-13, 16-19
Withdrawn claims: 11-13, 16-19 (Claims 11 and 12 are still considered to be withdrawn for the reason provided below in the Examiner’s response.)
Previously cancelled claims: 14-15
Newly cancelled claims: 2
Amended claims: 1
New claims: None
Claims currently under consideration: 1, 3-10
Currently rejected claims: 1, 3-10
Allowed claims: None

Continued Examination Under 37 CFR 1.114
A request for continued examination (RCE) under 37 CFR 1.114 was filed in this application on 04/12/2025 after a decision by the Patent Trial and Appeal Board, but before the filing of a Notice of Appeal to the Court of Appeals for the Federal Circuit or the commencement of a civil action. 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 04/12/2025 has been entered.

Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):

(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.

Claims 1 and 3-10 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites that the composition comprises a first protein sources in an amount of 45-95 wt.% based on the total weight of the protein component; and a second protein source in an amount of 10-30 wt.% based on the total weight of the protein component. Per the footnote on page 2 of the Patent Board Decision filed 02/12/2025, “how could the protein component contain, for example, 93% by weight of the first source of protein, yet still contain 10% to 30% by weight of the second protein source?”. Therefore, the claim is indefinite.
Claims 3-10 are rejected by reason of dependency from claim 1.

In order to address these rejections, the Examiner suggests amending the first source of protein to comprise 45-90 wt.% based on the total weight of the protein component.

Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
The indicated allowability of claims 2-3, 5, and 9 is withdrawn in view of Horimoto and Eppler. Rejections based on these reference(s) follow.

Claims 1 and 3-10 are rejected under 35 U.S.C. 103 as being unpatentable over Horimoto (WO2013/085059; Google translation relied on for citations; previously cited) in view of Eppler (US 2005/0266137; previously cited).
Regarding claim 1, Horimoto teaches a nutritional composition comprising a protein component, minerals (page 4, paragraph 2), a lipid component (page 8, paragraph 9), a carbohydrate component (page 8, paragraph 2), vitamins (page 9, paragraph 9), and water (page 5, paragraph 9), wherein the protein component comprises at least two different protein sources (page 6, paragraph 4); wherein the nutritional composition has pH in the range of 2.5-8 (page 6, paragraph 3), which overlaps the claimed pH range. It would have been obvious to one of ordinary skill in the art to select any portions of the disclosed ranges including the instantly claimed ranges from the ranges disclosed in the prior art references, particularly in view of the fact that; "The normal desire of scientists or artisans to improve upon what is already generally known provides the motivation to determine where in a disclosed set percentage ranges is the optimum combination of percentages" In re Peterson 65 USPQ2d 1379 (CAFC 2003). Also In re Malagari, 182 USPQ 549,533 (CCPA 1974) and MPEP §2144.05.I.
It teaches that: (A) the first protein source is hydrolyzed collagen (corresponding to collagen hydrolysate and gelatin) (page 6, paragraph 5); (B) the lipid component provides 0-72 EN% of the total energy of the composition (corresponding to amount of energy from lipids is 0-36 kcal/100 ml in a composition with an amount of energy of 50-250 kcal/100 ml) (page 13, paragraphs 2-3), which falls within the claimed range; and (D) the second protein source is selected from milk proteins (corresponding to whey) (page 6, paragraph 2) wherein the composition has a caloric density preferably of 0.5-2.5 kcal/ml (corresponding to 50-250 kcal/ 100 ml) (page 13, paragraph 2). A prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985). MPEP §2144.05.I.
Horimoto teaches that the second source of protein is 2-12 g/100 ml (page 6, paragraph 2) and that the concentration of the first protein is not limited (page 6, paragraph 7). Horimoto also teaches that the composition is sterilized using conventional heat-sterilization treatment conditions in the field of food and medicine (page 11, paragraph 5) and that the end product is stable (corresponding to good storage stability of the product which had been homogenized during manufacture) (page 12, paragraphs 1 and 12). It does not teach (C) the first source of protein represents 45-95 wt.% based on the total weight of the protein component; the second protein source represents 10-30 wt.% based on the total weight of the protein component; or the composition comprises at least 10 wt.% of protein based on the total weight of the composition or that the composition is subject to UHT treatment.
However, Eppler teaches a food composition comprising a protein component containing 5-30 wt.% of hydrolyzed collagen (corresponding to hydrolyzed gelatin ([0038], [0041]) and less than 25 wt.% whey protein based on the total weight of the composition ([0049]), so that the composition comprises more than 5 wt.% protein and less than 55 wt.% protein based on the total weight of the composition, which overlaps the claimed protein content. Also, the contents of hydrolyzed gelatin and whey protein in the disclosed composition teach amounts of the first source of protein and amounts of the second source of protein which overlap the claimed contents of the first and second protein sources. Eppler also teaches that the compositions are subjected to a UHT treatment ([0123]).
It would have been obvious for a person of ordinary skill in the art to have modified the composition of Horimoto to include amounts of first and second proteins and subject the composition to UHT treatment as taught by Eppler. Since Horimoto teaches that the protein component comprises hydrolyzed collagen and whey protein, but does not disclose a specific amount of hydrolyzed collagen, a skilled practitioner would be motivated to consult an additional reference such as Eppler in order to determine a suitable concentration of hydrolyzed collagen, and therefore, a suitable concentration of total protein in the composition. Since Eppler teaches concentrations of first and second protein sources and a concentration of total proteins in the composition which overlap the claimed ranges, a selection of an amount within the overlapping ranges renders the claim obvious. MPEP §2144.05.I. In consulting Eppler, the skilled practitioner would also find that UHT is a suitable heat treatment for the composition, thereby rendering the claimed UHT treatment obvious.
Regarding claim 3, Horimoto teaches the invention as disclosed above in claim 1, including the total amount of energy in the nutritional composition is preferably 50-250 kcal/100 ml (page 13, paragraph 2); and that the protein component provides energy in an amount of 2-24 kcal/100 ml. Therefore, Horimoto teaches that the protein component provides 0.8-48 EN% based on the total energy of the composition, which overlaps the claimed range. The selection of an amount within the overlapping range renders the claim obvious. MPEP §2144.05.I.
Regarding claim 4, Horimoto teaches the invention as disclosed above in claim 1, including the composition comprising 2-12 g/100 ml of whey protein (page 6, paragraph 2) and the composition comprising 5-30 wt.% of hydrolyzed collagen (corresponding to hydrolyzed gelatin (Eppler [0038], [0041]) and less than 25 wt.% whey protein based on the total weight of the composition (Eppler [0049]). Therefore, the prior art teaches the composition comprising amounts of protein which overlap the claimed content range. The selection of an amount within the overlapping range renders the claim obvious. MPEP §2144.05.I.
Regarding claim 5, Horimoto teaches the invention as disclosed above in claim 1, including the total amount of energy in the nutritional composition is preferably 50-250 kcal/100 ml (page 13, paragraph 2); and that the lipid component provides energy in an amount of 0-36 kcal/100 ml. Therefore, Horimoto teaches that the lipid component provides 0-72 EN% based on the total energy of the composition, which encompasses the claimed range. The selection of an amount within the encompassing range renders the claim obvious. MPEP §2144.05.I.
Regarding claim 6, Horimoto teaches the invention as disclosed above in claim 1, including the total amount of energy in the nutritional composition is 50-250 kcal/100 ml (page 13, paragraph 2) and that: the protein component provides energy in an amount of 2-24 kcal/100 ml; the lipid component provides energy in an amount of 0-36 kcal/100 ml; and the carbohydrate component provides energy in an amount of 0-96 kcal/100 ml (page 13, paragraph 3). Therefore, Horimoto teaches that: (A) the protein component provides 0.8-48 EN% based on the total energy of the composition; (B) the lipid component provides 0-72 EN% based on the total energy of the composition; and (C) the carbohydrate component 0-98 EN% based on the total energy of the composition, which encompass the claimed ranges. The selection of an amount within the encompassing ranges renders the claim obvious. MPEP §2144.05.I.
Regarding claim 7, Horimoto teaches the invention as disclosed above in claim 1, including the composition has a pH in the range of 2.5-8 (page 6, paragraph 3), which encompasses the claimed pH range. The selection of an amount within the encompassing range renders the claim obvious. MPEP §2144.05.I.
Regarding claim 8, Horimoto teaches the invention as disclosed above in claim 1, including the total amount of energy in the nutritional composition is 50-250 kcal/100 ml (page 13, paragraph 2) and that: the protein component provides energy in an amount of 2-24 kcal/100 ml; the lipid component provides energy in an amount of 0-36 kcal/100 ml; and the carbohydrate component provides energy in an amount of 0-96 kcal/100 ml (page 13, paragraph 3). Therefore, Horimoto teaches that: (A) the protein component provides 0.8-48 EN% based on the total energy of the composition; (B) the lipid component provides 0-72 EN% based on the total energy of the composition; and (C) the carbohydrate component 0-98 EN% based on the total energy of the composition, which encompass the claimed ranges. The selection of an amount within the encompassing ranges renders the claim obvious. MPEP §2144.05.I.
Horimoto also teaches that the composition has a caloric density of 0.5-2.5 kcal/ml (corresponding to 50-250 kcal/ 100 ml) (page 13, paragraph 2). Although the disclosed caloric density does not fall within the claimed density range, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985). MPEP §2144.05.I.
Regarding claim 9, Horimoto teaches the invention as disclosed above in claim 1, including the composition has a caloric density of 0.5-2.5 kcal/ml (corresponding to 50-250 kcal/ 100 ml) (page 13, paragraph 2). Although the disclosed caloric density does not fall within the claimed density range, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985). MPEP §2144.05.I.
Regarding claim 10, Horimoto teaches the invention as disclosed above in claim 1, including the composition is to provide the necessary nutrients for people with difficulty swallowing (page 3, paragraph 6). Therefore, making the composition nutritionally complete is rendered obvious.

Response to Arguments
Claim Rejections – 35 U.S.C. §103 of claims 1, 4, 6-8, and 10 over Horimoto and Eppler: Applicant’s arguments have been fully considered and are considered unpersuasive.
Applicant amended claim 1 to recite that the composition has a caloric density of at least 3 kcal/mL as previously recited by claim 2. Claim 2 was indicated as being allowable over Isaji in the Examiner’s Answer to Appeal Brief filed 08/28/2023. Applicant argued that Horimoto does not disclose a nutritional composition having a caloric density of at least 3 kcal/mL as now recited by amended claim 1 (Applicant’s Remarks, pages 8-9, section 4).
However, during continued examination of the claims after the filing of an RCE, the minimum caloric density of 3 kcal/mL recited by amended claim 1 was found to be rendered obvious by the combination of Horimoto and Eppler. Horimoto discloses that the caloric density of the composition may be appropriately adjusted according to the components contained in the composition; and discloses that the composition has a caloric density of preferably within the range of 0.5-2.5 kcal/ml (page 13, paragraph 2). A prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985). MPEP §2144.05.I. Since the prior art has been shown to render the present claims obvious, Applicant’s arguments are unpersuasive. Therefore, claims 1 and 3-10 are maintained as written herein.
Since claim 1 remains rejected, claims 11 and 12 are not eligible for rejoinder and they are considered to still be withdrawn.

Conclusion
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/K.P.K./ Examiner, Art Unit 1791
/Nikki H. Dees/ Supervisory Patent Examiner, Art Unit 1791