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 Response and Amendment after Non-Final Office Action filed 08/20/2025 is acknowledged.
Applicant has overcome the following rejections by virtue of the amendment: (1) the 35 U.S.C. §112(b) rejections to claims 1 and 3-10 have been withdrawn; and (2) the 35 U.S.C. §103 rejection of claim 4 over Horimoto and Eppler has been withdrawn.
The status of the claims upon entry of the present amendment stands as follows:
Pending claims: 1, 3, 5-13, 16-20
Withdrawn claims: 11-13, 16-19
(*The status identifiers for claims 11 and 12 are incorrect; these claims should be marked as “Withdrawn”. Appropriate correction is required.*)
Previously cancelled claims: 2, 14-15
Newly cancelled claims: 4
Amended claims: 1
New claims: 20
Claims currently under consideration: 1, 3, 5-10, 20
Currently rejected claims: 1, 3, 5-10, 20
Allowed claims: None
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.
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, 3, 5-10, and 20 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.
Horimoto teaches that: the first protein source is hydrolyzed collagen (corresponding to collagen hydrolysate and gelatin) (page 6, paragraph 5); 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); and the second protein source is selected from milk proteins (corresponding to whey) (page 6, paragraph 2). This disclosed EN% of the lipid component overlaps the claimed EN%. Horimoto also teaches that the calories in the composition may be appropriately adjusted according to the components contained within the composition and discloses that 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). This caloric density overlaps the claimed caloric density. The selection of a value within the overlapping ranges renders the claimed EN% of the lipid component and the claimed caloric density obvious. 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 as long as the composition may be uniformly stirred (page 6, paragraph 7). Therefore, Horimoto at least suggests that the composition may comprise a combination of the first protein and the second protein in an amount greater than 12 g /100 ml, which at least overlaps the claimed “at least 14 g protein per 100 mL product”. The selection of a value within the overlapping range renders the claimed protein content obvious. MPEP §2144.05.I. 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).
Horimoto does not teach that: the hydrolyzed collagen of the first protein source has an average molecular weight of 1000-6000 Da; the first source of protein represents 70-90 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; the composition comprises at least 10 wt.% of protein based on the total weight of the composition; or the composition is subjected 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]); therefore, Eppler teaches 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. These disclosed contents of hydrolyzed collagen and whey protein in the composition provide the first source of protein and the second source of protein in amounts which encompass the claimed contents of the first and second protein sources based on the total weight of the protein component. Eppler also teaches that the hydrolyzed collagen provided as the first protein source has an average molecular weight of 2,000-10,000 Da (corresponding to 2.0 to 10.0 kDalton in [0042]), which overlaps the claimed average molecular weight. 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 a suitable average molecular weight for the hydrolyzed collagen which overlaps the claimed average molecular weight. The selection of a value within this overlapping range renders the claimed molecular weight obvious. 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 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 calories in the composition may be appropriately adjusted according to the components contained within the composition and discloses that the composition has a caloric density preferably of 0.5-2.5 kcal/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 that the calories in the composition may be appropriately adjusted according to the components contained within the composition and discloses that the composition has a caloric density preferably of 0.5-2.5 kcal/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.
Regarding claim 20, modified Horimoto teaches the invention as disclosed above in claim 1, including the composition containing 5-30 wt.% of hydrolyzed collagen (Eppler [0038], [0041]) and less than 25 wt.% whey protein based on the total weight of the composition (Eppler [0049]); therefore, modified Horimoto teaches that the composition comprises more than 5 wt.% protein and less than 55 wt.% protein based on the total weight of the composition. Modified Horimoto also discloses that the composition comprises water in a concentration of 20-95 wt.% (Eppler [0109]). These protein and water concentrations provided weight ratios of protein to water which at least overlap the claimed ratio (e.g., a composition comprising 9 wt.% of the first protein source; 1 wt.% of the first protein source; and 50 wt.% water would have a protein to water weight ratio of 2:10 (g/g), which falls within the claimed range).
Response to Arguments
Claim Rejections – 35 U.S.C. §112(b) of claims 1 and 3-10: Applicant amended claim 1 to fully address the rejections and canceled claim 4; therefore, the rejections are withdrawn.
Claim Rejections – 35 U.S.C. §103 of claims 1 and 3-10 over Horimoto and Eppler: Applicant’s amendments have been fully considered and are not considered to overcome the prior art rejections. Applicant’s arguments have been fully considered and are considered unpersuasive.
Applicant canceled claim 4. Applicant amended claim 1 to incorporate the features of now-canceled claim 4 requiring that the nutritional composition comprises at least 14 g protein per 100 mL product. Applicant argued that Horimoto does not disclose a nutritional composition containing at least 14 g protein per 100 mL product as Horimoto limits the concentration of whey protein in its composition to be 2-12 g/ 100 mL; and discloses that a whey protein content of 14-20 g/100 mL causes the composition to become impossible to stir uniformly (Applicant’s Remarks, page 7, 1st paragraph under section 3(a)- page 9, 2nd paragraph).
However, the Examiner points out that the acceptable range of 2-12 g/100 mL and the unacceptable range of 14-20 g/100 mL disclosed in Horimoto and cited by the Applicant are directed to whey protein only. Horimoto does not limit the concentration of any other protein source beyond that which would cause the composition to become impossible to stir uniformly. The “at least 14 g protein per 100 mL product” recited in present claim 1 refers to the total content of protein in the composition, not to the content of whey protein (which corresponds to the claimed milk protein) alone.
As described above in the rejection of amended claim 1, 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 as long as the composition may be uniformly stirred (page 6, paragraph 7). Therefore, Horimoto at least suggests that the composition may comprise a combination of the first protein and the second protein in an amount greater than 12 g /100 ml, which at least overlaps the claimed “at least 14 g protein per 100 mL product”. The selection of a value within the overlapping range renders the claimed protein content obvious. MPEP §2144.05.I.
Applicant then argued that Eppler does not teach that the composition comprises at least 14 g protein per 100 mL of liquid product as the compositions of Eppler are solid compositions and Eppler discloses components within these composition in terms of weight (Applicant’s Remarks, page 9, 3rd paragraph – page 10, 4th paragraph).
However, Horimoto has been shown to render the claimed protein content obvious as described above in the rejection of claim 1 and in the response to Applicant’s arguments above. Therefore, Eppler is not needed to teach this limitation. The Examiner points out that Eppler discloses liquid compositions ([0104]); and that present claim 1 does not require the claimed nutritional composition to be in the form of a liquid. Since the prior art has been shown to render the present claims obvious and Applicant’s arguments have been shown to be unpersuasive, the rejections of the claims 1, 3, and 5-10 are maintained as written herein. The rejection of claim 4 is moot due to its cancellation.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/K.P.K./Examiner, Art Unit 1791
/Nikki H. Dees/Supervisory Patent Examiner, Art Unit 1791
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