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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 04/28/2026 has been entered.
Application Status
Amended claim 1-4 and 6-10 are under examination.
Claim 5 and 12 are cancelled.
Claim 11 and 13-20 are withdrawn from examination.
Withdrawn Rejections
The 35 U.S.C. 103 rejection over claim(s) 1-4 and 6-10 are rejected under 35 U.S.C. 103 as being unpatentable over Strozier et al. (WO 2016/070017) in view of Mower (US 2006/0210697) have been withdrawn in light of Applicant’s amendment to recite new limitations of “…a viscosity of the nutritional composition is from 148 centipoises (cPs) to 1000 cPs, wherein the natural ingredient has a weight percentage from 5% to 15%…” in claim 1, and “…the natural ingredient has the weight percentage from 9% to 15%” in claim 2 and 6.
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) 1-4 and 6-10 are rejected under 35 U.S.C. 103 as being unpatentable over Strozier et al. (WO 2016/070017) in view of Borschel et al. (US 6,589,576).
Regarding claim 1, Strozier et al. (Strozier) discloses a pediatric nutritional composition (‘017, [0009]) comprising milk which contains fat (’017, [0036], [0063]), carbohydrates (‘017, [0022]), protein (‘017, [0035]); and vegetable powder (‘017, [0015]-[0016], [0020]) and natural flavorant (‘017, [0041]-[0044]) (natural ingredient).
With respect to new limitation of a viscosity of the nutritional composition is from 148 centipoises to 1000 centipoises; Strozier discloses the pediatric nutritional composition has a viscosity (‘017, [0055]). Strozier is silent on the viscosity is from 148 centipoises (cPs) to 1000 cps. Borschel et al. (Borschel) discloses a pediatric formula (nutritional composition) comprising carbohydrates, lipids (fat), and protein (‘576, Abstract; col. 4, ln. 29-41). Borschel discloses the pediatric formula comprising a viscosity in a range of no greater than about 200 centipoises (cPs) (‘576, claim 1), which overlaps the cited range. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990). Strozier and Borschel are of the same field of endeavor of pediatric nutritional composition. It would have been obvious to one of ordinary skill in the art to be motived to use Borschel’s viscosity in Strozier’s pediatric nutritional composition since Borschel clearly teaches the viscosity in a range of no greater than about 200 centipoises as successful, known and acceptable values in pediatric formula.
With respect to new limitation of “wherein the natural ingredient has a weight percentage from 5% to 15%…”, Strozier discloses the pediatric nutritional composition (‘017, [0009]) comprising the natural flavorants (natural ingredient) including pumpkin, mushroom, tomato (natural ingredient) (‘017, [0041]-[0044]) in a range of about 0.1% to about 8% by weight of the nutritional composition (‘017, [0045]), which overlaps the cited range of 5% to 15% by weight. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Regarding claim 2, modified Strozier discloses the natural flavorants (natural ingredient) including pumpkin, mushroom, tomato (natural ingredient) (‘017, [0041]-[0044]) in the range of about 0.1% to about 8% by weight of the nutritional composition (‘017, [0045]). Modified Strozier does not explicitly disclose the cited range of from 9% to 15% of the natural ingredient.
However, attention is invited to In re Levin, 84 USPQ 232 and the cases cited therein, which are considered in point in the fact situation of the instant case, and wherein the Court stated on page 234 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. 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.
Strozier’s natural flavorants (natural ingredient) including pumpkin, mushroom, tomato (natural ingredient) are common ingredients in the formulas. It would have been obvious to one of ordinary skill in the art to adjust Strozier’s range of natural flavorants including the cited range to provide a desired flavor profile in modified Strozier’s pediatric nutritional composition, absent ‘…a proper showing further establishes a coaction or cooperative relationship between the selected ingredients which produces a new, unexpected, and useful function…”.
Regarding claim 3, modified Strozier discloses the pediatric nutritional composition (‘017, [0009]) comprising 1% fat milk (‘017, [0063]), which is in range with the cited range. Modified Strozier discloses the protein in a range of about 35 grams to about 70 grams per liter of nutritional liquid (pediatric nutritional composition = nutritional powder plus milk) (‘017, [0036]), which corresponds to the protein in a range of about 3.5% to 7.0%, which is in range with the cited range. Modified Strozier discloses the carbohydrate in a range of about 30% to about 40 wt% of the nutritional powder (‘017, claim 24, claim 39), which overlaps the cited range. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Regarding claim 4, modified Strozier discloses the pediatric nutritional composition comprising the carbohydrates including sugar with an average particle size (count median diameter) of about 100 um to about 350 um (‘017, claim 34), which is in range with the cited range.
Regarding claim 6, modified Strozier discloses the natural flavorants (natural ingredient) including pumpkin, mushroom, tomato (natural ingredient) (‘017, [0041]-[0044]) in the range of about 0.1% to about 8% by weight of the nutritional composition (‘017, [0045]). Modified Strozier does not explicitly disclose the cited range of from 9% to 15% of the natural ingredient.
However, attention is invited to In re Levin, 84 USPQ 232 and the cases cited therein, which are considered in point in the fact situation of the instant case, and wherein the Court stated on page 234 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. 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.
Strozier’s natural flavorants (natural ingredient) including pumpkin, mushroom, tomato (natural ingredient) are common ingredients in the formulas. It would have been obvious to one of ordinary skill in the art to adjust Strozier’s range of natural flavorants including the cited range to provide a desired flavor profile in modified Strozier’s pediatric nutritional composition, absent ‘…a proper showing further establishes a coaction or cooperative relationship between the selected ingredients which produces a new, unexpected, and useful function…”. Modified Strozier discloses the pediatric nutritional composition comprising the nutritional powder with an average particle size (count median diameter) in a range of about 125 um to about 215 um (‘017, [0054]), which is in range with the cited range.
Regarding claim 7, modified Strozier discloses the pediatric nutritional composition (‘017, [0009]) comprising the natural flavorants including pumpkin (natural ingredient) (‘017, [0041]-[0044]) in the range of about 0.1% to about 8% by weight of the nutritional composition (‘017, [0045]), which overlaps the cited range of 5% to 10% by weight. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Modified Strozier discloses the pediatric nutritional composition comprising the nutritional powder with an average particle size (count median diameter) (‘017, [0053]). Strozier does not disclose an average particle size as cited; however, it would have been obvious to one of ordinary skill in the art to provide pediatric nutritional composition comprising the nutritional powder with the cited average particle size (count median diameter) provide a desirable sensory characteristics (‘017, [0052]).
Regarding claim 8, modified Strozier discloses the pediatric nutritional composition (‘017, [0009]) comprising the natural flavorants including pumpkin (natural ingredient) (‘017, [0041]-[0044]) in a range of about 0.1% to about 8% by weight of the nutritional composition (‘017, [0045]), which overlaps the cited range of 5% to 10% by weight. In the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Modified Strozier discloses the pediatric nutritional composition comprising the nutritional powder with an average particle size (count median diameter) (‘017, [0053]). Strozier does not disclose the average particle size as cited; however it would have been obvious to one of ordinary skill in the art to provide pediatric nutritional composition comprising the nutritional powder with the cited average particle size (count median diameter) provide a desirable sensory characteristics (‘017, [0052]).
Regarding claim 9, modified Strozier discloses the pediatric nutritional composition (‘017, [0009]) comprising the nutritional powder is packaged in a single serving container, which encompass in a sealed container (‘017, [0012]). The phrase “can be stored stably at room temperature”, is considered a functional limitations of the claimed product; hence it has been held that where the claimed and prior art products are identical or substantially identical in structure or are produced by identical or substantially identical process, a prima facie case of either anticipation or obviousness will be considered to have been established over functional limitation that stem from the claimed structure (product). The prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed products. In re Best, 195 USPQ 430, 433 (CCPA 1977), In re Spade, 15 USPQ2d 655,1658 (Fed. Cir. 1990).
Regarding claim 10, Strozier discloses the pediatric nutritional composition (‘017, [0009]) comprising vitamins and minerals (‘017, [0031]).
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-4 and 6-10 have been considered but are moot because the new ground of rejection does not rely on the combined references applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
In response to Applicant’s remarks to Table 1, Example 8, “as shown in Table 1 of the present application, Example 8 discloses that when the natural ingredient is corn, with a weight percentage of 0.1% (less than 5%) and a viscosity of 64 cps (less than 148 cps), the aroma preference score is only 2.9 (the present application discloses in paragraph [0080] that "The natural ingredient aroma preference and taste preference were evaluated on a 5 point scale, the higher the score, the greater the preference, and the preference was acceptable if the score was above 3," and conversely, below 3 points is unacceptable). That is, when the viscosity is less than 148 cps and the weight percentage of unacceptable). That is, when the viscosity is less than 148 cps and the weight percentage of the natural ingredient is less than 5%, the aroma of the natural ingredient will be poor and unable to present its original flavor…”.
It is noted Table 1, Example 8 discloses a score of 3.5 in taste preference, wherein a score above 3 is acceptable, however it in noted in the Example 8 having a viscosity and natural ingredient, corn outside of the claimed ranges; hence Applicants’ remarks are not convincing. Attention to Table 1, Example 6 and Example 7 also having a viscosity and natural ingredient, corn outside of the claimed ranges, but have acceptable taste preference scores of 3.8 and 3.7, respectively. The Example 6, 7 and 8 does not properly showing that establishes a coaction or cooperative relationship between the selected ingredients and ranges of the instant claims, which produces a new, unexpected, and useful function. The Example 6, 7 and 8 in fact is contradicting to Applicant’s remarks, and instant claimed ranges, wherein outside the claimed ranges provides acceptable taste preference.
Conclusion
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/HONG T YOO/ Primary Examiner, Art Unit 1792
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