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 .
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Claim 11 and 13-20 are withdrawn from examination.
Withdrawn Rejections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 Borschel et al. (US 6,589,576) have been withdrawn in light of Applicant’s amendment to recite new limitation of “wherein a pH value of the nutritional composition is from pH 5.5 to pH 8.5” in claim 1.
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) and Bindels et al. (US 6,863,918) .
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 the 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 motivated 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 the 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).
With respect to the new limitation of “…wherein a pH value of the nutritional composition is from pH 5.5 to pH 8.5”, Strozier does not explicitly disclose the pediatric nutritional composition is in a range of from pH 5.5 to pH 8.5. However, Bindels et al. (Bindels) discloses an infant formula comprising lipid (fat), protein, carbohydrates (‘918, col. 16, ln. 60-67; col. 17, ln. 1-25). Bindels discloses the infant formula comprising a pH range of 4.0 to 7.5 (‘918, col. 7, ln. 41-42), 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 Bindels 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 motivated to use Bindels’ pH range in Strozer’s pediatric nutritional composition because Bindels teaches known and successful pH range to provide a stable pediatric nutritional composition.
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 argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, with respect to the new limitation of “…wherein a pH value of the nutritional composition is from pH 5.5 to pH 8.5”, Strozier does not explicitly disclose the pediatric nutritional composition is in a range of from pH 5.5 to pH 8.5. However, Bindels et al. (Bindels) discloses an infant formula comprising lipid (fat), protein, carbohydrates (‘918, col. 16, ln. 60-67; col. 17, ln. 1-25). Bindels discloses the infant formula comprising a pH range of 4.0 to 7.5 (‘918, col. 7, ln. 41-42), 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 Bindels 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 motivated to use Bindels’ pH range in Strozer’s pediatric nutritional composition because Bindels teaches known and successful pH range to provide a stable pediatric nutritional composition.
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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/HONG T YOO/Primary Examiner, Art Unit 1792
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