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 1-27 are under examination.
Claim 28-31 are cancelled.
Claim 32-34 are withdrawn from examination.
Withdrawn Rejection
The 35 U.S.C. 103 rejection over claim(s) 1-7 as being unpatentable over JP 2009513641 (English Machine Translation) in view of 정승환 (KR 101249082 B1, Machine Translation English, Ref. U) has been withdrawn in light of Applicant’s amendment to recite new limitation in claim 1.
The 35 U.S.C. 103 rejection claim(s) 8-27 as being unpatentable over JP 2009513641 (English Machine Translation) in view of 정승환 (KR 101249082 B1, Machine Translation English, Ref. U) as applied to claim 1 above, and further in view of Morelli et al. (US 2018/0133287 A1) has been withdrawn in light of Applicant’s amendment to recite new limitation in claim 1.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) 1-7 are rejected under 35 U.S.C. 103 as being unpatentable over JP 2009513641 (English Machine Translation) in view of Theuer (US 2004/0013787 A1).
Regarding claim 1, 2, 3, and 4, JP 2009513641 (‘641) discloses infant formulation (nutritional formula) (‘641, pg. 3, ln. 8-11) comprising nonfat dry milk powder (‘641, pg. 9, 8th paragraph), lactose (‘641, pg. 12, last paragraph), oils combination (oil blend) (‘641, pg. 5, 8th paragraph; pg. 8, 4th paragraph), whey protein concentrate (enriched whey protein concentrate) (‘641, pg. 8, 4th paragraph), fructooligosaccharide (oligosaccharides) (‘641, pg. 5, 8th paragraph), choline (‘641, pg. 5, 9th paragraph; pg. 8, 4th paragraph), docosahexaenoic acid (‘641, pg. 4, 9th and 10th paragraph), arachidonic acid (‘641, pg. 5, 2nd paragraph), magnesium oxide (‘641, pg. 6, 4th paragraph), lactoferrin (‘641, pg. 6, 6th paragraph), inositol (‘641, pg. 5, 9th paragraph), taurine (‘641, pg. 5, 7th paragraph), iron (‘641, pg. 5, last paragraph), L-carnitine (‘641, pg. 8, 4th paragraph), zinc (‘641, pg. 8, 4th paragraph), nucleotides (‘641, pg. 8, 4th paragraph), vitamins(‘641, pg. 5, 9th paragraph), soy lecithin (‘641, pg. 8, 4th paragraph), pantothenic acid (‘641, pg. 5, 9th paragraph), copper (‘641, pg. 5, last paragraph), biotin (‘641, pg. 5, last paragraph), folic acid (‘641, pg. 5, 9th paragraph), lutein (‘641, pg. 3, last paragraph -pg. 4, 8th paragraph), manganese sulfate (‘641, pg. 8, 4th paragraph), iodine (‘641, pg. 6, 4th paragraph), beta-carotene (‘641, pg. 9, 8th paragraph), sodium citrate (‘641, pg. 9, 6th paragraph), and sodium selenate (selenium) (‘641, pg. 8, 4th paragraph).
JP 2009513641 (‘641) infant formulation (nutritional formula) does not contain polydextrose, and meet the limitation of the nutritional formula excludes polydextrose.
With respect to new limitation, JP 2009513641 (‘641) infant formulation (nutritional formula) does not contain beta-casein, and meet the limitation of the nutritional formula excludes beta-casein.
JP 2009513641 (‘641) teaches different proteins (‘641, pg. 5, 6th paragraph), but does not explicitly teach demineralized whey protein. However, Theuer discloses an infant formula (‘787, [0023], [0031]) comprising protein including demineralized whey and whey protein concentrate and mixtures thereof (‘787, [0024], [0070], claim 19). Theuer and JP 2009513641 (‘641) are of the same field of endeavor of infant formula. It would have been obvious to one or ordinary skill in the art to be motivated to use Theuer’s demineralized whey protein in JP 2009513641 (‘641) infant formulation since Theuer teaches known and successful mixture of including demineralized whey and whey protein concentrate and mixtures thereof (‘787, [0024], [0070], claim 19) as protein source for infants.
Regarding claim 5, modified JP 2009513641 (‘641) discloses vitamin C (‘641, pg. 5, 9th paragraph).
Regarding claim 6, modified JP 2009513641 (‘641) discloses the nucleotides including adenosine 5’- monophosphate (‘641, pg. 8, 4th paragraph).
Regarding claim 7, modified JP 2009513641 (‘641) discloses the lactose is comprised of 100% lactose (‘641, pg. 8, 4th paragraph), which is in range with the cited range.
Claim(s) 8-27are rejected under 35 U.S.C. 103 as being unpatentable over JP 2009513641 (English Machine Translation) in view of Theuer (US 2004/0013787 A1) as applied to claim 1 above, and further in view of Morelli et al. (US 2018/0133287 A1).
Regarding claim 8-27, modified JP 2009513641 discloses the claimed invention as discussed above. However, modified JP 2009513641 does not teach the cited amounts as claimed in claims 8-27.
However, Morelli et al. (Morelli) discloses a nutritional composition (formula) (‘287, [0036]). With respect to claim 8, Morelli discloses the nutritional composition (formula) comprising fat (oil blend) is 5.3g per 100kcal (‘287, [0229]), which is in range with the range.
With respect to claim 9, Morelli discloses the whey protein in a range of about 40% to about 85% of total protein (‘287, [0144]), 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).
With respect to claim 10, Morelli discloses the nutritional composition (formula) comprising the choline in amount of 24mg per 100 kcal (‘287, [0229]), which is in range with the cited range.
With respect to claim 11, Morelli discloses the nutritional composition (formula) comprising arachidonic acid in an amount of 36 mg of 5.3g total fat (‘287, [0229]), which corresponds to 0.07% of arachidonic acid of total fat, and in range with the cited range.
With respect to claim 12, Morelli discloses the nutritional composition (formula) comprising the docosahexaenoic acid in an amount of 17.8 mg of 5.3g total fat (‘287, [0229]), which corresponds to 0.03% docosahexaenoic acid of total fat, and in range with the cited range.
With respect to claim 13, Morelli discloses the sodium citrate (‘287, [0228]). Morelli does not explicitly disclose an amount as cited. However, it would have been obvious to one of ordinary skill in the art to be motivated to adjust an amount of the sodium citrate, including the cited amount in modified JP 2009513641’s formulation to provide a desired known health benefit (‘287, [0206], [0208]).
With respect to claim 14, Morelli discloses the nutritional composition (formula) comprising the lactoferrin in an amount of between about 15 and about 300 mg the lactoferrin per 100 kcal (‘287, [0099]) which is in range with the cited range.
With respect to claim 15, Morelli discloses the nutritional composition (formula) comprising 8.5 mg of the inositol per 100 kcal (‘287, [0229]), which is in range with the cited range.
With respect to claim 16, Morelli discloses the nutritional composition (formula) comprising 6 mg of the taurine per 100 kcal (‘287, [0229]), which is in range with the cited range.
With respect to claim 17, Morelli discloses the nutritional composition (formula) comprising 1 mg of the iron per 100 kcal (‘287, [0229]), which is in range with the cited range.
With respect to claim 18, Morelli discloses the nutritional composition (formula) comprising 2 mg of the carnitine per 100 kcal (‘287, [0229]), which is in range with the cited range.
With respect to claim 19, Morelli discloses the nutritional composition (formula) comprising 0.8 mg of the zinc per 100 kcal (‘287, [0229]), which is in range with the cited range.
With respect to claim 20, 23 and 25, Morelli does not explicitly disclose an amount of the nucleotides, biotin and lutein as cited. However, it would have been obvious to one of ordinary skill in the art to be motivated to adjust effective amounts of the nucleotides, biotin and lutein, including the cited amount in modified JP 2009513641’s formulation to provide a desired known health benefit (‘287, [0206], [0208]).
With respect to claim 21, Morelli discloses the nutritional composition (formula) comprising 570 ug the pantothenic acid per 100 kcal (‘287, [0229]), which is in range with the cited range.
With respect to claim 22, Morelli discloses the nutritional composition (formula) comprising 65 ug of the copper per 100 kcal (‘287, [0229]), which is in range with the cited range.
With respect to claim 24, Morelli discloses the nutritional composition (formula) comprising 18 ug of the folic acid per 100 kcal (‘287, [0229]), which is in range with the cited range.
With respect to claim 26, Morelli discloses the nutritional composition (formula) comprising 17 ug of the iodine per 100 kcal (‘287, [0229]), which is in range with the cited range.
With respect to claim 27, Morelli discloses the nutritional composition (formula) comprising 2.7 ug of the iodine per 100 kcal (‘287, [0229]), which is in range with the cited range
JP 2009513641 and Morelli are of the same field of endeavor of infant formula. It would have been obvious to one of ordinary skill in the art to use successful amounts of the ingredients as cited in claim 8-27, as taught by Morelli in modified JP 2009513641’s infant formulation to provide desired health benefits.
Response to Arguments
Applicant’s arguments with respect to claim(s) have been considered but are moot because the new ground of rejection does not rely on the reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
The 35 U.S.C. 103 rejection over claim(s) 1-7 as being unpatentable over JP 2009513641 (English Machine Translation) in view of 정승환 (KR 101249082 B1, Machine Translation English, Ref. U) has been withdrawn in light of Applicant’s amendment to recite new limitation in claim 1.
The 35 U.S.C. 103 rejection claim(s) 8-27 as being unpatentable over JP 2009513641 (English Machine Translation) in view of 정승환 (KR 101249082 B1, Machine Translation English, Ref. U) as applied to claim 1 above, and further in view of Morelli et al. (US 2018/0133287 A1) has been withdrawn in light of Applicant’s amendment to recite new limitation in claim 1.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). Morelli is not relied upon a teaching of an infant formula without polydextrose. JP 2009513641 (‘641) infant formulation (nutritional formula) does not contain polydextrose, and meet the limitation of the nutritional formula excludes polydextrose.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HONG THI YOO whose telephone number is (571)270-7093. The examiner can normally be reached M-F, 7AM to 3PM.
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/HONG T YOO/Primary Examiner, Art Unit 1792
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