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 .
DETAILED ACTION
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 2/2/26 has been entered.
Claims 2-19 are pending. Claims 8 and 14 are withdrawn. Claims 2 and 4 have been amended. Claims 2-7, 9-13, and 15-19 are under consideration.
Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied and constitute the complete set presently being applied to the instant application.
Election/Restrictions
Applicant’s election without traverse of the species of eHF as the infant formula and ear infections as the type of infection in the reply filed on 5/9/25 is acknowledged.
The elected species are free of the art.
The claims will be considered to the extent of the non-elected species, AAF and respiratory infections.
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 of this title, 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claims 2-6 and 8-19 are rejected under 35 U.S.C. 103 as being unpatentable over Sprenger et al. (WO 2016/139328; cited in IDS) in view of Łoś-Rycharska (Gastroenterology Rev 2016).
Sprenger et al. teach a nutritional composition comprising at least one fucosylated oligosaccharide and at least one N-acetylated oligosaccharide in particular amounts, for use in preventing and/or treating infections and/or inflammations of the lower respiratory tract and/or of the ear in an infant or a young child (e.g. abstract).
Regarding Claims 2-6, 8, and 10-19, Sprenger et al. exemplify an infant formula comprising: 1.83 g of protein per 100 kcal, 5.3 g fat per 100 kcal, 1 g/L 2FL and 0.5 g/L LNnT (e.g. Example 1). The composition does not appear to include any MCTs (i.e. 0%). While not explicitly exemplified, Sprenger et al. teach that the proteins may be fully hydrolyzed (i.e. 100% hydrolyzed), wherein a protein has been hydrolyzed or broken down into its component amino acids (i.e. AAF) (e.g. page 26, line 18-page 27, line 11). Sprenger et al. teach that the composition according to the invention is a hypoallergenic nutritional composition (e.g. page 10, lines 27-30). It would have been obvious to one of ordinary skill in the art to have selected fully hydrolyzed proteins (i.e. amino acids) for the infant formula for administration to infants who are intolerant or allergic to cow’s milk protein allergens because Sprenger et al. teach that it may be desirable to supply hydrolysed proteins, for example for infants or young children believed to be at risk of developing cow's milk allergy (e.g. page 26, lines 18-22).
The composition of Sprenger et al. does not appear to include any MCTs (i.e. 0%). In addition, as disclosed by Łoś-Rycharska et al., medium-chain triglycerides are not recommended as an additive to standard formulas for healthy children. Their use should be limited to strictly specified medical indications (e.g. page 229, column 2, last paragraph).
It would have been obvious to one of ordinary skill in the art at the time of filing to limit or omit MCTs in the compositions of Sprenger et al. because (1) they are not recited or required by Sprenger et al. and (2) Łoś-Rycharska et al. teach that MCTs are not recommended as an additive to standard formulas for healthy children.
Regarding Claim 9, Sprenger et al. teach from 1.6 to 3 g of protein per 100 kcal, which overlaps the claimed range (e.g. page 25, lines 27-32). 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) (MPEP 2144.05.I).
Allowable Subject Matter
Claim 7 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Response to Arguments
Applicant's arguments filed 1/2/26 have been fully considered but they are not persuasive. Arguments relevant to the current grounds of rejection will be addressed below.
Regarding the unexpected results provided by Example 1, the Examiner is persuaded to the extent of the compositions tested, however the claims are not commensurate in scope with Example 1. Whether the unexpected results are the result of unexpectedly improved results or a property not taught by the prior art, the “objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support.” In other words, the showing of unexpected results must be reviewed to see if the results occur over the entire claimed range. In re Clemens, 622 F.2d 1029, 1036, 206 USPQ 289, 296 (CCPA 1980). No data has been provided for an amino acid-based formula.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NICOLE PLOURDE BABSON whose telephone number is (571)272-3055. The examiner can normally be reached M-Th 8-4:30; F 8-12:30.
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/NICOLE P BABSON/Primary Examiner, Art Unit 1619
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