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 .
Applicants' arguments, filed 09/02/2025, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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. They constitute the complete set presently being applied to the instant application.
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-6, 9, 17, and 18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Reverri et al (Nutrients, 2018, 10(10), 1346; https://doi.org/10.3390/nu10101346).
Reverri et al discloses 2’-FL was known to be synthetically synthesized and included in some commercial infant formulas where the formulations provided reduction in respiratory infections, improved immune systems, and improved gut health (see Abstract, pg2, lines 17-28, and Table 1). Some of the disclosed formulas included 2’-FL: at 0.2g/L (Table 1)
As previously noted, while the instantly claimed mechanism of increasing Kynurenic acid production by the microbiota may not be recognized in the prior art, it appears to be inherent in the method where the only active step includes administration of 2’-FL in a formulation which is not breast milk. See MPEP 2112(I).
Claims 1-6, 9, 17, and 18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Stahl (WO 2011/136648).
Stahl teaches formulations with 2’-FL and LNT and 6’-SL were known oligosaccharides in human milk present in high concentrations (pg 18 lines 29-32 and pg 20 lines 27-34). Additional oligosaccharides may be present which act as prebiotics (pg 2 lines 5-7). The amount of 2’-FL is taught to vary based on the other oligosaccharides (pg 9 lines 15-32). The formulations may be used to reduce infections disease, including diarrhea (pg 24 line 31 to pg 25 line 4).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 1-6, 9, and 17-22 are rejected under 35 U.S.C. 103 as being unpatentable over Stahl (WO 2011/136648).
Stahl is discussed above but does not disclose a composition with 2’-FL, LNT, and 6’-SL as actives or the ratio of components.
It would have been obvious to one of ordinary skill in the art to combine the actives disclosed in Stahl to produce an infant formulation comprising 2’-FL, LNT, and 6’-SL, and then to vary the concentration based on the teaching of the prior art in order to optimize the benefit, i.e. nutritional properties of the resulting formulation.
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 BENJAMIN J PACKARD whose telephone number is (571)270-3440. The examiner can normally be reached Mon-Fri (8am-5pm + mid-day flex).
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sandy Kaup can be reached at (571) 272-6897. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BENJAMIN J PACKARD/ Primary Examiner, Art Unit 1612