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
This application is a US national phase of PCT/JP2020/022291, filed June 5, 2020, with a foreign priority application JP2019-105521, filed June 5, 2019.
Applicant’s amendment filed January 9, 2026 is acknowledged. Claims 1-12, 15-16, and 18-19 are canceled, and claims 13 and 17 are amended. Currently claims 13-14 and 17 are pending and under examination.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 January 9, 2026 has been entered.
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.
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 13-14 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Van (WO 2013/025104 A1, cited in PTO-892 mailed 9/26/2024, hereinafter “Van”) in view of Thongaram et al. (J. Dairy Sci. 2017, 100:7825-7833, hereinafter “Thongaram”).
Regarding claims 13 and 17, Van teaches a method of administering to infants a composition comprising HMO’s and lactoferrin and assessing fecal microbiota before and after administration (pg. 25-26, Materials & Methods, Table 2). Van teaches the composition comprises 0.1g each of 2’FL and lactoferrin, which calculates to each compound is present in an amount of 0.8% by mass of the total composition, which meets the limitations in claim 13 (pg. 32, Example 5, Formula C).
Van teaches the babies administered the composition with lactoferrin and HMO’s (2’FL) promoted growth of Bifidobacterium, though a lower effect was noted compared with the composition comprising 100% lactoferrin (pg. 31, lines 16-19, pg. 28, lines 13-16).
Van does not specifically teach the Bifidobacterium is B. infantis M-63 strain.
However, Thongaram teaches HMO consumption by probiotic and human-associated bifidobacteria, and discloses out of 24 strains tested, B. infantis M-63 is able to ferment and degrade almost 90% of 2’-fucosyllactose in an in-vitro HMO growth study (abstract). Thongaram teaches in-vitro HMO utilization experiments revealed strain-dependent HMO fermentation, specifically B. infantis consumes fucosylated, sialylated, and Type I & II HMO (pg. 7825, col. 2, para 2). Thongaram also teaches overwhelmingly their results support the conclusion that B. infantis strains are uniquely efficient HMO utilizers compared with most other commensal GIT bifidobacteria (pg. 7828, col. 1, para 1). Thus, the property of promoting this particular bacterial strain is inherently a part of the composition taught by Van.
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to administer the composition taught by Van to promote the growth of B. infantis M-63 as taught by Thongaram with a reasonable expectation of success. A person of ordinary skill in the art would have been motivated to target B. infantis M-63 due to its well-known health benefits and compatibility with 2’-fucosyllactose based compositions. The claimed method differs from Van only in the selection of a known bifidobacterial species (B. infantis M-63), which would have been obvious to a person of ordinary skill in the art at the time of the invention.
Regarding claim 14, Van does not explicitly teach the mass ratio recited in claim 14. However, Van teaches the protective effect of the additive (i.e. lactoferrin) allows for the supplementation with lower concentrations of (synthetic) complex HMOs while still achieving an effect similar to breast milk (pg. 9, lines 19-22). Van teaches the ratio of 2’FL to lactoferrin is between 10:1 to 1:200 by weight, and the protective compound (e.g. lactoferrin) is present in excess of the HMO (pg. 14, lines 18-22). Van teaches the composition comprises 0.02-10 wt% 2’FL and 0.24-15 wt% of the protective compound (i.e., lactoferrin), which calculates to a mass ratio of 0.08-0.7 wt% of the composition, thus overlapping with the instant range recited in claim 14 (pg. 14, lines 28-30). 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).
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the methods taught by Van and Thongaram by selecting specific concentrations of 2’FL to lactoferrin, to effectively promote growth of Bifidobacterium species. The selection of specific concentrations clearly would have been a routine matter of optimization using standard laboratory techniques available at the time of filing on the part of the artisan of ordinary skill, said artisan recognizing that the effectiveness of the composition would have been affected by these concentrations. Furthermore, there is no evidence on the record that indicates that the claimed ratio of 2’FL to lactoferrin exhibits any unexpected results compared to the prior art.
Response to Arguments
Applicant’s arguments with respect to claim(s) 13-14 and 17 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Applicant’s arguments are directed to the newly added limitation B. infantis (M-63).
Applicant also argues the claimed method results in an unexpected synergistic effect produced by the combination of lactoferrin and 2’FL, which showed an enhanced effect on the growth of M-63. Thus Applicant argues this effect would not have been expected by the prior art.
As described above in the new 103 rejection, it would have been obvious to determine if the lactoferrin and 2FL composition that enhances bifidobacterial growth taught by Van would also enhance the particular claimed B. infantis M-63 strain taught by Thongaram. Thus Applicant’s alleged unexpected results to the claimed amounts or ratios in the composition would represent routine optimization of result-effective variables, therefore is not sufficient to overcome obviousness.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JESSICA EDWARDS whose telephone number is (571)270-0938. The examiner can normally be reached M-F 8am-5pm EST.
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/LOUISE W HUMPHREY/Supervisory Patent Examiner, Art Unit 1657
/JESSICA EDWARDS/
Examiner, Art Unit 1657