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 .
Election/Restrictions
Applicant’s election without traverse of Group I, claim 20-32 in the reply filed on July 13, 2026 is acknowledged.
Claim 33-35 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group II, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on July 13, 2026.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on June 13, 2024 and July 22, 2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 112
Claim 20-32 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 20 recites the phrase “…able to express at least one extracellular enzyme selected from a fucosidase, and a sialidase…” in line 3-4, is confusing. It is not clear if the least one extracellular enzyme selected from a fucosidase, and a sialidase, is a component within the claimed nutritional composition. For examination purposes the limitation is considered a functional limitation of the Bifidobacterium bifidum strain’s ability to express with at least one extracellular enzyme selected from a fucosidase, and a sialidase; wherein the least one extracellular enzyme s is not required component in the claimed nutritional composition. Claim 21-32 are also rejected since the claims are depended upon rejected claim 20.
Claim 20 recites the phrase “…able to metabolize a saccharide selected from L-fucose and sialic acid…” in line 3-4, is confusing. It is not clear if the saccharide selected from L-fucose and sialic acid, is a component within the claimed nutritional composition. For examination purposes the limitation is considered a functional limitation of the Bifidobacterium breve strain’s ability to able to metabolize saccharide selected from L-fucose and sialic acid; wherein the saccharide selected from L-fucose and sialic acid is not required component in the claimed nutritional composition.
Claim 24 recites the phrase “…able to express extracellular beta 1,4 endogalactanase…”, is confusing. It is not clear if extracellular beta 1,4 endogalactanase, is a component within the claimed nutritional composition. For examination purposes the limitation is considered a functional limitation of the Bifidobacterium breve strain’s ability to express extracellular beta 1,4 endogalactanase; wherein the beta 1,4 endogalactanase is not required component in the claimed nutritional composition.
Regarding claim 32, the phrase "preferably" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
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) 20-32 are rejected under 35 U.S.C. 103 as being unpatentable over Schmitt et al. (US 2011/0150851) and in view of Buck et al. (US 11,337,990 B2).
Regarding claim 20, 21, 22, 23, 24, 25 and 27, Schmitt et al. (Schmitt) discloses a composition, infant formula (nutritional composition) (‘851, [0053]) comprising at least four different at least four different Bifidobacterium species, which includes B. breve CNCM 1-2219 and B. bifidum (‘851, [0029)]. Schmitt’s B. breve CNCM 1-2219 is expect to have functional property of able to metabolize a saccharide, L-fucose as disclosed as much as Applicant’s B. breve C50 also known as CNCM 1-2219 (instant application published [0034]-[0035]). Additionally, Schmitt’s B. bifidum (‘851, [0029) encompasses the functional limitation of the Bifidobacterium bifidum strain’s ability to express with at least one extracellular enzyme selected from a fucosidase, and a sialidase as recited in claim 20.
Schmitt discloses the composition comprising galacto-oligosaccharides and lacto-N-neotetraose, fucosyl-lactose, fucosylated LNT refers to lacto-N-tetraose (LNT) (human milk oligosaccharides) (‘851, [0044]). Schmitt’s galacto-oligosaccharides comprising beta 1,4-linkages with an average degree of polymerization of 3 to 6 (‘851, [0046]), which overlaps the cited range of claim 20 and 25. 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 25, Schmitt discloses the galacto-oligosaccharides comprising beta 1,4-linkages as a non-digestible carbohydrates (‘851, [0044]) in a range of 80 mg to 3 g per 100 ml of the composition (‘851, [0051]), which overlaps the cited range of claim 25.
With respect 2’fucosyllactose as recited in claim 20 and 22, Schmitt does not explicitly disclose the fucosyl-lactose, fucosylated LNT (human milk oligosaccharides) (‘851, [0044]) includes 2’fucosyllactose. However, Buck et al. (Buck) discloses nutritional composition for infant comprising human milk oligosaccharides (‘990, col. 5, ln. 1-8; col. 6, ln. 39-59) including 2’fucosyllactose (‘990, col. 11, ln. 57-63) and probiotic strains, B. breve and B. bifidum (‘990, col. 18, ln. 58). Buck and Schmitt are of the same field of endeavor of nutritional composition for infant, comprising human milk oligosaccharides and probiotic strains, B. breve and B. bifidum. It would have been obvious to one of ordinary skill in the art to use Buck’s human milk oligosaccharides (‘990, col. 5, ln. 1-8; col. 6, ln. 39-59) including 2’fucosyllactose (‘990, col. 11, ln. 57-63) in Schmitt’s composition to provide a synergistic benefit in promoting growth of
microbiota in gastrointestinal tract of infant as taught by Buck (‘990, col. 18, ln. 21-45). Modified Schmitt’s composition is not mammalian milk (‘990, col. 5, ln. 1-8; col. 6, ln. 39-59). With respect to claim 21 and 23, Buck’s human milk oligosaccharides (‘990, col. 5, ln. 1-8; col. 6, ln. 39-59) including 2’fucosyllactose (‘990, col. 11, ln. 57-63) in an amount of from 2.5 mg/ml to about 20 mg/ml (‘990, col. 2, ln. 47-54), which overlaps the cited range.
With respect to claim 27, Schmitt’s B. bifidum (‘851, [0029]) does express beta 1,4 endogalactanase.
Regarding claim 26, modified Schmitt discloses the composition comprising fructo-oligosaccharides (‘ also known as non-digestible polyfructose (‘851, [0050]).
Regarding claim 28, Schmitt’s B. breve CNCM 1-2219 is expect to have functional property of does not express fucosidase and do not express sialidase, as much as Applicant’s B. breve C50 also known as CNCM 1-2219 (instant application published [0034]-[0035]).
Regarding claim 29, modified Schmitt discloses the Bifidobacterium species, which includes B. infantis and B. longum (‘851, [0029]).
Regarding claim 30, modified Schmitt discloses optional lactobacilli (‘851, claim 21), hence Schmitt meets the limitation of the composition does not comprise lactobacilli.
Regarding claim 31, modified Schmitt discloses the Bifidobacterium species, which includes B. breve CNCM 1-2219 and B. bifidum (‘851, [0029]), in amount of more than 1x106 cfu (‘851, [0041]) on dry weight, which overlaps the cited range.
Regarding claim 32, modified Schmitt discloses the composition, infant formula comprising protein, fat, carbohydrates (‘851, [0053]-[0056]), vitamins and minerals (‘851, [0083], [0088]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
James et al. discloses Bifidobacterium breve M‑16V and L‑Fucose Metabolism wherein Bifidobacterium breve M‑16V strain expresses enzymes such as L‑fucosidases and fucose‑1‑phosphate aldolase, which break down L‑fucose into metabolites that can be further processed for energy production (pg. 1, Abstract).
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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