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 .
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) 1-9,12-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Berger(WO 2017/021476) in view of Benyacoub(US2012/0321600).
Regarding claims 1-4,8,9,12,13,17,18, Berger teaches a nutritional composition comprising(p.19, line 32-p.20, line 2; p.18, line 16-25)
Human milk oligosaccharides in the form of N-acetylated oligosaccharide and a siaylated oligosaccharide
A prebiotic combination comprising a combination of Galacto-oligosaccharide(GOS) and polydextrose
Wherein the nutritional composition is adapted and formulated for administration/delivery to an infant delivered by C-section(claim 13) and promotes development and stabilization of a healthy core microbiome comprising at least one bacterial species capable of producing compounds beneficial for the functioning of the c-section infant’s gut(abstract). The bacterial species can be in the form of B. longum or Bifidobacterium lactis(p.21-22).
Berger is silent as to the presence of milk fat globule membrane(MFGM). However, Benyacoub teaches a nutritional composition comprising a probiotic and milk fat globule membrane (MFGM) from a bovine source wherein the MFGM and the probiotics mutually potentiate their respective effects and promote complementary beneficial protective mechanisms that reflect physiological synergy. The nutritional composition can be an infant formula, infant cereals, baby food or health care nutritional product. The synergistic effect can include promoting immune maturation and/or immune education and/or reducing inflammation and/or treating or preventing disease or infections(abstract, paragraph 35). Benyacoub teaches including from 0.01g to 0.1 g of MFGM per 100g of liquid composition(paragraph 34). Since infant formula is mostly water, 100g would roughly be equivalent to 100ml. Therefore, the formula would contain 0.1mg/ml to 1mg/ml, which is “about 1.5mg/ml” as claimed. It would have been obvious to include MFGM in an amount of 0.1mg/ml to 1mg/ml and probiotics in the nutritional composition of Berger as taught in Benyacoub in order to promote immune maturation and/or immune education and/or reducing inflammation and/or treating or preventing disease or infections.
Berger teaches the presence of lactoferrin in the infant formula(p.26, line 20-21) but does not specifically teach a non-human lactoferrin. However, Berger further teaches oligosaccharide should be from a bovine source(p.19, line 24-25). Therefore, it would have been obvious to have the lactoferrin come from a bovine source in order to have a consistent source throughout the composition.
Berger teaches that the composition promotes a guy microbiome similar to a breast fed infant(abstract). Since Berger and Benyacoub teach administering to an infant the composition of claim 1, one of ordinary skill in the art to expect that the composition would modify the Bacteroidetes to Firmicutes ratio in the claimed amount.
Regarding claims 5,14, Berger teaches that the siaylated oligosaccharide can be in the form of 3’ sialyllactose or 6’ saiyllactose(p.20, line 4-9).
Regarding claims 6,15, Berger teaches that the human milk oligosaccharide N-acetylated oligosaccharide is present in an amount of 0.5-0.8g/L(p.17, line 6-7) and the siaylated oligosaccharide is present in an amount of 0.05 to 5g/L(p.20, line 28-32). Therefore, the total amount of human oligosaccharide equates to 0.55mg/ml to 5.8mg/ml
Regarding claims 7,16, Berger teaches that GOS and PDX are present in an amount of 0 to 10%(0 to 100 mg/ml)(p.18, line 16-25), which overlaps the claimed range of about 1mg/1mg to about 6mg/ml.
Claim(s) 10,11,19,20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Berger(WO 2017/021476) in view of Benyacoub(US2012/0321600) further in view of Wittke(US 2015/0125570).
Regarding claims 10,19, Berger does not specifically teach the presence of beta-glucan in the infant formula. However, Wittke teaches an infant formula that can comprise beta-glucan(paragraph 132). Wittke teaches that addition of a beta-glucan to infant formula “will improve the subject’s immune response by resistance against invading pathogens and therefore maintaining or improving overall health”(paragraph 136). It would have been obvious to include beta-glucan in the formula of Berger as taught in Wittke in order to “improve the subject’s immune response by resistance against invading pathogens and therefore maintaining or improving overall health”.
Regarding claims 11,20, Berger teaches the presence of iron in the composition(p.26, line 6-15) but does not specifically identify the source. However, Wittke teaches that the infant formula comprises minerals such as iron from ferric orthophosphate or ferrous fumarate(paragraph 142). It would have been obvious to use ferric orthophosphate or ferrous fumarate as the iron source in Berger since Wittke teaches that they are both conventional iron sources in infant formula.
Conclusion
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/KATHERINE D LEBLANC/Primary Examiner, Art Unit 1791
