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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 08/04/2026 was filed after the mailing date of the Non-Final Rejection on 06/12/2026. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Application Status
Amended claim 2-11, 13, 15-17 and new claim 21-26 are under examination.
Claim 1, 12, 14, and 18-20 are cancelled.
Claim 2-11, 13, 15-17 and 21-26 are rejected.
Withdrawn Rejections
The 112, second paragraph rejection over claim 9 has been withdrawn in light of Applicant’s amendment submitted on 09/02/2026.
The 35 U.S.C. 102(a)(1) rejection over claim 1-11, 13 and 15-17 as being anticipated by Benyacoub et al. (US 9,629,908 B2) in light of Applicant’s amendments.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 2-11, 12, 15-17 and 21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by van Neerven (US 2013/0011415).
Regarding claim 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 15, 16, 17, and 21, van Neerven discloses a method of administering (‘415, [0008]-[0011]) to an individual a composition, infant formula (‘415, [0014]) for treating (‘415, [0071]-[0072]) symptoms of infectious disease including virus in the respiratory tract. Van Neerven discloses the composition comprising antigen-specific antibody (‘415, claim 50 and 51) including IgA (biotic complex) and a mixture of probiotics including Lactobactillus and Bifidobacterium (‘415, [0090]). With respect to claim 5, van Neerven discloses Bifidobacterium infantis (‘415, [0090]). With respect to claim 7, van Neerven discloses Lactobacillus casei (‘415, [0090]). With respect to claim 21, van Neerven discloses the composition, infant formula including follow-on formula (‘415, [0082]).
With the recitation of “for the treatment of a respiratory viral infection” as recited in claim 11, 13, 15, 16 and 17, on language solely recited in preamble recitations in claim(s). When reading the preamble in the context of the entire claim, the recitation in claim 11, 15, 16 and 17 are not limiting because the body of the claim describes a complete invention and the language recited solely in the preamble does not provide any distinct definition of any of the claimed invention’s limitations. Thus, the preamble of the claim(s) is not considered a limitation and is of no significance to claim construction. See Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999). See MPEP § 2111.02. Additionally, it has been held that where the claimed and prior art products are identical or substantially identical in structure or are produced by identical or substantially identical process, a prima facie case of either anticipation or obviousness will be considered to have been established over functional limitation that stem from the claimed structure (product). The prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed products. In re Best, 195 USPQ 430, 433 (CCPA 1977), In re Spade, 15 USPQ2d 655,1658 (Fed. Cir. 1990).
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) 22, 23, 24, 25 and 26 are rejected under 35 U.S.C. 103 as being unpatentable over van Neerven (US 2013/0011415) as applied to claim 11 above, and further in view of Wilson (US 2003/0060445).
Regarding claim 22, 24 and 25, van Neerven discloses the method of administering (‘415, [0008]-[0011]) to the individual the composition, infant formula (‘415, [0014]) wherein the composition comprises prebiotic oligosaccharides including siallyllactose (SL) and fucosyllactose (FL) (‘415, [0090]). Van Neerven does not explicitly disclose the siallyllactose (SL) as 3’ siallyllactose and 6’ siallyllactose. However, Wilson discloses a nutrition formulation, infant formula (‘445, [0018]-[0019]) comprising prebiotic oligosaccharides including siallyllactose (SL) including 3’ siallyllactose and 6’ siallyllactose (‘445, [0007]-[0008]). Wilson and van Neerven are of the same field of endeavor of nutritional composition, infant formula comprising prebiotic oligosaccharides including siallyllactose (SL). It would have been obvious to one of ordinary skill in the art to be motivated to use Wilson’s prebiotic oligosaccharides including siallyllactose (SL) including 3’ siallyllactose and 6’ siallyllactose (‘445, [0007]-[0008], claim 2, 3, 4) in van Neerven’s composition to promote beneficial microorganisms and the inhibition of pathogenic organisms (‘445, [0002]). With respect to claim 25, Wilson discloses the mixture of the 3’ siallyllactose and 6’ siallyllactose in an amount of 6 mg/L to 10 g/L (‘445, claim 5), which overlaps the cited range. 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). Wilson does not disclose a ratio of the 3’ siallyllactose to the 6’ siallyllactose as cited, whoever it would have been obvious to one of ordinary skill in the art to optimize the amounts of the 3’ siallyllactose to the 6’ siallyllactose in modified van Neerven’s composition to provide a desired beneficial microorganisms and the inhibition of pathogenic organisms (‘445, [0002]) as taught by Wilson.
Regarding claim 23 and 26, van Neerven discloses the composition comprising the antigen-specific antibody (‘415, claim 50 and 51) including the IgA (biotic complex) and the mixture of probiotics including Lactobactillus and Bifidobacterium (‘415, [0090]). van Neerven’s mixture of the IgA (biotic complex) and the probiotics including the Lactobactillus and the Bifidobacterium (‘415, [0090]) is expected to layer coat next to each other the mixture. With respect to claim 26, modified van Neerven is silent on amount of the mixture of the probiotics Bifidobacterium infantis coated with 10 ug SigA. However, it would have been obvious to one of ordinary skill in the art to adjust amounts of the Bifidobacterium infantis with SigA to provide a desired health benefit, absent a clear and convincing argument or evidence to the contrary.
Response to Arguments
Applicant’s arguments with respect to claim(s) 2-11, 13, 15-17 and new claim 21-26 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.
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 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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