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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 02/16/2026 (RCE) and 01/21/2026 (amended claims) has been entered.
Application Status
Amended claim 6, 8-9 and 15 are under examination.
Claim 1-5, 7 and 10-14 are cancelled.
Claim 16 is withdrawn from examination.
Claim 6, 8-9 and 15 are rejected.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 6, 8-9 and 15 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 6 recites new limitation of “…not an infant of non-Chinese ethnicity and/or born from a mother of non-Chinese ethnicity…” is not supported in the instant specification as filed. The new limitation is considered a negative limitation, wherein the instant specification does not support. Attention is directed to MPEP 2173.05(i)…[a]ny negative limitation or exclusionary proviso must have basis in the original disclosure. If alternative elements are positively recited in the specification, they may be explicitly excluded in the claims. See In re Johnson, 558 F.2d 1008, 1019, 194 USPQ 187, 196 (CCPA 1977) ("[the] specification, having described the whole, necessarily described the part remaining."). See also Ex parte Grasselli, 231 USPQ 393 (Bd. App. 1983), aff’d mem., 738 F.2d 453 (Fed. Cir. 1984). In describing alternative features, the applicant need not articulate advantages or disadvantages of each feature in order to later exclude the alternative features. See Inphi Corporation v. Netlist, Inc., 805 F.3d 1350, 1356-57, 116 USPQ2d 2006, 2010-11 (Fed. Cir. 2015). The mere absence of a positive recitation is not basis for an exclusion.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 6, 8-9 and 15 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.
The term “non-Chinese ethnicity” in claim 6 is a relative term which renders the claim indefinite. The term “non-Chinese ethnicity” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
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) 6, 8, 9, and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Buck et al. (US 2012/0172330).
Regarding claim 6, 8, 9, and 15, Buck et al. (Buck) discloses a method of providing a nutritional composition, synthetic pediatric formula (‘330, [0006]m [0007], [0009]-[0011]) comprising a mixture of 3’-sialyllactose (3’-SL) and 6’-sialyllactose (6’-SL) in a concentration (‘330, [0008], claim 1-6) to infant, up to age 36 months (‘330, [0044]), wherein the Buck’s age 0 to 36 months overlaps the cited range.
Buck discloses the nutritional composition, synthetic pediatric formula is in powder format and reconstituted (adding) with water (‘330, [0035]-[0036]). Buck discloses a concentration of the 3’-sialyllactose (3’-SL) in a range of about 0.001 mg/ml to less than 0.15 mg/ml, (‘330, [0008]) which corresponds to 1 mg/L to less than 150 mg/L, which overlaps the cited range; and a concentration of the 6’-sialyllactose (6’-SL) in a range of about 0.001 mg/ml to less than 0.25 mg/ml (‘330, claim 5), which corresponds to about 1 mg/L to less than 250 mg/L, 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). With respect to claim 8, Buck’s concentration ranges of the 3’-sialyllactose (3’-SL) and 6’-sialyllactose (6’-SL) are considered optimal levels.
With respect to claim 6, the limitations of “not an infant of non-Chinese ethnicity” and “…wherein the Chinese infant is an infant of Chinese ethnicity and/or born from a mother of Chinese ethnicity”; Buck clearly teaches the method of the administering of the nutritional composition, synthetic pediatric formula to the infant (‘330, [0140]). It would have been obvious to one of ordinary skill in the art to administer the nutritional composition, synthetic pediatric formula to an infant of any racial background or ethnicity group including of Chinese ethnicity in need of assistance of disease or condition (‘330, [0143]) as motivated by Buck (‘330, [0140]-[0141]), absent evidence to the contrary.
It is noted the cited “the administering of the synthetic nutritional composition promotes brain and/or bone development”, is considered a functional limitations of the claimed product when the synthetic nutritional composition is administered to the infant; hence 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).
As Buck clearly teaches the method of the administering of the nutritional composition, synthetic pediatric formula to the infant (‘330, [0140]). Buck uses like materials in a like manner as claimed, it would therefore be expected that Buck’s nutritional composition, synthetic pediatric formula will have the same characteristics claimed, particularity promotes brain and/or bone development as recited in claim 6; and promotes metabolic health as recited in claim 9. Buck discloses the nutritional composition, synthetic pediatric formula for metabolic health, such as reducing inflammation (‘330, [0008]-[0011]).
Response to Arguments
Applicant's arguments filed 01/21/2026 have been fully considered but they are not persuasive.
With respect to claim 6, the limitations of “not an infant of non-Chinese ethnicity” and “…wherein the Chinese infant is an infant of Chinese ethnicity and/or born from a mother of Chinese ethnicity”; Buck clearly teaches the method of the administering of the nutritional composition, synthetic pediatric formula to the infant (‘330, [0140]). It would have been obvious to one of ordinary skill in the art to administer the nutritional composition, synthetic pediatric formula to an infant of any racial background or ethnicity group including of Chinese ethnicity in need of assistance of disease or condition (‘330, [0143]) as motivated by Buck (‘330, [0140]-[0141]), absent evidence to the contrary.
It is noted, Applicant has not provided a showing of statistical and practical significance of the criticality. (i.e. several data points that confirm the test result was not just a statistical flier, all infants of non-Chinese ethnicity, all infants of Chinese ethnicity) The results are not shown to be due to the claimed features (including how the ranges for the components are established, in other words how the specifically claimed ranges provide the unexpected result), not to unclaimed features, including a sufficient number of tests both inside and outside the claimed range to show the criticality of the claimed narrow range.
Conclusion
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.
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, ERIK KASHNIKOW can be reached at (571)270-3475. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/HONG T YOO/Primary Examiner, Art Unit 1792