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 .
Application Status
Amended claim 6, 8-9, 15 and new claim 17 and 18 are under examination.
Claim 1-5, 7 and 10-14 are cancelled.
Claim 16 is withdrawn from examination.
Withdrawn Rejections
The 112, second paragraph rejection as set forth in previous office action with respect to recitation in claim 6, “not an infant of non-Chinese ethnicity” has been withdrawn in light to Applicant’s amendment.
Claim Objections
Claim 17 is objected to because of the following informalities: recitation of “born born” in line 1-2, appears to be a typographical error. Appropriate correction is required.
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, 15 and 17 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, line 3 recites new limitation of “…but not an infant born from a European mother…” and claim 17, “the Chinese infant was not born from mother in Germany, Ireland, Switzerland, Spain, France, Italy, Norway, Portugal, Romania, or Sweden” are not clearly supported in the specification as filed. It is noted instant specification in published [0079]-[0084] and [0091] disclose studies with mother and infant in specific European countries and/or regions, but there is not support for “not an infant born from a European mother”, in others words there is no disclosure to an infant born is from a European mother but only disclosure a location, i.e. Spain, France or Italy. The specification supports studies performed in Europe and China, but no clear disclosure of a “not an infant born from a European mother” or “the Chinese infant was not born from a mother in Germany, Ireland, Switzerland, Spain, France, Italy, Norway, Portugal, Romania, or Sweden”.
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.
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, 15, 17 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Buck et al. (US 2012/0172330).
Regarding claim 6, 8, 9, 15 and 17, 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 infant age of 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 new limitation of “not an infant from a European mother” in line 3; and the limitation of “…wherein the Chinese infant is born from a mother of Chinese ethnicity”; and new claim 17, the limitation of “…the Chinese infant was not born from mother in Germany, Ireland, Switzerland, Spain, France, Italy, Norway, Portugal, Romania, or Sweden…”; Buck clearly teaches the method of the administering of the nutritional composition, synthetic pediatric formula to the infant (‘330, [0140]). Buck does not explicitly disclose not an infant from a European mother nor the Chinese infant born from a mother of Chinese ethnicity. However, 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/and ethnicity group including from a mother of Chinese ethnicity or not from European mother, in need of assistance of disease (‘330, [0143]) as motivated by Buck (‘330, [0140]-[0141]), absent evidence to the contrary.
With respect to the limitation of “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]).
Regarding claim 18, 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 infant age of 0 to 36 months overlaps the cited range.
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 the recitation of “…Chinese infant was born in China”, Buck clearly teaches the method of the administering of the nutritional composition, synthetic pediatric formula to the infant (‘330, [0140]). Buck does not explicitly disclose a Chinese infant was born in China. However, 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 including a Chinese infant born in China, in need of assistance of disease (‘330, [0143]) as motivated by Buck (‘330, [0140]-[0141]), absent evidence to the contrary.
Response to Arguments
Applicant's arguments filed 06/10/2026 have been fully considered but they are not persuasive.
Applicant maintains that, Buck fails to disclose or suggest each and every element of the
present claims. For example, Buck fails to disclose administering a nutritional composition to a
Chinese infant, but not an infant born from a European mother. Buck does not disclose the claimed subject, namely, a Chinese infant between 0 and 6 months of age. Buck provides no teaching or suggestion to administer a composition, let alone the claimed composition, to the claimed Chinese infant, which excludes infants born from a European mother.
In response to Applicant’s remarks, as noted in the rejection above With respect to claim 6, the new limitation of “not an infant from a European mother” in line 3; and the limitation of “…wherein the Chinese infant is born from a mother of Chinese ethnicity”; and new claim 17, the limitation of “…the Chinese infant was not born from mother in Germany, Ireland, Switzerland, Spain, France, Italy, Norway, Portugal, Romania, or Sweden…”; Buck clearly teaches the method of the administering of the nutritional composition, synthetic pediatric formula to the infant (‘330, [0140]). Buck does not explicitly disclose not an infant from a European mother nor the Chinese infant born from a mother of Chinese ethnicity. However, 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/and ethnicity group including from a mother of Chinese ethnicity or not from European mother, in need of assistance of disease (‘330, [0143]) as motivated by Buck (‘330, [0140]-[0141]), absent evidence to the contrary.
Applicant asserts “…"One way for a patent applicant to rebut a prima facie case of obviousness is to make a showing of unexpected results,' i.e., to show that the claimed invention exhibits some superior property or advantage that a person of ordinary skill in the relevant art would have found surprising or unexpected." As set forth in In re Soni, "when an applicant demonstrates substantially improved results [...] and states that the results were unexpected, this should suffice to establish unexpected results in the absence of evidence to the contrary." The experimental results set forth by the specification and reiterated herein rebut any alleged prima facie case of obviousness based on the cited references because Applicant's Table 2 clearly shows, based on statistical analysis, a clear difference between the level of 3'SL and 6'SL in China and Europe…”
In response to Applicant’s remarks, Applicant has not provided a showing of statistical and practical significance of the criticality. 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.
Furthermore, in response to Table 2; Applicant’s study 2 denoted as Europe, then Germany, Ireland and Switzerland has own studies in 6, 8, 9 respectively. Studies 2, 6, 8 and 9 are Longitudinal Study whereas China in Study 5 is a Cross-sectional Study. It is well known, Cross-sectional studies provide a snapshot of a population at a single point in time, whereas Longitudinal studies track the same individuals over time to observe changes and causal relationships. Additionally, the birth studies are all different stages, different population numbers in each studies, i.e. different days, and months in each studies for sample collections in the studies. Multiple variables and parameters is not clear how data are comparable between infants wherein the Study of China and Europe have different parameters of testing, i.e. Longitudinal Study and Cross-sectional Study. Hence Applicant does not provide a showing criticality. With respect to unexpected results, the Examiner’s assertions that feeding, a composition that has 3’SL and 6’SL will be suitable for all infants as the composition has been disclosed as a human milk fortifier specially for 3’SL and 6’SL to any infant as taught by Buck to be found to be lacking would be in fact would be the expected outcome, a supplementation with 3’SL and 6’SL.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Ameye et al. (US 2015/0088304 A1) discloses a system of providing metered amounts of ingredients to a nutritional composition for use in administration to an infant (Abstract; [0029]). The nutritional composition ([0063]-[0067] is tailored to that specific infant ([0012], [0113]-[0114]); however Ameye et al. does not discloses parameter including an infant ethnical background or maternal location.
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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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.
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/HONG T YOO/Primary Examiner, Art Unit 1792
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