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 II (claim 10 and 11), species of claim 11 in the reply filed on 07/22/2026 is acknowledged.
Claim 2-5, 8, 9 and 12 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Group I, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 07/22/2026.
Application Status
Claim 10 and 11 are under examination.
Claim 2-5, 8, 9 and 12 are withdrawn from examination.
Claim 10 and 11 are rejected.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 04/11/2024 and 04/27/2026 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claim 11 objected to it because of the following informalities: the values and unit of measurement should have a space between them. Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 10 is 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 10 recite the term “combination” is not clear. It is not clear what the term “combination” encompasses to meet the limitation. Does Applicant intend the “combination” is a composition, product, since “combination” is not a recognized category. Additionally, the claim is improper claim construction wherein the claim does not recite a transitional language such as “comprising” or “consisting”; hence it is not clear if the claim is open-ended or close-ended claim. The claim is indefinite. For examination purpose, the Examiner interprets the claim as a composition with transitional language of “comprising” to read onto the claim.
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) 10 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Rueda et al. (US 2008/0003329 A1) in view of Kuang et al. (US 10,617,701 B2).
Regarding claim 10 and 11, Rueda et al. (Rueda) discloses an infant formula (synthetic nutritional composition) (‘329, [0031]) comprising sphingomyelin and phospholipids (‘329, [0033]), iron (‘329, [0075]), Vitamin B12 (‘329, [0071], [0074]), folic acid (‘329, [0071], [0074]), docosahexaenoic acid (DHA, ‘329, [0077} and arachidonic acid (ARA, ‘329, [0077]). Rueda discloses the phospholipids (‘329, [0033]) includes the sphingomyelin, phosphatidyl choline, phosphatidyl inositol, phosphatidyl serine and phosphatidyl ethanolamine.
Rueda discloses phospholipids concentrations from about 200 mg/L to about 600 mg/L (‘329, [0056]), which corresponds to about 200 mg/Kg to about 600 mg/Kg. Rueda does not explicitly disclose an individual concentration of the sphingomyelin, the phosphatidyl choline, the phosphatidyl inositol, the phosphatidyl serine and the phosphatidyl ethanolamine, however it would have been obvious to one of ordinary skill in the art to adjust an individual concentration of the sphingomyelin, the phosphatidyl choline, the phosphatidyl inositol, the phosphatidyl serine and the phosphatidyl ethanolamine in Rueda’s infant formula (composition) to include the cited amounts, as a matter of preference for desired health benefits. Additionally, 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).
Rueda discloses amounts of the Vitamin B12, the folic acid and the iron (‘329, [0074]-[0075]). Rueda does not explicitly disclose the cited amount; however, it would have been obvious to one of ordinary skill in the art to adjust amounts of the Vitamin B12, the folic acid and the iron in Rueda’s infant formula (composition) to include the cited amounts, as a matter of preference for desired health benefits.
Rueda discloses amounts of the docosahexaenoic acid (DHA, ‘329, [0077} and the arachidonic acid (ARA, ‘329, [0077]). Rueda does not explicitly disclose the cited amount; however, it would have been obvious to one of ordinary skill in the art to adjust amounts of the docosahexaenoic acid (DHA, ‘329, [0077} and the arachidonic acid in Rueda’s infant formula (composition) to include the cited amounts, as a matter of preference for desired health benefits.
Attention is invited to In re Levin, 84 USPQ 232 and the cases cited therein, which are considered in point in the fact situation of the instant case, and wherein the Court stated on page 234 as follows:
This court has taken the position that new recipes or formulas for cooking food which involve the addition or elimination of common ingredients, or for treating them in ways which differ from the former practice, do not amount to invention, merely because it is not disclosed that, in the constantly developing art of preparing food, no one else ever did the particular thing upon which the applicant asserts his right to a patent. In all such cases, there is nothing patentable unless the applicant by a proper showing further establishes a coaction or cooperative relationship between the selected ingredients which produces a new, unexpected, and useful function. In re Benjamin D. White, 17 C.C.P.A (Patents) 956, 39 F.2d 974, 5 USPQ 267; In re Mason et al., 33 C.C.P.A. (Patents) 1144, 156 F.2d 189, 70 USPQ 221.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Kuang et al. (US 10,617,701 B2) discloses a composition comprising of sphingomyelin, phospholipids including phosphatidyl ethanolamine and phosphocholine (col. 8, ln. 32-46), and docosahexaenoic acid (DHA, col. 10, ln. 45-60) and arachidonic acid (ARA).
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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