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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 08/29/2025 has been entered.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 06/18/2025 was filed in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Arguments
Applicant's arguments filed 08/29/2025 have been fully considered and are persuasive in part but insufficient to support a conclusion of nonobviousness.
Applicant’s amendments provide for a conversion factor between the units of the instant claims and those of the prior art. When converted, instant claim 19 is are drawn to amounts as follows:
133-167 mcg/100 kcal folic acid;
5.33-6.67 mcg/100 kcal vitamin B12;
6.67-8.33 mg/100 kcal iron;
80 – 583.3 mg/ 100kcal a fatty acid derivative comprising DHA;
80 – 583.3 mg/ 100kcal a fatty acid derivative comprising ARA;
and at least 0.4 mg/100kcal sphingomyelin.
Accordingly, applicant’s assertion that the instantly claimed amounts do not overlap with those of the prior art is well-taken. Nevertheless, the claims are still drawn to the same components as the prior art albeit in different amounts. That the prior art discloses different embodiments with different quantities and broad ranges of each component is an implicit suggestion that said amounts are result-effective variables and supports that a PHOSITA would have been motivated to modify the prior art to discover the optimum or workable ranges under routine optimization. See MPEP 2144.05(II). There does not appear to be any criticality to the ranges claimed nor does the prior art appear to teach away from modifying the ranges as claimed. Accordingly, the preponderance of evidence supports a conclusion of obviousness based upon routine optimization of prior art conditions.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 19-24 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 2017/0006897 A1 to Ao et al.
Ao et al. teaches compositions comprising folic acid in exemplary amounts from 16-33 mcg/100 Kcal (Para. [0150], Examples 1-4), vitamin B12 in amounts of from about 0.018 mcg/100 Kcal to about 1.4 mcg/100 Kcal (Para. [0095], Examples 1-4), iron in exemplary amounts of from 1.0 mg/100 Kcal to 1.33 mg/100 Kcal (Para. [0151], Examples 1-4), docosahexaenoic acid in exemplary amounts from 13.9 mg/100Kcal to 17.8 mg/100 Kcal (Examples 1-4) and arachidonic acid in exemplary amounts from 35 mg/100 Kcal to 36 mg/100 Kcal (Examples 1-2 and 4). The compositions also include an enriched milk product, such as an eWPC, Lacprodan MFGM-10, or Lacprodan PL-20 (Para. [0070], Examples 1-4) which contain from 0.4% to 3% sphingomyelin with theoretical values of each shown in Para. [0071]). A range of 1 mg/100 Kcal to about 30 mg/100 Kcal is disclosed.
The prior art does not disclose a composition comprising the amounts claimed.
The prior art discloses compositions comprising the exact components claimed albeit in different amounts. Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." See MPEP 2144.05(II). In the instant case, the prior art discloses the purpose of each component and each is known in the art to provide nutritional value, rendering the amounts of each component a result-effective variable. This is exemplified by the ranges disclosed by the prior art and different amounts used in the examples, showing that it is routine to modify the amounts of each component. Accordingly, claims 19-24 are obvious. See also arguments supra.
Conclusion
Claims 19-24 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JED A KUCHARCZK whose telephone number is (571)270-5206. The examiner can normally be reached Mon-Fri 7:30 to 5.
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, Adam Milligan can be reached at (571) 270-7674. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JED A KUCHARCZK/Examiner, Art Unit 1623
/ADAM C MILLIGAN/Supervisory Patent Examiner, Art Unit 1623
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