COMPOSITIONS AND THEIR USE

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 05/26/2026 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 07/13/2026 have been fully considered but they are not persuasive. Applicant first argues that a PHOSITA would not consider the amounts of each component would not be recognized as result-effective variables. Aside from that variable amounts are recited, there is sufficient disclosure in the prior art reference as a whole to consider that the amounts of each component are result-effective. See for example Para. [0002]: “Human milk contains a number of components that contribute to the growth and development of the brain in infants. But, cow's milk and many commercially available infant formulas that are based on cow's milk provide lower than desirable amounts of some of these components, like long chain polyunsaturated fatty acids, lactoferrin and polar lipids. Therefore, there is a need to provide a formula matrix that more closely mimics the composition and qualities of human milk in order to optimize brain growth and development in infants and children.” Emphasis added. See also Para. [0042] – [0046] defining the terms “nutritionally complete” and “essential”. It is clear to a PHOSITA that the amounts of each component are recognized as result-effective parameters to achieve a nutritionally complete composition. Applicant also argues unexpected results at p. 6. As recognized by applicant, Ao teaches folic acid and iron as components of the compositions taught by the prior art. While applicant’s observations are acknowledged, it is unclear how the results are unexpected and significant to a sufficient degree to support a conclusion of nonobviousness. Applicant is reminded that the burden is on applicant to establish results are unexpected and significant and applicants have burden of explaining proffered data. See MPEP 716.02(b). Additionally, evidence of unexpected and expected results must be weighed. See MPEP 716.02(c). Appicant presents data but it is unclear how the data can support a conclusion of nonobviousness in view of the preponderance of the evidence. Examiner disagrees with applicant’s assertion that Ao does not provide a reasonable expectation of success. Ao teaches various components and amounts thereof, and as previously argued a PHOSITA understands that nutritional components are result effective variables. Absent a teaching away or unexpected results, it is unclear how the amounts disclosed can be considered nonobvious. While the amounts claimed differ from those taught, criticality of the amounts has not been shown. 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 19-29 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), arachidonic acid in exemplary amounts from 35 mg/100 Kcal to 36 mg/100 Kcal (Examples 1-2 and 4), and protein in exemplary amounts from 2.1 g/100 Kcal to 3.4 g/100 Kcal. 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. While the compositions claim prebiotics such as polydextrose, there is no indication that their inclusion is critical to the functionality of the nutritional compositions. Accordingly, claims 19-29 are obvious. See also arguments supra. Conclusion Claims 19-29 are rejected. 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 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. 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. /JED A KUCHARCZK/Examiner, Art Unit 1623 /ADAM C MILLIGAN/Supervisory Patent Examiner, Art Unit 1623