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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 10 December 2025 has been entered.
Claim Status
Applicant’s remarks and amendments, filed 17 November 2025 in response to the final rejection mailed 19 September 2025, are acknowledged and have been fully considered. Applicant’s amendments to the claims are acknowledged. The listing of claims filed 17 November 2025 replaces all prior versions and listings of the claims.
Claims 1 and 12-20 are pending. Claims 19 and 20 remain withdrawn. Claims 8-11 are canceled by Applicant’s amendment. Claims 1, 12-15, and 18 are amended. Claims 1 and 12-18 are being examined on the merits.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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 1 and 12-15 are rejected under 35 U.S.C. 103 as being unpatentable over Reverri et al. (Nutrients, 2018, 11 pages), Hernell et al. (J Pediatr, 2016, S60-S65), and EFSA NDA Panel (EFSA J, 2016, 70 pages).
The instant claims are as of record, drawn to a nutrient composition consisting of 2’-focosyllactose, milk fat globule membrane, and either choline chloride or choline bitartrate with the specific claimed mass ratios.
Reverri et al. teach that the human milk oligosaccharide (HMO) 2’-fucosyllactose is the most abundant HMO in human breast milk and that infant formula (food; formula food for infants; as required for instant Claim 16) supplemented with 2’-fucosyllactose is safe, well-tolerated, provides immune benefits, and improves symptoms of formula intolerance (Reverri et al., Abstract, page 1). The addition of 0.2 g of 2’-fucosyllactose per L of infant formula makes it compositionally and functionally more similar to human milk (Reverri et al., Conclusions, page 8).
Hernell et al. teach that milk fat globule membrane (MFGM) concentrates fed to infants at a dose of 6-9 mg/L performed better at hand and eye coordination IQ, performance IQ, and general IQ in comparison to formula without the MFGM enrichment, and that MFGM concentrate fed to children aged 2.5-6 years at a dose of 500 mg daily reduced the number of fever days and behavioral problems in comparison to a control group (Hernell et al., Clinical Studies…, pages S62-S63; as required for instant Claim 1). Additionally, milk powder supplemented with MFGM and provided to infants aged 8-24 months is taught (Hernell et al., Clinical Studies…, page S63; as required for instant Claim 17).
EFSA NDA Panel teaches that choline is necessary for normal functioning of the body, particularly infants who use high amounts of choline for phospholipid synthesis in the brain (EFSA NDA Panel, 6.3., page 38), and that choline chloride and choline bitartrate may be added to food intended for infants and young children (EFSA NDA Panel, 3.1., page 23) and the dose ranges from 125 mg/day from birth to six month to 550 mg/day for boys age 14-18, adult men, and lactating women (EFSA NDA Panel, Table 1, page 26). Additionally, the average concentration of choline in breast milk is 160 mg/L (EFSA NDA Panel, 4.2., page 25).
Neither Reverri et al., Hernell et al., or EFSA NDA Panel include polydextrose in their compositions (as required for instant Claim 16). Additionally, based upon the values presented, the mass range for each claimed component and the respective mass ratios are as follows (as required for instant Claims 1 and 12-14):
HMO: 200 mg 2’-fucosyllactose
MFGM: 9-500 mg
Choline: 125-550 mg choline chloride or choline bitartrate
Low HMO:MFGM [Wingdings font/0xE0] 200:9 [Wingdings font/0xE0] 1:0.05
High HMO:MFGM [Wingdings font/0xE0] 200:500 [Wingdings font/0xE0] 1:2.5
Low HMO:Choline [Wingdings font/0xE0] 200:125 [Wingdings font/0xE0] 1:0.625
High HMO:Choline [Wingdings font/0xE0] 200:550 [Wingdings font/0xE0] 1:2.75
It would have been obvious to a person of ordinary skill in the art prior to the effective filing date of the instant application to provide a nutrient composition consisting of the 2’-fucosyllactose of Reverri et al., the MFGM of Hernell et al., and the choline chloride or choline bitartrate of EFSA NDA Panel to arrive at the instantly claimed invention because all three ingredients provide benefits when included in formula as described above, including immune benefits, improvement of formula intolerance symptoms, increased IQ, decreased behavioral problems, and provision of a compound necessary for normal body function and brain development in infants. Additionally, it would have been obvious to provide the ingredients in combination at the known, safe doses for infants as taught by the prior art, and to modify those doses for different age groups, sexes, and life stages (e.g., lactation and pregnancy; see for example EFSA NDA Panel, Table 1, page 26) or to modify amounts to make doses appropriate for multiple feedings per day, a singular feeding, etc. The adjustments of particular conventional working conditions (e.g., determining one or more suitable mass ratio ranges of HMO:MFGM (instant Claim 1) and mass ratio ranges of HMO:choline (instant Claim 15)) is deemed merely a matter of judicious selection and routine optimization which is well within the purview of the skilled artisan.
Claims 1 and 12-18 are rejected under 35 U.S.C. 103 as being unpatentable over Reverri et al. (Nutrients, 2018, 11 pages), Hernell et al. (J Pediatr, 2016, S60-S65), and EFSA NDA Panel (EFSA J, 2016, 70 pages) as applied to Claims 1 and 12-15 above, and further in view of Lee et al. (J Allergy Clin Immunol, 2019, pages 707-710).
The instant claims and teachings of Reverri et al., Hernell et al., and EFSA NDA Panel are as of record.
Neither Reverri et al., Hernell et al., or EFSA NDA Panel teach a composition that does not comprise galacto-oligosaccharides.
Lee et al. teach that acute allergic reactions and anaphylaxis to galacto-oligosaccharides occurred when infants consumed milk formula comprising it as an ingredient (Lee et al., page 707; as required for instant Claim 16). A person of ordinary skill in the art prior to the effective filing date of the instant application would therefore be motivated to exclude galacto-oligosaccharides from the nutrient composition which can be provided as a milk powder for infants as taught by Reverri et al., Hernell et al., and EFSA NDA Panel and could do so with a reasonable expectation of success.
Reverri et al., Hernell et al., and EFSA NDA Panel are relied upon for the reasons discussed above. If not expressly taught by the prior art, based upon the overall beneficial teaching provided by these references with respect to ingredients in combination at the known, safe doses for infants as taught by the prior art, and to modify those doses for different age groups, sexes, and life stages (e.g., lactation and pregnancy; see for example EFSA NDA Panel, Table 1, page 26) or to modify amounts to make doses appropriate for multiple feedings per day, a singular feeding, etc., the adjustments of particular conventional working conditions (e.g., determining one or more suitable content by weight in a food composition (instant Claim 18)) is deemed merely a matter of judicious selection and routine optimization which is well within the purview of the skilled artisan.
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Please note, since the Office does not have the facilities for examining and comparing Applicants’ composition with the composition of the prior art, the burden is on applicant to show a novel or unobvious difference between the claimed product and the product of the prior art. See In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977) and In re Fitzgerald, 619 F.2d 67, 205 USPQ 594 (CCPA 1980), and “as a practical matter, the Patent Office is not equipped to manufacture products by the myriad of processes put before it and then obtain prior art products and make physical comparisons therewith.” In re Brown, 459 F.2d 531, 535, 173 USPQ 685,
688 (CCPA 1972).
Response to Arguments
Applicant's arguments filed 17 November 2025 have been fully considered but they are not persuasive. Applicant argues that the HMO:MFGM mass ratio inferred from the teachings of the prior art does not overlap the newly narrowed mass ratio of Claim 1 and therefore is not obvious. The cited references, however, show a mass ratio range of HMO:MFGM of 1:(0.05-2.5) as discussed above. Whether these masses are per liter of formula or as a daily dose, a skilled artisan could reasonably adjust amounts in order to match the desired dose and consumption frequency. Additionally, the instant specification (page 17, lines 5-23) indicates that an acceptable range for HMO:MFGM in the composition is 1:(0.01-500) and there is no data presented indicating that antagonistic synergy would not occur with a lower HMO:MFGM ratio.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., reduction of antagonism regarding number of A2B5, MAG, and MBP cells; neuron maturation, synaptogenesis, and myelination) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). It is also noted that the applicant indicates on page 26 of the response that new Claim 21 addresses antagonism and synergy, however this claim is not present in the claim set of 17 November 2025.
Additionally, evidence of a greater than expected result may be shown by demonstrating an effect which is greater than the sum of each of the effects taken separately. However, a greater than additive effect is not necessarily sufficient to overcome a prima facie case of obviousness because such an effect can either be expected or unexpected. Applicants must further show that the results were greater than those which would have been expected from the prior art to an unobvious extent, and that the results are of a significant, practical advantage. See MPEP § 716.02(a). In the instant case, the known safe, effective mass ranges for each individual component was known in the art as described in the rejection above, and the inferred ratios overlap those of the instant invention.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JENNIFER L CAIN whose telephone number is (703)756-1318. The examiner can normally be reached M-Th 11:00am to 5:00pm EST.
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/J.L.C./
Examiner, Art Unit 1655
/AARON J KOSAR/Primary Examiner, Art Unit 1655
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