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 .
The amendment filed 3/2/2026 has been entered. Claims 25-38 are pending. Prior objections and rejections not included below are withdrawn in view of Applicant’s arguments and amendments.
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.
For clarity, a portion of Plows, et al. (“Longitudinal Changes in Human Milk Oligosaccharides (HMOs) Over the Course of 24 Months of Lactation”, DOI: 10.1093/jn/nxaa427, Supplementary Information, Supplementary Table 1 is replicated below and the relevant portions are annotated.
[AltContent: rect][AltContent: rect]
Secretors
Non-secretors
HMO
1 month
6 months
12 months
18 months
24 months
1 month
6 months
12 months
18 months
24 months
(μg/mL)
n = 183
n = 104
n = 76
n = 54
n = 26
n = 24
n = 15
n = 7
n = 5
n = 2
2’FL
3480 (2420 - 4340)
3840 (2800 - 4950)
3350 (2670 - 4140)b
3100 (1950 - 3850)ab
2490 (1660 - 3730) abc
20.5 (6.20 - 47.3)
47.7 (20.5 - 57.2)
34.8 (22.9 - 56.9)
30.7 (16.5 - 33.8)
11.8 (7.10 - 16.5)
3FL
202 (144 - 439)
507 (277 - 1710) a
1850 (495 - 2500) ab
1990 (1450 - 2670) abc
1870 (978 – 2600) ab
108 (48.6 - 315)
337 (196 - 1470) a
558 (282 - 3800) a
3230 (3140 - 4120) abc
2960 (2590 - 3320) ab
3’SL
281 (206 - 377)
468 (362 - 583) a
467 (387 - 607) a
529 (405 - 689) a
568 (460 – 726) a
188 (156 - 331)
385 (286 - 530)
408 (267 - 650)
267 (261 - 410)
506 (416 - 595)
6’SL
621 (481 - 746)
156 (120 - 200) a
67.9 (50.2 - 98.8) ab
50.4 (35.9 - 76.8) ab
51.9 (39.5 - 75.1) a
782 (520 - 891)
182 (146 - 292) a
107 (97.6 - 139) a
44.8 (42.3 - 44.8) a
39.6 (31.3 - 47.9) a
DFL
247 (191 - 361)
381 (275 - 552) a
403 (342 - 499) a
452 (385 - 622) a
478 (384 - 636) a
13.7 (8.10 - 27.4)
29.3 (9.40 - 43.5)
19.7 (8.80 - 31.1)
9.8 (8.90 - 13.0)
10.8 (8.50 - 13.1)
Claim(s) 25-34, 38 are rejected under 35 U.S.C. 103 as being unpatentable over Plows, et al. (“Longitudinal Changes in Human Milk Oligosaccharides (HMOs) Over the Course of 24 Months of Lactation”, DOI: 10.1093/jn/nxaa427, Supplementary Information, Supplementary Table 1).
Note that an excerpt of the data table is replicated above for the teachings cited below.
Regarding Claim 25, Plows teaches that breast milk from secretors and non-secretors for infants at 1 month of age has the compositional ranges of .156-.377 g/L of 3’SL, .049-.439 g/L of 3FL, .008-.361 g/L DFL. Note that the ratio of 3’SL and 3FL taught by Plow ranges from 377/49 to 156/439, and the ratio of 3’SL to DFL ranges from 377/8 to 156/361, which is 1:0.13:0.02 to 1:2.8:2.3. The ratio of 3’SL to DFL encompasses the claimed range.
Regarding the ratio of 3’SL to 3FL, the disclosed composition is so close in value to the claimed composition that there is an expectation is will provide an identical product. No material difference is expected between a composition comprising a 3’SL : 3FL ratio 1:1.28 as taught by Plows and 1:1.31 as claimed. The Applicant’s claimed range is thus obvious over the prior art range. Note that a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. See MPEP 2144.05 I.
Plows does not address the use of the claimed amounts and ratios in a formula that does not comprise human milk. However, it would have been obvious to one having ordinary skill in the art to formulate an infant formula with any of the amounts of human milk oligosaccharides, including in the amount(s) and ratio(s) claimed. One would have been motivated to make such a modification to formulate a product to mimic a natural product.
Regarding Claim 26, Plows teaches .191-.361 g/L of DFL (Secretors, 1 month).
Regarding Claim 27, Plows teaches that breast milk comprises 2’FL (Secretors and Non-secretors, 1 month).
Regarding Claim 28, Plows teaches that breast milk for infants at 6 months of age, for both secretor and non-secretors, comprises .286-.583 g/L of 3’SL, .196-1.71 g/L of 3-FL, and additionally comprises .009-552 g/L of DFL. Note that the ratio of 3’SL and 3FL taught by Plows ranges from 583/227 to 361/1710, and the ratio of 3’SL to DFL is 583/9 to 286/552, which is a ratio of 1:0.38:0.015 to 1:4.7:1.93. The ratio of 3’SL:3FL:DFL overlaps the claimed range.
Regarding Claim 29, Plows teaches that breast milk for infants at 6 months of age comprises .275-.552 g/L of DFL (secretors and non-secretors).
Regarding Claim 30, Plows teaches that breast milk comprises 2’FL (secretors and non-secretors, 6 months).
Regarding Claim 31, Plows teaches that breast milk for infants at 12 months of age for secretors and non-secretors comprises .267-.650 g/L of 3’SL, .282-3.8 g/L of 3FL, and .008-.499 of DFL. Note that the ratio of 3’SL and 3FL taught by Plows ranges from 650/282 to 267/3800, and the ratio of 3FL to DFL is 650/8 to 267/499, which is a ratio of 1:0.81:0.53-1:6.45:81.25, which overlaps claimed ranges and ratios.
Regarding Claim 32, Plows teaches .342-.449 g/L of DFL (secretors, 12 months).
Regarding Claim 33, Plows teaches that the breast milk comprises 2’FL (secretors, 12 months).
Regarding Claim 34, Plows teaches that a breast milk for infants at 1 month of age additionally comprises 6’SL, LNt, LNnt, and LNFP I, II and III (Secretors and non-secretors, 1 month).
Regarding Claim 38, Plows teaches that breast milk for infants at 1 month of age for secretors and non-secretors has the compositional ranges of .156-.377 g/L of 3’SL, .049-.439 g/L of 3FL, .008-.361 g/L DFL. Note that the ratio of 3’SL and 3FL taught by Plow ranges from 377/49 to 156/439, and the ratio of 3’SL to DFL ranges from 377/8 to 156/361, which is 1:0.13:0.02 to 1:2.8:2.3. The ratio of 3’SL to DFL encompasses the claimed range.
Regarding the ratio of 3’SL to 3FL, the disclosed composition is so close in value to the claimed composition that there is an expectation is will provide an identical product. No material difference is expected between a composition comprising a 3’SL : 3FL ratio 1:1.28 as taught by Plows and 1:1.31 as claimed. The Applicant’s claimed range is thus obvious over the prior art range. Note that a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close. See MPEP 2144.05 I.
Plows additionally teaches that breast milk for infants at 6 months of age for secretors and non-secretors comprises .286-.583 g/L of 3’SL, .196-1.71 g/L of 3-FL, and additionally comprises .009-552 g/L of DFL. Note that the ratio of 3’SL and 3FL taught by Plows ranges from 583/227 to 361/1710, and the ratio of 3’SL to DFL is 583/9 to 286/552, which is a ratio of 1:0.38:0.015 to 1:4.7:1.93. The ratio of 3’SL:3FL:DFL overlaps the claimed range.
Plows teaches that breast milk for infants at 12 months of age for secretors and non-secretors comprises .267-.650 g/L of 3’SL, .282-3.8 g/L of 3FL, and .008-.499 of DFL. Note that the ratio of 3’SL and 3FL taught by Plows ranges from 650/282 to 267/3800, and the ratio of 3FL to DFL is 650/8 to 267/499, which is a ratio of 1:0.81:0.53-1:6.45:81.25, which overlaps claimed ranges and ratios.
Plows does not address the use of the claimed amounts and ratios in a formula that does not comprise human milk. However, it would have been obvious to one having ordinary skill in the art to formulate an infant formula with any of the amounts of human milk oligosaccharides, including in the amount(s) and ratio(s) claimed. One would have been motivated to make such a modification to formulate a product to mimic a natural product. It additionally would have been obvious to utilize the claimed amounts and ratios in formulas intended for infants of a specific age, since Plows teaches that the claimed amounts and ratios occur in naturally occurring breastmilk.
Claim(s) 35 is rejected under 35 U.S.C. 103 as being unpatentable over Plows as applied to Claim 25 above, and further in view of Spevacek (“Infant Maturity at Birth Reveals Minor Differences in the Maternal Milk Metabolome in the First Month of Lactation”, DOI: 10.3945/jn.115.210252, June 2015), and PubChem (3’galactosyllactose, https://pubchem.ncbi.nlm.nih.gov/compound/3-Galactosyllactose)
Regarding Claim 35, modified Plows teaches the infant formula as discussed above in regard to Claim 25. Spevacek teaches that human breast milk for an infant 0-1 months of age additionally comprises 0.51 mmol/L of 3’galactosyllactose, which is .257 mg/L (Table 1, “3’GSL”, note that 3’galactosyllactose has a molecular weight of 504.4 grams/mol, see evidentiary reference of PubChem). Therefore, it would have been obvious to have included the amounts of 3’GSL taught by Spevacek in the formula of modified Plows. One would have been motivated to make such a modification to mimic natural breast milk.
Claim(s) 36 is rejected under 35 U.S.C. 103 as being unpatentable over Plows as applied to Claim 25 above, and further in view of Plows (2) (original text, DOI: 10.1093/jn/nxaa427)
Regarding Claim 36, Plows teaches that the total content of HMO ranges from ~8.5-12 g/L for infants at 1 month of age (Figure 1, Part T of Plows (2), see reproduction of relevant figure portion below.
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237
263
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Greyscale
Claim 37 is rejected under 35 U.S.C. 103 as being unpatentable over Plows as applied to Claim 25 above, and further in view of Akbari (“Characterizing microbiota-independent effects of oligosaccharides on intestinal epithelial cells: insight into the role of structure and size” , DOI: 10.1007/s00394-016-1234-9, 2017).
Regarding Claim 37, Plows teaches a composition for infants as discussed above in regards to Claim 25 but does not discuss the addition of fructo-oligosaccharides or galacto-oligosaccharides to the composition.
Akbari teaches that mixtures of galacto-oligosaccharides and long chain fructo-oligosaccharides are widely used in infant formulas (Page 1920, Paragraph 1). Akbari additionally teaches that galacto-oligosaccharides have a degree of polymerization ranging from 2-8, and long chain fructo-oligosaccharides have a degree of polymerization ranging from 2-60.
Therefore, it would have been obvious to one of ordinary skill in the art before the filing date of the claimed invention to utilize galacto-oligosaccharides or fructo-oligosaccharides with the degree of polymerization claimed in a composition intended to be fed to infants. One would have been motivated to make such a modification since Akbari teaches that such compounds are widely used in infant formulas. The selection of a known material based on its suitability for its intended use support a prima facie obviousness determination. See MPEP 2144.07
Response to Arguments
Applicant’s arguments filed 3/20/2026 have been fully considered but they are not persuasive.
Regarding rejections under 35 U.S.C. 101 and 102, note that the rejections have been withdrawn in view of Applicant’s amendments.
Regarding rejections under 35 U.S.C. 103, Applicant argues that the use of Plows is fundamentally flawed, as ratio ranges are calculated by selecting statistical outliers across different populations. Applicant additionally argues that the claimed ratio requires more DFL than the highest natural samples, and does not exist in any of the natural samples (Page 8 of Remarks)
Applicant additionally argues that the Examiner’s ratio calculations are statistically invalid, as the ratios require outlying values from different populations of individuals. Applicant alleges that the “correct” analysis uses the median values. (Page 9 of Remarks)
This argument is not convincing. Where Plows teaches an observed range of oligosaccharides in human breast milk, it would have been obvious to have selected any amount of the naturally occurring oligosaccharides, including in the amounts and ratios claimed, observed by Plows for a formula intended to mimic breast milk. The Office has not taken the position that the claimed ratios are typical or median values of natural breast milk; however, the claimed amounts and ratios are known to lie within the ranges observed for naturally occurring breast milk.
Regarding the ratio of DFL, see above in regard to Claim 25.
Applicant additionally argues that Plows teaches away from the claimed formulas, specifically in regards to the 3-FL levels (Page 9 of Remarks).
This argument is not convincing. Plows teaches a range of naturally occurring 3-FL levels. It would have been obvious to have selected any of the 3-FL levels taught by Plows.
Applicant additionally argues that Plows is observational, not descriptive, and does not provide teaching or motivation to select specific compositions for manufactured infant formulas as claimed (Page 9 of Remarks).
This argument is not convincing. Where Plows provides observation of the naturally occurring ranges of breast milk composition, it would have been obvious to have selected any amount of the naturally occurring oligosaccharides observed by Plows for a formula intended to mimic breast milk.
Applicant additionally argues that Akbari does not provide motivation to utilize GOS and FOS in infant formulas.
This argument is not convincing. Akbari teaches that GOS and FOS are widely used in infant formulas. It would therefore be obvious to utilize GOS and FOS in an infant formula composition. The selection of a known material based on its suitability for its intended use support a prima facie obviousness determination. See MPEP 2144.07
Conclusion
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 DEBORAH LIU whose telephone number is (571)270-5685. The examiner can normally be reached 12-8 Eastern Time.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Nikki Dees can be reached at 571-270-3435. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/D.L./
Examiner, Art Unit 1791
/Nikki H. Dees/Supervisory Patent Examiner, Art Unit 1791
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